Type II Diabetes Mellitus

30 drops in 1 cup of water three times a day for 3 months

Abroma Augusta Q (mother tincture)

,Father Muller Homoeopathic Medical College, Prasanth Nivas Ashram Nmpt Hospital

Therapeutic Efficacy of "Abroma Agusta" in HbA1c % in NIDDM

Therapeutic Efficacy of Homoeopathic Mother Tincture of "Abroma Agusta" in Changing the Level of Glycated Hb (HbA1c %) in Diabetes Mellitus Type II (NIDDM

dr rita chakraborty

PROFESSOR, Head of The Department of Repertory

Fr Muller Homoeopathic Medical College

whole blood, serum, white cells, red blood cells, urine, breast milk, meconium

Exposure to Environmental Pollution

Rambam Medical Center

Lis Medical Center

Assaf Harofeh Medical Center

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

assessment of BFRs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations

To examine associations between exposure to PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function

To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children

Assaf-Harofeh Medical Center

Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.

Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Lillipops Iced Soothies (4 Flavours) (Experimental)

Lillipop Iced Soothies (Ginger Flavour) (Experimental)

Mr. Freeze Freezies (4 Flavours) (Active Comparator)

Natural Course Group (No Intervention)

Total

Sex: Female, Male

Region of Enrollment

To assess the effectiveness of Lillipops in the improvement of NVP symptoms. The primary endpoint of interest is the severity of NVP as compared between the 4 groups, defined according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.

Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.

Lillipops Iced Soothies (4 Flavours)

Lillipop Iced Soothies (Ginger Flavour)

Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol
Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.

Mr. Freeze Freezies (4 Flavours)

Natural Course Group

Improvement of Nausea and Vomiting of Pregnancy (NVP)

To assess if there are any changes to concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas). The secondary endpoint of interest is the effect of the 4 groups on the status of concurrent symptoms that may intensify NVP, such as metallic taste or gastroesophageal reflux disease, as well as preference for freezie flavours, according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.

Concurrent Symptoms

To assess preference for freezie flavours.

Freezie Flavour Preference

Overall Study

Dr Shinya Ito, Principal Investigator

Morning Sickness

Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger. The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

Lillipops Iced Soothies (4 flavours)

There are other commercially available freezies, such as Mr. Freeze. Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.

Mr. Freeze Freezies

Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger.The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

Lillipop Iced Soothies (Ginger flavour)

The Hospital for Sick Children

Freezie Remedy to Alleviate Morning Sickness

Effectiveness of a Natural Non-medicinal Freezie Remedy to Alleviate Morning Sickness

Shinya Ito

Division Head, Clinical Pharmacology and Toxicology

Four parallel groups: 1) Lillipops Group (4 flavours): 2) Ginger Lillipops Group; 3) Mr. Freeze Control Group; 4) Natural Course Group. The main comparison is Group 1 vs Group 3.

A computerized randomization table will be prepared by a third party who is not otherwise involved in the study. After a participant has given consent to enrol in the study, the next participant number in sequence will be assigned and the appropriate corresponding sealed envelope will be opened by the study coordinator, determining which product (if any) the participant will receive. The boxes will be given unique codes depending on whether they contain Lillipops (4 flavours), Ginger Lillipops or Mr. Freeze freezies, and the different flavours will also be coded. Participants will be shown a list of the ingredients that are found in Lillipops and Mr. Freeze freezies to ensure that they do not have allergies or take medications that interact with any ingredient(s) that they may be asked to consume.

The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.

H.E.L.P. Secura

Not all sites collected this information.

Gender

The Categories listed in the table are the Adverse Events (or similar) that resulted in death.

Occurence of Death

Adverse Events reported for Cardiovascular disease not directly related to therapy.

Occurrence of Cardiovascular Events and Interventions

Serious Unexpected Adverse Events

This is equatable to the incidence of Cardiovascular AEs.

Frequency and Severity of CHD Symptoms (Angina)

All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.
H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.
Flush system with normal saline;
Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;
Mix plasma with equal volume of acetate buffer containing heparin;
Precipitate LDL as a complex with heparin;
Remove LDL-heparin precipitate by continuous circulation through a filter;
Remove heparin with use of a heparin adsorber;
Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;
Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient.

Kevin Minnich

Familial Hypercholesterolemia

HELP Secura (apheresis treatment)

Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy

Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy

B. Braun Medical Inc.

Cutaneous Leishmaniasis

daily nitric oxide patch application during 20 days

controlled nitric oxide releasing patch

meglumine antimoniate

Fundación Cardiovascular de Colombia

Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis

Double Blind, Randomized Controlled Trial, to Evaluate the Effectiveness of a Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis

resin/nausea

Therapeutic Efficacy of "Abroma Agusta" in HbA1c % in NIDDM

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

Freezie Remedy to Alleviate Morning Sickness

Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy

Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis

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