Herbal melanin 1800 milligram(mg) orally thrice a day with meals (300mgx2 capsules)

omeprazole 40 mg once per day for one month.

Herbal melanin 1800 mg orally thrice a day(TID) with meals (300 mg x2 capsules)

omeprazole40 mg P.O. Twice per Day(BID) for one month + Amoxil 1000mg P.O. BID for 2 weeks+ Clarithromycin500 mg PO BID for two weeks.
Omeprazole+Amoxil+clarithromycin is the standard triple therapy given

omeprazole 40 mg P.O. BID for one month +1800 mg Herbal melanin PO TID (300mg x2 capsules) Omeprazole + Herbal melanin will be tested

Amoxil 1000mg P.O. BID for 2 weeks+ Clarithromycin500 mg PO BID for two weeks +1800 mg Herbal melanin PO TID(300 mg X 2 capsules) Herbal melanin+Amoxil+Clarithromycin will be tested

Acid Dyspepsia

Gastritis

Herbal melanin extracted from Nigella sativa seeds

Herbal Melanin

Nexium

Amoxil

Clarithromycin

Safety Trial of Herbal Melanin in Gastritis Patients

Open Label, Randomized, Single Site Clinical Trial To Compare The Safety Of Herbal Melanin Extracted From Nigella Sativa Seeds Vs Standard Of Care Treatment In Treating Gastritis Patients

Investigators hypothesize that HM is an effective candidate that can decrease stomach acidity and eradicate H.Pylori by working as Proton Pump Inhibitor(PPI) and/or antibacterial agent, respectively. Investigators suggest the role of HM in activation of Toll like Receptor 4 (TLR4)/Cycloxygenase2(COX2)/ProstaglandinE2( PGE2) as one underlying mechanism.

Gastritis as indicated by improving the clinical presentation of gastritis and confirmed by end of treatment endoscopy and stool antigen test

By using stomach biopsies for measuring the expression of TLR4 and COX 2 expression.

King Abdullah International Medical Research Center

Pediatric Glaucoma

FP7 Ahmed Glaucoma Drainage Implant

FP8 Glaucoma Drainage Implant

Federal University of São Paulo - Ophthalmology Department

Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma

Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma: a Randomized Clinical Trial.

The primary endpoint is to evaluate the position of the drainage implant plate and if the plate is positioned at a distance ≥ 8 mm from the corneal limbus after 1 year of surgery, considered successful. If the plate is positioned at a distance <8 mm from the corneal limbus, we have a failure.

We will use as a criterion of success an IOP ≤ 21 mm Hg and> 5 mmHg and a 30% reduction of preoperative IOP. If the patient meets these criteria, without the use of eyedrop, classified as complete success. If the use of eyedrop is necessary to meet the criteria, a qualified success will be defined.
For failure criterion is assumed: IOP ≤ 5 mmHg or > 21 mm Hg, even with the use of eye drops, need for further surgery, and / or loss of light perception.

Camila Fonseca Netto

Federal University of São Paulo

standard anti-tuberculosis drugs plus dexamethasone for 6-8 weeks

standard anti-tuberculosis drugs plus placebo for 6-8 weeks

Tuberculosis

Tuberculous Meningitis

Drug-Induced Liver Injury

IRIS

Active treatment with dexamethasone from randomisation (IV followed by oral according to disease severity at the start of treatment): dexamethasone for intravenous injection and dexamethasone for oral ingestion

Dexamethasone

Treatment with matched placebo:
Standard saline for intravenous injection and placebo oral tablets containing cellulose

Placebo

Cipto Mangunkusumo Hospital

Eijkman-Oxford Clinical Research Unit

RSUP Persahabatan Hospital

Hospital for Tropical Diseases

Oxford University Clinical Research Unit

Pham Ngoc Thach Hospital

Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)

A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis

The primary endpoint is overall survival, i.e. the time from randomization to death, during a follow-up period of 12 months. Survivors known to be alive at 12 months will be censored at that time-point and subjects who withdrew or were lost to follow-up before 12 months will be censored at the date they were last known to be alive.

Neurological disability will be assessed by the modified Rankin score (see below) on months 3, 6, 9, 12, 18 and 24 from randomisation. The main endpoint is the 12 month assessment and subjects who died before 12 months will be treated as having a score of 6 ('Dead').
The Modified Rankin Scale Score Description 0 No symptoms
Minor symptoms not interfering with lifestyle
Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients ability to look after themselves
Symptoms that restrict lifestyle and prevent totally independent living
Symptoms that clearly prevent independent living, although the patient does not need constant care and attention.
Totally dependent, requiring constant help day and night.
Death

A neurological event is defined as a fall in Glasgow coma score by ≥2 points for ≥2 days from the highest previously recorded Glasgow coma score (including baseline) or the onset of any of the following clinical adverse events: cerebellar symptoms, focal neurological signs, or onset of seizures.

The rate is defined as the number of IRIS events divided by the observed person-time of follow-up in each treatment group.

AIDS-defining illnesses will be defined as per the WHO classification.

Comparison of the frequency of serious adverse events between treatment groups will form an important part of the study analysis.

The three major HIV-associated malignancies are Kaposi sarcoma, high grade B-cell non-Hodgkin lymphoma and invasive cervical cancer.

The main analysis of this trial will be performed at the time point where all randomized subjects have completed 12 months of follow-up. However, all participants will continue to be followed up for 24 months and overall survival will be reported once 24 month follow-up has been completed for all participants.

The main analysis of this trial will be performed at the time point where all randomized subjects have completed 12 months of follow-up. However, all participants will continue to be followed up for 24 months and neurological disability will be reported once 24 month follow-up has been completed for all participants.

The main analysis of this trial will be performed at the time point where all randomized subjects have completed 12 months of follow-up. However, all participants will continue to be followed up for 24 months and this outcome will be reported once 24 month follow-up has been completed for all participants.

The Oxford University Clinical Research Unit recognizes the ethical obligation to ensure that optimal use is made of the data and specimens that the investigators collect for our research and the value of sharing individual level data. The investigators aim to ensure that data generated from all our research are collected, curated, managed and shared in a way that maximizes their benefit. When sharing data the investigators have an obligation to ensure that the interests of research participants, researchers and other stakeholders are appropriately protected. The Oxford University Clinical Research Unit data sharing policy and the data request form outline the default procedures for data sharing.

iris/nausée

Safety Trial of Herbal Melanin in Gastritis Patients

Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma

Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)

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