cyrilzakka/clinical-trials huggingface dataset:
Evaluation of South Africa's National Adherence Strategy

NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs) throughout South Africa in the coming year. Early implementation of the "minimum package" of interventions described in the Adherence Guidelines for HIV patients will take place at 12 primary health clinics and community health centres in four provinces starting in July 2015. To maximize the learning potential of this early implementation stage, NDOH will match the intervention clinics with 12 comparison clinics and randomly allocate intervention or comparison status within the pairs of clinics. This will allow the outcomes of the interventions to be evaluated using a cluster-randomized design and generate data on the costs of implementation and the potential need for adherence support for the other diseases addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for the evaluation, which will generate information on the effectiveness of minimum package interventions and help improve the design, implementation, and budgeting of the guidelines.

The study will assess the effectiveness of five interventions in the minimum package: 1) Fast track initiation counseling for patients eligible for antiretroviral therapy; 2) Enhanced adherence counseling for unstable patients on HIV treatment; 3) adherence clubs for stable patients on HIV treatment; 4) decentralized medication delivery for stable patients on HIV treatment; and 5) early tracing of all patients who miss an appointment by two weeks. This study will also estimate for each study site an overall "adherence guideline impact" to provide an indication of the effectiveness of the package as a whole.

In addition, the study will estimate the cost of each of the interventions listed above compared to standard of care. Finally, the study will describe the cascade of care for tuberculosis, hypertension, and diabetes, three other chronic diseases for which little information currently exists. To evaluate these interventions the study team will work with the National Department of Health (which will implement the interventions) to randomize 24 clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. All evaluations will use data routinely collected by the clinics, with no study interaction with subjects. A total of 8,256 patients will be enrolled and followed for up to 20 months to estimate short- and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Meet the inclusion criteria for one or more intervention
* Not resident in the facility's catchment area
* Recorded intention to transfer care to a different facility within 12 months

Exclusion Criteria:

* Pregnant and eligible for PMTCT
SB3 Battery Life Observational Study

Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.

While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended.

This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 19 or greater who are referred for small bowel capsule endoscopy
* Willing and able to provide written informed consent

Exclusion Criteria:

* Unwillingness or inability to swallow pill
* Known or suspected obstruction or bowel stricture
* Endoscopic placement of capsule camera
* Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)
Staphylococcus Aureus Skin and Soft Tissue Infections

The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training.

This study will be conducted on three different bases among groups of male recruits to IDF training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for skin infection until the end of the training program.


Eligibility Criteria:
Inclusion Criteria:

* new recruit for a combat training unit
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.


Eligibility Criteria:
Inclusion Criteria:

* T1D
* Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
* Age above or equal to 14 years and below or equal to 40 years
* Body weight above 45 kg
* T2D
* Male or female subjects diagnosed within the last 15 years with good general health based on medical history
* HbA1c between 6.5% and 10%
* Body mass index (BMI) below 45 kg/m\^2
* Age above or equal to 18 and below 65 years
* On insulin treatment
* HS
* Male or female subjects with good general heath based on medical history
* Age above or equal to 18 years and below or equal to 40 years

Exclusion Criteria:

* Any chronic disorder (besides T1D or T2D) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
* Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Small-cell lung cancer
* Stage of extensive disease
* Adequate function of major organs and systems
* Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

* Prior chemotherapy for small-cell lung cancer
* Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
* Superior vena cava syndrome or obstruction of any vital structure
* Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
* Known allergy or hypersensitivity to platinum-containing drugs
* Pregnancy or breast-feeding
* Use of any investigational drug within 4 weeks before start of the study
Ulcer Bleeding After Band Ligation of Esophageal Varices

Primary Outcomes:

assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.

Secondary Outcomes:

minimize post-banding ulcer bleeding

Esophageal variceal bleeding represents the most vital complication among patients with liver cirrhosis at rate of 5-15% per year. Endoscopic variceal ligation (EVL), either used as therapeutic in emergency or as prophylactic, is one of the best modalities used in EV treatment. The procedure is effective and generally safe. After banding, a superficial ulcer is formed, which usually heals in 2-3 weeks. The main complications of variceal banding are pain, dysphagia, fever, bleeding during the procedure and post banding ulcer bleeding (PBUB). The prevalence of PBUB is reported to be 3.6-15% . Rebleeding can be fatal, and is mainly resulted from early spontaneous slippage of the rubber bands, before occlusion of the varix with a mature thrombus, leaving an unhealed ulcer . The time frame of variceal rebleeding can be divided into very early rebleeding (within 5 days of acute bleeding), early rebleeding (within 6 weeks of acute bleeding), and delayed rebleeding. Previous reports showed that early rebleeding ranged from 30% to 40% within the first 6 weeks, and was significantly associated with the risk of death within 6 weeks. Therefore, the aim of this research is assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis, in order to minimize post-banding ulcer bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age is 18 years or above.
2. Patient who are diagnosed with esophageal varices by upper endoscopy.
3. Patient who are fit for surgery to undergo endoscopic banding procedure.

Exclusion Criteria:

1. Pediatric patients.
2. patient refuse to participate at this study
NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares

Gout is a chronic joint disease associated with deposition of monosodium urate crystals, as a consequence of hyperuricemia. Gout is an intermittent flaring condition and acute gout flares are driven by NLRP3 inflammasome and IL1-beta production.

However pathogenesis of acute gout flares remains poorly known in vivo in human.

The aim of this study is to evaluate NLRP3 inflammasome activation in vivo in patients cells during acute gout flares.

Blood and synovial fluid will be obtained from remainder of patients' samples during an acute gout flares. White blood cells will be isolated and NLRP3 inflammasome activation will be assessed. Then, NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score \> 8
* Aged \> 18

Exclusion Criteria:

* Gout treatment already started
* Inflammatory Arthritis other than Gout Arthritis
* Pregnant or breast feeding women
* Patient protected by law
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 45 years of age
* Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin lesions for more than 2 weeks
* Subject has a complete angiography of pelvis, thigh and calf within one month of inclusion
* Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery
* Subject is not in the position to be primarily revascularized or refuses surgery

Exclusion Criteria:

* Imminent or foreseeable amputation
* Major amputation on the affected extremity
* History of chronic alcohol or drug abuse
* More than two ischemic ulcerations
* One ulcer ≥ 6 cm\^2, both ulcers ≤ 1 cm\^2 or at least one ulcer affecting the bone or tendons
* Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
* Neuropathic or venous ulcers
* Buerger's disease
* Septic gangrene
* Use of vasoactive medication or prostaglandins
* Treatment with prostanoids within 3 months prior to inclusion
* Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment
A Non-interventional Cohort Safety Study of Patients With hATTR-PN

This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.

Study Rationale:

hATTR-PN is an inherited, progressive, fatal disease caused by misfolded transthyretin (TTR) proteins that accumulate as amyloid fibrils predominantly in the peripheral nerves, heart, gastrointestinal tract, and other organs. hATTR-PN is a rare disease and there are no large epidemiological studies that reliably provide an indication of its prevalence. The worldwide distribution is unequal, with higher rates in Portugal, Japan, Brazil, Northern Sweden, and the US. Current estimates suggest there may be 10,000 afflicted patients worldwide.

TEGSEDI (inotersen) is an antisense oligonucleotide inhibitor of human TTR protein synthesis. In Europe and Canada, TEGSEDI is indicated for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). In the US, TEGSEDI is indicated for treatment of the polyneuropathy of hereditary TTR-mediated amyloidosis in adults. Efficacy has been demonstrated in patients with hATTR-PN, as reflected by a slowing or reversal of disease progression.

Research Question:

The overarching goal of this study is to further characterize the long-term safety of TEGSEDI in patients with hATTR-PN under real-world conditions.

Population:

Patients in Europe, US, and Canada will be enrolled from centers that manage patients with hATTR-PN. Physicians participating in the study will be instructed to invite all patients who meet study eligibility criteria to enroll until the enrollment period is closed.

Eligibility Criteria:
Inclusion Criteria:

1. Either:

   1. TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment
   2. TEGSEDI Unexposed Cohort: Patients diagnosed with hATTR-PN who have not taken any dose of TEGSEDI within 25 weeks prior to enrollment and are eligible for TEGSEDI treatment per applicable product label
2. Clinically managed in Canada, Europe, or the US
3. Have provided appropriate written informed consent

Exclusion Criteria:

* None
Genetic Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic

This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

The investigators will invite up to 60 families to complete a standardised online questionnaire (ICFET) about their child's eating behaviour and collect a saliva sample from their child, sent by post. The investigators will identify how many genetic markers for thinness each carries and relate this to their ICFET appetite scores and existing growth measurements as well as their feeding history.

Eligibility Criteria:
Inclusion Criteria:

All participants currently attending Glasgow Feeding Clinic or assessed there within the last 2 years. NB current ethical application is restricted to children aged 1-7 years, but the investigators plan to apply to extend that to age 16 years.

Exclusion Criteria:

Sample not to be collected with 2 weeks of any symptoms or recent contact with Covid 19
Research Into Biomarkers Predictive of Survival and Response to Cancer Treatment

Research into biomarkers predictive of survival and response to cancer treatment


Eligibility Criteria:
Inclusion Criteria:

* Patient having a blood test, venous line insertion or injection on an implantable venous device scheduled as part of their standard care,
* Patient who has read the information note and stated that he/she has no objections
* Patient who has not objected to the use of this data for medical research purposes
* Patient with social security cover.

Exclusion Criteria:

* Patient already included in the study
* Patient considered to be a vulnerable person; vulnerable persons are defined in article L1121-5 to -8
A Research Study for Patients With End-Stage Renal Disease (ESRD)

The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
* The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
* The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

Exclusion Criteria:

* Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
* Have had a parathyroidectomy in the 6 months before day 1
* Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
* Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
* Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
* Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
Evaluation of the Effectiveness of the POWER Through Choices Program

The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes.

Youth in foster care are at especially high risk for teen pregnancy and associated sexual risk behaviors. The POWER Through Choices (PTC) program is a 10-session sexuality curriculum that aims to increase contraceptive use and delay sexual initiation by empowering youth to make healthy, positive choices about their sexual behaviors. This study uses a cluster randomized design to compare the effectiveness of PTC to usual programs and services provided to youth living in group foster care homes. Study participants will be youth living in group foster homes recruited in four locations: Kern County, CA; Cook County, IL; Baltimore County, MD; and Oklahoma (statewide). The study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the Office of Adolescent Health in the U.S. Department of Health and Human Services.

Eligibility Criteria:
Inclusion Criteria:

* Resident of group foster care home

Exclusion Criteria:

* Pregnant or parenting
Substance Misuse To Psychosis for Stimulants

In Hong Kong, less than 5% of stimulants abusers were reported to misuse these substances via injection. Also, it is well known that patients with co-morbid substance abuse/dependence and psychosis or schizophrenia-related disorders are prone to earlier treatment discontinuation and high oral medication non-adherence, resulting in poorer overall outcomes. With the recent availabilities of the 4-weekly long-acting injectable form of aripiprazole, and the 4-weekly and the 3-monthly long-acting injectable form of paliperidone palmitate, on the background of the surging phenomenon of stimulant misuses in Hong Kong, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with substance use disorders with psychosis to develop into a more chronic disabling dependence or co-morbid state.


Eligibility Criteria:
Inclusion Criteria:

• Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis

Exclusion Criteria:

* Age \<16 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)
* Had been diagnosed to have Schizophrenia
* Had been diagnosed to have other substance-induced psychotic or mood disorder, including alcohol
* Had been diagnosed to have bipolar disorder viii. Had been diagnosed to have major depressive disorder with psychotic features
* Had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeks AND with psychotic symptoms in remission
* Had been receiving any maintenance dose of long-acting injectable (LAI/depot) antipsychotics continuously ≥4 month AND with psychotic symptoms in remission
* Had known hypersensitivity to risperidone (oral or LAI), paliperidone (oral or LAI), or aripiprazole (oral or LAI)
* Had known history of tardive dyskinesia
* Had known history of neuroleptic malignant syndrome
* Pregnant
* Mother currently breast-feeding
* Had history of prolonged corrected QT interval (QTc) ≥500ms and/or known unstable or untreated cardiac disorder
* Had mild to severe renal impairment with Glomerular Filtration Rate \<80 mililitre /min