cyrilzakka/clinical-trials huggingface dataset:
Continuous Observations of Behavioural Risk Factors in Asia (COBRA)

The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore.

BACKGROUND: Modifiable risk factors for non-communicable diseases, including unhealthy diets and movement behaviours, are influenced by complex and dynamic interactions between people and their social and physical environment. Therefore, understanding patterns and determinants of these risk factors as they occur in real-life is essential to enable the design of precision public health interventions.

AIMS: The aims of this study are to (1) examine patterns of dietary and movement behaviours in real-time as people go about their daily lives, (2) examine how interactions with the social and physical environment influence dietary and movement behaviours, and (3) examine how these patterns differ by ethnicity and other socio-demographic characteristics.

METHOD: This is an observational study in free-living participants over 10 consecutive days, with a 9-day follow-up 6 months later. 1500 participants will be recruited from a large prospective cohort study. Real-time data capture strategies will be used: an ecological momentary assessment (EMA) app with global positioning system (GPS) enabled to collect location data, accelerometers to measure movement, and wearable sensors to monitor blood glucose levels. Participants receive six EMA prompts per day to capture information on diet and movement behaviours (physical activity, sedentary behaviour, sleep), and related contextual factors. A second wave of EMA prompts and GPS monitoring will occur 6 months later. Data will be integrated and analysed using generalised linear models to examine associations between behavioural risk factors and contextual determinants.

Eligibility Criteria:
Inclusion criteria:

* aged 21 to 69 years of age
* citizen or permanent resident of Singapore
* of Chinese, Malay, or Indian ethnicity
* able to read English
* own or have continued access to a smartphone with a data plan
* able to use smartphone apps
* able to walk independently

Exclusion criteria:

* history of stroke, heart disease, renal failure, diabetes mellitus, thyroid disease, cancer, or a serious mental health condition (e.g., schizophrenia, depression, or dementia)
* have had vascular bypass surgery or angioplasty procedure performed
* known sensitivity to medical-grade adhesives
* bleeding disorder
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patients under 18.
* Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
* Other protocol-defined exclusion criteria may apply.
A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
* A female 10 years of age and above at the time of the first vaccination.
* Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
* Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
* Subjects of childbearing potential must not be pregnant.
* Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
* Pregnant or breastfeeding.
* Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
* Hypersensitivity to latex (found in syringe-tip cap and plunger).
* Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* Cancer or autoimmune disease under treatment.
* Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
* Acute disease at the time of enrolment.
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).


Eligibility Criteria:
Inclusion Criteria:

* Established IBD diagnosis (UC or CD)
* Active disease (clinically defined as at least mild activity using dedicated scoring indices and biochemically defined by a fecal calprotectin \> 60 µg/g, measured within the last 6 weeks before inclusion)
* Patients must be eligible for adalimumab therapy
* Clinical indication for an endoscopic procedure
* Age: 18 years or older
* Written informed consent
* For female patients of premenopausal age with intact reproductive organs or who are less than 2 years postmenopausal, a negative pregnancy test must be available.

Exclusion Criteria:

* Pregnancy or breast feeding
* Female patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT administration and the following 10 weeks.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Prior anti-TNF therapy in the last 6 weeks before inclusion
* Active extra gastrointestinal manifestations of Crohn's disease
* Previous treatment with adalimumab and detectable anti-adalimumab antibodies levels
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically verified adenocarcinoma of the colon or rectum
* Metastatic disease
* Planned treatment with FOLFOX or capecitabine combined with bevacizumab
* Evaluable disease according to RECIST 1.1
* Performance status 0-2
* Expected survival ≥ 3 months
* Patient acceptance to collection of blood samples for translational research
* Age ≥ 18 years
* Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  * WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l
  * Platelet count ≥ 100 x 10\^9/l
  * Hemoglobin ≥ 6.0 mmol/l
  * Serum bilirubin ≤ 2.0 x ULN
  * Serum transaminase ≤ 2.5 x ULN
  * Serum creatinine ≤ 1.5 ULN
* Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g.
* Written and orally informed consent

Exclusion Criteria:

* Other active malignant disease within 5 years prior to inclusion in the study.
* Other experimental therapy within 28 days prior to treatment initiation.
* Underlying medical disease not adequately treated.
* Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
* Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
* Bleeding tumor
* Pregnant or breastfeeding women
* Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.
* Hypersensitivity to one or more active substances or auxiliary substances
Management of Children With Moderate Acute Malnutrition in Mali

The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing \~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing \~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing \~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.


Eligibility Criteria:
Inclusion Criteria:

* age from 6 to 35 months,
* MUAC \<12.5 cm and \>11.0 cm, and weight-for-length (WLZ) Z-score \> -3.0 (WHO standard, 2006); or WLZ \<-2.0 and \>-3.0 and MUAC \>11.0 cm
* absence of bi-pedal edema
* absence of current diseases requiring inpatient care
* expected availability during the period of the study
* residency within the study communities
* acceptance of home visitors, and
* written consent of a parent or guardian

Exclusion Criteria:

* age \<6 months or \>36 months
* MUAC \>12.5 cm and WLZ \>-2.0; or MUAC \<11.0 cm; or WLZ \<-3.0
* presence of bi-pedal edema,
* severe anemia (defined as hemoglobin \<50 g/L),
* other acute illnesses requiring inpatient treatment,
* congenital abnormalities or underlying chronic diseases, including known HIV . infection, that may affect growth or risk of infection
* history of allergy towards peanuts or previous serious allergic reaction to . any substance, requiring emergency medical care
* concurrent participation in any other clinical trial
Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

Of the many treatments proposed for COVID-19, few directly address the severe hypoxia among COVID-19 patients. Interim results from our single-center, non-randomized clinical trial (NCT04332081) suggest that hyperbaric oxygen therapy may reduce inpatient mortality or the need for mechanical ventilation among COVID-19 patients by more than half. Hyperbaric oxygen therapy is delivered by increasing the atmospheric pressure surrounding a patient, which results in increased oxygen delivery to a patient's blood at a rate higher than any other available modality. It is already FDA-approved for several indications, including conditions with impaired gas exchange and severe infectious processes. Furthermore, several studies have found that hyperbaric oxygen therapy inhibits the production of proinflammatory cytokines, which may play a role in the pathophysiology of COVID-19. The goal of this proposal is to perform a multi-center, randomized controlled trial to evaluate the short-term and long-term efficacy of hyperbaric oxygen therapy for COVID-19 patients. This proposal will rigorously test whether hyperbaric oxygen therapy can reduce the substantial mortality and morbidity of this challenging disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Positive COVID 19 test or clear clinical diagnosis of COVID-19. Positive COVID-19 test will be confirmed based on a PCR or antigen test result or patient reported history. Clear clinical diagnosis of COVID-19 will be a combination of respiratory symptoms and clinical findings based on laboratory values and radiographs.
3. Moderate to severe hypoxemia defined by a baseline supplemental oxygen requirement of 6 liters or higher (including high flow oxygenation devices) as measured within the 24 hours before enrollment

Exclusion Criteria:

1. Pregnancy
2. Untreated pneumothorax, which must be evaluated with a baseline chest radiograph or computerized tomography scan at least 72 hours prior to enrollment
3. Presence of pneumomediastinum, pneumopericardium, significant subcutaneous emphysema, or pulmonary blebs, which should also be evaluated with a baseline chest radiograph prior to enrollment
4. Current invasive mechanical ventilation
5. Current non-invasive mechanical ventilation
6. Any patient who will not be stable for transport to the hyperbaric chamber, in addition to any relative contraindications identified by the treating hyperbaric physician or inpatient hospital team (e.g., severely impaired cardiac output due to significant myocardial injury).
7. Any patient without the capacity to provide informed consent
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)


Eligibility Criteria:
Inclusion Criteria:

1. Patients (males or females) aged 18 years or older
2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit
5. Willingness and ability to comply with clinic visits and study-related procedures
6. Patients should be able to read, understand, and be willing to sign the ICF

Exclusion Criteria:

1. Presence of any of the following laboratory abnormalities

   * Hemoglobin \< 11 g/dL
   * WBC \< 3.5 × 103/μL
   * Platelet count \< 125 × 103/μL
   * Neutrophils \< 1.75 × 103/μL
   * AST/ALT \> 1.5 × ULN
   * Total bilirubin \> ULN
   * Creatinine \> ULN
   * Creatine phosphokinase \> ULN
2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
3. Active dermatologic conditions that may confound the diagnosis of AD
4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit
7. Known history of human immunodeficiency virus (HIV) infection
8. Pregnant or breastfeeding women
Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects

Infectious anorectitis is a poorly described clinical entity. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly made in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

The proctology center of the Marie Thérèse Center is the leading proctology center in the Ile-de-France region both in terms of recruitment and reputation, and drains a large proportion of patients with anorectitis for specialized care. The clinical microbiology laboratory of the Saint Joseph Hospital Group is linked to the Marie Thérèse Center to provide its expertise in the microbiological and infectious aspects of the management of these infections.

In recent years, the analysis of data from this large population of patients referred to the Léopold Bellan proctology center for suspected ano-rectitis has revealed the pathogens Neisseria gonorrhoeae and/or Chlamydia trachomatis.

Mycoplasma genitalium (MG) is an emerging pathogen responsible for Sexually Transmitted Infections (STI) and has been described increasingly in recent years. Studies on this pathogen will allow to better identify risk factors and to target optimized prevention and therapeutic management strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patients treated at the Centre de proctologie of the Centre de santé Marie-Thérèse or the GHPSJ (consultation and/or hospitalization) and for whom an anorectal swab will be taken for suspected infectious sexually transmitted ano-rectitis
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
Focusing on Body Functionality After Bariatric Surgery

This study investigated whether focusing on one's body functionality (i.e., everything the body can do, rather than how it looks) would lead to improvements in body image, self-esteem, and self-kindness among women who have undergone bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Identifying as female, being between 18 and 65 years old, having undergone bariatric surgery 5-7 months prior to the study, and qualifying for standard aftercare at the Nederlandse Obesitas Kliniek (NOK; Dutch Obesity Clinic).

Exclusion Criteria:

* N/A
Forefoot Adduction (FFA) in Infants and Toddlers. Differences of Neuromuscular Activity.

Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction. Most of them usually need only reassurance and education how to manipulate the deformed foot. During the examination we usually use provocative maneuver to trigger peroneal activity. This manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of the children, but not in all of them. Small part of the children reacts in opposite direction - instead of the typical eversion they demonstrate inversion and some plantar flexion of the foot. We have the impression that this subgroup of children improves the deformity slower and sometime less complete than most of the children. We did not find in the literature any description of this phenomenon. We postulate, that atypically reacting patients probably have different response due to abnormalities of neuromuscular balance between invertors-flexors and evertors-extensors muscle groups. This small subgroup of children may need more close follow-up and probably casting to speed up and secure the improvement of their deformity.

Study goals:

1. Evaluate ability of children with FFA to respond on mechanical triggering of peroneal activity

   1. The majority of the patients with standard reaction - foot dorsiflexion and eversion (evertors)
   2. The minority of the patients with nonstandard reaction - foot plantarflexion and inversion (invertors)
2. Evaluate randomly selected children from each group for character of muscular response on electrical stimulation (EMG) of calf muscles.


Eligibility Criteria:
Inclusion Criteria:

1. Boys and girls between two months and one year old.
2. Non associated pathology.
3. Signing Informed consent.

Exclusion Criteria:

1. Unwillingness to sign informed consent.
2. Associated pathology
Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients

Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* Patient with HIV Infection
* The use of immunosuppressive agents in patients with nearly three months