cyrilzakka/clinical-trials huggingface dataset:
Faith Leaders Advocating for Maternal Empowerment (FLAME)

In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility.

The investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable.

The primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Willing to receive intervention counseling

Exclusion Criteria:

* None
Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia

The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* 1. Discomplete spinal cord injury;
* 2. Traumatic etiology;
* 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
* 4. The level of SCI in T9-T12;
* 5. ≥12 months post injury;
* 6. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
* 7. Emotional stability;

Exclusion Criteria:

* 1. Absence of SCI, or presence of multi-segmental injury;
* 2. SCI non-traumatic etiology;
* 3. Age\<18 years or Age\>60 years;
* 4. Emotional instability;
* 5. Unavailable time to join the protocol activities;
* 6. Already enrolled in other research protocol;
* 7. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
* 8. Alcohol/drugs abuse and dependence;
* 9. Psychiatric disorders (exception: treated depression);
* 10.Cognitive deficit; visual deficit; auditory deficit;
* 11. Incapacitating pain;
* 12. Pregnancy;
* 13. Presence of limb amputations (exception: hand distal phalanges);
* 14. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
* 15. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
* 16. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
* 17. Movement disorders(e.g. ataxia);
* 18. Use of medication that can negatively impact on neurological/motor recovery;
* 19. Presence of joint deformities, presence of fractures;
* 20. Lower limb spasticity MAS (Modified Ashworth Scale)\>2;
* 21. Pressure ulcer: considering grade 3 or 4, injury size and body location;
* 22. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
* 23. Presence of cardiac or neural pacemaker;
* 24. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
* 25. Severe osteoporosis (Tscore\>-4);
* 26. Syringomyelia;
* 27. Lokomat or ZeroG training within the prior 3 months.
Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients

We will conduct a sub-study of "An Innovative Telephone Intervention for HIV+ Smokers," (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized, prospective trial that will evaluate a cellular phone delivered counseling intervention versus standard of care for smoking cessation. In our sub-study, we will evaluate rates of progression in atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT in those who quit smoking versus those who continue smoking, based on race, sex, state of HIV disease, comorbid diseases, and lipid profile.

HIV/AIDS patients may have an increased risk of myocardial infarction. Traditional risk factors for coronary artery disease, including cigarette smoking, likely play a large role. The prevalence of smoking in the HIV patient population is higher than the general population. We will conduct a sub-study of "An Innovative Telephone Intervention for HIV+ Smokers," (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized prospective trial that will evaluate a cellular phone delivered counseling intervention versus standard of care for smoking cessation. In our sub-study, we will evaluate rates of progression in atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT in those who quit smoking versus those who continue smoking based on race, sex, state of HIV disease, comorbid diseases and lipid profile. The central hypothesis is that smoking cessation win slow the atherosclerosis progression in HIV patients. A successful behavioral intervention is being evaluated in the parent study. The goal of this sub-study is to assess the effect of a modifiable coronary artery disease risk factor, smoking, in HIV/AIDS patients through this collaboration of cardiovascular expertise and metrics.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet eligibility criteria for "An innovative telephone intervention for HIV-positive smokers".
* Patients who consent to the sub-study.
* Patients who are able to participate in the study for 3 years.

Exclusion Criteria:

* Patients with a history of coronary bypass surgery, percutaneous coronary intervention, valve replacement, pacemaker or defibrillator implantation.
Interventional Reference Levels (IRL) in Digestive Endoscopy

Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.

Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.

Secondary objective(s) :

* Application of regulatory texts
* Assessment of patient radiation protection
* Radiation protection assessment for workers

Prospective data collection using an e-CRF available via Easymedstat. Data completed during the endoscopy procedure Completion of a questionnaire by the practitioner who performed the procedure afterwards, including the scopy doses used during the procedure, the type of scopy, the type of intention-to-treat

Eligibility Criteria:
Inclusion Criteria:

* All patients who have received an X-ray dose during an endoscopic procedure

Exclusion Criteria:

* No X-rays produced
* Medical indication not in favour of the scopy procedure in view of the benefit/risk balance
Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.

CONTINUUM+ CONNECT is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. The remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. These questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). The data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take.

In order to evaluate the impact of remote monitoring by CONTINUUM+ CONNECT on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out.

Four main types of cancer will be studied: Breast, Lung, Colorectal and Prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal, prostate cancer) at the metastatic stage followed on an outpatient basis;
2. Patients initiating oral and/or injectable anticancer treatment, whatever the line of treatment, administered on an outpatient basis including day hospitalization;
3. Patients who have given their written, free and informed consent;
4. Patients with life expectancy of more than 3 months;
5. Patients able to complete questionnaires according to the investigator's judgment, and to use the CONTINUUM+ CONNECT electronic application either alone or accompanied by a professional (home nurse);
6. Patients affiliated to a social security scheme or beneficiaries of such a scheme.

Exclusion Criteria:

1. Patients receiving home hospitalization care or being hospitalized at the time of treatment initiation;
2. Patients receiving concomitant radiotherapy;
3. Patients using another remote monitoring application;
4. Patients enrolled in another clinical trial;
5. Patients protected by law.
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

The primary objectives of this study were to evaluate the efficacy of ibrutinib administered at 560 mg once per day in relapsed or refractory de novo ABC and GCB DLBCL, and to evaluate the efficacy of ibrutinib administered at 840 mg once per day in relapsed or refractory de novo ABC DLBCL.

The secondary objective was to evaluate the safety and tolerability of a fixed daily oral dosing regimen of ibrutinib in relapsed/refractory de novo DLBCL.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years of age.
2. ECOG performance status ≤ 2.
3. Pathologically confirmed de novo DLBCL
4. Subjects must have available tissue for central pathology review to be eligible. Treatment Group 2: Subjects will be eligible if they have the non-GCB phenotype, as confirmed by Central IHC testing by the Hans method.
5. Relapsed or refractory disease, defined as either: 1) recurrence of disease after a CR, or 2) PR, SD, or progressive disease (PD) at completion of the treatment regimen preceding entry to the study (residual disease): Subjects must have previously received an appropriate first-line treatment regimen. Subjects who have not received HDT/ASCT must be ineligible for HDT/ASCT
6. Treatment Group 1: Subjects must have ≥ 1 measurable (\> 2 cm in longest dimension) disease sites on CT scan. Treatment Group 2: Subjects must have ≥ 1 measurable (\> 1.5 cm in longest dimension) disease sites on CT scan.

Exclusion Criteria:

1. Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).
2. Primary mediastinal (thymic) large B-cell lymphoma.
3. Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary.
4. Certain exclusions on prior therapy
5. Major surgery within 2 weeks of first dose of study drug.
6. Any of the following laboratory abnormalities:

   1. ANC \< 0.75 x 10\^9/L. Treatment Group 2: Eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
   2. Platelet count \< 50 x 10\^9/L independent of transfusion support. Treatment Group 2 only: Eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
   3. AST or ALT ≥ 3.0 x upper limit of normal (ULN)
   4. Creatinine \> 2.0 x ULN
   5. Treatment Group 2 only: Hemoglobin \< 8.0 g/dL
   6. Treatment Group 2 only: Total Bilirubin \> 1.5 x ULN
7. Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon)
8. Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
9. Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease, hemophilia.
Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy

The purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with Duchenne muscular dystrophy (DMD).

Glutamine inhibits whole body protein degradation in children with Duchenne Muscular Dystrophy (DMD). The effect is observed after 5 h oral glutamine administration and is also found when glutamine is given over a 10-day period. This multi-site national study aims to evaluate the functional benefit of long-term oral glutamine administration in 30 DMD children using a randomized double-blind placebo-controlled cross-over design. The study includes two 4-month periods: 1) a treatment period in which the subject receives oral glutamine (0.5 g/kg/d) and 2) a control period in which the subject receives a placebo. The order of treatment allocation is randomized. The two 4-month periods are separated by a 1 month wash-out period. The children are monitored every 2 months during period 1 (M0, M2, M4) and period 2 (M5, M7, M9) in the clinical investigation centres of Hospital Robert Debré in Paris and the CHR\&U de Lille, as well as the clinical research centre of the CHU de Poitiers. Evidence of a functional benefit would involve evaluating the administration of glutamine over longer periods (as early as possible following diagnosis) among severely handicapped children and in other chronic pathologies associated with increased muscle protein catabolism. In DMD, such evidence would enable children to undergo gene therapy under improved physical condition.

Comparisons: Glutamine administration compared to placebo on the following outcome measures: walking speed on a standard course, work (kcal) and power (kcal/s) in relation to effort, body composition (bioelectrical impedance analysis and BIPHOTONIC absorptiometry), muscle mass (24-h urinary creatinine excretion), indices of protein degradation (CPK and 3-methyl histidine excretion) and biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BPI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Duchenne muscular dystrophy
* Able to walk \>170 m
* Absence of hepatic insufficiency
* Absence of renal insufficiency

Exclusion Criteria:

* Dependent upon wheelchair
* Body weight \>60kg
* Liver failure
* Kidney failure
* Surgery scheduled during the year following the first visit
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target

The researchers believe that pro-angiogenic factors are upregulated in a wide range of dermatologic diseases, including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea, and psoriasis. Select specimens may undergo genetic analysis to investigate underlying molecular pathways associated with dysregulated angiogenesis in cutaneous disease.

Biospecimens, either previously obtained or newly collected from dermatologic conditions, will be analyzed for angiogenic markers. Discarded skin tissue from surgical or biopsy procedures may also be used, including both diseased and non-diseased tissue from the same donor. Some specimens may also undergo genetic analysis to investigate underlying molecular pathways.

De-identified data such as age, sex, race, cause of death, lesion location, and description will be recorded. Currently, specimens are limited to clinically diagnosed lesions not typically biopsied, or lesions already confirmed by prior biopsy.

Biospecimens from various dermatologic diseases, including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea, and psoriasis will be evaluated for markers of angiogenesis. Additionally, researchers can use discarded human skin tissue samples from skin biopsy/surgery sites, which are removed for closure but are not submitted for histopathologic analysis. We may use donated tissue with both dermatologic disease and non-diseased tissue from the same donor. Biopsies may also be taken for molecular and genetic analysis of specimen. Non-identifiable information regarding the patient, such as age, sex, race, cause of death, location, and description of diseased skin may be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older.
* willing to have a skin biopsy

Exclusion Criteria:

* under 16 years of age
* unable to carry out instructions
Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.

Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation.

Aim: This research aimed to determine whether Waterpik or Superfloss was more effective in lowering the gingival bleeding score and plaque.

Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-35 years undergoing orthodontic treatment and
* systemically healthy without habits

Exclusion Criteria:

* Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
* missing teeth and
* treated previously for periodontal conditions
Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.

Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.

This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 90 years old
* Outpatients
* Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
* Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification

Exclusion Criteria:

* History of allergy to lansoprazole or mosapride
* Pregnant or lactating women
* Uremia
* Decompensated liver disease
* Age under 18 and over 90 years-old
* Lack of informed consent
Ultrasound Guided Diagnostic Cervical Medial Branch Block

The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* patients who have headache, neck pain, and shoulder pain due to possible facet joint disease

Exclusion Criteria:

* patients/volunteers with BMI \> 35
* patients/volunteers with short thick neck
* coagulopathy
* allergy to local anesthetic, ultrasound gel
* patient unable to fill out post procedure pain diary
Pharmacokinetics and Metabolic Activation of Capecitabine

The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).


Eligibility Criteria:
Inclusion Criteria selected:

* signed written informed consent
* male or female \> 18 years
* K-ras wild type adenocarcinoma of the colon or rectum
* metastatic colorectal carcinoma
* ECOG \<= 2

Exclusion Criteria selected:

* brain metastasis
* previous chemotherapy
* stage 3 or 4 heart failure
* uncontrolled angina
* pregnancy or lactation
Marfan Syndrome and Quality of Life of Pediatric Patients

The goal of this observational study is to learn about the impact of Marfan syndrome (MFS) in paediatric affected subjects. the main questions it aims to answer are:

* The assessment of quality of life in MFS Italian patients;
* The impact of phenotypic manifestations on self-image and self-management skills;
* Stratify patients according to the need of psychological support. Participants will take part in the study by completing four self-report questionnaires.

In literature, adolescents with MFS experience difficulty in connecting with peers, and are convinced that they would have been more physically attractive without the disease. Additionally, due to physical activity restrictions and orthopedic limitations, these patients reported having difficulty adjusting and participating in educational events.

Data from present study will be able to support clinicians in identifying patients who need psychological support (through parental counseling interviews) aimed at increasing compliance with treatments and adaptation to the disease.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* MFS diagnosis according to Revised Ghent criteria (2010);

Exclusion Criteria:

* Known cognitive deficits