cyrilzakka/clinical-trials huggingface dataset:
DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly

The aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (CC) in elderly during a 12-week consumption period.

The study is conducted in the frame of the collaborative project 'FibeBiotics' (No. 289517) (Fibers as support of the Gut and Immune function of Elderly - From polysaccharide compound to health Claim) within the Seventh Framework Programme (FP7) for Research and Technological Development of the European Union (EU).

Eligibility Criteria:
Inclusion Criteria:

* men and postmenopausal women aged ≥ 50
* willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willingness to sustain a low dietary fibre diet for 14 weeks
* written informed consent

Exclusion Criteria:

* subjects currently enrolled in another clinical study
* subjects having finished another clinical study within the last 4 weeks before inclusion
* surgery or intervention requiring general anaesthesia within 2 months before the study
* current symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract
* history of allergic rhinitis, allergic asthma, anaphylactic shock, quincke edema, food allergy (type I allergy)
* allergy or hypersensitivity to any component of the test product (e. g. wheat, corn)
* known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
* active autoimmune diseases
* severe chronic disease (COPD, respiratory insufficiency, cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, severe renal, hepatic or cardiac diseases)
* known coeliac disease (gluten enteropathy)
* chronic systemic or chronic topical treatment likely to interfere with evaluation of the study parameters: antiallergic drugs, antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases (in the last 4 weeks before inclusion)
* diabetes mellitus
* other chronic treatments likely to interfere with study outcome: e.g. laxatives, body weight management and/or medication
* chronic abdominal pain
* bowel movement less than 3 times per week
* subjects, who meet 2 or more Rome III criteria for constipation or who take laxatives on a regular basis
* vegetarian, vegan diet
* eating disorders (e.g. anorexia, bulimia)
* alcohol and drug abuse
* severe neurological, cognitive or psychiatric diseases
* subjects not understanding or speaking fluently German
* legal incapacity
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia

From 2004, OBS'CEREVANCE is a national real-world prospective clinical cohort of patients with auto-immune cytopenia of pediatric-onset : Immune thrombocytopenia (ITP), Autoimmune Hemolytic anemia (AIHA), or Evans syndrome (all bi or tri cytopenias). Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.

Immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AHAI) are rare childhood diseases that involve autoimmune destruction of platelets and erythrocytes respectively.

They may be associated with an even rarer entity, Evans syndrome (ES). These three conditions are referred to as autoimmune cytopenias (AIC).

In association with CAI, patients may present with various immunopathological (IM) manifestations such as lymphoproliferation, autoimmune autoimmune/autoinflammatory organ diseases that may be absent at the time of at the time of diagnosis of CAI and develop during follow-up.

Since 2004, the CEREVANCE reference center for childhood autoimmune CEREVANCE has been coordinating a national prospective cohort of patients with pediatric-onset CAI including over 1900 patients (data 05/2023).

Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ITP, AIHA, Evans Syndrome
* Onset before the age of 18

Exclusion Criteria:

* Opposition of legal representative or to data collection
Phase 2 Study of TD-9855 to Treat Fibromyalgia

The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

  * Informed consent
  * 18 to 65 years of age
  * Discontinue therapy with adrenergic-acting drugs, and certain other medications

    * Only acetaminophen or NSAID as rescue pain medication
    * No narcotic pain meds or benzodiazepines
    * Only non-benzodiazepines as rescue hypnotics

Exclusion Criteria:

* Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
* Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
* Risk of suicide (investigator opinion and/or C-SSRS)
* Recent history of substance or alcohol abuse
* BMI \<18 or ≥45
* Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
* Abnormal lab values (liver, kidney, thyroid, and others)
Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5\*10\^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.

Eligibility Criteria:
Inclusion Criteria (in brief):

* Type 2 diabetes mellitus
* Diabetes duration≤20 years
* 18.5kg/m\^2 ≤ BMI\< 30 kg/m\^2
* 7.5%≤HbA1C≤10%
* UACR≥30mg/gCr
* eGFR ≥45/milliliter/1.73m\^2

Exclusion Criteria (in brief):

* Type 1 diabetes mellitus
* tumor history
* Other causes of chronic kidney disease
* Abnormal liver function
Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer

The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.

Eligibility Criteria:
Inclusion Criteria:

* Advanced (non-resectable) malignancy in the thorax
* Age \>18 years old
* Willing and able to provide consent
* No prior history of neoadjuvant therapy

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent
* Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)
The Welcome Incoming Neighbor (WIN) Community Trial

Migration is common in rural Africa: in-migrants have higher HIV incidence and prevalence than community residents, but underutilize combined HIV prevention and care services, including voluntary medical male circumcision and antiretroviral therapy, increasing the risks of HIV acquisition and onward transmission. Uptake of combined HIV prevention (CHP) is critical in this vulnerable population. The investigators will conduct a community randomized trial to rapidly identify and link migrants to CHP in rural Uganda; if effective, the intervention could be widely implemented as an important strategy towards HIV epidemic control.

The Rakai Health Sciences Program (RHSP), Uganda, proposes an implementation science community- randomized controlled trial (CRCT) of a novel intervention to newly in-migrated individuals ("Welcome Incoming Neighbor" \[WIN\]), to optimize in-migrated individuals' rapid linkage to combination HIV prevention (CHP) services. RHSP data show that within the first 36 months after in-migration, compared to residents, HIV-negative in-migrants are at increased risk of HIV acquisition and HIV+ in-migrants underutilize antiretroviral therapy (ART) increasing the risk of onward transmission. The theory-based WIN intervention includes community sensitization and community-based WIN scouts (WINs). WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide the in-migrants with information about the availability of CHP and high rates of use by residents (to "normalize" uptake), utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, and follow-up in-migrants to assess and further encourage engagement in CHP. Specific Aims: Aim 1: To randomize 40 individually matched communities in a 1:1 ratio to the WIN intervention or control arm. In-migrants aged 15-49 in each arm will undergo a baseline and 2 follow-up surveys at \~18-month intervals. Study end points are CHP coverage rates, HIV incidence in initially HIV-negative in-migrants (n \~3,800 py per arm), and viral load suppression in HIV+ (n \~740 per arm). Aim 2a: To use a mixed methods approach (in-depth interviews, process \& survey data) and Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) to (i) guide interim intervention adaptation as necessary; (ii) interpret trial results; and, (iii) translate the research into future action. Aim 2b: To conduct cost studies to provide information on affordability and sustainability. Innovation and Impact: This novel intervention will rapidly engage a vulnerable priority population of in-migrants, to optimize CHP and HIV impact in rural Uganda.

Eligibility Criteria:
Inclusion Criteria:

* Residing in study community

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle

This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .

The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.

Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.

Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed COPD (post- bronchodilator FEV1/FVC \< 0.7)
* 40\~80 years
* CAT≥10
* At least two moderate or at least one severe exacerbation history in past 1 year
* Able to sign informed consent

Exclusion Criteria:

* Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
* Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
* Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
* Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
* Not living in the healthcare area
* Patients currently participating in any other interventional studies
Primary Care Based Depression Prevention for Adolescents/Young Adults/Young Adults and Young Adults

The purpose of this research is to evaluate the feasibility of an interview between an adolescent / young adult and a PCP (Primary Care Physician).

A web-based depression prevention program will evaluate the interview. Depression is a condition where people feel sad, tired, have changes in sleep, and lose interest in fun things for more than two weeks. This program teaches adolescents/young adults new skills. They learn new skills by talking with their doctor and doing a workbook at an Internet site. Counselors have used some of these lessons to successfully treat, and in some cases, prevent depression. We do not know if these lessons given in a primary care doctor's office or over the Internet will prevent depression. We will have to do further studies to determine this. If subjects are clinically depressed right now, they cannot be a part of this study.

Eligibility Criteria:
Inclusion Criteria:

* age 15-21 years and
* two risk factors for developing depression in the next two years:

  * Center for Epidemiologic Studies-Depression (CES-D) score \> 12 and either a family history or past personal history of depression.
  * Exclusion criteria include meeting criteria or undergoing active treatment for M. depression, or having suicidal ideation

Exclusion Criteria:

* undergoing active treatment for M. depression, or having suicidal ideation
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.

Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years old or older, male or female
* able to sign informed consent
* CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)
* intact Parathyroid hormone level (iPTH) \> 100 pg/ml for stage 3 or iPTH \> 150 pg/ml for stage 4
* calcidiol levels ≤ 20 ng/ml
* ability to ambulate without assistance

Exclusion Criteria:

* intact PTH \> 400 pg/ml
* initial corrected Calcium \> 9.7 mg/dl
* initial serum Phosphorous \> 5.0 mg/dl
* initial standardized blood pressure of \> 160/100
* history of significant liver disease or cirrhosis
* anticipated requirement for dialysis in 6 months
* malabsorption, severe chronic diarrhea, or ileostomy
* no calcimimetic or active vitamin D therapy 30 days prior to enrollment
* use of digoxin, magnesium containing products, mineral oil, or cholestyramine
Mymobility Knee ROM

This prospective study aims to evaluate the agreement, also referred as concordance, of the mymobilty knee ROM with a clinician's assessment of knee ROM via goniometer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent form

Exclusion Criteria:

* The patient is currently participating in any other study that would hinder the assessor's ability to measure knee ROM
* Complex primary knee pathology with significant restrictions on the range of motion per surgeon discretion
* Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

This study is divided into two parts:

Part 1: An interventional study, with a pre-post study design to determinate the grade of knowledge of established GC risk factors.

Part 2: An observational study to know impact on prevalence and infection eradication of H. pylori

Part 1: to determinate the grade of knowledge of established GC risk factors and identification of attitudes about, GC screening programs at baseline, prior to the intervention though an educational program.

Part 2: to generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at 6th, 12th, 24th and at Month 36th.

Eligibility Criteria:
Part A: Educational Intervention Inclusion criteria

* Subjects \>18 years old, from EU and CELAC countries participating in this study.
* Has given and signed the IC to participate in this study. Exclusion criteria
* Subjects who have received some prior preparation (Cancer Gastric Information).
* Subjects who have previous Knowledge in Gastric Cancer (Example, near relatives who have suffered Gastric Cancer

Part B: H. pylori Register Inclusion criteria

* Subjects ≥18 years old diagnose from H. pylori infection and treated at participant sites
* Has given and signed the IC. Exclusion criteria
* Subjects with chronic gastritis without confirmed diagnose of H. pylori infection, pathologically of by urease test.
* Patient's with CG diagnosis (including gastroesophageal junction cancer).
Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.

Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:

Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia

Eligibility Criteria:
Inclusion Criteria:

- all patient \> 18years old undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Patients with fractures of the bones of the facial mass;
* Patients with laryngeal tumors
* Patients previously undergoing demolition of the larynx or neck;
* Tracheostomized patients;
* Pregnancy;
* Inter-incisive distance \<3 cm;
* severely limited cervical mobility;
* Patients who are not given muscle relaxants
* Patient rejection.
Kinetic Analysis Due to Foot Dysfunction

The aim of the current study is to examine the biomechanical changes of gait kinetics in patients with either partial foot amputation or peripheral neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Partial foot amputees who didn"t receive physiotherapy and don"t use prosthesis. patients with PN grade (1-2) Age 40-65y Both sexes. Walking independently however, no walking aids were used during the testing procedures

Exclusion Criteria:

* Foot amputation levels more proximal than tarso metatarsal joint. Less than 4 months after partial foot amputation. Foot amputees who use prosthesis or suffer from phantom pain. Active foot problems; ulcer, infection, or gangrene. Patients with PN who received physiotherapy or injections like Puerarin Major surgeries in lower limb that could affect either gait or balance like ACL, hip/knee arthroplasty Spine problems that could affect either gait or balance History of ankle sprain. Pathologies such as skin diseases, inflammatory diseases, congenital diseases, or neurological diseases rather than PN.

Fractures or dislocations. Symptomatic degenerative changes that require medications. BMI over 35. Inability of walking independently