cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years \[5\]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women ≥ 50 years
* Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture
* having signed an informed consent

Exclusion Criteria:

* Taking a "loading dose" of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study).
* Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance \* \*)
* Treatment with thiazide diuretic
* Known malabsorption (celiac disease)
* Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism.
* Persistent or nephrolithiasis occurred in the previous 5 years
* known sarcoidosis
* Persons under guardianship or trusteeship
* Hypercalcemia and hypercalciuria
* 25OH vitamin D levels\> 50ng / ml
Mindfulness Based Stress Reduction for Parents of Children With IBD

Parents of children with chronic diseases often report increased level of stress and anxiety. The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions.

Parents of children with chronic diseases often report increased level of stress and anxiety. Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are chronic debilitating conditions with significant implications of both patients and parents. Thus, there is a necessity to address the stress and anxiety derived from parenting a child with IBD.

Mindfulness is the psychological process of bringing one's attention to the internal and external experiences occurring in the present moment,which can be developed through the practice of meditation and other training. Clinical studies have documented both physical and mental health benefits of mindfulness in different patient categories as well as in healthy adults and children.

The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate in 4 separated courses. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions: Profile of mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS). Differences in questionnaires' scores will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* A parent to an IBD patient who is younger than 18 years of age

Exclusion Criteria:

* None
A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.


Eligibility Criteria:
Inclusion criteria

* Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible).

Exclusion criteria:

* Age \< 21 years
* Activated Clotting Time (ACT) \> 200 seconds immediately prior to PCI
* Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
* Currently receiving an oral anticoagulant (OAC) agent with an INR \> 1.8
* Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
* Active internal bleeding or history of hemorrhagic diathesis
* Thrombocytopenia (platelet count \< 100 x 10-9/L)
* Pregnant women or women of childbearing potential who are not using an effective method of contraception
* Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel
* Absolute contra-indication to anticoagulation
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.
Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1

This is a randomized quality improvement project to evaluate the impact of an audit and feedback intervention to motivate pharmacists to provide heart failure (HF) medication management to patients in the Veterans Health Administration (VHA) Sierra Pacific region (VISN 21). The results of this project could provide guidance for how to successfully scale a pharmacist-based HF remote management program in the VHA more broadly.

Pharmacists providing clinical care as part of Patient Aligned Care Team (PACT) within VHA VISN 21 will be included. Pharmacists will be randomized to one of 3 arms in a 1:1:2 ratio: (1) monthly audit and feedback of HF medication titration activities (AF) vs. (2) educational resources and monthly notification of HF medication titration actions in addition to a list of potential patients for HF optimization (AF+) vs. (3) usual care without audit and feedback (UC). Pharmacists across all three arms will be given access to shared educational resources on HF pharmacist care and educational webinars. Six months after the intervention, rates of pharmacist HF medication titration encounters will be compared among the 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Clinical pharmacists in the Veterans Health Administration that provide Patient Aligned Care Team (PACT) care in VA Sierra Pacific Network (VISN 21)

Exclusion Criteria:

* Excluded per pharmacist supervisor decision
Primary Reperfusion Secondary Stenting Trial

The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.

The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined with adjunctive anticoagulation is superior to immediate stent implantation at improving cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, or unplanned target vessel revascularization over a 9-month period.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years;
2. STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
3. ECG that fulfills any of the following criteria: ≥ 2 mm ST elevation in two anterior or lateral leads; or ≥ 1 mm ST elevation in two inferior leads; or new left bundle branch block (LBBB) with at least 1 mm concordant ST elevation;
4. Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
5. Successful reperfusion (TIMI 2-3 flow), either spontaneously or after wire passage, thrombectomy, small size (≤ 2.0mm) angioplasty catheter, and persisting for more than 10 minutes;
6. Infarct related artery with a diameter above 2.5 mm.

Exclusion Criteria:

1. Prior STEMI in the qualifying coronary artery;
2. Coronary dissection following reperfusion;
3. STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
4. Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
5. Cardiac condition requiring emergent or urgent surgical repair;
6. Failed thrombolysis and rescue PCI;
7. High risk of bleeding;
8. Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;
9. STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
10. Women who are pregnant or breastfeeding;
11. Creatinine clearance \< 20 ml/min;
12. Other contraindication to PCI;
13. Participation with another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
14. Any condition that in the opinion of the investigator would preclude compliance with the study protocol.
Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with hyperuricemia, and to evaluate the safety of orlistat treatment


Eligibility Criteria:
Inclusion Criteria:

(Items 1, 2, and 4 meet at the same time, and items 3 and 5 meet one of them)

1. Obtain the informed consent of the subjects before any trial-related activities (including activities carried out to assess the eligibility of subjects);
2. Men or women over the age of 18 at the time of screening;
3. The diagnosis of hyperuricemia refers to the fasting of serum uric acid \> 420umol/L (7 mg/dl) twice on different days under a normal purine diet.
4. The weight meets the following requirements (a or b): a) BMI ≥ 25.0 kg/m2; b) waist circumference, female ≥ 85 cm, male ≥ 90 cm.
5. Suffering from hyperuricemia and/or gout.-

Exclusion Criteria:

1. Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.;
2. Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal;
3. Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.;
4. Diabetic patients with poor blood sugar control: HbA1c\>7%;
5. Chronic kidney disease or severe renal impairment, according to eGFR grading \<45mL/min/1.73m2;
6. The life expectancy does not exceed 5 years;
7. Female subjects who are pregnant or plan to become pregnant within the next 24 weeks;
8. Those who are expected to be unable to complete the intervention follow-up in other circumstances;
9. If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment;
10. Participated in other clinical trials within the past 4 weeks;
11. Use of drugs that affect body weight within 3 months before screening, including: systemic steroids (intravenous, oral or intra-articular), tricyclic antidepressants, psychiatric drugs or sedatives (eg, imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salt), etc.;
12. Obesity caused by secondary diseases or drugs, including: elevated cortisol hormone (for example: Cushing's syndrome), obesity caused by pituitary and hypothalamus damage, obesity caused by reduction/discontinuation of weight loss drugs, etc.;
13. Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-
The Efficacy of Front-of-package Labelling Schemes: an Experimental Study

This is an online study that aims to test the effectiveness of Interpretative Nutrition Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by Health Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to help educate consumers on each INRS prior to their exposure on food packages.


Eligibility Criteria:
Inclusion Criteria:

* speak English as a primary language
* reside in Canada excluding the Northern Territories
* are 18 years or over
* provide informed consent
* do at least some of the household grocery shopping
* own a smartphone (version iPhone 3 or later or Android)
* are able to complete the survey on a minimum screen size of 9.7 inches.
Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers

The goal of this clinical trial is to learn if Front-of-Pack labels, namely Nutri-Score and NutrInform Battery, work to improve adherence to the Mediterranean diet among healthy Italian adult participants. It will also learn about the label's ability to increase nutritional knowledge and participant's response in terms of orthorexic behaviour. The main questions it aims to answer are:

* Does FOP nutritional labels work to guide participants' food choices towards healthier diets?
* Do they increase participants\&#39; nutritional knowledge?
* To what extent are they related to obsessive focus on healthy eating, such as orthorexia nervosa? Researchers will compare the labels to a no label condition (in which participants were only given a conventional nutrition education flyer) to see if labels work to improve healthiness in individual diets.

Participants will:

* Complete an initial questionnaire's battery
* Use the assigned FOP label every day for 1 month to orient their food choices
* Answer to final questionnaires


Eligibility Criteria:
Inclusion Criteria:

* limited to participants older than 18 years

Exclusion Criteria:

* people currently on a diet for religious/ethical/personal choice or medical prescription
* people with a degree or a professional expertise in the area of field, nutrition, and physical exercise
* people who know one of the interventions
Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus

The aim of the study is to examine the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. It is planned to reach at least 100 participants during the data collection phase of the study. Demographic information, plasma glucose levels, and HbA1C levels of the participants included in the study will be recorded. The upper extremity problems of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions.

This study is aimed to evaluate the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. The study will conduct in the Internal Medicine Clinic of Kutahya Health Sciences University Evliya Celebi Training and Research Hospital. Approval for the study was granted by the Clinical Research Ethics Committee of Kutahya Health Sciences University and written informed consent forms will be obtained from all the participants. This study is planned to reach at least 50 participants with type 2 diabetes mellitus for the study group and 50 participants without diabetes for the control group. The participants will be questioned about their eligibility for the inclusion criteria. The demographic and descriptive data of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions. The test will be performed with and without the dual-task. Counting backward from a random three-digit number 3 by 3 will be used for the dual-task. The effect of dual-task will calculate using the difference between the completion time of both tests for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with type 2 diabetes mellitus for at least 5 years for study group, having no diagnosed type 2 diabetes mellitus or prediabetes for control group,
* Being able to count down 3 by 3 from a three-digit number,
* Volunteer to take part in the study.

Exclusion Criteria:

* History of traumatic or inflammatory injury in the upper extremity,
* History of involving the upper extremity in the last year,
* Having rheumatological/inflammatory arthritis or deformity,
* Having a deformity caused by osteoarthritis in the upper extremity,
* Having a neurological problem affecting the upper extremity,
* Getting 23 points or less on the Mini-Mental Test.
Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic RCT

The goal of this pragmatic randomized control trial is to evaluate the effectiveness of three interventions in improving follow-up adherence among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. The interventions include structured nurse-led telephone call reminders, home-visit reminders led by health extension workers, and application-based automated SMS text reminders. The main questions it aims to answer are:

* Does structured nurse-led telephone call reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?
* Does home-reminder visits led by a Health Extension Worker (HEW) improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?
* Does app-based automated SMS reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?

Structured Nurse-Led Telephone Call Reminders

* Participants will receive proactive phone call reminders for scheduled follow-up visits.
* The intervention includes three rounds: initially at 4 months post-recruitment, then every 4 months for HIV-negative women over a year, and every 2 months for 6 months for women living with HIV.

Home-Reminder Visits Led by HEW Health Extension Workers (HEWs) will conduct door-to-door visits to remind participants of their scheduled follow-up appointments.

• Door-to-door Visits will occur initially at 4 months (for HIV-negative women) and 2 months (for HIV-positive women) post-recruitment, then every 2 months for 6 months for HIV-positive and every 4 months for 12 months for HIV-negative participants.

App-Based Automated SMS Reminders

* Participants will receive SMS-based reminders for their follow-up visits.
* The intervention consists of three rounds: initial texts at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively, followed by reminders every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-49 (HIV-negative).
* Women over 25 (HIV-positive).
* Treated for suspicious cervical lesions after a positive VIA screening.

Exclusion Criteria:

* History of hysterectomy.
* Diagnosis of other histological invasive cervical cancer.
* Suspicious cervical cancer cases.
* Pregnancy.
* Prior screening history.
* Vaginal bleeding.
* Lack of consent.
A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE \[ifosfamide+carboplatin+etoposide\] or GEMOX \[gemcitabine+oxaliplatin\] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is willing to provide written ICF.
2. Age≥ 18 years.
3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
4. Previously received at least one or more standard regimens including anthracycline.
5. Recurrence or the recurrence disease after the last treatment completed.
6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
7. ECOG PS 0 or 1.
8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
9. Expected life time longer than 3 months.

Exclusion Criteria:

1. Current have disease or history of central nervous system lymphoma.
2. HBV-DNA positive, or HCV-RNA positive.
3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
4. Received major surgery within 4 weeks of first dose of study drug
5. Known received SINE, including ATG-010.
6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
7. Known allergy to ATG-010, or ICE, or GEMOX.
8. A woman who is pregnant or nursing.
9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.
Cohort of Children With Severe Cerebral Palsy

" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.

The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.

Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.

385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Children aged from 2 to 10 years at inclusion,
* with bilateral cerebral palsy,
* Grade IV or V of the GMFCS.
* Affiliated with the French healthcare system.
* Oral consent of the parents obtained.

Exclusion Criteria:

- Progressive pathology.