cyrilzakka/clinical-trials huggingface dataset:
Promoting Fall Prevention Workshops

Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation resulting in PA approaches designed to prevent falls actually only benefiting a limited number of elderly subjects.

It's a qualitative study. The target population was people aged 60 and over who had refused to participate in fall prevention workshops.

The study covered three different French departments. A total of 19 semi-structured interviews were conducted over a period of 5 months.

The analysis of reports revealed there were multiple motives for not participating in the balance workshops. The current means of promoting these fall prevention workshops are not adapted. Finally, the social experience provided by the program was identified to be the principal motivator for encouraging the interviewed subjects to participate.

Eligibility Criteria:
Inclusion Criteria:

* People who received a proposal to participate in our workshop and who denied it
* People living in one of the three departments of the study (Loire, Haute-Loire and Rhône)

Exclusion Criteria:

- People who refused to participate to the study.
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

Antidepressant therapy has a delayed onset of action of 4-6 weeks. Pindolol has in some studies shown an accelerating effect. In this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with Venlafaxine compared to placebo Pindolol and Venlafaxine for a duration of 19 days.

Effect is measured by the Hamilton Depression rating Scale and the Preskorn Scale (self-rating).

Eligibility Criteria:
Inclusion Criteria:

* Major depression

Exclusion Criteria:

* Allergy towards pindolol, venlafaxine or other tablet constituents
* Liver or kidney impairment
* Diabetics
* Age below 18 years
* Severe cardiac disease
* Asthma.
Remote Ischemic Preconditioning in Elective Percutaneous Interventions

Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. In this study the investigators aim is to show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during percutaneous coronary intervention.

About in one third of elective percutaneous coronary interventions (PCI) troponin release occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to coronary interventions has also adverse effects on long term prognosis.

Beneficial effects of of ischemic preconditioning in elective PCI and in coronary artery bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc interventions. The investigators found one study showing that one cycle will also be enough to prevent troponin elevation after elective PCI.

The investigators aim was also to show that one cycle preconditioning performed just before coronary intervention will also be useful in preventing myocardial necrosis due to elective PCI.

Eligibility Criteria:
Inclusion Criteria

* Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography
* Patients with informed consent

Exclusion Criteria:

* Acute or chronic renal failure (Creatinin clearance \<60ml/dk)
* Acute heart failure
* Presence of hemodynamic instability
* Left main interventions
* Acute Coronary Syndrome
* Patients in whom cuff inflation is contraindicated in upper extremities (fistula, lymphoedema etc)
* Patients using nicorandil, glibenclamide or trimetazidine
* Patients not accepting the study
* Presence of troponin elevation before intervention
* Presence or suspicion of pregnancy
Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver disease are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. Therefore, early inoculation of SARS-CoV-2 vaccine in patients with liver disease is an important protective measure. However, information on the effectiveness and safety of the COVID-19 vaccine for liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Patients with liver disease, especially liver cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and individuals who are immunosuppressed after liver transplantation, have an increased risk of COVID-19 infection and increased mortality. Therefore, early inoculation of SARS-CoV-2 vaccine in liver disease patients is an important protective measure. A small number of SARS-CoV-2 vaccines have been tested in clinical trials in healthy individuals and have evidence of short-term safety, immunogenicity and efficacy. However, information on the effectiveness and safety of the COVID-19 vaccine for patients with liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.;
2. Receiving the whole-course COVID-19 vaccination for 14 days or more;
3. Volunteer to participate in this study.

Exclusion Criteria:

1. Younger than 18 years old;
2. Women during pregnancy or lactation;
3. Research on other situations deemed unsuitable for selection.
Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer

The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster.

This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio.

For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.


Eligibility Criteria:
Main Inclusion Criteria:

1. Men and women aged between 18 and 70 years old.
2. Diagnosed as herpes zoster.
3. Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA).
4. Self-rated Numerical Rating Scale (NRS) in pain ≤ 6.
5. Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age.
6. Subjects must have signed an informed consent form (ICF).

Main Exclusion Criteria:

1. Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis.
2. The lesion is complicated with other skin diseases that may affect the evaluation of efficacy,
3. Skin lesions combined with severe bacterial or fungal infections.
4. Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing.
5. Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy.
6. Liver and/or renal disfunction，ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) \> 2 times of upper normal limit（ULN）; Creatinine Clearance Rate (CCR) \< 50 L/min.
7. Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs.
8. Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment.
9. History of psychiatric illness or inability to fully comply to the protocol.
10. Use of another investigational product within 4 weeks prior to the first dosing.
11. Pregnant or lactating women.
12. Other conditions deemed by the investigator to be inappropriate for participation in this trial.
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* age 18-50y,
* BMI 18-27,
* caucasian origin,
* type 1 diabetes diagnosed between age 5 and age 40,
* no known diabetes complications or cardiovascular diseases,
* no medication known to influence glucose homeostasis,
* no pregnancy

Exclusion Criteria:

* diabetes complications,
* autonomous nerve dysfunction,
* anaemia,
* HbA1c \< 8.5% at screening,
* estimated by the investigator to be incapable of completing the trial.
Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

This project allows for the systematic collection and analysis of long-term follow-up clinical parameters in children who have received a stem cell transplant. The data collected will assist in determining appropriate intervention and treatment plans for patients enrolled on this study. In addition, future patients may benefit by having the ability to anticipate problems and develop methods of prevention or early intervention.

Primary Objective: Implement long-term follow-up guidelines for children, adolescents and young adults who are survivors of HSCT while establishing a database which captures the survivor's lifetime care.

Secondary Objectives:

* Collect evidence-based data through a structured framework of periodic physical examination, laboratory and medical tests to monitor late effects in our HSCT survivors.
* Establish standards of care for late effects of therapy post HSCT for malignant and non-malignant diagnoses.
* Provide early identification and intervention towards recognized problems, as well as consistent education to foster a healthy lifestyle to all survivors.
* Collect blood and tissue samples to study immune reconstitution of all immune cell types and learn more about immune reconstitution and its affect on post-HSCT complications and disease free survival.

Eligibility Criteria:
Inclusion Criteria:

* Participant is scheduled to receive OR has received a hematopoietic stem cell transplant (HSCT) for any condition.
* Participant may have had a HSCT in another institution than Lucile Packard Children's Hospital (LPCH) yet has transferred follow-up long-term care to our institution and is being seen through the late-effects clinic from the Pediatric HSCT program.
* Participant AND/OR parent/legally authorized representative is able to provide written informed consent and assent (as applicable) for participation.

Exclusion Criteria:

* Participant has relapsed from a malignant diagnosis post HSCT and is not being worked-up for a new HSCT.
* Participant or patient's authorized guardian is unable to provide consent and assent
Pediatric Intubation During Resuscitation

The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.

Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease

The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease
* At least mild to moderate depression or anxiety defined as HADS-A or HADS-D \> 7

Exclusion Criteria:

* Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
* Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
* Difficulties that hamper the use of a computer
* The patient states difficulties in finding enough time for treatment
* Too low cognitive functioning defined as MoCA \< 24
* Too severe depression, defined as MADRS-S over 30
* Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview
Abdominal Fat and Imaging Measurements of Heart Disease

Although it is frequently mentioned in the media that overweight and obesity have reached epidemic proportions worldwide and in this country, some Canadians are perplexed and sometimes confused about the role of obesity in diabetes and heart disease. In fact, the investigators even hear from time to time that there could be "healthy" obese individuals. In clinical practice, assessment of obesity as a risk factor for cardiovascular disease (CVD) remains a challenge as even some physicians are confused. However, studies conducted in our laboratory and by other research teams around the world over the last 20 years have clearly shown that body shape is more important than body size when evaluating the risk of overweight/obesity and that high accumulation of abdominal fat (excess belly fat) increases the risk of diabetes and cardiovascular disease (CVD).

The investigators now need to better understand the link between excess belly fat and atherosclerosis (the thickening of artery walls by fatty deposits, also referred to as atherosclerotic plaque), leading to complications such as angina (chest pain) and myocardial infarction (heart attacks). Using non-invasive imaging techniques such as magnetic resonance imaging, the investigators therefore propose to examine the relationships between measures of fatness and of abdominal fat and the size of atherosclerotic plaque in large blood vessels of apparently healthy human subjects. This study is also a unique opportunity to look, for the first time, at the relationship between belly fat, blood sugar, several well-known risk factors for heart disease (cholesterol, blood pressure, cardiorespiratory fitness, etc.) and the size of atherosclerotic plaques. This research program should pave the way to the development of new improved preventive/therapeutic approaches focusing not on body weight but rather on abdominal fat and associated blood abnormalities which are predictive of the development of atherosclerotic plaques leading to the premature development of heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 35-65 years

Exclusion Criteria:

* Massive obesity (BMI ≥ 40 kg/m2)
* Pharmacological treatment for lipids, hypertension and/or type 2 diabetes
* Clinical signs of cardiovascular disease
* Chronic inflammatory or auto-immune diseases
* Pulmonary diseases on corticosteroids
* Cancers not in remission
* History or clinical evidence of coronary heart disease (CHD)
* History of revascularisation procedures
* Current smoking
* Hormonal replacement therapy
Shared Medical Appointments for Weight Loss

Randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.

Obese patients will be randomized to either the control or intervention group. The intervention group will participate in 90-minute group visits occurring weekly for 4 weeks, then biweekly for a total of 26 weeks/15 visits. Each visit will focus on intensive lifestyle changes: calorie restriction to produce a 500-750 calorie deficit, increased physical activity, and behavioral therapies including regular self-monitoring of food intake, physical activity, and weight. Additional behavioral therapies that will be offered include techniques for reducing stress, maximizing sleep, and controlling environments. Further, these patients will each have the opportunity to meet one-on-one with a member of the research team at the end of each visit in order to discuss individual goals and progress.

Eligibility Criteria:
Inclusion Criteria:

* Current patients of the USF Family or General Internal Medicine Clinics
* BMI of 30 or greater
* Able to speak and read English

Exclusion Criteria:

* Age over 75 years, patients with end-stage renal disease with estimated GFR less than 15 mL/min, diabetes mellitus with an A1C \> 9%, Acute Coronary Syndrome (such as unstable angina, pacemaker or defibrillator due to impedance scale), recent history of weight loss (\>5% of body weight), pregnant or breastfeeding women, dementia or unstable psychiatric disorder, participation in any structured weight loss program currently or in the previous 3 months, cancer, or anyone unable to complete study protocol (exercise amounts, food intake).
Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota

The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in combination with purified ITF supplementation on weight management, metabolic alteration and gut microbiota composition. Obese patients were treated for 3 months and several parameters were measured before and after the study period.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 30 kg/m²
* Caucasian
* Presence of at least one of the following comorbidity : prediabetes, diabetes, dyslipidemia, hypertension, steatosis.

Exclusion Criteria:

* Psychiatric problems or use of antipsychotic
* Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (\<6 weeks)
* Pregnancy in progress or planified within 6 months
* Specific dietary practise (vegetarian, vegan,...)
* Specific dietary treatment (\<6 weeks) (e.g. high protein diet)
* Type 1 diabetes
* Excessive alcohol consumption (\>3 glasses/day)
* Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)
Plasmaexchange in Early Septic Shock

Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (\< 12 hrs) and high catecholamine doses (noradrenaline \> 0.4 ug/kg bodyweight/min) will be included. Those in the treatment group will receive 3 TPEs within three consecutive days. The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to 45% in the experimental group, a sample size of 173 patients per group has been calculated. The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months observation) and will be performed in 11 national centers in Germany. Secondary endpoints (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14.

Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics (Prof. Koch) at Hannover Medical School.

The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease.


Eligibility Criteria:
Inclusion Criteria:

* Onset of septic shock within less than 12 hrs
* Noradrenaline dose of ≥ 0.4 ug/kg/min bodyweight (target MAD ≥ 65 mmHg) ≥ 30 min

Exclusion Criteria:

* Age\<18 years and \> 80 years
* Pregnancy
* Known history of transfusion reactions
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
* ECOG PS status 0-2;
* life expectancy \>= 12weeks;
* adequate renal, liver and hematological function.

Exclusion Criteria:

* mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
* hemoptysis (\>=1/2 teaspoon of bright red blood) in previous 3 months;
* evidence of tumor invading major blood vessels on imaging;
* evidence of CNS metastases, even if previously treated.
* major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
* prior chemotherapy for stage IIIb/IV disease.