cyrilzakka/clinical-trials huggingface dataset:
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available. The investigators hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea. To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult patients in several hospitals.

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patient (≥ 18 years)
* patient hospitalized
* patient receives systemic antibiotic treatment
* patient contractually capable
* patient able to follow study procedures
* informed consent of patient

Exclusion Criteria:

* allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.
* central venous catheter
* immunosuppression
* diarrhoea and/or chronic diarrhoea
* regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study
* systemic antimycotic treatment
* systemic antibiotic treatment within the last 6 weeks
* no protection against conception, pregnancy, or lactation
* simultaneous participation in other clinical trials
Berlin Magnetic Seizure Therapy Depression Trial 01

This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with a severe major depressive episode
* Patient is in a chronic current MDE and/or has had a history of recurrent MDEs
* Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode
* Patient has a score \> 20 on the HAMD24
* Patient is stable on current psychotropic medication for at least 4 weeks
* Patient is \> 25 and \< 80 years

Exclusion Criteria:

* Atypical Depression or psychotic depression (according to DSM IV)
* Other relevant psychiatric axis I or axis II diseases
* Relevant neurological diseases
* Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score \> 3)
* Patient is currently enrolled in another investigational study not associated with the current study
* Patient has a history of, or evidence of, significant brain malformation or significant head injury
Increasing Physical Activity Among Overweight Women With Mobility Disabilities.

This study aims to increase physical activity among overweight African-American women with mobility limitations.

Regular, sustainable physical activity can have a dramatic effect on reducing obesity and other secondary conditions and increasing quality of life. People with mobility limitations have a higher level of physical inactivity resulting from numerous personal and environmental barriers to physical activity participation. This project will evaluate the feasibility of increasing physical activity among overweight individuals with mobility limitations through physician-referrals to a personalized exercise programme at the Chicago-based National Center on Physical Activity and Disability (NCPAD).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Self-reported mobility limitation
* BMI greater than or equal to 27
* Receiving care at the University of Illinois, Chicago (UIC) Medical Center
* Sedentary

Exclusion Criteria:

* did not receive physician approval to participate
A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
* Age \>18 and \<65 years
* Signed informed consent
* If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
* If male, patient agrees to use an acceptable barrier method for contraception
* ECOG performance status \<2
* Platelet count \>100.000/mmc
* Hemoglobin \>7.5 g/dL
* Absolute neutrophil count (ANC) \>1.500/mmc
* Serum calcium \<3.5 mmol/L (\<14 mg/dL)
* AST/ALT: \<2.5 x the ULN
* Total bilirubin: \<1.5 x the ULN

Exclusion Criteria:

* Previous treatment with velcade
* Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
* Immunotherapy or antibody therapy within 4 weeks before enrollment
* Experimental drug or medical device within 4 weeks before start of treatment
* Major surgery within 4 weeks before enrollment
* History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
* Peripheral neuropathy of NCI CTCAE Grade 2 or higher
* Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
* Need for therapy with concomitant CYP 3A4 inhibitors or inducers
* HIV-positive, if known
* Hepatitis B surface antigen-positive or active hepatitis C infection, if known
* Active systemic infection requiring treatment
* If female, pregnancy or breast-feeding.
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee

The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with microfracture, while the other will only receive microfracture as a control group.

Decalcification bone scaffold is a tissue engineering scaffold with the closest biomechanics and structure of normal cartilage. The objective of the study is to evaluate the clinical efficacy of arthroscopic decalcification bone scaffold combined with microfracture in the repairment of articular cartilage defects by randomized controlled trial. Sixty patients with clinically diagnosed knee cartilage injury according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with decalcification bone scaffold combined with microfracture .The control group will be treated with microfracture . The patients will be treated by the same surgeon in this study group. MRI evaluation, Lysholm score, IKDC score, Tegner score, VAS score are selected as the measures of outcome, while the blood routine, blood biochemistry, urine, CRP, ECG and other laboratory tests will be recorded inclduing the incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old, male or female
* Cartilage defect 2-8 cm²
* Subjects have the surgical indication of microfracture and no contradiction
* Subjects participate the clinical trial voluntarily, and sign informed consent
* Subjects could comply with follow-up

Exclusion Criteria:

* Participated in other drug or medical device clinical trials in the last 6 months.
* Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
* Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
* Complex multi-ligament injury
* Suffered from systemic immune disease or systemic, locally infected
* Joint fibrosis, joint rigidity, mobility was significantly limited
* Moderate and severe osteoarthritis
* With contraindications to MRI
* Hemophilia
* General condition can not tolerate surgery
* Pregnant or planned pregnant women and lactating women
* With abnormal spirit and selfless ability
* Other circumstances judged by doctors that can not participate in the trial
Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy

This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.

This study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. A total of 224 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who is informed and give a consent in voluntary
* Patients who is scheduled a colonoscopy
* BMI 19≤and\<30

Exclusion Criteria:

* Patients who participate in other interventional study or had participated within 30 days before screening
* Pregnant or breast-feeding women who do not want to stop breast-feeding
* Women of childbearing potential who do not agree with appropriate contraception during this study
* Patients who had experienced any hypersensitivity study drug or ingredient
* Uncontrolled hypertension
* Arrhythmia with clinically significant findings from EKG
* Congestive heart failure; NYHA functional class III or IV; unstable coronary artery disease; myocardiac infarction history within 6 months
* Uncontrolled diabetes
* Active infection except acute upper respiratory infection or local skin infection; Fever (38 °C and higher) within 1 week before study administration
* HIV infection and/or chronic hepatitis B or C
* Patients who has a difficulty to participate because of severe nausea or vomiting
* Suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon
* History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
* Colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting)
* Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
* Severe dehydration risk (e.g., rhabdomyolysis, ascites)
* History of hypersensitivity of drug or others
* Alcohol or drug abuse within 6 months
* Clinically significant underlying disease or medical history at investigator's discretion
Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males

Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. This study will determine if an effective strategy includes increased physical activity in conjunction with higher intakes of dairy products immediately following exercise. Fifty-six overweight adult males who do not regularly exercise will be assigned to one of four groups for 12 weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5 times per week). Two groups will consume supplemental low fat milk (3 servings per day) with one these groups consuming it immediately after exercise while the other will consume it either well before or long after the exercise session. The other two groups will consume a carbohydrate drink that has the same amount of energy as the low fat milk, with one of these groups consuming the drink right after exercise and the other another group will consume it either well before or long after the exercise session. Markers of health status including body weight, muscle mass, and bone mass will be measured at the start and after the 12- week intervention. The investigators anticipate that providing the low fat milk immediately after exercise will result in the most favorable changes in health outcomes, and provide a realistic lifestyle intervention for overweight individuals to attain a healthy body weight, and by doing so, optimize their ability to prevent chronic disease.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater or equal to 25
* healthy

Exclusion Criteria:

* any chronic cardiovascular condition or metabolic condition
* kidney disease
* gastro-intestinal disease
* milk or dairy protein allergies
* lactose intolerance
* chronic lung conditions
* any condition that could potentially prevent participant from performing exercise
* allergy to local anaesthetics
* cumulative x-ray exposure and cumulative muscle biopsies
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age;
2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
3. Sufficient recanalization within 9 hours of stroke onset;
4. Sufficient recanalization （TICI 2b-3）;
5. Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;
6. First ever stroke or mRS≤1 after previous disease
7. The availability of informed consent.

Exclusion Criteria:

1. Acute ischemic stroke patients with insufficient recanalization（TICI \< 2a）
2. Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）;
5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
6. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
7. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
8. Pregnancy, plan to get pregnant or during lactation;
9. Patients with contraindication or allergic to any ingredient of drugs in our study;
10. Unsuitable for this clinical studies assessed by researcher.
Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity

The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity.

The main questions it aims to answer are:

Is glycemic control worse in diabetic patients with sarcopenic obesity? Are irisin levels higher in patients with non-sarcopenic obesity?

Participants will be asked to:

* Fill in three questionaries on lifestyle
* Perform two physical performance tests

The investigators will collect the following data:

* Anthropometric measurements
* Body composition by bioelectrical impedance analysis.
* Results of routine blood analyses
* Irisin levels by drawing a vial of blood from the antecubital vein

Patients will be enrolled from our Diabetology Center. Eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit.

The patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. All visits will be performed in the afternoon, at about 4-6 p.m.

Participants will be asked to:

* Fill in three questionaries (SARC-F \[Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire\], IPAQ-EIT \[International Physical Activity Questionnaire validated in the Elderly Italian population\], MEDI-LITE \[Adherence to the Mediterranean diet questionnaire\])
* Perform two physical performance tests (5-times chair stand test and handgrip test).

Anthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. A venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2 diagnosed less than 10 years before
* age \>60 years
* BMI (Body Mass Index) \>30 kg/m2
* eGFR (estimated Glomerular Filtration Rate) \>30 ml/min
* On stable antidiabetic therapy for at least 3 months

Exclusion Criteria:

* Insulin or insulin secretagogues use
* Diabetes mellitus type 1, previous diabetic ketoacidosis
* Neuromuscular diseases
* Endocrinopathies that may cause myopathies (hypercortisolism, GH \[growth hormone\] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism)
* Severe vit. D deficiency (\<12 ng/ml)
* Hemoglobinopathies
* Prolonged immobilization
* Pathologies with fluid retention (heart failure with NYHA \[New York Heart Association\] class III/IV, severe renal insufficiency, hepatic insufficiency)
* Active tumors in the past 5 years
* Severe arthritis of the knee or hip
* Pacemaker wearer
Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

The goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. Researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

Patients with peripheral artery disease who will be undergoing femoral endarterectomy will be randomized 1:1 to receive colchicine (0.6mg oral) or placebo daily for 4 weeks prior to 18F-FDG PET/CT imaging. At the baseline visit, study procedures will be reviewed with eligible participants and the study team will obtain written informed consent. Baseline blood samples for laboratory studies will be collected and assayed, as well as additional blood samples for research. Participants will completed study questionnaires at baseline and at the imaging visit. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. At the imaging visit, participants will repeat laboratory tests and undergo non-invasive molecular imaging to evaluate the effects of colchicine on the extent of atherosclerotic plaque macrophage activity as assessed by 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. Diagnosis of peripheral artery disease
3. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
2. Allergy to colchicine
3. Presence of medication with drug-drug interaction
4. Acute limb ischemia requiring emergent intervention
5. Vascular connective tissue disorders
6. Autoimmune/autoinflammatory disorders
7. Systemic infection
8. Blood dyscrasia
9. Pregnant or lactating women
10. Uncontrolled diabetes (A1C \>10%)
11. History of CrCl \< 30 mL/minute or ESRD (HD)
12. History of liver disease or chronically-elevated (\>3 months) ALT/AST \> 3.0 x ULN
13. Claustrophobia
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Eligibility Criteria:
Pre-operative Inclusion Criteria:

* Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular surgery
* Patient is willing and able to give prior written informed consent for investigation participation;
* Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

* Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
* The TBS(s) has been treated with HEMOBLASTTM Bellows as per their instructions for use.

Exclusion Criteria:

* Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
* Patient has religious or other objections to porcine, bovine, or human components;
* Patient has any significant coagulation disorder;
* Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
* Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator