cyrilzakka/clinical-trials huggingface dataset:
Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.

The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. Secondary objectives included assessments of efficacy through measuring time to target blood pressure (BP) lowering effect defined as 15% reduction in SBP, change in mean arterial pressure (MAP) and the incidence of bailout by causality. Assessments for safety included change in heart rate (HR) from baseline.

Eligibility Criteria:
Pre-randomization Inclusion Criteria:

* Provide written informed consent before initiation of any study-related procedures.
* Be at least 18 years of age
* Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting \[CABG\], Off Pump Coronary Artery Bypass \[OPCAB\], Minimally Invasive Direct Coronary Artery Bypass \[MIDCAB\] surgery, and/or valve replacement/repair procedures)

Pre-randomization Exclusion Criteria:

* Women of child-bearing potential (unless they have a negative pregnancy test)
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing left bundle branch block or permanent ventricular pacing
* Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial.
* Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study

Post-randomization Inclusion Criteria:

* Expected to survive beyond 24 hours post-surgical procedure
* No surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study
* Determined to be hypertensive (SBP \> 140 mm Hg) within 4 hours of arrival in a postoperative setting
* It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value
Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.

Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary type 2 diabetes mellitus
2. BMI ≥ 24 kg•m-2
3. 30-70 years old
4. HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L
5. Informed consent has been signed
6. stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation

Exclusion Criteria:

1. The patients accepted diabetic treatment for more than a month continuously
2. The patients were treated by drugs in 3 week before they were given test drugs
3. Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
4. The contractive pressure \>160 mmHg or diastolic pressure \>100 mmHg
5. Pregnant, preparing for pregnancy or breast-feeding women
6. Mental patients
7. The patients who have serious heart, lung, liver, kidney and brain or other primary complications
8. Allergic persons
9. The patients who are attending other clinical trial
10. The patients who have serious diabetic complications
11. The patients who ever attended this clinical trial
12. Alcohol and / or psychoactive substances, drug abuse and dependency
13. The person maybe loss for some reason such as work or life condition according to the investigator's judgement
14. The lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable
15. The patients who are eating some drugs or health food which can affect the body weight
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes.

Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged over 18 years
* people with skin ulcers of the lower limbs for at least 3 months

Exclusion Criteria:

* Lesion with a diameter larger than 12 cm ²
* injury over 2 years of evolution; injury infected
* neoplastic lesions in activity
* poorly controlled diabetes mellitus
* HAS poorly controlled
* signs of ischemia in the limb
* not offset any disease
* allergic to components of formula
* urticaria
* pregnancy
* breastfeeding
* emotional disturbance
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease

Primary objective:

To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.

Secondary objectives:

Comparison, between the two treatment groups, of :

* Primary patency,
* Assisted primary patency,
* Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
* Ankle Brachial Pressure Index (ABPI) changes from baseline


Eligibility Criteria:
Inclusion Criteria: A patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled:

* Informed consent obtained;
* Chronic background treatment with daily ASA, whatever the dose, started at least 4 weeks before surgery. A window of a few days without ASA before surgery is acceptable, according to local practice. Post-randomization use of ASA must be between 75 and 100 mg/day.
* Unilateral below knee bypass graft (i.e. the distal anastomosis is below the level of the knee joint) for atherosclerotic PAD within the previous 4 days;
* Demonstration of initial patency of the index graft by an objective measurement (e.g. intra-operative Doppler scanning, flow measurement, angiography, Duplex scanning) during bypass surgery, or between surgery and the time of randomization;
* No clinical evidence of graft occlusion at time of randomization.

Exclusion criteria :

PAD medical/surgical history

* Onset of PAD symptoms before the age of 40 years
* Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome)
* Patient receiving aorto-bifemoral, iliac-femoral or crossover (femoral-femoral) grafts, or undergoing peripheral transcutaneous angioplasty (PTA), with or without stenting, during the same surgery.

Medical history related to bleeding risk

* Current active bleeding at surgical site
* Withdrawal of an epidural catheter less than 12 hours before randomization
* Current active bleeding or increased risk of bleeding, such as severe hepatic insufficiency, proliferative diabetic retinopathy, peptic ulceration, bleeding diathesis or coagulopathy
* Peptic ulceration within 12 months of randomization
* Previous or current intracranial hemorrhage or hemorrhagic stroke, or any previous stroke for which the diagnosis of hemorrhagic stroke cannot be excluded
* Any history of severe spontaneous bleeding such as gastrointestinal bleeding, gross hematuria, intraocular bleeding

Other medical conditions

* Previous disabling stroke (severe cerebral deficit such that the patient is bedridden or demented)
* NYHA Class IV heart failure
* Uncontrolled hypertension: Systolic Blood Pressure (SBP) \> 180 mm Hg, or Diastolic Blood Pressure (DBP) \> 100 mm Hg
Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

This study represents an important step to validate the use of contrast-enhanced ultrasound (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be used to accurately assess therapeutic improvements in tissue perfusion that are linked to symptom improvement.

The study will be performed in patients with known history of PAD that are scheduled to undergo either surgical or percutaneous revascularization. Limb rest-stress CEU perfusion imaging will be performed before and 3-4 weeks after revascularization. Quantitative measurements of pre-revascularization perfusion, post-revascularization perfusion, and change in perfusion will be compared to symptom status (Rutherford classification and PAD \[Criqui\] questionnaire) at each study point, and to data on time to onset of claudication on an upright treadmill exercise study (Gardiner protocol). Results of angiography will be scored and allow determination of the relationship between angiographic severity of disease and exercise perfusion.

Eligibility Criteria:
Inclusion Criteria:

1. History of symptomatic PAD
2. Rutherford score \<6
3. Age ≥18 y.o.
4. Scheduled to undergo surgical or percutaneous revascularization

Exclusion Criteria:

1. Major medical illness affecting the limb other than PAD (muscle disease, neuromuscular disease, blood diseases).
2. Pregnant or lactating females (- HCG in women of child bearing age)
3. Hypersensitivity to any ultrasound contrast agent
4. Evidence right-to-left, bi-directional, or transient cardiac shunt; unexplained pulmonary hypertension (PA systolic pressure \>40 mm Hg) or more than moderate reduction in left ventricular systolic function identified on screening echo.
5. Allergy to eggs
6. Inability to perform modest plantar flexion exercise
Prevalence of Dementia and Delirium in Outpatient Clinics (DESTAN Trial)

The aim of this study is to assess the prevalence and etiologic risk factors of delirium in outpatient geriatric patients and also hospitalized patients.

This study aimed to investigate the frequency of delirium and examines the association between delirium and other possible risk factors and prognostic factors (dementia etc.)

Eligibility Criteria:
Inclusion Criteria:

* We included all 65 years older patients who evaluated according to a comprehensive geriatric assessment that is consistently performed during admission to the outpatients' clinic of the hospital.

Exclusion Criteria:

* Exclusion criteria were serious psychiatric disorders such as schizophrenia or major depression.
Video Consultation During Follow up Surgical Care

The aim of this study was to compare the willingness to use and attitude towards VC amongst both patients with colorectal cancer and healthcare providers during follow up care. Second, to determine the satisfaction with the quality of the healthcare provider and the usability of the used VC technology. 50 patients will be asked to choose between video consultation or face-to-face contact at the outpatient surgical clinic.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Fluent in speaking and writing in Dutch
* Follow up appointments in which overall progress, new complaints, results with good news and treatment was discussed were considered feasible.

Exclusion Criteria:

* Introductory appointments
* Bad news consultations
* Physical examination needed
* No access to Internet
* No access to a smartphone, tablet or computer with a camera
* Not willing to activate their electronic patient portal
Probiotics for Weight Loss

This study will investigate a compound of probiotics and prebiotics in females and males with overweight with the aim to evaluate the effect on weight and metabolic markers.

The design is a three month randomized doubled-blinded, three-armed placebo-controlled trial of probiotics for weight loss. Normal dose (2 capsules á 0.4g per day) doubled dose (4 capsules á 0.4g per day), or placebo.

A second, non-blinded, phase with only the compound of probiotics and prebiotics, with tripple dose (6 capsuled á 0.4g per day), will be performed for individuals who had the compound in the first phase.

Participants Total number of study participants will be 75-90, consisting of overweight men and women, 18-45 years of age.

Treatment Dietary supplement consisting of probiotic capsules called LB001. It contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram. The placebo is made of rice flour.

Since one of the inclusion criteria is "willingness to lose weight", all study participants, regardless of randomized treatment, will receive general advice regarding healthy lifestyle habits.

Eligibility Criteria:
Inclusion Criteria:

* BMI 26.0 - 29,99 kg/m2
* 18-45 years old
* Willingness to lose weight

Exclusion Criteria:

* Active weight loss in the last three months
* The desire for or planned pregnancy upcoming months
* Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disorder (IBD), gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease)
* Allergies with previous anaphylactic reactions
* Abdominal surgery six months prior to inclusion
* Current or history of eating disorders
* Extreme or unusual diets for the last three months, which the investigator considers could negatively affect the outcome of the study
* Psychiatric disorders (e.g., schizophrenia, and other diagnoses that may influence compliance)
* Drug or alcohol abuse
* Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study
* Present or recent usage of other probiotic agents
* Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance
Physiotherapy Management in Women With Urinary Incontinence

Main objective:

The primary aim of the study is to assess whether the author's exercise programme has an effect on reducing urinary incontinence and pelvic floor dysfunction after childbirth, considering vacuum extractor, forceps and caesarean section deliveries.

Secondary objective:

The secondary objective is to determine whether the duration of the author's exercise programme is sufficient to achieve positive changes in women.

The study will involve women with stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. Participants will be women aged 20-80 years (meeting inclusion criteria: urinary incontinence, regular menstrual cycles, pre-and post menopausal period, natural childbirth or cesarean section, and deliveries using forceps and vacuum extractors; exclusion criteria: no urinary incontinence, irregular menstrual cycles, no childbirth, abdominal surgeries/procedures, active cancer, no gynecological check-up in the last 12 months, recurrent urogenital infections, joint hypermobility). A total of 300 women will be examined, including 100 women meeting the inclusion criteria, 100 women meeting the inclusion criteria but not interested in exercising, and 100 healthy women. Participants can withdraw from the study at any stage.Study Group Division

Based on the evaluation of posture type, pelvic pattern, and postural stability, participants will be divided into three groups:

1. Women meeting inclusion criteria performing the author's exercise program - experimental group.
2. Women meeting inclusion criteria but not interested in performing the author's exercise program - control group.
3. Healthy women - control group. The experimental group will perform the author's pelvic floor muscle exercise program daily for six weeks, at a fixed time each day, under weekly physiotherapist supervision and independently on other days (after proper instruction by the physiotherapist).

Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence
* Regular menstrual cycles
* Pre and post-menopausal period
* Natural childbirth or cesarean section
* Deliveries using forceps and vacuum extractors

Exclusion Criteria:

* No urinary incontinence
* Irregular menstrual cycles
* No childbirth
* Abdominal surgeries/procedures Active cancer No gynecological check-up in the last 12 months Recurrent urogenital infections Joint hypermobility

Contorl group will be healthy women
Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil

The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of crack abuse or dependence
* \> 18 years old
* Initiating treatment (maximum of 1 month)

Exclusion Criteria:

* Homeless without permanent contact
* Psychotic symptoms during the intake interview
Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions.

The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* COLD with forced expiratory volume at one second (FEV1) \<50%, without long term oxygen therapy
* COLD with FEV1 \<50%, with long term oxygen therapy
* ILD with diffusion capacity of lung for carbon monoxide (DLCO) \< 50%, without long term oxygen therapy

Exclusion Criteria:

* comorbidity which decreases cognitive function
* comorbidity which decreases concentration
* physical comorbidity which makes it impossible to complete the test
Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery.

The main questions it aims to answer are:

* to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model.
* to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis.

Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..


Eligibility Criteria:
Inclusion Criteria:

* Male patients over 18 years of age
* Patients, without genetic pathology, scheduled for epididymal sampling surgery
* Patients with cystic fibrosis or bilateral vas deferens agenesis, scheduled for epididymal sampling surgery.
* Signature of a consent form

Exclusion Criteria:

* Patients not scheduled for epididymal harvesting surgery
* Patients under legal protection (guardianship, curatorship)
* Refusal to participate