cyrilzakka/clinical-trials huggingface dataset:
Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders

The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks) green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric, inflammation and metabolic parameters in a healthy aging men and women.

A prospective, crossover trial in which every individual served its own control. All subjects undergo a four weeks washout period, during which they briefed to avoid tea drinking and antioxidant supplements until the end of the study. At the end of the washout period, blood and saliva samples is collected after 12 hours of night fast. Subsequently, all subjects receive the maltodextrin containing placebo "tea bags". The subjects instructed to brew the placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (placebo period). After the placebo period, fasting samples collected once more and the subjects receive the green tea bags. Preparation and drinking instructions are the same as the placebo drink. At the end of the 12 weeks, green tea drinking, fasting blood and saliva samples drawn for the third time. During the study, every 4 weeks the subjects get additional placebo or green tea bags. Assessment of nutritional consumption of macronutrients and antioxidants using a food diary, physical activity lifestyle as well as weight, body fat and circumference measurements is made at the beginning, middle and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age: 60-76 Years
* Able to understand the meaning of Informed Consent procedure and willing to consent

Exclusion Criteria:

* Any active disease state
* Unstable chronic disease (diabetes, vascular, renal)
Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

Objectives:

To elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW progression are on patient's function.

Hypothesis to be tested: Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission.

Design and subjects: 110 consecutive ERA patients will participate in this 1-year prospective, hospital-based, cohort study.

Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission. Physical function will be assessed by Health Assessment Questionnaire (HAQ) at each visit. HR-pQCT and radiographs will be performed at baseline, 6 (HR-pQCT only) and 12 months. Quantitative analysis of joint space width (JSW) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by HR-pQCT. Radiographic progression will be scored using van der Heijde-Sharp (SvdH) score.

Outcome measures: The primary outcome is the change in JSW and volume over a period of 12 months. Main secondary outcomes include changes in the i) number and size of erosion, ii) SvdH score and iii) HAQ over a period of 12 months.

Expected results: Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared


Eligibility Criteria:
Inclusion Criteria:

* fulfilled the 2010 ACR/EULAR classification criteria for RA
* have symptoms onset of less than 2 years,
* have active disease (SDAI \>3.3)

Exclusion Criteria:

* have severe clinical deformity at the 2nd, 3rd or 4th MCP joint which precluded a reliable HR-pQCT examination and resulted in motion artefacts influencing the scanning accuracy
* are pregnant or breast feeding
Effect of Acupuncture on Anti Mullerian Hormone and Assisted Reproduction Outcome in PCOS Patients Undergoing IVF

Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.

Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.

Eligibility Criteria:
Inclusion Criteria::

* PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
* infertility
* 20-40 years
* IVF treatment -

Exclusion Criteria:

* patients with disorders that have the similar clinical presentation
* closed both tubes
* abnormal semen parameters
* intracytoplasmic sperm injection (ICSI)
Posterior Capsule Opacification After Lens Capsule Polishing

Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification

Cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. Cataract surgery is nowadays considered a safe and efficient procedure. However, one of the most frequent complications after surgery is posterior capsule opacification (PCO), that results in diminished postoperative visual acuity. PCO occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate.

PCO can be easily treated by performing a neodymium-doped yttrium aluminium garnet (Nd-YAG) laser capsulotomy. However, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. Furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia.

Therefore, it would be necessery to identify different approaches to prevent generation of PCO. One approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. Hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of LECs.

Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract.
* Patients in the age group of 21 years and above.
* Patients with uncomplicated cataract.
* Patients without any relevant systemic or ocular morbidity.
* Patients with well dilating pupils.
* Written informed consent prior to any study specific action.

Exclusion Criteria:

* Patients with complicated cataract.
* Patients having corneal pathology.
* Patients with any form of ocular inflammation.
* Patients with glaucoma, retinal pathologies.
* Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
* Any intraoperative complications like posterior capsule rupture.
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
HydroMARK Post-market Clinical Follow-up Study

The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.


Eligibility Criteria:
Inclusion Criteria:

Safety Cohort

* Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use
* Subject has been followed at least 90 days according to the hospital's standard of care (SOC)
* Subject was ≥ 18 years of age at the time of the breast biopsy procedure
* Subject has accessible medical records documenting the breast biopsy procedure including, at minimum: age, sex, primary diagnostic indication and documentation of device-related adverse events which occurred, if any

Performance Cohort

* Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use
* Patient is ≥18 years of age
* Patient has provided informed consent to participate in study, including follow-up visit for ultrasound imaging at 6-12 weeks post-biopsy

Exclusion Criteria:

Safety Cohort

• Biopsy area was infected at the time of implant

Performance Cohort

* Contraindication to HydroMARK Breast Biopsy Site Marker implantation
* Biopsy area is infected at the time of implant
* Patient has a breast biopsy marker (in the same breast) implanted from a previous procedure
Drug-induced Brugada Syndrome Research Database

All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with drug-induced Brugada Syndrome

Exclusion Criteria:

* Missing Informed Consent Form
* Missing Contact Informations for Follow up
Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM

The purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.

Gestational diabetes mellitus (GDM) was defined as abnormal glucose tolerance detected for the first time in pregnancy. GDM is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. About 50-60% of woman with prior GDM will develop type 2 diabetes during their lifetime. Recent studies show that women with previous GDM exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. For both maternal and future offspring, women with prior GDM need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. The intrauterine device (IUD) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior GDM. Progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. A nonrandomized open-label prospective trial of healthy obese, reproductive-age women in California were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (LNG-IUS) and etonogestrel implant (ENG-I)\] comparing with nonhormonal contraception (NHC). The changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women with diagnosis of gestational diabetes mellitus
* Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization

Exclusion Criteria:

* Age less than 18 years old
* Diagnosis of diabetes mellitus at post partum period
* Cardiovascular disease, Liver disease, autoimmune disease
* The women that reject to continue in the study.
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.


Eligibility Criteria:
Inclusion Criteria:

* must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
* negative pregnancy test prior to enrolment (females)
* agree to practice effective birth control during the study
* treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (\<230 µmol/l (\<2.6 ml/dl)) on Day 1

Exclusion Criteria:

* receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
* pulmonary vascular resistance ≥4 Wood units despite medication
* required an emergency ventricular assist device within one week prior to transplantation
* significant renal impairment
* significant liver disease
* malignancies or a history of malignancy within the last 5 years
* significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
* requires systemic immunosuppressive medication for any other indication than transplantation
* diagnosis of cystic fibrosis
* pregnant or breast-feeding
New Transporting Solution in Parathyroid Allotransplantation

The aim of this study is to measure of the parathyroid cell viability and the the amount of calcium sensing receptor of the parathyroid cells which were placed into a new transportation solution (BAVU solution) for parathyroid allotransplantation.

The cold ischemia of organs, has harmful effects on the tissues due to oxidative stress and inflammation. This is physiopathologically defined as ischaemia/re-perfusion injury (IRI) in organ transplantation. Parathyroid allotransplantation has an increased popularity at the last decade. But the cold ischemia due to transportation of the transplant tissue is a very important problem.

Calcium sensing receptor plays a crucial role in regulating Parathormone secretion which means controlling of the calcium-dependent systemic ion homeostasis.

The investigators developed a new tissue transporting solution for parathyroid allotransplantation and the investigators measured the parathyroid cell viability and the the amount of calcium sensing receptor of the parathyroid cells at the 0., 6., 12. and 24. hours of the parathyroid cells which were placed into our new solution.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have parathyroid hyperplasia due to chronic renal failure

Exclusion Criteria:

* Patients who refused to join to the study
* Patients younger than 18 years and older than 80 years.
* Patients who have hepatitis B,
* Patients who have hepatitis C,
* Patients who have human immunodeficiency virus (HIV)
Physical Activity Recommendation Behaviour in German Psychiatrists

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Psychiatrists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychiatrists.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Eligibility Criteria:
Inclusion Criteria:

* Physician specialized in psychiatry or currently in training for specialization in psychiatry
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None
Light Constraint Induced Therapy Experiment

The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.

The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).

Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.

Eligibility Criteria:
INCLUSION CRITERIA:

* Age \> 18 years
* First ischemic or hemorrhagic stroke between 2 and 12 months
* at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
* adequate balance while wearing the restraint

EXCLUSION CRITERIA:

* Major cognitive impairment
* Prior stroke
* Excessive fatigability
* Severe aphasia
* MAL score ≥ 2,5
* Specific exclusion criteria for fMRI ancillary study
Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 and under 80 years of age
* Suffering of common spinal pain: cervical pain including cervico-brachial neuralgia, lumbar pain including lumbo-radiculalgia
* Having attended a "pain consultation" or referred to a pain consultant during hospitalization
* Having signed the consent form
* Can be contacted directly by phone if patient is not hospitalized
* Be affiliated to a national insurance scheme or benefiting from such a program

Non-inclusion Criteria:

* Pregnant or breast-feeding women
* Patients with a pacemaker
* Patients whose skin condition makes the use of SCENAR impossible (wounds, recent scars, skin infections)
* Patient whose spinal pain is known to be related to inflammatory pathology (spondylarthropathy, rheumatoid arthritis, chondrocalcinosis), trauma (fractures and dislocations), tumor (metastases, myeloma localization), spondylodiscitis infectious, neurological (intrarachidian tumor or posterior fossa) or radiculalgia with deficient signs
* Patients who have already had a SCENAR session
* Patients who have already participated in this study
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM

Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysis).

3D customized airway stents (computer-aided conception using CT-scan data), perfectly suited to airway anatomy, should improve the tolerance and safety of airway stenting.

We demonstrated in a previous pilot study, dedicated to patients with anatomically complex stenoses the safety of 3D patient-specific stents. These appealing results in highly complex situations suggest the need to evaluate these devices in more common situations.

In this study we aim to test our new generation stents in all patients planned for airway stenting. After computer-assisted segmentation of airways (VGStudioMAX 3.0 software), the stenosis is virtually corrected, leading to the conception of a virtual stent (AnatomikModeling, Toulouse), allowing for the fabrication of a mold using a 3D printer. The stent is then built and sterilized (NOVATECH, Berlin) and inserted during rigid bronchoscopy.

Close follow up is then conducted, including clinical evaluation after one week, three, six and 12 months; spirometry at one week, 3 months, 6 months and 12 months and chest CT-scan at one week.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Informed consent
* Complex, proximal and symptomatic (dyspnea, cough, peak flow \< 50%, FEV1 \< 50% or post-stenotic infection) airway stenosis

Exclusion Criteria:

* Acute respiratory distress, mechanical ventilation
* Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
* Pregnancy
Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards

After reports from observational studies suggesting an association between acutely ill medical patients and venous thromboembolism (VTE), interventional trials with anticoagulants drugs have demonstrated a significant reduction of VTE during and immediately after hospitalisation. Although several guidelines suggest the clinical relevance of reducing this outcome, there is a low tendency to use anticoagulants in patients hospitalised for acute medical illness. This observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

Epidemiological studies have provided evidence of a high rate of thromboembolism in patients hospitalised in medical wards. Based on this, several clinical trials with anticoagulants including low-molecular-weight heparin (LMWH) and fondaparinux have been performed in patients hospitalised for acute medical illness to prevent thromboembolism. Interventional trials consistently showed that prophylaxis with anticoagulants reduces the risk of composite endpoints of deep venous thrombosis (DVT), pulmonary embolism (PE) and DVT-related death. These results prompted recommendation to the use anticoagulant prophylaxis in patients hospitalised for acute medical illness, but, despite this, there is a widespread underuse of anticoagulant prophylaxis in the medical wards of hospitals.

This observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

Eligibility Criteria:
Inclusion Criteria:

* pneumonia
* heart failure
* Chronic Obstructive Pulmonary Disease
* Kidney failure
* syncope
* atrial fibrillation
* Urinary Tract Infection
* Anemia
* arthritis
* Diabetic Ketoacidosis
* unstable angina
* asthma
* cirrhosis

Exclusion Criteria:

* treatment with vitamin k inhibitors
* surgical interventions
* deep venous thrombosis
* pulmonary embolism