cyrilzakka/clinical-trials huggingface dataset:
Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)

The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.

Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic critical limb ischemia (Rutherford 4 - 6)
* Patients with signed informed consent
* Target lesion length \< 8 cm by angiographic estimation
* Stenosis of \>50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
* Reference vessel diameter should be 2.0-4.5 mm

Exclusion Criteria:

* Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
* Patient takes warfarin
* Patient has a history of previous life-threatening contrast media reaction
* Patient is currently enrolled in another investigational device or drug trial
* Patient is currently breast-feeding, is pregnant, or intends to become pregnant
* Patient is mentally ill or retarded
* Acute critical limb ischemia
* Major bleeding history within prior 2 months
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* Life expectancy \<1 year due to comorbidity
* Reference segment diameter is not suitable for available stent design
* Previously implanted stent(s) or PTA at the same lesion site
* Inflow-limiting arterial lesions left untreated
Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer

The purpose of the study is:

To estimate patients with lung cancers who will undergo surgery total haemostatic / thrombotic capacity pre, per-and postoperatively.

To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH) affects the patient's potential hypercoagulability.

To investigate whether there are differences in patients who will undergo Video Assisted Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.

Lung cancer is a serious and very frequent disease. For those 25% of the patients who will undergo surgery, there are two different methods of operation: either open surgery (thoracotomy) or Video Assisted Thorascopic Surgery (VATS). The latter method is increasing in use.

Patients are often prescribed heparin pre- postoperatively, but it is unclear whether this prophylactic treatment is necessary, and it has never been thoroughly investigated.

When patients receive heparin there is an increased risk of bleeding.

Furthermore, it is unclear what changes occurs in the coagulation system pre, per- and postoperatively in patients undergoing surgery for lung-cancer, and hereby it is unclear whether these patients should have some sort of medical prophylactic treatment.

By using new analysis methods in terms of Thromboelastometry, Thrombin generation and thrombocyte function analysis, hereby the total coagulation profile can be characterized and hereby estimate the risk of thrombosis and bleeding. Thereby better be able to give the right treatment for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Undergo surgery for lung cancer with an expected lobectomy or bilobectomy
* The surgery shall be VATS (for patients in the group randomized to other low molecular weight heparin and no prophylactic)
* Willing to be randomized (VATS-patients)
* Over 18 years old.
* Able to give assigned informed consent
* Women should be prescribed secure anticonception.

Exclusion Criteria:

* Thromboembolic events within the last three months (both venous and arterial)
* Pregnant
* Lactating
* Treatment with anticoagulation therapy in terms of vitamin K antagonist or direct or indirect thrombin inhibitors (dabigatran, apixaban or rivaroxaban)
* Treatment with thrombocyte function inhibitors in terms of Clopidogrel, ASA (acetylsalicylic acid), prasugrel and ticagrelor, and no pause of minimum 5 days (7 days with regards of prasugrel) before surgery
* Allergy for LMWH
Screening for Genes in Patients With Poikiloderma

In the context of this study, the investigators wish to take advantage of high-throughput genetic techniques (microarray and high-throughput exome sequencing) to identify new genes implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these syndromes, opportunities for genetic counselling for patients and their families and the follow-up of patients, notably with regard to the risk of tumours.

This study will make it possible to identify new genes implicated in syndromic poikiloderma and improve the diagnostic strategy proposed to patients with these syndromes, and to propose to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who would like to have one for future pregnancies.

The identification of new genetic causes of syndromic poikiloderma will also make it possible to complete the current classification of these syndromes


Eligibility Criteria:
Inclusion Criteria:

patients with syndromic poikiloderma, defined by the association of poikiloderma with other extradermatological clinical signs,

* normal array-CGH, screening for chromosomal rearrangements,
* absence of mutations in the genes RECQL4, KIND1 or C16orf57,
* sporadic or familial involvement.

Exclusion Criteria:

* None
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup and AF.

EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation as well as the early optimization of cardiac resynchronization therapy via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator backup (CRT-ICD) and paroxysmal or persistent AF.

300 patients with a documented history of AF will be enrolled and randomized 1:1 to standard patient management or AF management and early optimization of CRT via Home Monitoring. The patient outcome regarding days lost due to cardiovascular mortality, cardiovascular hospitalization and inappropriate ICD therapy will be documented during an observational period of 1 year.

Another 300 patients undergoing CRT-ICD implantation without a history of AF will undergo an AF evaluation during the first three months of CRT. If a patient shows an AF episode during this period, he is eligible for study inclusion. If no AF episode occurs during AF evaluation, the patient be treated as screening failure.

Eligibility Criteria:
Inclusion Criteria:

* Indication for CRT with ICD-backup
* Paroxysmal or persistent AF
* Optimized HF-related medication

Exclusion Criteria:

* Permanent AF
* Contraindication for anticoagulation
* Stroke within the last 6 weeks
* Acute coronary syndrome within the last 2 months
* Cardiac surgery within the last 2 months
* Acute myocarditis
* Severe chronic obstructive pulmonary disease (COPD)
* Planned cardiac surgery or interventional measures within the coming 3 months
* Dialysis dependency
* Life expectancy \< 12 months
* Insufficient GSM (Global System for Mobile Communication)/GPRS (General Packet Radio Service)-network coverage
* Previously implanted unipolar right atrial lead
* Previously implanted right atrial lead with tip-ring distance \> 11 mm
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease

Open-label study with 30-day run-in phase and adaptive design component to include more participants if deemed appropriate by investigators.

This is a within-subject, controlled open-label study seeking to determine if PTC-589 can alter the biochemical signature of Parkinson's disease as assessed by peripheral blood biomarkers, central nervous system (CNS) biomarkers, and urine biomarker analysis. In addition, data on a number of disease-relevant clinical measures will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr stage ≤3.0
* Ambulatory with or without assistance
* Sexually active fertile participants and their partners must agree to use medically accepted methods of contraception (such as, hormonal methods, including oral, subcutaneous, and intrauterine; barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.
* Willingness and ability to comply with study procedures
* If on medications for Parkinson's disease drugs, then medication regimen must be stable for 60 days prior to enrollment
* Abstention from use of other investigative or non-approved drugs for the duration of the trial

For Idiopathic Participants

* A diagnosis of idiopathic Parkinson's disease confirmed by the presence of bradykinesia plus one or both of the following symptoms: rigidity or resting tremor; and with an abnormal DaTscan consistent with a dopaminergic deficit
* Age 40 to 75 years
* Within 5 years of diagnosis of Parkinson's disease

For Genetic Subtype Participants

* A confirmed diagnosis of Parkinson's disease plus a genetic diagnosis consistent with Parkinson's disease, specifically PTEN-induced kinase 1 (PINK1), parkin, Leucine-rich repeat kinase 2 (LRRK2) or other mitochondrial genetic subtype
* Age 21 to 75 years

Exclusion Criteria:

* Allergy to PTC-589 or other components of the PTC-589 tablet formulation
* Use of antioxidant supplements, specifically vitamins E and C beyond the recommended daily allowance
* Other Parkinsonian disorders
* Montreal Cognitive Assessment (MoCA) score of \<24
* Revised Hamilton Rating Scale for Depression ≥11
* Parkinsonism due to drugs or toxins
* Diagnosis of any other clinically significant neurologic disease that will confound the assessment of effect of study drug on disease progression
* Malignancy within past 2 years
* Pregnant or plans to become pregnant or breast feeding
* History of stroke
* History of brain surgery
* Hepatic insufficiency with liver function tests (LFTs) \>3 times upper limit of normal
* Renal insufficiency as defined by creatinine \>1.5 times normal
* End stage cardiac failure
* Participation within past 3 months and for duration of study in a trial of a device, drug, or other therapy for Parkinson's disease
Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women

Like in the full immersion, studied in the context of diving, immersion in water causes a cascade of events with hemodynamic and hormonal consequences.

First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60 minutes later, hypovolemia by stimulating diuresis.

Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.

However, when the labor progresses, the dilatation bath is no longer sufficient and epidural analgesia remains the only effective method to control pain.

Used before the realization of an epidural analgesia, dilatation bath could affect blood volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked to the installation of sensory block of the epidural analgesia in the parturient (severe prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal distress).

Before beginning a study in pregnant women, it seems essential to study the hemodynamic consequences of the dilatation bath in a comparable population of volunteers healthy young women and out of the obstetrical context.


Eligibility Criteria:
Inclusion Criteria:

Healthy female volunteers aged 18 to 45 years

Exclusion Criteria:

* pregnancy
* menopause (confirmed for at least 12 weeks)
* breastfeeding
* Proteinuria\> 2 cross on the dipstick
* Glycosuria \> 2 cross on the dipstick
* subject with no empty stomach for at least 8 hours
* Taking medication in the week before the test affecting diuresis, production of antidiuretic hormone or on the cardiovascular system: paracetamol, nonsteroidal anti-inflammatory Alcohol intake the day before the tes
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.

Eligibility Criteria:
Inclusion Criteria:

* Primary renal transplant recipients with end stage renal disease
* No prior history of diabetes mellitus before transplant
* Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) \< 50%
* Absence of severe infection and hepatitis C or B infection
* Efficient contraception in women during the study

Additionally must meet one of these "Metabolic Criteria

* Recipient age \>or =60 or
* Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) \>200mg/dl or the combination of a body mass index (BMI)\> 27 and Triglycerides\>150 mg/dl or the combination of HDL-cholesterol\<40 mg/dl for men or \<50 mg/dl for women and Triglycerides \>150 mg/dl.

Exclusion Criteria:

* Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
* Recipient age under 45
* Patients receiving a second renal transplant
* Patients with high immunological risk or PRA (panel reactive antibody level) \>or =50%
* Severe infection or hepatitis C or B infection.
* Dual renal transplant or double transplant with any other organ.
Improving High School Breakfast Environments

The goals of this intervention study are to implement best practice strategies to expand and promote the school breakfast program and test the impact upon student participation rates among a) all 10th and 11th grade students and among a randomly selected cohort of 800 students b) total diet and body mass index and percent body fat inin 16 rural Minnesota school districts.

School-wide Primary Aim: Improve participation in the school breakfast program among high school students. Hypothesis: School-wide school breakfast program participation will be higher in the intervention versus comparison group.

We will accomplish the following secondary aims using a random subsample of 800 incoming 10th and11th grade students.

Student-level Secondary Aims Secondary Aim 1: High school students in the intervention condition will decrease their rate of weight gain relative to height gain as measured by change in body mass index and percent body fat compared to students in the control condition. Hypothesis: Body mass index and percent body fat will be maintained or reduced in the treatment versus control group.

Secondary Aim 2: High school students in the intervention condition will maintain or decrease their energy intake while improving dietary intakes of low fat dairy, whole grains and fresh fruits compared to the control students.

Hypothesis: Energy intake (measured by 3, 24-hour recalls) will be maintained or reduced and intakes of low fat dairy, whole grains and fresh fruits will increase more in the intervention groups.

Secondary Aim 3: Compared to students in the control condition, high school students in the intervention condition will report receiving more support to eat school breakfast. Support will be social (increased peer and school support) or related to the school environment (satisfaction with serving locations and times, eating locations, foods and increased availability of low fat dairy, fruits and whole grains for breakfast).

Hypothesis: The treatment group will report receiving more social and school environment support for eating school breakfast than the comparison group (measured by a student survey).

Eligibility Criteria:
Inclusion Criteria:

Must be in 10th or 11th grade in school year 2013-14 Must have access to the internet Must have access to a phone

Exclusion Criteria for the Cohort:

Unable to read English Unable to speak English Pregnant Plan to move out of the school district within school year Not in school most mornings Eat breakfast 4 or more days a week
Application Contract Management Mode in Maintaining PD Fluid Balance

Contract management is a new management mode.

To help patients achieve fluid balance through contract management, that is:

1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；
3. Fluid intake and output keep in balance;
4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

Contract management is a new management mode, it stipulate and constraint various relationship by various duties, institutions and regulations.

To help patients achieve fluid balance through contract management, that is:

1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；
3. Fluid intake and output keep in balance;
4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

In addition to help keeping the fluid balance through contract balance, but also:

1. Improve compliance;
2. Improve the patients' cognition of fluid balance;
3. Improve the ability of self-management of fluid balance.

Eligibility Criteria:
Inclusion Criteria:

1. Older or equal to 18 years, younger or equal to 65 years, CAPD duration over 6 months
2. Edema or congestive heart failure happen
3. Patients with poor control of blood pressure, that is less than 90/60mmHg,or over 140/90mmHg, or the Bp does not meet the value given by doctors
4. Patients with fluid imbalance of intake and output.

Exclusion Criteria:

1. Younger than 18, or older than 65, or CAPD period less than 6 months
2. The primary disease is high blood pressure, or edema due to low protein
3. Patients that lost control of daily life
4. Malignant tumor or pregnancy
5. Falling in Chronic infection or severe complication within 1 month, such as hepatic disease, hemorrhage of digestive tract, etc.
6. Patients with cognition impairment, conscious disorder, or mental disease.
Correlation of Toxins With Gastrointestinal (GI) and Overall Health

The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health.

This study aims to use urine samples to understand the effect of toxins such as environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health. Urine samples will be tested using mass-spectroscopy-based techniques. A 'total toxicity score' will be calculated based on the urine analysis of toxins. A 'symptoms score' will be determined using the 'Symptom History' form which will be used to assess the patient's GI conditions. Additionally, a 'diagnosis score' will be calculated from the diagnosis generated in the electronic medical record (EMR). The determined 'total toxicity score' will be correlated with the 'symptoms score' and the 'diagnosis score.' The observations from this study will help us understand the potential effect of environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from gastrointestinal and/or other symptoms
* Patients willing to provide urine samples
* Patients willing to provide consent

Exclusion Criteria:

* Use of antibiotics 2 weeks prior to the study
* Patients unwilling to consent