cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the GORE TIGRIS Vascular Stent

The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).


Eligibility Criteria:
Inclusion Criteria:

* Rutherford Class 2 - 4.
* Abnormal ankle brachial index (ABI ≤0.9).
* At least 21 years of age.
* Reasonable expectation of survival of at least 12 months after the procedure.
* Male, infertile female, or female practicing an effective method of preventing pregnancy.
* One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm
* Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually.
* Angiographic evidence of at least one patent tibial artery (\<50% stenosis angiographically).
* Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
* Lesion has been pre-dilated before stent deployment.

Exclusion Criteria:

* Prior enrollment in this study.
* Vascular access/catheterization in the target leg within 30 days of study enrollment.
* Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
* Flow-limiting aortoiliac disease.
* Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
* Arterial aneurysm in the target leg.
* Co-morbid conditions which would preclude compliance with study protocol.
* Obstructive or occlusive non-atherosclerotic disease.
* Creatinine greater than 2.5 mg/dl.
* Amputation above the metatarsals, resulting from vascular disease, in the target leg.
* Septicemia or uncontrolled infection.
* Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay.
* Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
* History of coagulopathy.
The Effect of a New Biomechanical Device

The purpose of this study is to examine (retrospectively) the effect of a new biomechanical device on gait patterns of patients suffering from musculoskeletal disorders. The analysis is conducted on an existing database of the therapy center.

Patients treated in the therapy center undergo a computerized gait test and complete several pain and function questionnaires at fixed time point. We examined the effect of the treatment on the level of pain, function and quality of life as well as on the gait patterns of these patients. Measurements were taken at baseline, after 3 months, and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* knee\\hip OA
* knee\\hip joint replacement
* ankle fractures\\instability
* NSLBP

Exclusion Criteria:

* neurological disorders
* lack of balance (2 falls in the last year)
* incapable to complete a questionnaire
Combined Steroid and Cyclosporin as First-line Treatment in Adults With Primary Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of cyclosporin plus standard steroid compared to standard steroid monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 253 adults with ITP in China. Patients were randomized to cyclosporin plus standard steroid compared to standard steroid monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Newly-diagnosed, treatment-naive primary ITP;
2. Platelet counts \<30×10\^9/L;
3. Platelet counts \< 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);
3. Received first-line and second-line ITP specific treatments (e.g., steroids, intravenous immunoglobulin, TPO-RAs, rhTPO, rituximab, etc);
4. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);
5. Severe medical condition (lung, heart, hepatic or renal disorder);
6. Patients who are deemed unsuitable for the study by the investigator.
Colchicine and Inflammation in Aortic Stenosis

Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%. Once at an advanced stage, AS will lead to the development of left ventricle hypertrophy, and eventually heart failure and death. At-present, there is no effective medical therapy for aortic stenosis. Current management of patients with AS consists of 'watchful waiting'. Valve replacement is needed when these patients (often acutely) become symptomatic. Recent studies have shown that inflammatory processes with similarities to atherosclerosis play an important role in AS. Therefore, we hypothesize that treatment with anti-inflammatory therapy, in the form of colchicine, could reduce the progression of AS. If positive, this trial will be the first to provide a potential therapeutic option for millions of people world-wide with AS.


Eligibility Criteria:
Inclusion Criterion:

• Asymptomatic moderate aortic valve stenosis on recent (\<6 months) echocardiography (based on peak velocity, mean gradient, aortic valve area). The severity of AS will be quantified according to current EACVI / ASE guidelines.

Exclusion Criteria:

* Heavily calcified aortic valve on echocardiography (defined as grade 4 calcification: extensive thickening/calcification of all cusps as described in the articles by Rosenhek et al.);
* a planned aortic valve replacement in the next six months;
* severe mitral valve stenosis (MVA \< 1cm2);
* severe mitral or aortic valve regurgitation;
* rheumatic aortic valve disease;
* bicuspid aortic valve;
* valvular disease due to history of chest radiation;
* left ventricular dysfunction (LVEF \< 35%);
* renal impairment (eGFR \<30 ml/min/1.73m2);
* patients aged \<50 and \>80 years;
* pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance;
* child-bearing potential without the use of contraception;
* use of CYP3A4 (e.g. verapamil) or P-glycoprotein inhibitors;
* use of bisphosphonate or denosumab;
* chronic use of immunosuppressants or anti-inflammatory drugs including colchicine and NSAID's (excl. acetylsalicylic acid);
* active or chronic liver disease;
* the presence of a pacemaker or internal cardiac defibrillator;
* life expectancy \<2 years.
Plant-Based Dietary Intervention in Type 2 Diabetes

The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.

Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

* hemoglobin A1c values \<6.5% or \>10.5%
* use of insulin for \> 5 years
* tobacco use within the preceding 6 months
* consumption of more than 2 alcoholic beverages per day
* current drug abuse
* pregnancy
* unstable medical status
* current use of a low-fat, vegetarian diet.
Treatment With Intravitreal Avastin for Large Uveal Melanomas

The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
* Patients diagnosed with uveal melanomas with tumor thickness \> 10 mm or basal diameter \> 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.

Exclusion Criteria:

* Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
* Patients with history of metastatic cancer (other than melanoma).
* Patients not able to provide consent for the study.
* Patients with clinical or radiographic evidence of extraocular extension of the tumor.
* Patients with a previous history of an adverse reaction to intravitreal injection.
* Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
* Patients with intravitreal silicone oil or gas tamponade.
* Patients \< 18 years of age.
* Women known to be pregnant.
Early Evaluation of the MAMAACT Trial

The MAMAACT#1 project's aim was to reduce ethnic disparity in stillbirth and infant death by improving the management of pregnancy complications through timely and appropriate response to warning signs of pregnancy. The intervention consisted of a training program for midwives and health education materials for pregnant women. The aim of the feasibility trial was to analyze the acceptability and feasibility of the MAMAACT intervention using mini-group interviews with midwives and to pilot outcome evaluation using surveys.

The MAMAACT project's aim was to reduce ethnic disparity in stillbirth and infant death by improving the management of pregnancy complications through timely and appropriate response to warning signs of pregnancy. The intervention was co-created with midwives at Hvidovre Hospital, the largest maternity ward in Denmark. The intervention consisted of a 5-hour training session for midwives in intercultural communication followed by three dialogue meetings in smaller groups. The first midwife visit was extended with 5 minutes allowing for more communication and health education on body symptoms. The women were given a leaflet and a mobile application at this first visit that were describing when and how to respond to warning signs during pregnancy. Both the leaflet and application were available in Danish, Arabic, Persian, English, Somali, Turkish, and Urdu.

The intervention was a complex intervention, and this phase was a feasibility study preceding a national trial. This feasibility trial was tested at one hospital 2014-2015. The national trial 2017-2021 is registered with ClinicalTrials.gov Identifier: NCT03751774.

The hospital had four antenatal clinics and the intervention was implemented at two clinics, while two served as control clinics. The MAMAACT leaflet and app were distributed to all pregnant women at the two intervention clinics, equivalent n=2000, attending antenatal care during the test period.

The aim of the feasibility trial was to analyze the acceptability and feasibility of the trial and to pilot outcome evaluation using surveys in a difference in difference design. The acceptability and feasibility of the intervention were evaluated using mini-groups interviews with midwives in the intervention arm. The difference in difference study was piloted comparing change in outcomes of women from the intervention arm from before the intervention to after the intervention relative to the change in the control arm. Survey assessed outcomes were women's' knowledge about warning signs of pregnancy complications, health system navigation and satisfaction with the midwifery based antenatal care.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant in gestational week 27+0-31+6 , affiliated to Hvidovre hospital, seen for antenatal care during recruitment weeks.

Exclusion Criteria:

* Not speaking Danish, English, Urdu, Turkish, Somali, Persian or Arabic.
Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.

GFAP measure

Eligibility Criteria:
Inclusion Criteria:

* children undergoing general anesthesia longer than 3 hours

Exclusion Criteria:

* past history of anesthesia
* cardiopulmonary bypass
* preexisting neurocognitive dysfunction
* abnormalities of liver profile (aspartate transaminase \> 40 unit/L, alanine aminotransferase \> 40 unit/L)
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.


Eligibility Criteria:
Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

Severity of disease meeting all of the following three criteria:

* PASI score of 12 or greater,
* Investigator's Global Assessment (IGA) score of 3 or greater
* Total body surface area (BSA) affected of 10% or greater.
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.
* Other protocol-defined inclusion/exclusion criteria may apply.
Helicobacter Pylori Eradication in Subjects With Non-alcoholic Fatty Liver Disease

The aim of study was to evaluate the effect of helicobacter pylori eradication on liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in subjects with non-alcoholic fatty liver disease.

Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline, eight weeks, and twelve weeks from the beginning of study.

Eligibility Criteria:
Inclusion Criteria:

* Dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic

Exclusion Criteria:

* Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any hepatotoxic medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, and pregnant or lactating women.
Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease

The purpose of this study is to learn about the impact of text messaging on physical activity in persons with risk factors for peripheral arterial disease (PAD).

Thirty-five million Latinos live in the U.S. and nearly 14% have peripheral arterial disease (PAD) defined as a build-up of plaque in the arteries that supply blood to the legs. Approximately 40% have at least one risk for PAD (i.e., aged 70 years and older, diabetes, high blood pressure, high blood cholesterol, or smoking). Persons with at least one risk factor and who are physically inactive are more likely to suffer from severe PAD. Physical inactivity is highly prevalent in Latinos and a major risk factor for PAD. Physical inactivity affects 50% of Latinos aged 60 years and older.

Participation in this study will last for about 3 months. Participants will be randomized to one of two groups. One group will receive text messages, brief telephone calls, and a handout. The other group will only receive the handout. The study will be looking at how the different groups respond to the different interventions used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Latino adults
* English or Spanish speaking
* Have one or more of the following: diabetes mellitus, smoking, hypertension, or hyperlipidemia.
* Adults age 70 years or older, regardless of having one or more the above noted risk factors for PAD, will also be eligible for enrollment.

Exclusion Criteria:

* Pregnancy
* Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
* Use of supplemental oxygen
* Myocardial infarction within preceding 3 months
Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.

To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes

Haemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of haemorrhoids. Through the catheterization of the femoral artery and a selective angiogram of the inferior mesenteric artery, embolic agents are delivered to occlude the SRA. Despite the technical success rate has been reported to reach 93%-100%, clinical success ranges between 63% and 94% with rebleeding occurring in 13.6% of cases due to the presence of a significant MRA in 24% of cases \[BIBLIO} . There is no data in the literature on how the arterial flow changes after the treatment.

The primary aim of the present study was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak before and after Hemborrhoid by using endoanal ultrasound (EAUS) combined with doppler. The secondary aim was to evaluate if a relation exists between the reduction and the efficacy of this treatment by the Hemorrhoidal Bleeding Score.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic hemorrhoidal disease (French bleeding score \[FBS\] \> 4), Goligher's classification score II or III, age \>18 years, failure of non-operative management (change life style, dietary modification, supplemental fibers for constipation, over-the-counter treatments).

Exclusion Criteria:

* age \< 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.
Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

Within the context of the proposed research study, the effect of soy isoflavonoid supplements on the quality of life and coagulation of menopausal women. It has been observed that menopause, as a physiological process, is associated with alterations in the physical, mental and sexual quality of life, making the use of hormone replacement therapy necessary; however, hormone therapy is associated with hypercoagulability, since it has been seen that women have higher levels of thrombogenic microvesicles such as: platelets with a greater probability of causing blood clotting were more likely to present a greater amount of white matter hyperintensities, which appear in the MRI scan.

The following study is aimed at clarifying the effects of soy isoflavonate supplements on the quality of life and markers of hypercoagulability in menopausal women. The reasons for conducting this research arise from the concern of minimizing side effects such as hypercoagulation caused by hormone replacement therapy, which is intended to be replaced with soy isoflavonates to evaluate its efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Submission of a signed and dated informed consent form.
* Declared willingness to comply with all study procedures and availability for the duration of the study.
* Can read and write
* Female, age 45 to 65 years
* Female with more than 1 year of amenorrhea.
* No hormone replacement therapy or herbal medications in the 6 months prior to the investigation.
* Ability to take oral medication and willing to comply with the \<study intervention regimen.
* Agreement to comply with Lifestyle Considerations for the duration of the study.
* Have a smartphone-type cell phone
* Residence in Francisco Morazán

Exclusion Criteria:

* Patient does not sign informed consent
* Patient does not wish to participate
* History of thrombo embolism
* History of cardiovascular disease
* Presence of estrogen-dependent neoplasm
* Presence of abnormal genital bleeding
* Uncontrolled metabolic diseases
* Smoking and drinking habits
* Use of anticoagulant or acetylsalicylic acid
* Known allergic reactions to soy isoflavonate components
* History of thrombophilias such as: Antithrombin deficiency, Protein C deficiency, Protein S deficiency, Factor V Leiden, Prothrombin G20210A, Hyperhomocysteinemia, Antiphospholipid syndrome, Acquired activated protein C resistance.