cyrilzakka/clinical-trials huggingface dataset:
Acoustic Analysis of VA Sounds

End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The AVG matures earlier than AVF (2/3 vs 6 weeks), but it is more prone to infections and has lower survival.

It would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope.

The purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs.

This is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD.

To reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved:

Group 1. Patients with AVF as first line HD access option.

Group 2. Patients with AVG as first line HD access option.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. Patients in HD treatment that need a new VA or patients that entered the pre-dialysis program because of ESRD. In all these cases the treatment of first choice should be the creation of a distal autogenous AVF, the creation of an AVG or the proximalization of an occluded VA.

Exclusion Criteria:

1. Contraindications for the creation of an autogenous AVF, for the AVG creation or the proximalization of a failed VA.
2. Patients who use catheter to perform HD.
3. Patients undergoing peritoneal dialysis.
4. Patients with life expectancy less than 2 years.
Impact of Two Guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation.

It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.

A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.

Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.

One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:

* The control group will be corrected up to a value of A10FIBTEM = 8mm.
* The intervention group will be corrected up to a value of A10FIBTEM = 11mm.

Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.

The main objective is to demonstrate that the administration of fibrinogen in the intervention group compared to the control group changes the administration of red blood cells pack during the liver transplant and in the first 24 hours after.

Secondary objectives consist in demonstrate that in the intervention group, there is also a change in the administration of other blood products, a change in acute renal damage, a change in hours of mechanical ventilation, no changes in thrombotic events in the hepatic graft or in the patient in the first 90 days of the liver transplant and no changes in re operations, re-transplantation, or mortality during the first 90 days of the liver transplant, compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Candidate to an orthotopic liver trasnplantation.
* Informed consent.
* Preoperative hemoglobine \</= 130 g/L

Exclusion Criteria:

* Preoperative hemoglobin\> 130 g / L
* Familial amyloid polyneuropathy
* Polycystosis hepatic
* Living donor liver transplant
* Uncontrolled donor after cardiac death
* Acute / subacute liver failure
* Re-transplant (in the same hospital admission)
* Use of Anticoagulation drugs before transplantation.
* Age \<18 years.
* Pregnancy and lactation.
The Role of Vitamin K on Knee Osteoarthritis Outcomes

The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,

The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.


Eligibility Criteria:
Inclusion Criteria:

* ≥60 years old
* Clinical diagnosis of knee OA by the treating rheumatologist
* English fluency

Exclusion Criteria:

* Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
A Study of the Effect of SYN-010 on Subjects With IBS-C

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)

This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study \[EOS\] visit telephone call).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have IBS-C and have a positive breath CH4 test result (\> 10 ppm) at Screening.
* Subject must meet the modified Rome III criteria for IBS-C.
* Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10) reported at Screening and Baseline.
* Subject must have an average of fewer than 3 complete spontaneous bowel movement (CSBMs) per week.
* Subject must agree to refrain from making any lifestyle changes that may affect IBS-C symptoms from the time of Screening to the end of the study.

Exclusion Criteria:

* Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics.
* Subject currently has any structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility, or any unexplained and clinically significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection.
* Subject has been diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
* Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale \[BSFS\] score of 6 or 7).
Predicting EONS in PPROM Patients

An EONS occurred in nearly 14-22 % of the preterm infant of pregnant women with PPROM. To this day no risk prediction is established. The main aim of this pilot study is generating primary data with a focus on the vaginal microbiome to set-up a prospective, multi-centre trial investigating the role of the vaginal microbiome for future EONS risk prediction.

The planned PEONS pilot trial is subdivided in three Work packages:

1. Recruitment, sample collection and routine clinical diagnostics
2. Microbiome analysis by 16S rRNA
3. Microbiome/ Metagenome analysis by "Nanopore" (proof-of-principle) and will enroll women with a PPROM event hospitalized between 22+0 and 34+0 weeks of gestation and neonates with signs of EONS (Subgroup 1) and without signs of EONS (Subgroup 2).


Eligibility Criteria:
Inclusion Criteria:

* full age pregnant woman with PPROM and their born preterm infants
* hospitalization between 22+0 and 34+0 weeks of gestation
* multipara possible

Exclusion Criteria:

* hospitalization with PPROM before limit of viability are reached
* intrauterine fetal death
* no study agreement
* not able to consent
PPAR - Combination With Metformin

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* HbA1c \> - 7.0% and \< - 10.0 %
* Mean serum triglyceride \< - 600 mg/dL
* Body mass index \< - 41 kg/m2
* Fasting c-peptide \> - 1.0 ng/mL

Exclusion Criteria:

* History of myocardial infarction (MI)
* coronary angioplasty or bypass graft(s)
* valvular disease or repair
* unstable angina pectoris
* transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
* Congestive heart failure NYHA Class III and IV
* Uncontrolled hypertension
* History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery

Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* Hospital level

  1. Public hospitals
  2. There are more than 100 cesarean deliveries per year
* Patient level

  1. Cesarean delivery
  2. Sign informed consent

Exclusion Criteria:

* Hospital level

  1. Data verification information cannot be provided
* Pregnant woman level 1. No blood routine results within 2 weeks before surgery
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Eligibility Criteria:
Main Inclusion Criteria:

* Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.


Eligibility Criteria:
Inclusion Criteria:

* Subject's age in accordance with the approved product label of the country where the study is conducted
* Subjects will be vaccinated with Focetria®, independently of this study.
* Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion Criteria:

• Received any prior H1N1 vaccination
Innovative Approach in Tuberculosis Care in Armenia

Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.

The innovative treatment approach integrates several educational, technological, and social evidence-based components. The aim of this study is to pilot the innovative approach for drug-sensitive TB patients during the outpatient phase of tuberculosis treatment. To test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. The intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, TB patient and family member training (including distribution of a leaflet about TB) and psychological counseling, reminder text messages to TB patients, and reminder phone call to TB patient family members. The control arm will include drug-sensitive tuberculosis patients that receive the regular Directly Observed Therapy recommended by the World Health Organization.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of drug-sensitive TB
* Age 18 years old and above
* Understanding and reading in Armenian
* Completion of the intensive treatment phase

Exclusion Criteria:

* Involvement in the Home Based TB Treatment Program of the National TB Control Office
Muscle Function and Tenderness Differences in Headache Patients

This cross-sectional study aims to compare muscle function of the neck, and shoulder and muscle tenderness in three groups of headache patients: migraine, tension-type headache, and posttraumatic headache. The study will evaluate muscle tenderness through the Total Tenderness Score (TTS) and muscle function through maximum voluntary isometric contraction (MVIC) and rate of force development (RFD). Additionally, functional assessments such as the Cranio-Cervical Flexion Test (CCFT) and Ito Test will be performed.


Eligibility Criteria:
Inclusion Criteria:Criteria: Inclusion Criteria:

* Aged 18 to 65 years.
* Diagnosis of migraine, tension-type headache, or posttraumatic headache, occurring at least 10 days per month.
* For tension-type headache patients, maximum of 3 days per month with migraine.

Exclusion Criteria:

* Pregnancy.
* Significant psychiatric comorbidities (e.g., severe depression).
* Medication-overuse headache.
* Severe osteoarthritis in the neck or shoulder, or cervical disc herniation.

Exclusion Criteria:

-
Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases

This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.

Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population.

20 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with hyperthyroidism (Graves' disease, toxic nodular goiter (TNG) or toxic multi hetero nodular goiter (GMHNT)) relevant to an indication for 131I treatment.
3. Patient with no risk of iodine saturation.
4. Patient able to maintain a sitting position in an armchair for 10 minutes with chin raised and held by a "chin rest" with head in extension.
5. WHO index ≤ 1.
6. For non-menopausal patients, use of an effective contraceptive method at the start of the clinical investigation and throughout the clinical investigation, and a negative pregnancy test before administration of the tracer activity and the 131I therapeutic activity.
7. Patient signed informed consent prior to inclusion in the clinical investigation and prior to any specific procedure for the clinical investigation.
8. Patient affiliated to a social security scheme in France.

Exclusion Criteria:

1. Absence of clinical or biological hyperthyroidism.
2. Patient with a contraindication to 131I treatment.
3. Existence of one or more nodule(s) associated with hyperthyroidism at risk of malignancy according to EU-TIRADS and Bethesda criteria if cytopuncture performed.
4. Active orbithopathy associated with Graves' disease.
5. Contrast-enhanced examination performed within the two months prior to inclusion.
6. Use of iodised products for skin disinfection (Betadine) in the 4 weeks prior to inclusion.
7. Treatment with Amiodarone and derivatives in the 18 months prior to inclusion. (Ioduria test to rule out iodine saturation).
8. Pregnant or breast-feeding woman.
9. Patient planning pregnancy within 6 months of 131I treatment.
10. Any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical monitoring and/or procedures set out in the clinical investigation protocol.
11. Any co-existing medical condition which, in the opinion of the investigator, could constitute a risk by participating in this study.
12. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Effects of WB-EMS in Runners.

The subjects will be randomly distributed into 3 experimental groups: training with basic global electrostimulation (WB-EMS-SRT), training with specific global electrostimulation for runners (WB-EMS-WT) and control group (CG).

Initially and at the end of the intervention period, which will consist of six weeks, the subjects will undergo a series of tests: (1) Maximum incremental effort test in tapestry to exhaustion to determine cardiorespiratory capacity (VO2max) and thresholds (aerobic and anaerobic). (2) Submaximal carpet test at constant speed to determine race economy (EC). (3) Lower train power test (CMJ and Abalakov). (4) Weight, size and waist circumference. The aforementioned tests will be carried out on different days to avoid the effect of fatigue on performance with a break of more than 48 hours between tests.

The participants in the control group will maintain the volume and intensity of the training prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will substitute one conventional training day for one with global electrostimulation for six weeks; the training of the first group will be non-specific and that of the second specific for runners and the duration of both will be 20 minutes.

A randomized controlled trial design was applied following CONSORT statements. After baseline measurements, participants were randomized into two groups: (i) WB-EMS group and (ii) Control Group (CG). Participants in the WB-EMS group were instructed to reduce their running training program volume, whereas the CG continued with their running training in term of volume and intensity: two or three times per week (45-60 minutes per day) at an intensity of 60-70% hearth rate reserve, which was controlled by heart rate monitor (Polar RS300X, POLAR, Kempele, Finland), and with 24-48 hours of rest between sessions

Eligibility Criteria:
Inclusion Criteria:

* Frequent runners

Exclusion Criteria:

* Received WB-EMS training.
Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes

Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.

This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.

This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.

Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 18+
* High risk of developing type 2 diabetes as identified through a risk score

Exclusion Criteria:

* Diagnosed diabetes
* Taking steroid medication
* Serious chronic illness preventing participation in trial
* Unable to speak English
Semen Analysis and Insight Into Male Infertility

Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines.

A retrospective study to assess the frequency of male factor infertility in the last years.

Eligibility Criteria:
Inclusion Criteria:

* infertile males

Exclusion Criteria:

* suergery