cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis PSC based on cholangiogram (magnetic resonance cholangiopancreatography \[MRCP\], endoscopic retrograde cholangiopancreatography \[ERCP\], or percutaneous transhepatic cholangiogram \[PTC\]) or liver biopsy
* Individuals have evidence of cirrhosis based on historical liver biopsy, abdominal imaging \[magnetic resonance imaging (MRI), computed tomography (CT), or Ultrasound\], or a screening FibroScan®, enhanced liver fibrosis (ELF)™, or FibroTest®.
* Individual has the following laboratory parameters at the Screening visit, as determined by the central laboratory:

  * Estimated glomerular filtration rate (eGFR) \> 60 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  * Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal (ULN)
  * Total 2 milligram/deciliter (mg/dL), unless the individual is known to have Gilbert's syndrome or hemolytic anemia
  * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
  * Platelet count ≥ 75,000/microliter (μL). Individuals with evidence of high-risk esophageal or gastric varices in the opinion of the investigator are excluded
  * Negative anti-mitochondrial antibody

Key Exclusion Criteria:

* Current or prior history of any of the following

  * Decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal hemorrhage
  * Liver transplantation
  * Cholangiocarcinoma or hepatocellular carcinoma (HCC).
* Model for End-stage Liver Disease (MELD) score \> 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
* Child-Pugh (CP) score \> 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
* Current moderate to severely active inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis).

  * Note: Individuals with IBD who currently have an external ostomy bag and/or proctocolectomy are not subject to this exclusion criterion and need not undergo IBD Symptom Severity Assessment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]

The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.

In HNC survivors with lymphedema and fibrosis (LEF), the investigators will: 1) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF severity; 2) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related symptom burden, functional impairments, and quality of life; and 3) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related knowledge, skills, self-efficacy, and self-care adherence.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Post HNC primary treatment
* No evidence of cancer (NED)
* Completion of initial lymphedema therapy for head and neck lymphedema
* Unable to obtain lymphedema therapy due to barriers noted above
* History of lymphedema on the face and neck, with or without fibrosis
* Ability to understand English in order to complete questionnaires
* Ability to perform self-care activities for LEF management
* Ability to provide informed consent
* Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
* A valid email address

Exclusion Criteria:

* Recurrent or metastatic cancer
* Any other active cancer
* Acute infection
* Acute congestive heart failure
* Acute renal failure
* Cardiac or pulmonary edema
* Sensitive carotid sinus
* Severe carotid blockage
* Uncontrolled hypertension
* Venous thrombosis
* Pregnant people
* Incarcerated patients
Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy

The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.


Eligibility Criteria:
Inclusion Criteria:

* Individuals receiving anti-epileptic drugs as a treatment for epilepsy

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding, receiving cancer treatments, have liver or kidney diseases, autoimmune diseases, or other diseases that may interfere with vitamin D and magnesium metabolism.
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases

This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.


Eligibility Criteria:
Inclusion Criteria:

* aneurysmal subarachnoid hemorrhage
* potential or actual cerebral vasospasm

Exclusion Criteria:

* non-aneurysmal subarachnoid hemorrhage
* outside the 4-21 day window after ictus
* peripheral deoxygenation
* contraindication for nimodipine administration
Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair

compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.

comparison between unilateral intrathecal block anesthesia (unilateral SA) and Quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. Limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events.

Previous case report studies stated that we can use Quadratus Lumborum Block as the sole anesthetic technique for open hernia repair.

Eligibility Criteria:
Inclusion Criteria:

- physical status ASA: I-II BMI \>18kg/m2\<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair

Exclusion Criteria:

* uncooperative patient
* Allergy to local anesthetic drugs
* patients on chronic alcohol, opioid, tranquilizer or sedative use
* Pregnant females.
* Psychological, mental disorders, or depression.
* Patients receiving anticoagulants therapy or suspected coagulopathy.
* Patients with infection or previous surgery at sit of anesthetic procedures.
* Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease
Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers

Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic menopausal women : \>=50 years and amenorrhea \>=1 year or \<50 years and amenorrhea \>=1 year and plasmatic FSH \>= 30 UI/l
* Normal mammography in the last 2 years before inclusion
* Normal cervical smear in the last 2 years before inclusion
* Written consent for participation in the study

Exclusion Criteria:

* Unconfirmed Menopause with amenorrhoea of less than year
* Oestrogen-progesterone Treatment anterior in 3 months previous the inclusion
* Recently a viral Infection or bacteriologic(at least of 2 weeks)
* Dental Infection
* Inflammatory Pathology chronicles
* Antecedent of pathology cancerous with or no a sly hemopathy
* Addiction to smoking of more than 20 cigarettes a day or an alcoholic consumption furthermore of 4 glasses a day
* Taken concomitant of one of the treatments forbidden:statine, vitamin B6 or B12, folates, antiinflammatory, anti aggregant Plaquettes, DHEA, phytoestrogens
* Refusal to sign the assent informed
* Not membership in a regime about social security
Expanding Rural Access: Distance Delivery of Support

The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.

Women with breast cancer in rural areas are likely exhaust their usual sources of psychosocial support while still facing challenges posed by breast cancer, but are unlikely to have access to professionally-led support groups. In this community-based project, we assessed the feasibility and acceptability of providing support groups to women with breast cancer in a large rural area using videoconferencing and a workbook journal, and we assessed the intervention's potential to reduce distress and increase emotional expression and self-efficacy for coping with cancer. Twenty-seven women in the Intermountain Region of northeastern California participated in 8-session support groups led by an oncology social worker by going to nearby videoconferencing sites. Feasibility and acceptability were demonstrated. Older as well as younger women were comfortable using videoconferencing and said the groups were valuable because they promoted information sharing and emotional bonds with other women with breast cancer. They emphasized the importance of a professional facilitator and identified advantages of using videoconferencing for support groups. Pretest and posttest comparisons showed significant decreases in depression and posttraumatic stress disorder symptoms. The results suggest that the intervention has the potential to provide a valuable service that is not readily available in rural communities.

Eligibility Criteria:
Inclusion Criteria:

* 1) has been diagnosed with breast cancer, and 2) is a woman

Exclusion Criteria:

* 1) under 21 years of age, and 2) does not speak and read English
Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients

PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.

Breast cancer has been the focused of many studies because it significantly affects both in developed and developing countries worldwide (Cameirão et al, 2008).

Lymphedema affects the range of motion of shoulder causing disability and affection of function.

Wii-console systems can be used as training tools to promote intensive training directed towards specific deficits and guide the patients in task-oriented activities. Moreover, it allows a real-time high-resolution monitoring, where is possible to have a quantitative assessment of relevant properties of the impairment, performance and recovery. On the other hand, virtual reality environment demand focus and attention of the patient, motivate the patient to perform the exercises, and provide a sense of achievement to the user (Torre et al, 2015).

HYPOTHESES:

The wii-console based exercise will have no effect on shoulder ROM for post-mastectomy patients.

Eligibility Criteria:
Inclusion Criteria:

* All the patients will be females.
* Patients undergone mastectomy with lymph nodes dissection.
* all developed lymphedema after the surgery.

Exclusion Criteria:

* Vision problems.
* Medically instable patients.
* Balance disorders.
* Other musculoskeletal condition of shoulders.
Gluteus Maximus Strengthening Exercises Augmented by High-Intensity Laser Therapy in Patients With Plantar Fasciopathy

Plantar heel pain is one of the most commonly encountered problems of the feet in adults \[1\]. It accounts for nearly 11%-15% of all foot symptoms, The purpose of this study was to investigate the effectiveness of high intensity laser therapy combined with gluteus Maximus strengthening exercise on pain, thickness of plantar fascia, and function of the foot.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral plantar heel pain with or without calcaneal spur for more than 3 months.
* Tenderness at the insertion of the plantar fascia
* BMI index will be from 25 up to 30
* Patient will wear silicone insole .
* Diagnosis of PF based on orthopedic referral

Exclusion Criteria:

* Patients with presence of foot deformity,
* systemic inflammatory arthritis disease,
* foot surgery, or
* plantar heel pain due to trauma,
* wound, or infection in the foot,
* received oral corticosteroids
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:

All Patients:

* Patient meets the minimum age as per local regulations at time of consent
* Patient requires treatment with study device(s) according to the IFU(s)
* Patient is willing and able to comply with all SOC procedures and study visits
* Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively

  * For prospective emergency patients, retrospective consent is permissible
  * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.

Retrospective Patients only:

* Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
* Patient implant date is no more than 5 years prior to study start date.

Exclusion Criteria:

* Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:

  * Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
  * Patient is contraindicated per the device IFU
  * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.


Eligibility Criteria:
Inclusion Criteria:

- Any person, male or female, over 18 years of age who underwent vaccination and

* anti-SARS-CoV-2 serological test after vaccination
* having already given their consent for their biological resources to be:

  * stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002;
  * subsequently reused, as well as the anonymized associated data, for research purposes

Exclusion Criteria:

* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
* Person under safeguard of justice
* Person under guardianship or curatorship-
Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine \>2.5 mg/dL, almost 50% require hemodialysis.

Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery

Eligibility Criteria:
Inclusion Criteria:

* Pts with baseline chronic kidney disease (eGFR\<60 ml/min/1.73m2)undergoing cardiac surgery

Exclusion Criteria:

* Patients on hemodialysis preoperatively
* IV contrast within 4 days prior to surgery
* Urgent/emergent surgery
* History of renal transplantation
Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery

The purpose of the study is to compare ultrasound measurements of the liver obtained prior to surgery on the skin to measurements obtained during surgery directly on the diseased liver. The objective is to determine if ultrasounds of the liver on the skin can provide accurate measurements of disease of the liver to provide an alternative option to liver biopsies.

A non-invasive, ultrasound platform based, ShearWaveTM Elastography measurement will be obtained at two time points on each qualified patient. The first time point will be in the operating room before the initial incision is made. The second time point involves placement of a small, hand-held modified ultrasound probe directly on the patient's diseased liver during the liver transplant surgery. The probe used in this study is the SuperCurved™SC6-1, capable of a band width of 1-6MHz with 192 elements.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females over the age of 18
* Patients undergoing a liver transplant surgery

Exclusion Criteria:

* Any person unable to provide informed consent
Perspections of Stroke Patients and Physiotherapists in Robotic Rehabilitation

This study was a cross-sectional study. The insights of stroke patients and physiotherapists were assessed with the quantitative questionnaires. The results were provided as number, percentage, mean, and standard deviation. The results of the insights of the current sapmle were given and compared the previous studies. The authors though that the results of the study can fill the gaps in robotic rehabilitation and support a better robotic rehabilitation experience.

Fifty stroke patients and fifty seven physiotherapists included the study. A seventeen-item and eight-item questionnaire s were created for stroke patients and physiotherapists, respectively. The descriptive data of the stroke patients and physiotherapists were presented. The results were compared with the literature and interpreted to guide future studies.

Eligibility Criteria:
For stroke patients

Inclusion Criteria:

* Having a single stroke

Exclusion Criteria:

* Having a communication problem
* Having another neurological condition which can affect the study

For physiotherapists

Inclusion Criteria:

* Graduating from a physiotherapy and rehabilitation program with at least a bachelor degree
* Working in Denizli

Exclusion Criteria:

-
COMMUNITY STUDY- A Study to Collect Information for the Cordio System

This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R\&D purposes. R\&D data will be analyzed retrospectively in order to validate algorithm efficacy.

The study will be conducted in the following settings: outpatinets clinics


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Symptomatic Heart Failure Patient.
3. The patient is willing to participate as evidenced by signing the written informed consent.
4. Male or non-pregnant female patient.

Exclusion Criteria:

1. Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
2. Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
3. Patient with severe alcohol or drug use.
4. Psychological instability, inappropriate attitude or motivation.
5. Patient with life threatening debilitating disease other than cardiac.
6. Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence

The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail

1. Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence
2. Study design: This is a randomized, double-blind, controlled, multi-center clinical trial
3. Study subjects: Females with mild to moderate stress urinary incontinence
4. Number of subjects: 60
5. Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University
6. Treatment methods:

Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.

Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed as mild to moderate female stress urinary incontinence in our hospital;
2. other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being;
3. volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form.

Exclusion Criteria:

1. other types of urinary incontinence;
2. blood routines indicate acute and chronic blood system diseases;
3. B-ultrasound suggests other gynecological diseases;
4. combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases;
5. previous or current history of pelvic surgery and radiotherapy and chemotherapy;
6. the investigator determined that it is not suitable for this clinical trial.