cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).

The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

  * Steatosis (scored 0 to 3),
  * Ballooning degeneration (scored 0 to 2), and
  * Lobular inflammation (scored 0 to 3).

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
* Presence of cirrhosis on liver biopsy (fibrosis stage 4).
* Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.
Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption

This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source.

Type 2 diabetes is a metabolic disorder characterized by elevated fasting blood glucose and impaired insulin signaling (insulin resistance) and is associated with several comorbidities including neuropathy, retinopathy, kidney disease, and elevated risk for heart attack and stroke. Lifestyle interventions targeted towards prevention of type 2 diabetes include: maintaining and achieving healthy bodyweight, physical activity, avoiding tobacco use, and reducing sugar and saturated fat intake. The International Scientific Consensus Summit from the International Carbohydrate Quality Consortium indicated that diets low in glycemic index and glycemic load were important in the prevention and management of diabetes. Health supplements that can lower the glycemic index and glycemic load of food have potential to support the prevention of diabetes and improve blood glucose management by reducing post prandial glycemia and insulinemia. This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source. This proposal will fill a void in the literature by testing for the first time the effect of a combination of mulberry leaf, white kidney bean extract and cinnamon on postprandial carbohydrate absorption and glucose control in overweight, insulin resistant men and women. This project will provide pilot data to support larger studies, and studies to investigate long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* Men and women
* Able to provide written consent in English
* A body mass index between 23.0 and 30.0 kg/m2
* A fasting serum blood glucose level between 100.0 and 126.0 mg/dL

Exclusion Criteria:

* Current smoker
* Having a BMI less than 23.0 kg/m2 and higher than 30.0 kg/m2
* Having a fasting blood glucose level less than 100.0 mg/dL and higher than 126.0 mg/dL
* Suffering from known serious cardiac, hepatic, renal, pulmonary, gastrointestinal, endocrine or hematological disease based on investigator determination, aside from pre-diabetes
* Currently pregnant or breastfeeding
* Consuming more than 2 alcoholic drinks per day on average.
* Weight loss of more than 5% of body weight over the past 6 months
Individualized Assessment of Motor Function and Balance in Intensive Therapy

The goal of this study is to assess the individualized use of technology to assess motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the program. Children 7-17 years old who can walk and are completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests will be selected including common balance tests (standing with eyes open, standing with eyes closed), walking, walking and turning, standing up and sitting down from a bench, reaction time, and step down. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care.

The goal of this study is to assess the individualized use of instrumented assessment of motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the intervention. Children 7-17 with neurodevelopmental diagnosis, GMFCS Levels I and II and completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests in single and dual conditions will be selected including Romberg balance tests, walking, walking and turning, sit to/from stand, reaction time, and step down administered while participant is recorded using a portable measurement platform which incorporates a custom force plate, Azure Kinect spatial sensor, and interface board. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care. Testing is estimated to last for 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory children 7-17 years old receiving care in an interdisciplinary, intensive therapy program
* GMFCS Levels I and II
* able to follow 2-3 step directions
* English speaking

Exclusion Criteria:

* orthopedic surgery in the past year or
* significant visual impairment
* significant hearing impairment.
Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study

At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy.

Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the GI lab for elective colonoscopy

Exclusion Criteria:

* Patients on Coumadin or other anti-coagulants
* Patients with Inflammatory Bowel Disease
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following conditions will be included:

* Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
* Patients with percutaneous implant.
* Patients undergoing the procedure under superficial sedation or Local anesthesia.
* Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
* Patients who have signed the informed consent.

Exclusion Criteria:

Patients who do not meet any of the following conditions:

* Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
* Hospitalized patients undergoing urgent TAVI implantation.
* Patients with access other than percutaneous transfemoral.
A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.

This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle

See Summary

Eligibility Criteria:
Inclusion Criteria:

1. Female.
2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
3. ECOG performance score of 2.
4. Patients who meet one of the following criteria:

   * Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
   * Stage IV.
5. Age greater than or equal to 18 years.
6. Adequate bone marrow function
7. Adequate renal function
8. Adequate hepatic function
9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
10. Patients who have had major surgery must be fully recovered from the surgery.
11. Ability to comply with the visit schedule and assessments required by the protocol.
12. For patients of reproductive potential, commitment to use adequate contraception.
13. Signed approved informed consent, with understanding of study procedures.
14. Agreement to begin study therapy within 8 calendar days after randomization.

Exclusion Criteria:

1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
5. Grade 2 or greater neuropathy.
6. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9).
7. Clinically significant active infection for which active therapy is underway.
8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
9. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
10. Pregnant women or nursing mothers.
11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)

This study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after ICU admission.

In addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* ICU ANTICIPATED LENGTH OF STAY \> 72 HOURS
* AGE \> 18 YEARS
* NEED FOR ARTIFICIAL NUTRITION

Exclusion Criteria:

* AGE \< 18 YEARS
* ICU ANTICIPATED LENGTH OF STAY \< 72 HOURS
* NO NEED FOR ARTIFICIAL NUTRITION
* BMI\<16 KG/M2
Cardiovascular Risk Evaluation and Antiretrovirals in HIV

The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk


Eligibility Criteria:
Inclusion Criteria:

* Serologically proven HIV infection
* Attending general HIV outpatient clinic

Exclusion Criteria:

* Attending a specialist outpatient clinic which might lead to recruitment bias
Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

The purpose of this study is to evaluate the effectiveness of continuous positive airway pressure ventilation when applied by paramedics to individuals with severe breathing difficulties in the prehospital setting.

Continuous positive airway pressure ventilation (CPAP) has been shown to be effective in avoiding endotracheal intubation (ETI) for patients with acute respiratory failure in hospital but despite several case series, the effectiveness of the prehospital application of CPAP by paramedics has not been studied in a randomized fashion. We performed a prospective, randomized, non blinded trial to determine whether patients in acute respiratory failure treated with CPAP in the prehospital setting had lower overall ETI rates than those treated with standard care.

Eligibility Criteria:
Inclusion Criteria:

* severe dyspnea
* respiratory rate \>25 breaths/minute
* hemodynamically stable
* able to cooperate with ventilatory support measures
* assessed by paramedics as being in urgent need of ETI and/or manual positive pressure ventilation
* a trip destination of the QEII Health Sciences Center or Dartmouth General Hospital

Exclusion Criteria:

* require ETI for immediate airway protection
* respiratory rate \< 8 breaths/minute
* evidence of hemodynamic instability
* cardiac ischemia
* any chest pain within 3 hours of presentation
* valid "do not resuscitate" advanced directive
* an inadequate supply of portable oxygen
Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD

Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb), cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate concretions in the lungs as seen in Pulmonary Alveolar Microlithiasis (PAM). Extra pulmonary calcifications, including heart valve calcification, have previously been reported in patients with PAM.

Calcific Aortic Valve Disease (CAVD) is a common disease in the elderly and is characterised by thickening and calcification of the aortic valve leaflets in the absence of rheumatic heart disease. CAVD is present in more than 25% of patients older than age 65 years and is associated with an increased risk of cardiovascular events. Currently, there is no effective therapy for the disease other than surgical aortic valve replacement. Both calcium and phosphate are the major components of calcific deposits in PAM and CAVD. Based on these preliminary findings, the investigators hypothesize that mutations in sodium phosphate co-transporters may play a role in both pulmonary and extra pulmonary calcifications.

Two studies will be performed: 1. A retrospective cross-sectional study including patients with an age ≤ 65 years with CAVD from Denmark and Örebro, will be carried out. Genetic association analysis will be performed to investigate the incidence of common variants in five genes representing sodium phosphate co-transporters (SLC34A1, SLC34A2, SLC34A3, SLC20A1, SLC20A2) compared to healthy controls. Associated genes will subsequently be sequenced to identify possible causal mutations. 2. In a prospective study, aortic valve tissue will be collected from patients with AS undergoing surgical valve replacement. Molecular characterisation of the transporters will be conducted by determining the level of specific mRNA and protein by RT-PCR/qPCR, and Western Blotting, respectively. The localisation and visualisation will be investigated by immunostaining and confocal laser microscopy. Fibroblasts and endothelial cells will be isolated and grown in cultures with subsequent functional studies of the phosphate uptake.


Eligibility Criteria:
Inclusion Criteria:

* Aortic valve calcification
* Informed consent before study participation
* Age: ≥ 18 years ≤ 65 years

Exclusion Criteria:

* Lacking ability to give informed consent
* Radiotherapy towards the thorax
* Severe kidney disease (in dialysis)
Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years old
* Quinnell grade I, II, III
* Acute (\< 6 months)

Exclusion Criteria:

* Quinnell grade IV
* Diabetes mellitus
* Rheumatoid arthritis
* Pregnancy
* Patient with prior injection or surgery of trigger finger
* Patient who are allergy to hyaluronic acid
Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria:

* None
Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection (CDI).

Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days. The rate of sustained clinical response (SCR; cure without recurrence at 30 days) will be assessed and compared to a historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. The data for the historical control group will be collected under a separate IRB-approved protocol. Standard of care therapy will be considered oral or intravenous metronidazole and / or oral vancomycin. The study will be powered to show non-inferiority of fidaxomicin compared to standard of care treatment in SOT recipients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater and up 85 years
* SOT recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas)
* First episode of CDI

Exclusion Criteria:

* Receiving additional therapies with activity again C. difficile (oral bacitracin, fusidic acid, and/or rifaximin)
* Toxic megacolon
* Ileus or significant abdominal distension
* Hypotension with vasopressor requirement
* History of inflammatory bowel disease
* Pregnancy
* Decisionally challenged
* Prisoners
* \>4 doses of metronidazole for the treatment of C. difficile in the previous 7 days
* \>4 doses of oral vancomycin in the previous 7 days
Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis

Cerebral palsy (CP) is described as a group of permanent disorders affecting motor development and posture, resulting in activity limitation attributed to nonprogressive disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased among the children with low birth-weight, jaundice, respiratory distress and intrauterine infection and so on. The incidence of cerebral palsy is increasing gradually with increased neonatal survival rate. Although there are many kinds of functional therapy programs especially the rehabilitation treatment for cerebral palsy, their effects are limited. Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell based therapy, a new prospective therapy for central nervous system disorders, has the potential to repair the damaged brain tissue in patients with cerebral palsy.

In this study, 300 patients with cerebral palsy will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP patients of them randomly. We will also follow up the other 100 patients who only receive rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of cell therapy and rehabilitation treatments for cerebral palsy patients.

Multiple sources of assessment were used to ascertain and classify all cases of cerebral palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and reliable outcome measure, has made it possible to evaluate the severity of movement disability，change over time and the effects of clinical interventions. It also will be the primary outcome measure in follow-up analysis of this study.

Patients enrolled in this study need to finish our whole follow-up survey for 12 months, which is carried out by clinical doctors, rehabilitators and epidemiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of cerebral palsy.
* Patients' curator must be able to give voluntary consent.

Exclusion Criteria:

* Intracranial infection.
* Severe respiratory and circulatory system diseases.
* Hematologic malignancies.
* Positive serological tests such as AIDS, hepatitis B virus, hepatitis C virus and syphilis （antigen or antibody）.
* Tumors.
* Genetic and metabolic diseases.