cyrilzakka/clinical-trials huggingface dataset:
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
* Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Exclusion Criteria:

* Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
* Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
* Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
* Patient has a planned or anticipated revascularization procedure.
* Pregnancy or planned pregnancy during the trial period.
* Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2.
* Patient has a history of gastroparesis or pancreatitis.
* Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of \>40 ng/L at baseline.
Exercise in Severely Disabled Patients With MS

In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.

For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.

Resistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score \> 6).

Patients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent

  -\>18 years
* Primary progressive or secondary progressive MS according to the McDonald criteria
* 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
* Maximal walking distance ≤ 10m

Exclusion Criteria:

* Patients are excluded if they:
* have dementia,alcoholism, or pacemaker treatment
* any serious medical comorbidities
* are pregnant
* have done systematic endurance training (\>1day/week) within the last 3 months.
* complete less than 80% of the planned training sessions
* medical conditions that exclude performance of a maximal endurance test.
Serum Biomarkers in Diagnosis of Mesothelioma

In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin, C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in combination, in distinguishing malignant pleural mesothelioma patients from patients with metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.

In the year 2002, a database for the pleural diseases was constructed to be prospectively filled in the department. The findings, outcome features and characteristics of follow-up for all cases with pleural diseases have been recorded in this database. The patient data, including epidemiological characteristics, smoking status, history of other diseases and co-morbid conditions, previous asbestos exposure, medications and additional physical and radiological examination findings, including computed tomography scans, both serum and pleural fluid laboratory investigational data and indications of invasive procedures, were recorded in the database mentioned above. The methods employed in the diagnosis of patients; any complications; characteristics such as the stages of diseases, treatments, and course of treatments; and results were also recorded in the database. From the date of the first database establishment, a "tissue, blood, serum, and fluid specimen bank" was constructed; tissue, blood, serum and pleural fluid samples of patients, which had been taken at the beginning of diagnosis process, were stored in this bank at -80°C. The blood, serum, and pleural fluid samples of patients were stored during the diagnosis process, and if conducted, pleural tissue samples taken during invasive procedures were also stocked.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a definite pleural diseases
* Age more than 18 year-old, less than 85 year-old.
* Willingness to participate in the study.

Exclusion Criteria:

* Patients with undiagnosed pleural diseases.
* Age less than 18 year-old or more than 85 year-old.
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?

There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:

1. The choice of anastomotic method - does it influence the postoperative course?
2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?

Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.

All patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.

The stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.

The stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.

Eligibility Criteria:
Inclusion Criteria:

* loop ileostomy after rectal cancer surgery
* loop ileostomy closure is permitted and possible according to clinical practice

Exclusion Criteria:

* patient unable to understand written or oral information
Proton Therapy for Low and Intermediate Risk Prostate Cancer

The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Eligibility Criteria:
Inclusion Criteria

* Prostate cancer.
* Gleason score 2-7.
* PSA ≤ 20 ng/ml.

Exclusion Criteria:

* Previous prostate cancer surgery or pelvic radiation.
* Prior or current chemotherapy for prostate cancer.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
* History of proximal urethral stricture requiring dilatation.
* History of hip replacement.
* Diabetes requiring medication.
* Prior intrapelvic surgery.
* Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
* On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Sonographic Evaluation Of Uterine Fibroids At Different Locations In Patient With Irregular Menstrul Cycle

Uterine fibroids are a major cause of illness in women of a reproductive age. There are many factors involved in the growth and reduction of these common tumors. The most likely cause of fibroids is their effect on a woman's menstrual cycle. For accurate diagnosis numerous diagnostic markers on ultrasound are present which increases the efficacy of ultrasound to diagnose uterine fibroids.

To evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on Ultrasound.

The descriptive and cross-sectional study was conducted. A total of 97 patient data were collected. All the patients with uterine fibroids due to heavy bleeding, abdominal pain, pelvic pain, disturbance in menstrual cycle undergoing ultrasound were included.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Pelvic pain
* Patient with Abdominal pain
* Patient with heavy bleeding
* Patient with Dysmenorrhea
* Polymenorrhea

Exclusion Criteria:

* Patient with H/O Cystectomy
* Patient with H/O cyst
First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.

It is a 2-part study in hospitalized COVID-19 patients.

* Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF-07304814 given as 24-hour IV infusion.

  2 planned and 3 optional cohorts with 8 participants each are planned.
* Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF- 07304814 given as 120-hour infusion.

  2 planned and 2 optional cohorts with 8 participants each are planned

Eligibility Criteria:
* Inclusion Criteria:

  1. Male or female participants between the ages of 18 and 79 years.
  2. Confirmed SARS-CoV-2 infection.
  3. Hospitalized for COVID-19.
  4. Symptoms consistent with COVID-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, new loss of taste and smell, nausea, chills, fatigue, rhinorrhea, diarrhea, vomiting or radiographic infiltrates by imaging consistent with COVID-19
  5. Total body weight \>=50 kg (110 lb), BMI \<40 kg/m2; BMI \<35 kg/m2 for 76- 79 years.
* Exclusion Criteria:

  1. Evidence of critical illness, defined by at least one of the following: Respiratory failure, Multi-organ dysfunction/failure, Cardiac failure or septic shock
  2. Participants that are anticipated by the study Investigator to progress to critical disease, including mechanical ventilation, within 24 hours of enrolment
  3. Participants with pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe COPD.

  3.Participants with a known medical history of recent acute or chronic liver disease (other than NASH), chronic or active hepatitis B or C infection, or primary biliary cirrhosis.

  4.Participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition.

  5. Participants with known HIV infection, acute or chronic history of hepatitis B or C.

  6.Participants with a known medical history of recurrent seizures. 7. Participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.Confirmed concurrent active systemic infection other than COVID-19. 9.Current diagnosis of cancer, unless in remission and untreated. 10.Other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.Females who are pregnant or breastfeeding.
Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome

This is a randomized-controlled trial evaluating the effect of the use of vitamin D supplementation on the live birth rate in women undergoing in vitro fertilization (IVF). The hypothesis is that administration of vitamin D can increase the live birth rate for women undergoing IVF.

Patients undergoing IVF treatment cycle at Queen Mary Hospital and Kwong Wah Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) vitamin D or (ii) placebo group in a 1:1 allocation ratio by computer-generated random numbers one month before IVF.

Subjects allocated to the vitamin D group will take vitamin D 50,000IU per week from recruitment for 4 weeks, followed by 50,000IU once every 2 weeks throughout the IVF cycle until fetal viability is confirmed at 6 weeks (if pregnant), after which they will be switched to Materna. If not pregnant, they will continue Vitamin D 50,000IU once every 2 weeks until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer.

Subjects allocated to the placebo group will take placebo tablets which will be identical to the active drug. If pregnant and fetal viability is confirmed at 6 weeks, they will be switched to Materna. If not pregnant, they will continue the placebo tablets until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer.

The clinician and patients will both be blinded to the randomization throughout the course of treatment. The live birth rate of the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women undergoing IVF
* Aged between 18 and 43 years old, inclusive, at the time of signing informed consent
* Having given voluntary written informed consent

Exclusion Criteria:

* Already taking vitamin D
* Undergoing preimplantation genetic testing
* Use of donor oocytes or donor embryos
* Presence of hydrosalpinx not corrected surgically
* Active tuberculosis/ receiving therapy for tuberculosis
* History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, including history of renal/ureteral stones, parathyroid disease, renal or liver failure, current use of anticonvulsants, current use of steroid
* Allergy to vitamin D
* Abnormal serum calcium values
Efficacy and Safety of HRS9531 Tablet in Obese Subjects

To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion Criteria:

1. Uncontrollable hypertension;
2. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
15. Surgery is planned during the trial;
16. Mentally incapacitated or speech-impaired;
17. Acute or chronic hepatitis;
18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Evaluation of Polyflex Stenting in Esophageal Cancer Patients

To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Willing and able to provide informed consent
* Willing to comply with follow-up requirements
* Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
* Indicated for chemotherapy and/or radiation therapy
* Ability to dilate stricture to 15mm diameter at extent of disease evaluation
* Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent

Exclusion Criteria:

* Patients contraindicated for endoscopy
* Patients with prior esophageal stent placements
* Advance stage of disease, greater than T3 tumor or M1 disease
A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects

The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).


Eligibility Criteria:
Inclusion Criteria

1. Men and women ≥ 18 years
2. Hepatitis C negative or chronic hepatitis C infection
3. Chronic HIV infection
4. CD4+ T-cell count \> 200 cells/mm3
5. Plasma HIV-1 RNA \< 50 copies/mL
6. On continuous and stable ART for at least 12 weeks
7. Ability and willingness to provide written informed consent.

Exclusion Criteria

1. Known cardiovascular disease
2. Diabetes requiring insulin therapy or hemoglobin A1c \> 8%
3. Inability to conform to requirements for PAT testing
4. Decompensated liver disease
5. Other known causes of significant liver disease
6. Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry
7. Presence of active or acute AIDS-defining opportunistic infections (OIs) within 12 weeks prior to study entry
8. History of major organ transplantation with an existing functional graft and on immunosuppressive therapy
9. History of known vascular or autoimmune disease
10. Pregnancy
11. HCV treatment (any approved or investigational agents) within 24 weeks prior to study entry
12. Use of immune-based therapies or systemic corticosteroids within 12 weeks prior to study entry
13. Advanced renal insufficiency as defined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or treatment by dialysis
Long Term Outcome After Hemorrhagic Stroke Surgery

The investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then telephoned the survivors for neurological and cognitive status.

Death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. Of patients who had intracerebral hemorrhage in the United States during 2002, only 20% are expected to be functionally independently at 6 months. Although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. With these in mind, we carried out this study.

Eligibility Criteria:
Inclusion Criteria:

* All hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008.

Exclusion Criteria:

* Spontaneous subarachnoid hemorrhage as the dominant etiology
* uncommunicable patients
* nonsurvivors
Myofascial Release and Foot Mobility in Basketball Players: A Randomized Controlled Trial

The purpose of this study was to investigate the acute effects of myofascial release on foot mobility and sportive performance in basketball players with hypomobile feet. This study was designed as randomized controlled experimental research.

Hypomobility in the foot structure causes functional limitations. These functional limitations affect the sportive performance negatively, especially in basketball where dynamic movements such as jumping and sudden change of direction are very intense. In this context, reducing hypomobility is important in terms of eliminating performance disorders caused by hypomobility. The purpose of this study was to investigate the acute effects of myofascial release on foot mobility and sportive performance in basketball players with hypomobile feet. This study was designed as randomized controlled experimental research. Twenty-four male basketball players (23.46±2.81 years) participated in the study. Athletes were first subjected to foot mobility, balance and vertical jump tests. Then the participants were divided into two groups as myofascial release (MR) and placebo myofascial release (PMR). Myofascial release was applied to the MR group and placebo myofascial release was applied to the PMR group. After the application, foot mobility and performance measurements were performed again and the results were analyzed. It was observed that there was a significant difference in right foot mobility (RFM), left foot mobility (LFM), vertical jump (VJ) and dynamic balance (DB) parameters after the application in MR group (p\<0.001), while there was no change in any parameter after the application in PMR group (p\>0.05). The results of this study show that a single session of myofascial release applied to the plantar sole temporarily increased foot mobility and improved vertical jump and dynamic balance performance in basketball players with chronic hypomobility.

Eligibility Criteria:
Inclusion Criteria:

* Basketball players who had hypomobility in at least one foot, had not had a serious foot or ankle injury in the last year, and had been actively licensed for the last five years were included in the study.

Exclusion Criteria:

* Those who did not meet the inclusion criteria were excluded from the study.