cyrilzakka/clinical-trials huggingface dataset:
A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS

The main objective of the study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the efficacy of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, and beans) on the clinical features, biochemical, and hormonal parameters of PCOS compared to the healthy therapeutic lifestyle changes diet.

The main objective of the study is to identify the effect of pulses on a range of PCOS and metabolic syndrome features. In this parallel clinical trial, 110 (18-35 years old) women with PCOS will be recruited. Participants will be randomly assigned to either a pulse-based diet or a therapeutic lifestyle changes-based diet. The effect of a pulse-based diet on a range of reproductive and metabolic parameters will be evaluated. The results of this study are anticipated to evaluate the therapeutic merits of a pulse-based diet for women with PCOS which would influence dietary guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
* Aged 18-35 years

Exclusion Criteria:

* Individuals that are Keto diet, vegetarian, pregnant, lactating, class 2 obese (body mass index (BMI) ≥35) current smoker, or if they have diabetes, cardiovascular, kidney, liver, or hormonal disease.
* Individuals taking any medication or supplementation known to affect lipid, glucose, or hormone levels, and/or body weight for at least the last 3 months.
* Any individual who has an allergy or intolerance to pulses.
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone

The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be collected from various sources including the Saskatchewan Health (SH) database and Cancer Registry.

The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. The study will be conducted using patient information from Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990 through 2005. The first objective of the study is to estimate the combined relative risk of the occurrence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population. Study drug dosing information not required for Observational Study

Eligibility Criteria:
Inclusion Criteria:

* Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005

Exclusion Criteria:

* Cancer free \>=1 year of history in the database before receiving the first dose of domperidone or a PPI
eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With MS

eFIT is a technology-enabled internet based psychosocial intervention to increase physical activity in persons with multiple sclerosis, who are at unique risk for sedentary behaviors and for whom exercise and physical activity hold many benefits.

This is a randomized controlled trial of an internet-based intervention to increase physical activity in persons with multiple sclerosis. Multiple sclerosis (MS) is the most common non-traumatic neurological cause of disability in young adults. Sedentary behavior, now recognized as a major contributor to increased morbidity is seen at higher rates and related to adverse health outcomes for persons with MS (PwMS). Prominent symptoms of MS (motor impairment, fatigue, depressed mood, pain), place this population at unique risk for increased sedentary behavior. And importantly, with increased age comes increased risk: patients over 60 are significantly more sedentary than middle-aged patients. On a positive note, current disease modifying therapies prolong time to disease progression, widening the window of opportunity for implementing behavioral interventions that support health and successful aging. Behaviors adopted early in life are more likely to be maintained into later adulthood. Physical activity is beneficial for PwMS on multiple levels: improved gait and balance, improved cognition, reduced depression and fatigue. Finding ways to increase physical activity is a key research priority for MS. Behavioral change is difficult to adopt and even more difficult to maintain. Here, we introduce a novel behavioral intervention to increase physical activity, eFIT, a technology-enabled (i.e., internet-delivered) support group-based treatment that leverages accountability to motivate and sustain behavioral change. Accountability constitutes the bedrock underlying the single most pervasive, successful, and widely embraced behavioral intervention known: Alcoholics Anonymous (AA). Through sponsors and support groups, AA utilizes accountability partners to deliver, reinforce, and sustain life-saving behavioral change. Here, we leverage accountability partners to motivate enduring behavioral change in physical activity participation, one of the single most difficult health behaviors to implement and maintain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Cannot be available for the next 12 weeks consecutively
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH

The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:

* Whether bio-mesh placement is safe for patients with a high risk of SSIH.
* Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
* Whether stoma reversal combining bio-mesh placement will trigger other complications.

Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old;
* Patients should have colonic prophylactic stoma and have not received reversal yet;
* There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
* No serious underlying diseases, can tolerate general anesthesia surgery
* Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
* Preoperative ASA (American Society of Anesthesiologists) grade I-III;
* Without vital organs function failure;
* All patients and their families signed informed consent before surgery.

Exclusion Criteria:

* Incapacitated persons;
* With a history of other types of hernia;
* Those who have had hernia mesh implantation before;
* Those who are allergic to bio-mesh or their components before;
* Combined with other surgeries;
* Severe mental illness;
* Severe respiratory disease;
* Severe liver and kidney insufficiency;
* Those who have absolute contraindications to surgery;
* Suffering from severe bleeding disorders or obvious abnormal coagulation function;
* History of unstable angina or myocardial infarction within 6 months;
* History of cerebral infarction or cerebral hemorrhage within 6 months;
* Continuous intravenous application of glucocorticoid within 1 month;
* The patient has participated or is participating in other clinical studies (within 6 months).
Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients

'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation

Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.

Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* adult patients with end-stage liver disease listed for primary liver transplant;
* calculated MELD score ≤ 25 at time of transplantation

Exclusion Criteria:

* HIV or RNA-positive Hepatitis C Virus infection;
* autoimmune liver disease
* previous organ transplant
* Ebstein Virus and/or Cytomegalovirus sero-negativity
* chronic use of systemic immunosuppressants
* hepatocellular carcinoma outside Milano criteria
* leukocytes \<1.5x10\^9/L and/or platelets \<50x10\^9/L.
POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS

Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).

ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent.

This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics.

ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication.

Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.

Eligibility Criteria:
Inclusion Criteria:

1. Cases (ME/CFS):

   - ME/CFS diagnosed by the indicated clinical criteria
2. Healthy Controls

   * clinically healthy
   * no known underlying disease
   * no prescription medication (except contraception)

Exclusion Criteria:

* Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
* pregnancy
* breastfeeding.
ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study

The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.

The study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. It is anticipated that approximately half of the patients will require an additional treatment. Patients will be enrolled from our patient population and be 50 years of age and older, male or female. Pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. Any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.

Eligibility Criteria:
Inclusion Criteria:• Individuals that are 50 years of age and older.

* Patients with retinal capilary abnormalities/vascular diseases such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomous proliferation (RAP).
* Patients with diabetic retinopathy and branch retinal vein occlusions
* Other patients who are non-responders to approved treatment methods

Exclusion Criteria:

* Patients whose diseases have approved methods of treatment.
* Pregnant women or women of normal child bearing age.
Effect of Genetic Polymorphism on Calcineurin Inhibitors Levels in Egyptian Renal Transplant Patients

Renal transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). Calcineurin Inhibitors tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejection.

The aim of the present study is to detect the incidence of some selected genetic polymorphism in Egyptian renal transplant population and investigate the influence of these genetic polymorphism (SNPs )on Cyclosporine and Tacrolimus blood concentration. In addition to detect the association between these genetic polymorphism variants and patients' clinical outcome after transplantation.

Tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejection.They both exert their immunosppressive action by inhibiting the calcinurein in T-lymphoctes. Subsequently,Cyclosporin and tacrolimus are both metabolic substrates for cytochrome P450 (CYP) 3A enzymes - in particular, CYP3A4 and CYP3A5 - and are transported out of cells by the P-glycoprotein (ABCB1) efflux pump. Different expression of CYP3A4, CYP3A5 and P-glycoprotein causes patient to-patient variability in the absorption, metabolism and tissue distribution of calcineurin inhibitors. This different expression is likely to be at least partially the result of mutations in the genes encoding for these enzymes and drug transporter. This may lead to variable drug concentrations within the systemic circulation and at target sites, influencing drug efficacy. Moreover, it will influence the individual's susceptibility to drug interactions and drug toxicity

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant patients.
2. Treatment with calcineurin inhibitors (CNI) either Cyclosporine (Neoral®) or Tacrolimus (Prograf®).
3. Absence of medication known to interact with CNI
4. Age18 years and more

Exclusion Criteria:

1. Patient who experience acute rejection, graft failure.
2. Medications that interact with Calcineurin Inhibitors.
3. Pregnant or nursing women.
4. Patients who decline to participate
Urinary Catheter Self-Discontinuation After Urogynecology Surgery

The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.

Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.

This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.

Eligibility Criteria:
Inclusion Criteria:

1. Are at least 18 years of age
2. Are fluent and able to read in English or Spanish
3. Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
4. Have transurethral catheter in place at the conclusion of surgery as part of standard care
5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
6. Are discharged home on the same day of surgery (POD 0)

Exclusion Criteria:

1. Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
2. Have physical or mental impairment that would impact their ability to remove their catheter themselves.
3. Undergo urethral bulking injections as part of surgery
4. Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients


Eligibility Criteria:
Inclusion Criteria:

* Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
* IOP \> 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
* Patient must be aged 18 years and more
* No previous cyclophotocoagulation procedure in the eye
* No previous laser treatment in the eye during the 3 months before HIFU procedure

Exclusion Criteria:

* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
* History of ocular or retrobulbar tumor
* retinal detachment, choroidal hemorrhage or detachment
* Ocular infectious diseasee within 14 days before HIFU procedure
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device

To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k) submission.

Standard of Care Study. Objective is to monitor the patients' heparin levels under treatment with continuous unfractionated heparin infusions. Blood samples collections (4 ml) are required routinely. A proportion of this standard sample (leftover plasma) will be used for study purposes. About three samples will be analyzed which are collected within 2 - 4 days. Time points for blood sample collections will be defined by the treating physician according the local standard of care and will be associated exclusively to clinical considerations. Results of the Pefakit® PiCT® UC assay will NOT be used to take therapeutic decisions for study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects receiving a continuous infusion with UFH
* Subjects who have given written informed consent (unless written informed consent is waived by local regulations or local EC/IRB)

Exclusion Criteria:

* Subjects treated with any other anticoagulants other than UFH
* Subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks
* Subjects who are known to have a congenital bleeding disorder
* Subjects known to present unexplained prolongations of clotting time
* Subjects known to have coagulation factor deficiencies
* Patient participating or who has participated within one month from enrolment in another investigational study
Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed rectal cancer; ASA score \< 3

Exclusion Criteria:

* palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery
Pathways of Eicosanoid Metabolism

Prostaglandins are important signaling compounds formed from arachidonic acid. The enzymes that form prostaglandins, cyclooxygenase-1 and -2 are the targets of non-steroidal anti-inflammatory drugs (NSAIDs). Because prostaglandins are very unstable in the body, they can not be measured directly. Instead, their metabolites are isolated from urine or blood and quantified as markers of formation of the parent, active compounds.

The investigators are testing the hypothesis that there is a previously unrecognized metabolic pathway between two prostaglandins. The investigators hypothesize that prostaglandin D2 (PGD2), in addition to its known metabolism to PGD-M, is also metabolized to 11-dehydro-thromboxane B2 (11-dehydro-TxB2).

The objective of this study is to determine whether PGD2 is metabolized to 11-dehydro-TxB2 in humans. Because the levels of PGD2 and its metabolite, PGD-M, are low in human urine, the investigators will use the model of niacin-induced flushing which is associated with a increased release of PGD2 from skin cells. It has been demonstrated that increased formation of PGD2 is associated with increased levels of urinary 11-dehydro-TxB2 in patients with mastocytosis.

In order to test whether niacin-induced biosynthesis of PGD2 is associated with formation of 11-dehydro-TxB2 the investigators will measure prostaglandin metabolites in blood and urine of volunteers receiving niacin. In addition, subjects will be treated with low or high dose aspirin prior to niacin to analyze the contribution of cyclooxygenase enzymes to biosynthesis of PGD2.

Arm 1: Subjects will receive 500 mg niacin. The subjects will collect urine (3-10 ml each) before niacin and every one-two hours after niacin for 10 h. Subjects will have blood drawn (2 teaspoons) before and at 0.5-1 h after niacin.

Arm 2: Subjects will take 81 mg aspirin (1 tablet of low-dose aspirin) daily for 7 days before niacin. Urine collection will be before and after aspirin, before niacin, and then in intervals as in arm 1. There will be a blood collection before niacin and 0.5-1 h after niacin.

Arm 3: Subjects will take 325 mg aspirin (1 tablet of regular strength aspirin) daily for 7 days before niacin. Urine collection will be before and after aspirin, before niacin, and then in intervals as in arm 1.

Arm 4: Subjects will be infused with 10 μg of deuterated PGD2 in a forearm vein over the course of 30 min. Subjects will collect a urine sample before and every two hours after deuterated PGD2 for 10 h.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy volunteers not currently taking any medication.

Exclusion Criteria:

* Use of anti-inflammatory/over-the-counter pain medications (NSAIDs) up to 2 weeks prior to study.