cyrilzakka/clinical-trials huggingface dataset:
Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).

This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.

Eligibility Criteria:
Inclusion Criteria:

* subject has clinical or biochemical hyperandrogenic symptoms
* subject has oligo/amenorrhea cycles

Exclusion Criteria:

* Hypersensitivity to metformin
* Hypersensitivity to sitagliptin presence of infertility factors other than anovulation,
* male infertility
* pelvic organic pathologies
* congenital adrenal hyperplasia
* thyroid dysfunction
* Cushing's syndrome
* hyper prolactinemia
* androgen secreting neoplasia
* diabetes mellitus
* consumption of medications affecting carbohydrate metabolism
* consumption hormonal analogues other than progesterone 2 months prior to enrolment in the study
* severe hepatic
* pancreatitis
* kidney diseases
* gallbladder diseases
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.

The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
* Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use.
* The subject must possess the ability to provide written Informed Consent.
* The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.

Exclusion Criteria:

* Subjects with a known sensitivity to porcine material.
Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants

To characterize muscle activity through electromyography (EMG) of the lumbar spine during high velocity, low amplitude (HVLA) spinal manipulation according to parameters of practitioner contact (location, applied force) in healthy participants and two categories of low back pain participants.


Eligibility Criteria:
Inclusion Criteria:

* male and female participants ages 18 to 55 years old

Exclusion Criteria:

Active Worker's Compensation claim related to low back pain episode Active personal injury case related to low back pain episode Currently taking muscle relaxers, steroids, or narcotics

* Body mass index \> 30 kg/m2
* Active cancer process
* Active infection
* Pregnancy
* High risk of osteoporosis assessed using the World Health Organization Fracture Risk Assessment Tool (included in submission)
* Osteogenic conditions (see screening questionnaire)
* Premature menopause
* Latex Allergies
* Lumbar spine or pelvic surgery
* Past spinal trauma producing spinal fracture
Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety

To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy.

The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient.

Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre.

The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient over 18 years of age
* Patient suffering from a cancerous pathology
* Patient taken care of for the installation of the ICH

Exclusion Criteria:

* Patient does not speak and understand French
* Patient who has had a previous ICH installation
* Patient with cognitive impairment
* Patient with pain perception disorder
Parental Consanguinity and Family History of Kidney Disease in Turkish Kidney Disease Population

Inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive disorders. The aim of this study was to examine the association between consanguinity and kidney diseases in the adult Turkish population.

This was a national, cross-sectional study recruiting patients from nephrology out-patient clinics and dialysis units. All patients between 18 and 70 years of age who were on follow up in outpatient clinic and dialysis unit at the Istanbul Medical Faculty from October 2009 to October 2015 were included in the study. All patients and healthy controls enrolled in this study gave informed consent to participate in the survey. They were all asked to answer a questionnaire including socio-demographic data, history of familial kidney disease and consanguineous marriage. Additional information was obtained from their private physicians and medical files. To ensure reliability of administration of the questionnaire, all interviewers underwent training using a standardized protocol.

Eligibility Criteria:
Inclusion Criteria:

* follow up in outpatient clinic and dialysis unit at the Istanbul Medical Faculty
* between 18-70 years old
* provide informed consent

Exclusion Criteria:

* follow-up shorter than 6 months
* patients whose data were not available
* patients who were unwilling or unable to provide informed consent
Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA)

The purpose of this study is to assess the potential interventions of exercises in adults with sickle cell anemia (SCA) and cardiopulmonary disease; only including the more severe genotypes of sickle cell disease.

Sickle cell disease is an inherited blood disorder that affects approximately 100,000 people in the United States. People living with sickle cell disease have numerous complications that cause significant morbidity and mortality such as painful episodes of vasoocclusion, acute chest syndrome, stroke, end organ damage, and early death. Unfortunately, their lifespan remains markedly shorter than the general population and this had not dramatically changed in the last 2 decades. Adults, are now not dying primarily from infections and sickle cell disease related complications, but cardiopulmonary disease is a leading cause of death. The etiology of cardiopulmonary disease in sickle cell disease is unclear but studies suggest that microvascular hypoxia, inflammation and endothelial dysfunction play a major role in the pathogenesis. In the general population, exercise reduces cardiovascular complications, pulmonary exacerbations, and decreases cardiovascular death. However, exercise used as primary or secondary prevention in sickle cell disease for cardiopulmonary disease has not been explored. Evidence shows that exercise in sickle cell disease can decrease oxidative stress, lower blood viscosity, and increase nitric oxide levels in both human and mouse models, but there remains some concern that high-intensity training in sickle cell disease may trigger vaso-occlusive crisis and adverse outcomes. However, multiple recent studies show that moderate intensity exercise can be safely performed in adults with sickle cell disease. Currently, providers lack evidence-based knowledge to inform the quantity and quality of regular exercise training that is safe but also improves cardiovascular outcomes in sickle cell disease. In addition, data does not exist on the feasibility and adherence of home-based training regimens in adults with sickle cell disease. Only one study has explored the feasibility and adherence in children. This study will be a qualitative assessment of potential interventions of exercises in adults with sickle cell anemia, only including the more severe genotypes of sickle cell disease.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with a known diagnosis of sickle cell anemia
* Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign a consent form and complete an interview

Exclusion Criteria:

- Subjects who does not meet the inclusion criteria above
Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain

Chronic neck pain is a common condition that can negatively impact quality of life. Substance P is one of the chemicals in the body that can transmit pain signals from overloaded neck muscles to the brain. Topical capsaicin blocks the action of Substance P by releasing, and subsequently depleting the body's store of Substance P in the nerves. Topical capsaicin has been reported to be an effective therapy for a number of persistent pain conditions including diabetic neuropathy, post-herpetic neuralgia, osteoarthritis, rheumatoid arthritis, and post-mastectomy pain. This study will evaluate the efficacy of topical capsaicin to reduce pain and improve health-related quality of life in adults with chronic muscular neck pain.

The study will employ a double blinded randomized controlled cross-over trial design. A total of 60 patients aged 18-65 with at least 3 months of myofascial neck pain will be recruited to participate in the study. The participants will be randomized into two groups. Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply a topical gel patch 12 hours each day overlying painful areas in the neck and shoulder girdle for each 4-week period. The topical gel patch used in each arm of the study will be identical except the placebo will not contain the active ingredient, 0.1% capsaicin. Both topical gel patches will be supplied by Caleb Pharmaceuticals. Each participant will complete 3 surveys at baseline and after each 4-week treatment arm: 1) McGill Pain Scale, 2) visual analog scale, and 3) Short Form 36 (general quality of life data). Paired T-tests will be used to evaluate for statistically significant changes between treatment with the control gel versus the active ingredient gel containing the capsaicin.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Speak, read, and write English who have greater than 3 month duration of myofascial neck pain.

Exclusion Criteria:

* Patients who have used capsaicin in the last 4 months and patients with allergy to capsaicin
* Rash/infection overlying neck and shoulder girdle area
* Radiculopathy or structural abnormalities in the area being treated
* Unstable underlying diseases such as cardiovascular, hepatic, renal and CNS disorders will be excluded from the study
* Pregnant or breast-feeding women will not be allowed to participate in the study, and women of child bearing age will be using an effective method of birth control.
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \</= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue).
* Patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups.
* Patient is in satisfactory condition, based on the physical exam and Investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively).
* Patient is geographically stable and willing to return to the implant center for follow-up visits.
* Patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

* Patient is older than seventy (70) years of age.
* Patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years.
* Patient is an intravenous drug and/or alcohol abuser.
* Female patient is pregnant (urine HCG test result positive), or lactating.
* Patient presents with active endocarditis.
* Patient presents with congenital bicuspid aortic anatomy.
* This patient presents with abnormal aortic root geometry.
* Patient has chronic renal failure or is on renal dialysis.
* Patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
* Patient requires mitral, tricuspid or pulmonic valve replacement.
* Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
* Patient is participating in concomitant research studies of investigational products.
* Patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy

While laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric surgery procedure in the US and worldwide, it is associated with significant postoperative nausea and vomiting (PONV), which can lead to patient readmission for rehydration and symptom control. Enhanced recovery after surgery (ERAS) is an approach that aligns the practice of anesthesia with the care given by the surgical team before, during, and after surgery. A number of prospective series, retrospective analyses and one randomized clinical trial of ERAS use in bariatric patients support the idea that ERAS in this population is feasible, effective and safe and that it is associated with shorter lengths of stay, fewer readmissions and decreased costs. In this protocol, the investigators will conduct a prospective, randomized control study using a structured and integrative perioperative plan (ERAS; n = 64) vs. current standard of care (SOC; n = 64) for patients undergoing LSG at Hartford Hospital. The investigators are guided by the idea that an enhanced recovery protocol can potentially serve to enhance the early patient experience and set the stage for a more rapid transition out of the recovery phase and into the weight loss phase of the patient's care. The investigators will incorporate a postoperative multidrug strategy targeting multiple receptors to decrease PONV and pain, similar to ERAS Society recommendations for bariatric patients.

Specific Aims and Hypotheses The central hypothesis is that the introduction of an ERAS pathway in patients undergoing LSG is feasible and will lead to better clinical outcomes.

Aim 1. To evaluate the effect that introducing an ERAS pathway will have on the use of narcotic medication for the management of postoperative pain, PONV, readiness for discharge, and overall length of stay in patients undergoing LSG.

Aim 2. To evaluate the safety of the ERAS protocol by measuring inpatient and 30-day adverse events, emergency department (ED) visits, outpatient hydration, readmission rates and delirium.

Participants will be recruited through fliers posted at Surgical Weight Loss Center locations (Glastonbury, Enfield, Hartford, Farmington, Manchester and South Windsor).


Eligibility Criteria:
Inclusion Criteria:

• Patients scheduled to have laparoscopic sleeve gastrectomy at our surgical weight loss center

Exclusion Criteria:

* Participants whose primary language is not English;
* Patients who are wheel chair-bound and those who are on dialysis with end stage renal disease;
* Patients who have known allergic reactions to any of the ERAS protocol medications, which upon review by the clinical team are deemed clinically significant;
* Patients with a history of cardiac events or a prolonged QTc interval on preoperative EKG which could in the opinion of the investigators increase their risk for prolonged QTc interval when certain ERAS medications are given in combination;
* Patients who have chronic kidney disease (contraindication to use NSAIDs) or are currently taking narcotic pain medications
Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium

This is a Phase I, Multicentre study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium \[sK+\] during 28 days in Patients with HFmrEF or HFpEF and eGFR in the range of ≥40 and ≤70 mL/min/1.73m2.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs consistent with a diagnosis of heart failure (HF)
* Left ventricular ejection fraction (LVEF) ≥40% by transthoracic echocardiography within the past 12 months
* Plasma NT-proBNP level ≥125 pg/ml (≥ 600pg/mL if patient has persistent or permanent atrial fibrillation, atrial flutter, or atrial tachycardia)
* Estimated glomerular filtration rate (eGFR) ≥40 and ≤70ml/min/1.73m2 (by CKD-EPI formula).
* Baseline serum potassium (sK+) level ≥3.5 and ≤4.8mmol/l.
* Stable doses of the following medications at baseline for at least 4 weeks prior to randomisation:

Angiotensin receptor blocker (ARB) or Angiotensin converting enzyme inhibitor (ACEi) Loop diuretic (up to a 120mg furosemide dose or equivalent

Exclusion Criteria:

* Patients with documented LVEF \<40% at any time (i.e. patients with previously impaired LVEF that has now improved are not permitted).
* Patients experiencing acute decompensation of heart failure requiring hospital admission or escalation in therapy.
* Primary cardiomyopathy (e.g. constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital or any primary cardiomyopathy in judgment of Investigator).
* Hyponatraemia, defined as serum Na+ \<135 mmol/L at the time of enrollment.
* Persistent resting sinus tachycardia \>110 bpm or sinus bradycardia \<45bpm.
* Systolic blood pressure (BP) \<110mmHg or \>180mmHg.
* Diastolic BP \<60 mmHg or \>100 mmHg.
* Patients previously intolerant to MRA (e.g. spironolactone or eplerenone) for any reason.
* Medical conditions associated with development of hyperkalaemia (e.g. Addison's disease).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the upper limit of normal (ULN).
* Patients who have been taking an MR antagonist within 1 month prior to randomization.
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

The purpose of this research is to examine effects of movement training with the aid of rhythmic auditory stimulation (RAS) on reducing severity of dyskinesia and bradykinesia in at-risk individuals and schizophrenia patients. The investigators hypothesize that training with the aid of RAS reduced severity of bradykinesia and dyskinesia in at-risk individuals as well as in schizophrenia patients.


Eligibility Criteria:
For at-risk individuals:

The inclusion criteria for at-risk individuals are:

1. A score of or above 9 in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16), or a score of or above 8.18 in the Chinese version of Community Assessment of Psychic Experiences with 15 items (CAPE-C15), or a score of or above 17 in Schizotypal Personality Questionnaire-Brief (SPQ-B);
2. A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;
3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.
4. The age ≥ 13 years.

The inclusion criteria for healthy controls are:

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
2. A score of or above 22 in MoCA;
3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
4. No first-degree family members having a diagnosis of mental illnesses.
5. The age ≥ 13 years.

At-risk participants and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.

For schizophrenia patients:

The inclusion criteria for schizophrenia patients are:

1. A diagnosis of schizophrenia without other psychiatric diseases;
2. Having stable psychotic symptoms;
3. A score of or above 22 in HK-MoCA;
4. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.
5. The age ≥ 18 years.

The inclusion criteria for healthy controls are:

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
2. A score of or above 22 in MoCA;
3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
4. No first-degree family members having a diagnosis of mental illnesses.
5. The age ≥ 18 years.

Patients and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.
Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population

Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that \~19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.

Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.

Eligibility Criteria:
Inclusion Criteria:

1. children birth to 10 years of age;
2. undergoing cardiac catheterization in the cath lab;
3. general anesthesia with an endotracheal tube;
4. subjects will also receive a chest x-ray as standard of care

Exclusion Criteria:

1. children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;
2. emergency procedures;
3. known airway anomalies;
4. children who are non-English and non-Spanish speaking -