cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
* taking \>/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

* receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
* scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review \& an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* With T2DM, diagnosed at least 1 year prior to entry in the study
* Currently treated with diet, OAD(s) and/or insulin with no change in the type of OAD(s) or insulin in the previous three months

Exclusion Criteria:

* Type 1 diabetes and/or history of diabetic ketoacidosis
* Secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced)
* Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed
The Endoscopic Assesment of Intestinal Grafts

The study validates prospectively a new endoscopic scoring system (Gothenburg Intestinal Transplant Endoscopy Score, GITES) designed to summarize and stratify the abnormal ileal endoscopic findings after intestinal transplantation. GITES is a five-tier, four grade score which asseses mucosal friability, mucosal erythema and mucosal injury (ulcerations) as well as villous changes according to severity. These features (i.e., endoscopic descriptors) are also grouped from mild to very severe in the same sequence as observed during the progression of several pathologic conditions encountered after intestinal transplantation (acute rejection, infectious enteritis).


Eligibility Criteria:
Inclusion Criteria:

* transplantation of a segment of small intestine (as isolated graft or together with other organs)

Exclusion Criteria:

* contraindications for ileoscopy
REHIT Versus SMIT in Sedentary Young Women

Reduced-exertion high-intensity training (REHIT) is a novel form of exercise known for being non-classical, time-efficient, and effective on different populations. However, REHIT was scarcely tested on sedentary women with mortality risks. The aim of the study is to compare the effects of REHIT versus short moderate-intensity training (SMIT) on functional capacity, resting heart rate (RHR), and activity enjoyment in sedentary young women.

The aim of the study is to compare the effects of reduced-exertion high-intensity training (REHIT) versus short moderate-intensity training (SMIT) on functional capacity, resting heart rate (RHR), and activity enjoyment in sedentary young women. Therefore, sedentary young women will be randomly allocated to either a: i) REHIT group or ii) SMIT group. Both groups will perform an intervention over 6 weeks duration for 10 minutes each session for 2 sessions/week, but with different intensities (REHIT or SMIT). Both forms of exercise will be conducted on a cycle ergometer with the subjects monitored throughout the intervention. Before and after the 3-week intervention, functional capacity (6-minute walking test) and RHR will be measured. Additionally, physical activity enjoyment (Physical Activity Enjoyment Scale) will be assessed after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women.
* Age between 18 and 25 years old.
* Those who score a low physical activity level (\< 600 METS min/week) in the International Physical Activity Questionnaire-short form.

Exclusion Criteria:

* Women who suffer from musculoskeletal.
* Women who suffer from neurological diseases.
* Those who are taking medications.
Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.

In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II risk group,
* between the ages of 20-60,
* undergo elective laporoscopic cholecystectomy operation under general anesthesia

Exclusion Criteria:

* allergy to anesthetic medication,
* coronary artery patients,
* obese patients,
* emergencies,
* pregnants,
* abdomen operation history
* heart block
The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder

The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.

Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Hebrew Speakers
* Age 21-50
* Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID).

Exclusion Criteria:

* Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study.
* BD patients diagnosed with an acute manic episode at screening, as established by YMRS\>8. It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history.
* Participants for whom there exists a contra-indication for consuming Ritalin.
* Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study.
* Drug use in the previous 6 weeks according to participants' self report
* Electroconvulsive therapy (ECT) in the previous 6 months
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 18 to 50 years
2. Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
3. Minimum weight 40kg
4. BMI within range 18.0 - 29.9

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\]
4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
5. Negative Allen's test for radial and ulnar patency
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]
7. Is pregnant
8. Has anemia as measured by co-oximetry \[values specific for sex\]
9. Has a history of sickle cell trait or thalassemia \[self-reported\]
10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\]
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\]
12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\]
14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]
15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]
Normal Values of Cardiac Measurements by Echocardiography in Chinese Based on Artificial Intelligence

Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.

We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.

Exclusion Criteria:

* Hypertension (blood pressure \[BP\] \> 140/80 mmHg) or receiving medication for hypertension; body mass index \> 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol \< 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism.
Evaluation of Low Source of Signal in SCOUT DS

The overall objective of this study is to increase the number of dark skin tone individuals in the data set and evaluate if this increase in dark skin tone data has an impact on the accuracy of the SCOUT DS Diabetes Risk Score (DRS).


Eligibility Criteria:
Inclusion Criteria:

1. Dark Skin Tone (Von Luschan chromatic skin color \> 35)
2. Age greater than or equal to 45 years;

   OR
3. Age 18 to 44 years and a BMI \> 25 kg/m² with one or more of the following diabetes risk factors:

   * Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week)
   * Has a first-degree relative with type 2 diabetes
   * African American, Latino, Native American, Asian American, Pacific Islander
   * Has delivered a baby weighing \> 9 lb or previously diagnosed with gestational diabetes
   * Hypertension (≥140/≥ 90 mmHg) or being treated for hypertension
   * HDL cholesterol level \< 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
   * Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
   * Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years
   * Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans
   * History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

* Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712
* Under 18 years of age
* Receiving investigational treatments in the past 14 days
* Psychosocial issues that interfere with an ability to follow study procedures
* Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
* Diagnosed with any type of diabetes, including type 1 or 2
* Taking glucose lowering medications
* Known to be pregnant
* Receiving dialysis or having known renal compromise
* Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
* Current chemotherapy, or chemotherapy within the past 12 months
* Receiving medications that fluoresce\*
* Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
* Known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream)
* Prior bariatric surgery
Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant

The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.

The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :

* Peri-implant vertical defect depth.
* Crestal bone level.
* Bucco-lingual bone width.
* Keratinized tissue width

Eligibility Criteria:
1. Inclusion criteria

   * The presence of non-restorable mandibular molar.
   * Patient 18-45 years old
   * Intact buccal and lingual walls
   * Good oral hygiene.
   * Prescence of sufficient restorative space.
   * Jumping gap more than 2 mm.
2. Exclusion criteria

   * Proximity of anatomical structures
   * Acute localized infection (suppuration at the surgical field)
   * Patients on chemotherapy or radiotherapy.
   * Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, ...etc},
   * Pregnant patients.
   * Smoking and Alcohols.
   * Presence of periapical pathology affecting the neighboring teeth.
EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)

The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes.

Minimum 2 - maximum 10 healthy volunteers will be included.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion Criteria:

* None
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

Autologous Fat Derived Stem Cell treatment of ED.

To assess safety and primary efficacy of stem cell infusion in refractory ED.

To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Male 40 years old and older suffering from moderate to sever erectile dysfunction -

Exclusion Criteria:

* Inability to give informed consent or attend follow up
* Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
* Viral disease from infectivity viewpoint
* Major penile fibrosis or severe Peyronie's disease
* Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
* Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
* Prior systemic chemotherapy, or radiotherapy to donor or recipient area
* Not in potentially active sexual relationship
* Age less than 40 or over 70
Investigation of the Effect of Physical Activity Level on Sleep Quality and Fatigue in Academicians

Physical activity is closely associated with well-being condition and health development. The sleep quality and fatigue levels of individuals are also important components of health. Within the scope of our study, it is aimed to investigate the physical activity levels, sleep quality and fatigue levels of the academicians, who are generally working on a desk and we think that they live a sedentary life. Within the scope of this study, academicians were asked to respond to , International Physical Activity Questionnaire-Short Form (IPAQ-Short Form), general evaluation form, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS) .

The aim of this study is to investigate that the effect of physical activity level on sleep quality and fatigue in academicians.

First of all, a form including the purpose of the study, demographic information, daily working hours and assignment durations, was arranged; then obtaining general information about academicians who participated in the study and the physical activity levels of the individuals with International Physical Activity Questionnaire-Short Form (IPAQ-Short Form); sleep quality with the Pittsburg Sleep Quality Index (PSQI); fatigue levels with Fatigue Severity Scale (FSS) were planned to be measured. On-line communication was preferred as a data collection tool for all these assessments. In order to prevent bias in the results of the study, it was planned to transmit the questionnaire on-line to the academicians working in any program of any higher education institution. In this way, the voluntary involvement of the participant or any other threat to abuse was prevented. In other words, it was planned to ensure that individuals answer or don't respond the form on a purely voluntary basis.

Eligibility Criteria:
Inclusion Criteria:

Volunteering, to work as academicians in any department of any higher education institution.

Exclusion Criteria:

refuse to participate in the study, not being an academician