cyrilzakka/clinical-trials huggingface dataset:
Rhythmic Auditory Stimulation on Neural Activity During Finger-tapping in PD Patients

Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. The investigators will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine real-time neural activity when patients with PD and healthy controls listen to RAS and execute finger-tapping task simultaneously.

Methods and analysis This study will recruit patients with PD and healthy controls. Electroencephalography (EEG) will be used under six conditions related to a finger-tapping task. Two-way repeated measures analysis of variance will be performed to investigate the group and condition effects on neural mechanisms.

Study significance This study will offer evidence on RAS effects and mechanisms by investigating the changes in upper-limb movements and neural mechanisms during auditory-motor entrainment. Results from this study will provide a solid foundation for further research and clinical applications of RAS.


Eligibility Criteria:
Inclusion Criteria:

* (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
* (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
* (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions;
* (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
* (e) types and doses of medications remain unchanged in the past month right before participation.
* Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities.

Exclusion Criteria:

* the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease

The study is planned to be conducted as a two-group randomized controlled trial to determine the effect of lavender inhalation on individuals with coronary heart disease. Research data will be collected at Çukurova University Medical Faculty Balcalı Hospital Cardiology Clinic between January-June 2023. In the study, at least 56 samples were found to be sufficient for the sample size. The data of the study will be collected using the Personal Information Form and the Pittsburg Sleep Quality Index.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and speak Turkish,
* Who agreed to participate in the research

Exclusion Criteria:

* People with communication difficulties and mental retardation
* People with coagulation disorders
* People with migraines and chronic headaches
* People with an allergy to lavender (Lavandula angustifolia Mill)
* It is the desire to leave the research.
Effect of Number of Meals on Metabolism After Weight Loss Surgery

The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.

The main goal is to study the effect of meal size and texture on incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.

Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.

Eligibility Criteria:
Inclusion Criteria: morbidly obese individuals, BMI above 35 and less than 50 kg/m2 who chose GBP as treatment for their obesity

* Must be able to attend all study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
* Individuals with or without Type 2 Diabetes Mellitus are eligible

Exclusion Criteria:

* Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
* Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome.
* Currently pregnant or nursing.
* Known cardiovascular disease.
* Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
* Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
* past history of severe food allergy
* History of Type 1 Diabetes Mellitus
* Individuals taking insulin, thiazolidinedione, exenatide, or DPP-IV inhibitors
Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

The purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin I,II, III and IV
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personal history of atopy;
* History of sensibilization or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study
Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written, personally signed, and dated informed consent.
* Healthy male and female participants between the ages of 18 to 45 inclusive.
* BMI 18 - 30 kg/m2.
* Non- or ex-smoker.
* Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.
* Participants must agree to use highly

Exclusion Criteria:

* History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
* Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
* Previous or current alcohol, or other drug dependence.
Effects of Dead Bug vs. Mc Gill Exercises on Pain, QOL and Core Stability in Patient With Chronic Nonspecific LBP

Low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. However, diagnosis and, in particular, the provision of specialized back pain therapy remain difficult.

This study aims to compare the effects of dead bug vs. Mc Gill exercises on pain, quality of life and core stability in patient with chronic nonspecific low back pain. It will be a randomized clinical trial study. The sample size of study will be 44 participants (22 in each group). Data will be collected from Azra Naheed Hospital. Data will be collected within 6 months after approval of synopsis. Group A will follow dead bug exercises and Group B will follow Mc Gill exercises (Curl up, Side Bridge and Bird Dog). The patients in both groups will be performed the corresponding exercises 3 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises. The exercises will be taught to the patients at the end of the first session in both groups. The data will be analyzed using SPSS version 24 for Windows software. Statistical significance will be set at P ≤ 0.05. Normality of data will be assessed through Kolmogorov-smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t test will be used for parametric data and Mann Whitney test will be used for non parametric data.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-50 years
* Patient with the history of 3 months nonspecific low back pain
* Pain intensity (3-7) according to VAS score

Exclusion Criteria:

* Spinal stenosis
* Neurological dysfunction
* Systemic disease
* Pregnancy
* Infections
* Carcinoma
* Any fracture or deformity
Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765

To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic plaque psoriasis for at least 6 months
* Prior systemic therapy

Exclusion Criteria:

* Current or prior history of illness precluding use of immunomodulatory therapy.
Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).

The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.


Eligibility Criteria:
Inclusion Criteria:

* Age not less than 18
* Planned abdominal surgery\> 2 hours.
* Signed informed consent for participation in the study.

Exclusion Criteria:

* Age less than 18 years.
* Pregnant or breast-feeding.
* Patients with BMI \>35.
* Syndrome of moderate or severe respiratory distress: PaO2/FiO2 \< 200 mmHg.
* Heart failure: NYHA IV.
* Hemodynamic failure: CI \<2.5 L/min/m2 and / or requirements before surgery ionotropic support.
* Diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmHg).
* Mechanical ventilation in the last 15 days.
* Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
* Patient with preoperatively CPAP.
* Participation in another experimental protocol at the time of intervention selection.
Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

This study is designed to evaluate the potential effect of the moderate CYP3A inducer modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects with a self-reported history of addiction, especially to stimulants.
* A positive urine drug screen or alcohol breath test.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
Understanding Factors in Decision Making for Children with Medical Complexity

The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity.

Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.

Children with medical complexity, their caregivers, and their providers face a multitude of complex, high stakes medical decisions throughout their lifetime. Best practices for the provision of high quality shared decision making in the care of children with medical complexity do not exist. Unique challenges to support decision making for caregivers of children with medical complexity include communication of decision-related risks and benefits and knowledge related to the decision. This study will test the efficacy of various communication techniques in the setting of a simulated patient encounter.

Eligibility Criteria:
Inclusion Criteria:

* Adult caregiver of a child with medical complexity
* English- or Spanish-speaking

Exclusion Criteria:

* Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
TURP; Complications and Outpatient Care

This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated.

The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection.

However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability.

Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.

Eligibility Criteria:
Inclusion Criteria:

* Planned for transurethral resection of the prostate (TUR P)

Exclusion Criteria:

* No consent to participate
Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.

Specific Aims:

1. To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
2. To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
3. To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
4. To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.

Eligibility Criteria:
Inclusion Criteria:

* Male and female military veterans and active duty military personnel aged 18 and older
* A DSM IV diagnosis of post-traumatic stress disorder
* Potential subjects on medications are eligible to participate in the study
* Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
* Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process

Exclusion Criteria:

* Potential subjects are ineligible if pregnant and in their third trimester.
* Potential subjects are ineligible if they are confined to a wheel chair.
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass

The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
* Willing to receive allogeneic blood product transfusions during and after surgery

Exclusion Criteria:

* Have had previous cardiac surgery
* Have had previous median sternotomy
* Have tendency for bleeding or family history of bleeding
* Have an abnormally low platelet count
* Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday

The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Diagnosis of osteoporosis in the medical record
* At least one prescription drug to treat osteoporosis in the last 5 years
* Insured by "Clalit" Health Services
* Hebrew-speaking capability and readiness to answer a questionnaire

Exclusion Criteria:

* Premenopausal women
* No diagnosis of osteoporosis in the medical record
* No treatment for osteoporosis in the last 5 years
* Women who do not speak Hebrew or are unable to answer a questionnaire
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions

To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to a currently approved active control product (High Viscosity DermaBond). Specifically, the study is powered to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in the rates of infection, dehiscence, cosmesis and apposition of the skin.

This is a prospective, randomized, controlled, double-masked multi-center clinical trial. Patients requiring laparoscopic surgery will be enrolled and randomized to receive either LiquiBand Laparoscopic™ or DermaBond High Viscosity for incision closure. No other closure methods will be allowed. All eligible laparoscopic incisions per patient will be enrolled. Patients will be followed at 2 weeks and 3 months post-procedure to assess wound characteristics, wound infection, wound dehiscence and at 3 months for cosmesis. The study will be double-masked in that both the wound evaluator and patient will be masked to the randomized study treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a laparoscopic surgical procedure
* Aged 18 years or older
* Agree to return to 2-weeks (3 days) post-procedure follow-up visit
* Agree to return to 3-month (5 days) post-procedure follow-up visit
* Able and willing to give informed consent and to comply with all study requirements

Exclusion Criteria:

* Known sensitivity to cyanoacrylate, formaldehyde or acetone products,
* Surgical procedures involving mucus membranes or eyes
* History of skin rashes or exfoliative condition at time of procedure
* History of keloid formation or hypertrophy
* Currently on immunosuppressive therapy
* Decubitus ulcer
* Pregnant or nursing.
* Participated in an investigational drug or device study within the past 3 months
* Conditions known to interfere with wound healing:
* Diabetes, Type I or II
* Advanced chronic renal insufficiency (GFR greater than 25 mL/min or with clinical signs of azotemia), uremia or endstage renal disease
* Advanced liver failure or cirrhosis (Child-Pugh score of B or C)
* Advanced malignancy, or cancer patients currently receiving chemotherapy (within 30 days of procedure)
* History of radiation therapy to the study area
* Advanced COPD (FEV greater than 1 litre and or PaO2 60 mmHg)
* Suspected infection at incision site
* Peripheral vascular disease
* Corticosteroid therapy
* Morbid obesity (50-100 percent or 100 pounds above their ideal body weight and/or a BMI value greater than 40)
* Blood clotting disorders (e.g. Haemophilia)
* Wounds under high tension forces (over joints)
* Life expectancy of greater than 3 months
* ASA level of 4 or 5