cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.

This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18 to 40 kg/m\*2 (inclusive)
* Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:

Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m\*2; or Severely impaired renal function: eGFR \<30 mL/min/1.73 m\*2 but not on dialysis

- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR ≥90 mL/min/1.73 m\*2

Exclusion Criteria:

* Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.
* Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.
* Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
* Acute renal failure or acute nephritis within the past 2 years.
* Pregnancy or lactation.
* Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.
* Insufficiently controlled diabetes mellitus with fasting blood glucose \>220 mg/dL or HbA1c \>10%.
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:

  * Male: 36.0%;
  * Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
Predictability of the Pulse Pressure Variation (PPV) During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia

The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil
* Patients requiring invasive arterial blood pressure monitoring for the surgery

Exclusion Criteria:

* Refusal of consent
* Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt, pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)
* FEV1 ≤ 50% predicted FEV1
* Patients with chronic renal failure
* ASA class IV, V, VI
* Systolic arterial blood pressure below 90mmHg before induction of anesthesia
tDCS as an add-on Treatment in SSRI-resistant OCD

The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)

Statistical analysis to address the primary and secondary objectives:

Chi squared test will be applied for quantitative data.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with OCD according to DSM V criteria
* YBOCS score of 16 and above, stable (\<20% of variation) during at least one month.
* have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
* age between 18 and 70
* voluntary and competent to consent

Exclusion Criteria:

* Major depressive disorder diagnosed with the DSM V criteria with a MADRS score \>30 (actual)
* schizophrenia and other psychotic disorder
* drugs or alcohol abuse
* acutely suicidal
* significant head injury, or of any neurosurgical procedure with implanted material
* pregnant women
Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama

This proposal seeks to improve the investigators' post-stroke TOC process through developing an innovative, patient informed and guided solution aimed at addressing the investigators' deep south African American population within the UAB system. The investigators will engage participants in both urban and rural Alabama through informational interviews and work to find common themes to address so that future interventions are useful to their unique needs and desires. This goes beyond simply identifying barriers and endeavors to discovering solutions.


Eligibility Criteria:
Inclusion Criteria:

1. African American
2. Aged 40 years and older
3. Required home health therapy, outpatient therapy, skilled nursing facility or inpatient rehabilitation
4. Alabama Resident
5. Fluent in English
6. Stroke confirmed by advanced imaging (CT, MRI)
7. Zoom capability (participants can either have video conference ability or can call into Zoom line)
8. Caregivers must be identified by patients as providing a significant portion of care and/or be able to articulate their role as a caregiver

Exclusion Criteria:

1. Did not require home health therapy, outpatient therapy or inpatient rehabilitation
2. Long term residents of skilled nursing facility
3. Severe aphasia
4. Severe cognitive impairments
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

"The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."

"Background: Studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias.

This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. Rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and should have a life expectancy of more than 18 months.

Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."

Eligibility Criteria:
Inclusion Criteria:

* indication for an ICD according to ACC/AHA guidelines
* ICD with rate response function implanted
* at least 5% rate response ventricular pacing during the one month screening phase
* signed informed patient consent"

Exclusion Criteria:

* rate responsive pacing contraindicated
* patient not able to perform 6 min walktest
* heart failure NYHA IV
* life expectancy below 18 months"
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* more than 5 years since diagnosis of diabetes
* c-peptide negative

Exclusion Criteria:

* ischemic heart disease
* previous transplant
* recurrent infections
* malignancy (except basal or squamous skin cancer)
Investigation of The Effect of Web-Based System With Oculomotor and Optokinetic Stimulation on Rehabilitation in Vestibular Hypofunction

The aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it.

Vestibular system is one of the sensory systems used for postural control. The function of this system is to maintain balance during head movements and to sense the sense of position in the space.Information from the vestibular system goes to the neural processing center. To achieve or maintain postural control as a result of neural reorganization, balance is achieved by controlling eye movements and muscles.

Basic symptoms in vestibular pathologies are; vertigo and dizziness. Besides these; vestibulo-visual symptoms (oscillopsia, decreased visual acuity, visual tilt, etc.), postural symptoms (feeling of falling, swaying, etc.), and symptoms of motion sickness are. The occurrence of these symptoms varies according to diseases and individual characteristics.

In the treatment of vestibular diseases; there are medical treatment, vestibular rehabilitation, surgical interventions and psychosocial education.Medical treatments; it is often used to suppress or control vestibular symptoms (nausea, etc.). Surgical interventions are the last choice of treatment in patients with severe attacks such as disabling function such as labyrinthectomy or signaling the vestibular nerve. Vestibular Rehabilitation is an exercise based approach to maximize central nervous system compensation for vestibular pathology.

In recent years, the effectiveness of the technologies that have been used in different areas of rehabilitation in vestibular rehabilitation has started to be investigated. In the researches, it is seen that virtual reality is one of the most used technologies. In terms of virtual reality usage, it has cost, size and portability advantages (3). However, in other studies, different systems apart from virtual reality are almost not found among the assistive technologies in vestibular rehabilitation.

In recent years, vestibular rehabilitation methods, adaptation to changing sensory conditions and sensory repetition methods in compensation process have been emphasized to increase adaptation to vestibular losses. However, individual therapeutic programs need to be planned in accordance with clinical symptoms. To this end, there is a need to develop reliable objective and technological feedback techniques to measure the interaction of peripheral senses and central adjustment mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral vestibulopathy between the ages of 18-75,
* No visual disability

Exclusion Criteria:

* Mental retardation,
* Inadequate communication in Turkish;
* Having neurological problems,
* Bilateral vestibular hypofunction
* There is a serious orthopedic problem that will prevent standing and walking.
Thyromental Height Test as a Predictor of Difficult Airway:

Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Thyromental height test (TMHT) is an objective measure of the height between the anterior borders of the mentum and thyroid cartilage, measured while the patient is lying supine with the mouth closed. This study was designed to assess the validity of the TMHT as a single objective predictor for difficult laryngoscopy and to be compared to other objective measures.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I \& II
* Scheduled for elective surgical procedures under general anesthesia using endotracheal with conventional laryngoscopy

Exclusion Criteria:

* Patients with a body mass index \>35 kg/m2.
* Patients with neuromuscular disorders, craniofacial abnormalities, and abnormal dentition.
* Patients with airway diseases e.g cancer larynx or tongue, uncooperative patients, those who will need awake intubation and patients who will undergo emergency operations.
Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

Type II diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. Thus Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given his consent
* Adult patient over 50 years of age Type II diabetic treated without modification of the antidiabetic treatment during the previous 3 months
* HbA1c ≥ 7%.
* Patient for whom a decision to start a GLP-1 agonist treatment has been made (Liraglutide, Semaglutide, Dulaglutide).
* At least one risk factor from among:
* Treated hypertension,
* treated dyslipidemia,
* History of obesity (BMI\>30 kg/m2)
* Active smoking (from 1 cigarette per day) or smoking cessation for less than 3 years,
* Coronary heredity (myocardial infarction or sudden death before age 55 in father/brother, myocardial infarction or sudden death before age 65 in mother/sister)

Exclusion Criteria:

- Protected adult Patient not affiliated to a national health insurance scheme Pregnant or breastfeeding woman Women who intend to become pregnant or of childbearing age and do not use adequate contraceptive methods.

Antidiabetic treatment of the incretin family (DPP4 inhibitor except sitagliptin) Severe renal failure (clearance \<30ml/min according to Cockroft due to gadolinium injection) Claustrophobia / contraindication to MRI (compatible non-MRI implanted metallic material) History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents and meglumine Hypersensitivity to Liraglutide, Semaglutide, Dulaglutide or any of the excipients History or presence of pancreatitis (acute or chronic) Chronic inflammatory bowel disease Diabetic gastroparesis Dysthyroidism
Focal Therapy for Localized Prostate Cancer

This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.

This observational study will serve to collect data from medical record and review questionnaires before and after focal ablation of prostate tissue. All enrolled subjects will have already undergone or scheduled to receive the focal therapy as part of their prostate cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject has elected or already undergone focal therapy as their standard of care treatment method and declined alternative treatment (active surveillance, radical prostatectomy, and radiation therapy)
* PSA ≤ 20
* Ability to complete informed consent form

Exclusion Criteria:

* Contraindication to follow-up multi parametric MRI or prostate biopsy
* Unable to tolerate general or regional anesthesia
Laughter Yoga for Improving Sexual Function and Psychosocial Outcomes in Multiple Sclerosis

The goal of this clinical trial is to evaluate whether laughter yoga can improve sexual functioning and reduce psychological symptoms in adults diagnosed with multiple sclerosis (MS). The main questions it aims to answer are:

Does laughter yoga improve sexual functioning in individuals with MS?

Does laughter yoga reduce anxiety, depression, and fatigue, and improve quality of life in this population?

Participants will:

Attend 10 online laughter yoga sessions over 5 weeks (2 sessions per week, 40 minutes each)

Complete online questionnaires before, during, and after the intervention to assess sexual functioning, anxiety, depression, fatigue, and quality of life

This quasi-experimental study investigates the effectiveness of laughter yoga in improving sexual functioning and psychosocial outcomes in adults with multiple sclerosis (MS). Laughter yoga is a behavioral intervention combining voluntary laughter with yogic breathing techniques, aiming to enhance emotional well-being and reduce stress-related symptoms.

The study includes three assessment points: baseline (pretest), five weeks after the baseline (pre-intervention), and post-intervention. The intervention consists of 10 structured laughter yoga sessions conducted via Zoom over a 5-week period. Each session lasts approximately 40 minutes and includes rhythmic clapping, deep breathing exercises, playful activities, and simulated laughter practices guided by a certified laughter yoga facilitator.

Validated self-report instruments are used to assess sexual functioning, anxiety, depression, fatigue, and quality of life. The study specifically targets individuals with MS who report sexual problems and experience mild to moderate psychological symptoms.

The primary aim is to determine the effect of laughter yoga on sexual functioning (measured by MSISQ-19). Secondary outcomes include changes in anxiety, depression, fatigue, and health-related quality of life. This study seeks to explore laughter yoga as a feasible, non-pharmacological, and low-cost approach to improving multidimensional well-being in MS patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosed with multiple sclerosis (MS)
* Literate and able to complete self-report questionnaires
* Expanded Disability Status Scale (EDSS) score \< 4
* HADS-Anxiety score \> 10
* HADS-Depression score \> 7
* Reporting sexual problems based on MSISQ-19
* Having an active sexual life
* Access to internet and a device capable of video conferencing
* Willing to participate and able to attend all 10 laughter yoga sessions

Exclusion Criteria:

* MS relapse or acute exacerbation within the last 3 months
* Severe cognitive impairment or communication difficulties
* Current participation in any laughter therapy, yoga, or similar psychosocial intervention
* Diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
* Unwillingness or inability to provide informed consent
Male Supplements for Sperm Quality and Aging

This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated.

Due to modern lifestyle factors such as high work pressure, stressful routines, and environmental pollution, there has been a significant decline in sperm quality among men, potentially leading to infertility. In response, various supplements have emerged claiming to enhance sperm quality. This prospective investigation aims to determine the efficacy of a new supplement in improving sperm quality among patients with poor sperm quality. The study will enroll 50 patients undergoing semen analysis at our reproductive center, administering the supplement over a three-month treatment period to those identified with poor sperm quality. Subsequent semen analysis will be conducted, alongside assessments of sperm mitochondrial metabolic function before and after supplement administration. Sexual function and aging symptoms will also be evaluated using the International Index of Erectile Function (IIEF-5) and the Aging Males Symptoms Scale (AMS) before and after the supplementation period. The study aims to compare differences in semen analysis, sperm mitochondrial metabolic function, sexual function, and aging symptoms before and after supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Not meet the criteria of the 6th edition of the WHO manual for human semen analysis
* BMI:18-30 kg/m2

Exclusion Criteria:

* Azoospermia
* Varicocele
* Chromosome anomaly
* Malignancy
* Using hormone therapy or supplements in recent 3 months