cyrilzakka/clinical-trials huggingface dataset:
Gait Variability in Healthy Youngs

Three hundred healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait trainer Biodex 2, at participant's preferred speed.

Three hundred healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 4nd and 6th minutes at walk.

Eligibility Criteria:
Inclusion Criteria:

Want to participate

Exclusion Criteria:

Have passive joint limitation at extremities Surgery at last 5 year Systemic problems such as neurologic disorders, rheumatoid disorders... Another orthopedic anomalies
Dexmed/Buspirone Synergism on Shivering

The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.

The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration.

Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* normal weight (BMI \<35)
* healthy

Exclusion Criteria:

* obese (BMI \>35)
* taking any drugs
* thyroid disease, dysautonomia, or Raynaud's syndrome
* severe claustrophobia
Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy).

Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age
2. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
3. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 109/L
   * Hemoglobin: \> 80 g/L
   * Platelets: \> 50.0 x 109/L
   * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
4. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Effect of Exercise After Heart Transplantation

This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Norwegian heart transplanted patients \> 18 years of age
* 1-8 years after heart transplantation
* Optimal medical treatment
* Stable condition
* Written informed consent
* Must have access to a physical therapist or personal trainer in their hometown
* Motivation for exercise

Exclusion Criteria:

* Unstable condition
* In need of revascularization or other invention
* Infections, open wounds or skin diseases
* Physical disabilities which prevent participation
* Other diseases, illnesses or conditions which contradict exercise
Effect of Goji Berry Consumption on Biochemical Parameters

Goji Berry as a functional food have been shown to reduce risk of hyperlipidemia, type 2 diabetes, etc. However, human studies are limited in this area. In this study, it has been aimed to evaluate the effect of goji berry consumption on some biochemical parameters in healthy individuals.

Healthy individuals have been divided into control and study groups. Individuals in both group have same characteristics such as age, gender, and body mass index (Control Group: 35 individuals - Study Group: 35 individuals). Both group were asked to maintain their normal diets. In addition, the study group consume 20 g of dried goji berry per day and did not consume any fruit with a similar antioxidant content during the 8 weeks study period. The control group was asked to exclude goji berry and similar fruits with high antioxidant content from their diet during the 8 weeks study period. The 20 g goji berry for per day was given weekly to each individual in a study group in transparent bags. At the beginning of the study and every 15 days, food consumption record for 3 consecutive days (2 weekdays and 1 weekend), a 3-day physical activity record, and anthropometric measurements (weight, height, waist and hip circumferences, body composition analysis) were taken. Blood parameters (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), triglyceride, glucose, insulin, homeostatic model assessment of insulin resistance (HOMA-IR), HbA1c) of individuals were taken at the beginning and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20-25 kg/m²
* Female individuals are not in the period of lactation and menopause,
* Absence of any chronic or acute disease diagnosed by a physician,
* No allergies to Goji Berry
* Not consuming goji berry and similar fruits regularly for the last 1 month.
* Not being in the process of body weight loss
* Not doing strenuous physical activity
* Not taking any medication or antioxidant vitamin support
* Not smoking
* Not consuming alcohol (moderate alcohol consumption)

Exclusion Criteria:

Not meeting the criteria for inclusion in the study
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
* Subject has failed to achieve seizure control with \>=4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
* Average of \>= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
* Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments

Exclusion Criteria:

* Subject has a history of or signs of generalized or combined generalized and focal epilepsy
* Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
* Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
* Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
* Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
* Subject has been taking vigabatrin less than 2 years at study entry
* Subject has been taking felbamate for less than 12 months
* Subject taking retigabine for less than 4 years
* Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) \<3 times per week for emergencies
* Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study
A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients

This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.

Patients meeting inclusion criteria will be consented at the time of scheduling. All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging with the AAA-provided dose. These scans will be performed no less than 8 hours, no more than 7 days apart. For patients undergoing same-day imaging, NETSPOT imaging will be performed prior to 18F-FDG-PET/CT. Following imaging, both 18F-FDG-PET/CT and NETSPOT imaging will be compared by trained neuroradiologists for SUV values and concordance with known sites of disease. Biopsies will be performed as is standard to verify all sites of primary or metastatic disease. Patients with oropharyngeal tumors will have HPV testing performed via the standard of care surrogate marker p16. Patients with p16-positive tumors will be recorded and analyzed separately for the above measures. Patients will be followed for a total of 1 year after the study and outcomes of overall survival, disease-free survival, presence and site of recurrence and development of metastatic disease will be recorded. All gathered data will be compared between reported 18F-FDG-PET/CT and NETSPOT imaging for true positive, true negative, positive predictive value and negative predictive value of patient groups.

Eligibility Criteria:
Inclusion Criteria:

Patients with suspected or diagnosed HNSCC undergoing planned 18F FDG PET/CT at the time of primary diagnosis or after completion of treatment.

Exclusion Criteria:

Inability to undergo 18F-FDG-PET/CT imaging due to medical comorbidities
Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage

The goal of this clinical trial is to learn if Glucophage (metformin) improves pregnancy outcomes in women with polycystic ovarian syndrome (PCOS). It will also evaluate the safety of Glucophage during pregnancy. The main questions it aims to answer are:

Does Glucophage reduce the risks of early pregnancy loss, preterm delivery, and gestational diabetes? Are there any medical problems associated with taking Glucophage during pregnancy? Researchers will compare Glucophage with standard care (diet and exercise) to see if it improves pregnancy outcomes in women with PCOS.

Participants will:

Take Glucophage or follow a standard diet and exercise plan throughout pregnancy.

Attend regular follow-up visits for checkups, ultrasounds, and blood tests. Have their pregnancy outcomes, such as fetal growth and gestational diabetes, recorded.

This randomized controlled trial aims to evaluate the effectiveness of Glucophage (metformin) in improving pregnancy outcomes for women with polycystic ovarian syndrome (PCOS). The study compares two groups: one receiving standard diet and exercise along with Glucophage and another receiving only standard diet and exercise. Outcomes such as early pregnancy loss, preterm delivery, gestational diabetes, intrauterine growth restriction, and fetal malformations will be assessed.

Participants will be enrolled during their first trimester and followed through delivery. Data will be collected during regular follow-up visits, including ultrasound scans and oral glucose tolerance tests. The study will use statistical analysis to determine whether Glucophage significantly improves maternal and fetal health outcomes compared to standard care. Findings will help guide clinical management strategies for PCOS during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

Pregnant females aged 18-40 years Diagnosed with polycystic ovarian syndrome (PCOS) before conception, as per operational definition.

Present in the 1st trimester at the booking visit. Singleton fetus on booking scan between 5th to 13th week of gestation.

Exclusion Criteria:

Females who do not give informed consent for follow-up. Females with preeclampsia (BP ≥140/90 mmHg with proteinuria \>+1 on dipstick method).

Females already diagnosed with gestational diabetes (OGTT \>186 mg/dl). Females already taking trial treatment (as per medical record). Twin pregnancy or abnormal placenta (assessed on ultrasound). Diagnosed hypertensives and diabetic patients.
Age Dependence of Audiometric Bone Conduction Threshold in Normal Hearing Subjects

Examination of the bone conduction of persons which according to the pure tone audiogram have a normal age related hearing threshold in the air conduction.


Eligibility Criteria:
Inclusion Criteria:

* All pure tone audiograms recorded and available in the system from the beginning of measurement as follows:
* age related normal hearing threshold level with air conducted pure tone audiogram

Exclusion Criteria:

* age younger than 20 years
* if inclusion criteria not given
Social Support and Reduced Fear Acquisition

University of California, Los Angeles researchers will recruit healthy participants and anxious participants (those diagnosed with social anxiety disorder) age 18-55 years old to participate in a study examining whether the ability of social support figure reminders to prevent the acquisition of fear in healthy participants extends to those with anxiety disorders.

After being recruited from the UCLA community (healthy participants, n = 50) or referred by treatment providers at the Anxiety and Depression Research Center at UCLA (anxious participants, n =50) and undergoing a telephone screening and in-person screening, 100 participants will be enrolled in the study. During the experiment, all participants will undergo the same procedures: undergoing fear acquisition procedures--the repeated pairing of a neutral image with a mild electric shock that ultimately leads to the association of threat of shock with the image--in the presence of an image of a social support figure (provided by participants) and an image of a smiling stranger.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults 18 and 35
* fluent in English
* no history of mental illness (healthy participants: including anxiety, depression, phobia, or any other mental health related disorder diagnosed by a mental health professional)
* diagnosis of social anxiety disorder (anxious participants: allowed co-morbid disorders include depression, other anxiety disorders, and PTSD)

Exclusion Criteria:

* pregnant or planning to become pregnant during the experiment period
* presence of chronic mental illness (healthy participants: as determined by the report of a past diagnosis of mental illness by a physician or psychologist and/or the prescription of medication related to mental health disorder; including anxiety, depression, phobia, or any other diagnosed psychological disorder)
* presence of non-allowed co-morbid disorders (anxious participants: including, bipolar disorder, psychosis, substance use disorder, neurological disorder, and/or obsessive-compulsive disorder)
* current and regular use of prescription medications related to mental health disorders
THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial

This research is a randomized clinical trial aims to evaluate the influence of cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients with sexual dysfunction. The notion of sexual health for the World Health Organization exceeds the concept of sickness absence, having a subjective well-being of significance in the spheres of self-concept, self-image, interpersonal relationships and sense of self worth. Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental disorders, improving health and quality of life of the treated populations. However, they did not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This study aims to then fill this gap by evaluating the relationship from the use of techniques of CBT.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-59 years;
* FSFI less than or equal to 26.

Exclusion Criteria:

* Scores of Beck Scales - moderate or severe;
* Prescribing hormone therapy after starting the group.
An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States

The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

This study is not recruiting patients in the United States.

The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

Eligibility Criteria:
Inclusion Criteria:

* Attended the Phase IIb study
* Able to fill out the patient diary

Exclusion Criteria:

* Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
* Dementia symptoms
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.
Effects of Acute Carbohydrate Intake Intra-training in Crosstraining

This study aims to investigate the effect of acute carbohydrate intake during a crosstraining session on exercise-induced muscle damage and the recovery of crosstraining athletes.

Carbohydrate intake during exercise could decrease the subjective perceived exertion and promote recovery during high-intensity and intermittent exercises such as crosstraining. Nevertheless, despite extensive research on carbohydrate ingestion during exercise across different sports disciplines, its effects have not been investigated in crosstraining sessions.

23 male trained crosstraining athletes will ingest carbohydrates (60g of maltodextrin + fructose, 2:1 ratio) or placebo during a one-and-a-half-hour crosstraining session. The session will consist of a warm-up, a weightlifting part, a strength part, a WOD, and an AMRAP. The rating of perceived exertion (RPE) will be assessed using the validated Borg scale at the beginning of the session, after each part of the training, and at the end of the session. DOMS will be assessed using a visual analog scale at 24 and 48 hours after the crosstraining session.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-35 years.
* Body mass index: 18.5-30 kg/m2.
* Ability to understand the instructions, objectives, and study protocol.
* Minimum of 3 years of experience in crosstraining, with at least 6 hours of weekly training over the past 3 months.
* Resident on the island of Tenerife.

Exclusion Criteria:

* History of a significant adverse cardiovascular event, renal insufficiency, cirrhosis, eating disorder, weight control surgical intervention, or type 2 diabetes mellitus.
* Any chronic condition in which the intake of nutritional supplements is not advisable.
* Any condition that, in the investigator's judgment, would impair the ability to participate in the study or represent a personal risk to the participant.
* Use of medications that may affect the study results.
* Unstable body weight for 3 months prior to the start of the study (\> 4 kg loss or gain in - weight).
* Active tobacco abuse or illicit drug use, or history of treatment for alcohol abuse.
* On a special diet or prescribed for other reasons (e.g., celiac disease).