cyrilzakka/clinical-trials huggingface dataset:
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test

* Evaluate for accuracy and reproducibility of data collected via the participant-operated Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician proctored 6MWT's.

  * Determine whether the WTT app on the Apple Watch can accurately collect information on distance traveled and heart rate (HR) during in-clinic 6MWT run by American Thoracic Society (ATS) guidelines
  * Determine whether participants can operate the WTT app and Apple Watch effectively to gather accurate data in a monitored and home-based setting
* Prospectively monitor for changes in WTT app recorded 6MWT results following initiation of therapy in a treatment naïve cohort of PAH participants

  * Evaluate whether changes from baseline in 6 minute walk distance (6MWD) and heart rate recovery at one minute (HRR1) as well as other variables that have been associated with disease severity in PAH and left-sided heart disease (resting HR, heart rate variability \[HRV\], chronotropic index \[CI\]) can be identified before the 12-week follow up when comparing the treatment arm and the control arm
  * Evaluate whether changes from baseline in the HRR1, resting HR, HRV and/or CI are more evident in treatment responders when compared to treatment non-responders.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of WHO Group I Pulmonary Arterial Hypertension (PAH) (Idiopathic (I)PAH, Heritable PAH (including Hereditary Hemorrhagic Telangiectasia), Associated (A)PAH (including collagen vascular disorders, drugs+toxins exposure, congenital heart disease, and portopulmonary disease).
* Do not meet exclusion criteria

Exclusion Criteria:

* Pulmonary Hypertension due to left heart disease (PH-LHD, WHO group 2), Pulmonary hypertension due to chronic lung disease (PH-CLD, WHO group 3), Chronic thrombo-embolic pulmonary hypertension (CTEPH, WHO group 4), pulmonary hypertension with unclear and/or multi-factorial mechanisms (WHO goup 5)
* Inability to perform a 6 minute walk test (6MWT)
Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals.

The primary objective in this study is to achieve a 15% 6-month improvement in therapeutic adherence among patients with chronic pathologies, thanks to a simple, standardized and redundant message delivered by healthcare professionals during consultations/interviews Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action concerning therapeutic adherence. This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake.

This project will enable us to adapt or even modify the practices of healthcare professionals, by making management recommendations to improve patients' adherence to treatment during their consultations/interviews, and throughout their entire course of care. This project will increase the benefit/risk ratio of treatments and reduce the waste of healthcare resources.

For patients, their participation by filling in the therapeutic adherence self-questionnaire will enable them to become active players in the management of their treatment.

If the results of our study prove positive, this will lead to a new, optimized organization of patient care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Affiliated to the French social security system
* Followed in hospital for a chronic pathology within a formalized care pathway
* Having signed a consent form to participate in the study.

Exclusion Criteria:

* Patients included in the control period.
* Patients under guardianship.
* Pregnant or breast-feeding patients.
* Patients taking part in research on compliance
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion

Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.

After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.

Eligibility Criteria:
Inclusion Criteria:

* Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
* Written informed consent obtained by the subject or subject's legal guardian.
* Written assent from subjects ages 8 years old and above
* Subject is between the ages of 5 and 22 years, male or female.
* Subjects from all racial and ethnic origins will have an opportunity to participate.

Exclusion Criteria:

- Corrected vision less than 20/500.
Role of Neutrophil Activation

Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation.

Blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.


Eligibility Criteria:
Inclusion Criteria

1. Ages 18 to 65
2. American Society of Anesthesiologists Physical Status Classification (ASA) I and II
3. Required to have endotracheal intubation
4. Scheduled for short admission (\<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures.
5. Estimated duration of surgery 3 to 4 hours.
6. Provide informed consent

Exclusion Criteria

1. Active pulmonary disease within 5 days prior to enrollment
2. On immunosuppressive medications
3. Previous tracheal surgery
4. On azithromycin
5. Diabetes
6. Pregnancy
7. Smoking history of less than 6 weeks prior to surgery
8. Surgery or intubation within 5 days of surgery
9. Planned surgical procedure involving neck or thoracic regions
10. Active pulmonary disease
11. Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis
12. Hepatitis
13. Cancer
Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment

This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.

This study will investigate the feasibility of implementing a time-restricted eating (TRE) intervention in females with mild cognitive impairment. Data will be collected for 10 weeks. Baseline food timing, activity/sleep, metabolic health (fasting labs and anthropometric measures), and cognitive testing will be collected in the first two weeks. Subjects will then be invited to enroll in a TRE intervention for 8 weeks. Subjects will be educated about the potential health benefits of TRE, and then each subject will self-select a 10-hr window and consume all daily calories during this time frame. Subjects will text the time of their first and last daily calories for the duration of the study. At the end of the 8-week TRE intervention, metabolic, anthropometric, activity/sleep, and cognitive measurements will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Women
* Age 45-95
* Diagnosis of mild cognitive impairment

Exclusion Criteria:

* Individuals prone to hypoglycemia
* Liver disease
* Taking medications that affect eating behaviors
* Alcohol consumption of \>2 drinks per day
* Significant circadian disruption
* Having care-taking responsibilities that significantly affect sleep
* Shift work or irregular lifestyle
* Diagnosed clinical eating disorder
* Participating in a formal weight loss program
Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment

The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.

Secondary purpose is the comparison of feasibility and economic aspects.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible

Exclusion Criteria:

* Technical reasons
* unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique
Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject participated and relapsed in prior PS study

Exclusion Criteria:

* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis
Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.

Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled diagnostic upper endoscopy
* Wish to be sedated
* ASA class I - III
* Signed informed consent

Exclusion Criteria:

* Emergency medical examinations
* Therapeutic Endoscopy
* ASA class IV
* Pregnancy
* Known allergy to propofol or lidocaine
Intermittent Catheterization Acceptance Test

The aim of the study is to create and validate a specific test named Intermittent Catheterization Acceptance Test (I-CAT), assessing "the acceptance" of clean intermittent self catheterization (CISC) in a neurological and no neurological population with indication to self catheterization.

CISC avoids urological complications in bladder with chronic and improves quality of life. Despite theses challenges, the learning of CISC can face some physical, cognitive and psychological difficulties. Recently, we have validate a new test for predicting the physical and cognitive abilities to practice CISC named "PP-Test". Meanwhile, psychological factors are not explored in this test. To our knowledge, no study has been conducted in order to demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise it would be interesting to create a new test assessing the psychological "acceptance" of the patients to CISC before learning (I-CAT). Based on the results of this self-assessment test, the specific nurse could then change her speech by playing down the importance of some fear and anxiety described by the patients. The learning of CISC would be facilitated.

The first version of the questionnaire (I-CAT) has already been elaborated from some neuro-urology experts and patients's comments.

The final version will be validated after a feasibility study. The psychometric criteria will be validated.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with neurological disease (brain, trauma and no trauma spinal injury, cauda equine syndrome) or non neurological disease
* Patients seen in consultation or in traditional hospital
* Indication for the realization of self-catheterization Intermittent must be asked because of a bladder-type retentionist or overactive bladder with an indication of medical (anticholinergics or botulinum toxin intra-detrusor injection) or surgical (kind of expansion enterocystoplasty) treatment to prevent bladder emptying without urinary catheterization
* PP-Test score ≥10/15
* Age \> 18 years
* Patient with social security

Exclusion Criteria:

* Urethral injury preventing the practice of self-catheterization
* Indication to installing a suprapubic catheter or probe
* Patients able to answer to questionnaire and communicate in French
Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation

There has been an increasing number of SARS-CoV-2 infections in pregnant women and neonates. Interventions including open airway suctioning, positive pressure ventilation, non-invasive respiratory support, tracheal intubation, and endotracheal drug administration are aerosol-generating medical procedures and may create a risk to the unprotected healthcare providers. The impact of using personal protective equipment during neonatal resuscitation maneuvers is unknown.

The objective of this study will be to compare the beginning of PPV and the duration of intubation between performing resuscitation with PPE for the prevention of SARS-Cov-2 infection and resuscitation without PPE for the prevention of SARS-Cov-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Level III neonatal intensive care unit consultants, pediatric residents, and nurses. Participants will be divided into teams including a consultant and a nurse or a resident and a nurse during the simulation.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma

Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.

Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
* unresectable HCC
* Karnofsky-Index \> 70
* estimated life expectancy \> 16 weeks
* adequate bone marrow function
* adequate contraception for female patients
* informed consent

Exclusion Criteria:

* portal vein thrombosis on the tumor side
* extrahepatic spread
* Child C
* other untreated malignant disease
* general contraindication for chemotherapy
* active infectious disease
* neuropathy, platin-allergy
* pregnancy
Evaluation of Physical Functions in Lower Limb Burn Injury

This study evaluates scar tissue, normal range of motion of lowr extremity joints, lower extremity functions, functional capacity, functional mobility, kinesiophobia and quality of life in lower limb burn injury.

Patients with lower extremity burns experience problems with range of motion, muscle strength, balance and gait. These problems contribute to prolonged physical disability, return to work or deterioration of work capacity and thus lead to a negative impact on quality of life.

In addition to studies showing that quality of life and functions may be affected adversely after burn, there are studies showing that burn percentage, health-related quality of life and functional outcomes are affected. The aim of this study is to determine the effects of burn area (with or without joint), percentage of burns and hypertrophic scar on the patient's function in patients with lower extremity burns.

Eligibility Criteria:
Inclusion Criteria:

* Having a lower limb burns
* To be a volunteer to participate

Exclusion Criteria:

* orthopedic problems affecting gait and stance
* Having a neurological disorders
* Walking with assist device
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
* 2. Aged between 18 and 45 years old of healthy male subjects ;
* 3. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
* 4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
* 5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;

Exclusion Criteria:

* 1. Have a history of fainting needles, fainting blood;
* 2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
* 3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
* 4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
* 5. Those who have been screened positive for drugs at screening;
* 6. Donated blood (\> 400 ml) within 3 months before taking the study drug;
* 7. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
* 8. Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ;
* 9. Those who have been screened positive for drugs or have a history of drug abuse;
* 10. Known allergy to Liraglutide or any of the excipients of the formulation;
* 11. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis;
* 12. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
* 13. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods
* 14. Other cases judged by researchers to be unsuitable for selection.
Hypofractionated Radiotherapy for Prostate Cancer

External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the alpha/beta ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the alpha/beta ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the alpha/beta ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.

Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.


Eligibility Criteria:
Inclusion Criteria:

* patients with T1-4 N0 M0 prostate cancer

Exclusion Criteria:

* other no skin cancer diagnosed within 5 years prior to enrolment
* no informed consent