cyrilzakka/clinical-trials huggingface dataset:
Effects of Gait Retraining With Auditory Feedback

There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* History of at least one ankle sprain
* Index ankle sprain \> 12 months prior to study enrollment
* Most recent ankle sprain \> 12 weeks prior to study enrollment
* Score \>10 on the Identification of Functional Ankle Instability (IdFAI) survey.
* Score \<95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a \<85% on the Sport subscales
* Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion Criteria:

* History of ankle surgery
* History of other musculoskeletal injuries within the past 6 weeks
* Any condition affecting plantar pressure distribution
* Neurological or vestibular disorders affecting balance
* Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair

"A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis."

Hernia recurrences post-repair remain a confounding problem. The prospective study described herein tested Cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall resistance causes hernia, by incorporating the Tensiflex mesh prosthesis which is a modified version of mesh prosthesis of Stoppa technique in the surgical treatment of patients with hernia. The study was 2-phased: the first phase involved the pre-peritoneal implantation of a bi-layered mesh for anatomical replacement of the damaged fascia. The second phase involved the implantation of the bi-layered Tensiflex mesh prosthesis for definitive and seamless augmentation of tensile strength in the myopectineal orifice of Fruchaud.

Eighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on day 3); however, by day 5, 86% reported pain intensity scores lower than 5. The median number of lost workdays was 7. Most importantly, the primary endpoint of 100% recurrence-free outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of workdays).

Eligibility Criteria:
Inclusion Criteria:

* all patients with confirmed groin hernia of both sexes.

Exclusion Criteria:

* none
Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects

Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects

Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.

Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.

A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
* Able to comply with study procedures
* Male subjects must agree to use 2 highly effective methods of contraception
* Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
* No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results

Exclusion Criteria:

* History of any significant illness
* Illness within 5 days before Day 1
* Regular treatment with any medications
* Any type of tobacco or nicotine use
* History of drug or alcohol abuse or addiction within 2 years before Screening visit
* Positive tuberculin skin test at Screening
* Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug
Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease

Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.

The investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy

Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .

Eligibility Criteria:
Inclusion Criteria:

* systemic isotretinoin therapy

Exclusion Criteria:

* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery

This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery. Using electronic neurocognitive screening tools may help to better assess mental impairment.

PRIMARY OBJECTIVES:

I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.

SECONDARY OBJECTIVES:

I. Comparison of the completion rate and time to completion between the written and electronic batteries.

II. Comparison of the scoring distribution between the screening tools.

EXPLORATORY OBJECTIVES:

I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery.

GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.
Validation of a High-Quality Low-Cost Open-Source Electrocardiograph

The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.


Eligibility Criteria:
Inclusion Criteria:

- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

* Healthy
* \> 18 years of age

Phase 2:

* \> 18 years of age
* non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint

Exclusion Criteria:

* \< 18 years old
* Unable to consent

Phase 1:

* \> 70 years of age
* Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
* current status of non-sinus heart rhythm

Phase 2:

- Critical patients in the ED where consent would inappropriately delay investigations or treatment
Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer

This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3 cohort design to determine the recommended dose of estetrol for the treatment of patients with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of treatment), patients will receive further treatment for 8 weeks at their individual phase I dose level (phase IIa part of the study).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with ER-positive and HER2-negative locally advanced and/or metastatic breast cancer, who progressed on standard therapies or for whom standard therapies are intolerant;
* Patients should have experienced a natural or surgical menopause at least 5 years ago;
* Failure of anti-estrogen treatment with tamoxifen and aromatase inhibitor(s) due to the development of resistance or unacceptable side effects with this treatment;
* No undiagnosed vaginal bleeding;
* No treatment with fulvestrant within 6 months of start of treatment;
* Life expectancy at least 6 months;
* Tumour assessment (CT scan) before the start of the E4 treatment;
* Body mass index (BMI) between (≥) 18 and (≤) 35 kg/m2;
* Able to swallow an oral medication;
* Acceptable values of hematological parameters, liver and kidney function and calcium levels;
* Acceptable values of hemostasis parameters (as of second cohort);
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2 (as of second cohort);
* Reasonable physical and mental health as judged by the investigator and determined by physical examination, clinical laboratory assessments and vital signs;
* Willing to give informed consent in writing.

Exclusion Criteria:

* Uncontrolled nausea, vomiting, or diarrhea;
* History of venous or arterial thromboembolic disease or a known defect in the blood coagulation system;
* History of severe cardiac events or life threatening cardiac dysrhythmia (as of second cohort);
* Patients who have unstable angina or clinical congestive heart failure (as of second cohort);
* Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication;
* Diabetes mellitus with poor glycaemic control in the last 6 months (HbA1c above 7.5%);
* Any other serious disease including systemic lupus erythematosus and untreated cholelithiasis;
* Smoking \>10 cigarettes/day;
* Use of any other cancer therapy including radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy, or use of other investigational agents at the start of treatment.
Establish a National Registry of REM Sleep Behavior Disorder

In this proposed study, the investigators aim to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Accumulating evidence suggests that RBD is implicated as an integral part of disease progress of α-synucleinopathy neurodegeneration, such as Parkinson's disease (PD) and dementia with Lewy bodies.Previous studies have identified a series of neurocognitive, autonomic, clinical and neurobiological markers for neurodegeneration in iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, the prevalence rate of RBD was relatively low and most of the RBD studies only have 100 or below cases. and there might be ethic differences in RBD which indicates that the findings from western countries might not be applicable to Chinese. In these regards, the investigators aimed to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

Eligibility Criteria:
Inclusion Criteria:

Case: According to the ICSD-3 for the diagnosis of RBD

1. Sleep talking or complex movement during sleep;
2. Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;
3. REM sleep without atonia (RWA) during PSG monitoring;
4. This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.

Control: Age and gender matched with consent

1. No RBD symptoms and PSG characteristics;
2. No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology;
3. No narcolepsy or hypersomnia, ruled out by multiple sleep latency test;
4. No history of mental illnesses or use of antidepressants.

Exclusion Criteria:

1. Subjects who refused to join the cohort.
Subcutaneous Lavage in Cesarean Section

The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.

intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section.

The main questions we aim to answer are:

Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases?

Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce

Participants will:

consent to participate in the trial Visit the postpartum clinic 30 days after surgery


Eligibility Criteria:
Inclusion Criteria:

* pregnant women undergoing cesarean delivery

Exclusion Criteria:

* pregnant women undergoing vaginal delivery
Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.

PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.

OBJECTIVES:

* Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage III non-small cell lung cancer and have no CNS metastatic disease.

OUTLINE: This is a pilot, nonrandomized study.

Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for analysis.

After completion of study, patients will be monitored for 1 month after LP to assess for any LP-related complications.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D.

  * Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week
* No known CNS primary or metastatic cancer at any time prior to time of enrollment
* No MRI evidence of pathological enhancement at the time of study entry

PATIENT CHARACTERISTICS:

* Patients must use adequate birth control measures while in the study
* No significant side effects to erlotinib that require dose reduction or interruption
* None of the following medical issues which could make a lumbar puncture unsafe:

  * Platelets \< 100,000/mm³
  * INR \> 1.1
  * Known bleeding dyscrasia
  * Absolute neutrophil count \< 1,500/mm³
  * Ongoing systemic bacterial infection

PRIOR CONCURRENT THERAPY:

* Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following:

  * Neurontin
  * Lamictal
  * Depakote, Depakene
  * Felbatol
  * Keppra
  * Gabitril
  * Topimax
  * Zonegran
* No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital
* No concurrent other drug known to affect the metabolism of erlotinib
* No concurrent anticoagulant therapy
Exercise Therapy With Telerehabilitation in Patients Living With HIV

To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH).

55 individuals living with HIV (PLWH) were included in the study. Among those individuals, 25 individuals who volunteer to exercise with telerehabilitation will be grouped in the telerehabilitation group. The rest of the individuals who do not participate in the exercise group will be in the control group.

Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attend sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an investigator over the videoconference through zoom. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.

Group 2: Control group: Individuals in the control group continue their routine drugs.

Both the telerehabilitation exercise group and the control group continue their drug treatments during the 12 weeks of the period.

Eligibility Criteria:
Inclusion Criteria:

* Patients living with HIV (PLWH),
* Ages between 18 and 65 years old,
* Participants attend and follow instructions through telerehabilitation.

Exclusion Criteria:

* Participants who use recreational drugs
* Participants who do not adapt to the exercises through telerehabilitation,
* Participants who did not agree to be volunteers are not included in our study.
Sleep Hygiene Measures for Sleep Bruxism in Children

The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. In randomization both groups will receive information about bruxism, and the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will be assessed through a diary to be completed by the child's responsible party. A randomized, stratified sample of approximately 16 children will be included in the study. One group will be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene intervention, and another group of children who will only receive instructions on sleep bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger / thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental smoking, problems breathing, parental profession and also on psychological issues. Sleep habits will also be answered in this questionnaire, and parents will also answer the Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child Stress Scale and the Child of stressing sources in child; children less than 6 years will have the questionnaire responded by parents. The children will undergo a clinical examination to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The study evaluations consist of baseline, 1, 7, 15 and 30 days.


Eligibility Criteria:
Inclusion Criteria:

* children with probable sleep bruxism

Exclusion Criteria:

* systemic diseases;
* Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 20-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
* Abuse or intake of alcohol, defined as any of the below:

  * Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits).
  * Positive alcohol test at screening.
* Abuse or intake of drugs, defined as any of the below:

  * Known or suspected drug or chemical substance abuse within 1 year before screening
  * Positive drug of abuse test at screening
Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy

This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.

Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
* Must be able to communicate clearly
* Must be above age 20

Exclusion Criteria:

* Previous radiotherapy
* History of arrhythmia or use of a pacemaker
* Local swelling or infection over the acupoint area