cyrilzakka/clinical-trials huggingface dataset:
Effect of Neuromuscular Warm-up on Injuries in Female Athletes

The goal of the study is to determine effect of coach-led neuromuscular warm-up on non-contact, lower extremity (LE) injury rates among female athletes in a predominantly non-white public high school system. The investigators hypothesized the warm-up would reduce non-contact LE injuries.

We will recruit basketball and soccer coaches and their athletes from Chicago public high schools. We will randomize teams to intervention and control groups. We will train intervention coaches to implement a 20-minute neuromuscular warm-up and tracked training costs. Control coaches will use their usual warm-up. All coaches will report weekly athlete exposures (AEs) and injuries resulting in a missed practice/game. Research assistants will interview injured athletes. We will compare injury rates between control and intervention groups.

Eligibility Criteria:
Inclusion Criteria for High School Students (initial part of study - completed)

* plays basketball or soccer for a Chicago public high school team
* coaches basketball or soccer for a Chicago public high school team
* female, age 14-20

Inclusion Criteria for coaches (current part of study):

* Willing to implement a new warm-up before their team's practices and games
* Willing to complete a pre- and post-season survey before and after using the warm-up program for one season (surveys are attached).
* Willing to complete a pre- and post-workshop test before and after the workshop (tests are attached).
* Willing to allow study personnel to observe their implementation of the warm-up at up to three team practices or games.

Exclusion Criteria for coaches (current part of study) There are no separate exclusion criteria for coaches.
A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer

The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radical resection of lung cancer enrolled from 2014 to 2019;
* Pathologically diagnosed patients with non-small cell lung cancer;
* Patients with age \> 18 years old;
* Patients who did not receive chest surgeries before hospitalization;
* Patients with N2 lymph nodes (+) after surgeries;
* Patients who received lymphadenectomy for one group or more groups of lymph nodes;

Exclusion Criteria:

* Patients with second primary tumors or multiple primary tumors;
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures

The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.

Inadequate alveolar bone height as a consequence of tooth loss is a common limitation for properly placing endosseous dental implants in the posterior maxilla. Grafting of the maxillary sinus has been regarded as one of the most reliable surgical alternatives to correct this problem. Several sinus grafting techniques, using different materials, have been reported showing high survival rates. However, there are many factors that may alter the outcomes of this procedure.

The maturation and consolidation of the grafted area relies on the proper formation of a functional graft-vital bone complex. This maturation process requires an adequate migration of osteogenic cells from native bone, that could be limited in situations where the dimensions of the maxillary sinus are excessive. Hence, the purpose of this research project is to determine the influence of the distance from the lateral to the medial wall of the maxillary sinus on the outcomes of a sinus augmentation procedures performed using the lateral approach using clinical, radiographic and histomorphometric analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (Older than 18 years), up to 85 years-old.
* Physical status according to the American Society of Anesthesiologists (ASA) I or II
* Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
* No uncontrolled systemic disease or condition known to alter bone metabolism
* Adequate oral hygiene (O'Leary plaque score ≤20%)

Exclusion Criteria:

* Long term (\>2 weeks) use of antibiotics in the past 3 months
* Patients smoking more than half-pack a day
* Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc...)
* Pregnant or attempting to get pregnant
* Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.
Pilot Feasibility of App-supported Vestibular Rehabilitation

The primary goal of the study is to examine the feasibility of accompanying vestibular practice supported by a phone app for vestibular rehabilitation. Feasibility will be established using the following parameters: (1) the User Satisfaction Evaluation Questionnaire (USEQ) (2) a custom-made questionnaire to collect feedback from participants, and (3) compliance measurements derived from app usage. The secondary goal of the study is to examine the effect of practice supported by the app on balance and anxiety indices. These will be measured using the following parameters: (1) Instrumented Timed Up and Go Test (iTUG), (2) Dizziness Handicap Inventory (DHI), (3) State-Trait Anxiety Inventory (STAI). The third goal is to assess the correlation between balance function (iTUG) and anxiety (STAI).

A randomized crossover pilot study will be conducted with 24 participants. During the study, each group will undergo two and a half weeks of conventional vestibular rehabilitation and two and a half weeks of app-supported vestibular rehabilitation. Measurement sessions will be conducted at three-time points: upon enrollment in the study (T0), after two and a half weeks (T1), and at the end of the study (T2).


Eligibility Criteria:
Inclusion Criteria:

Participants that will meet the following inclusion criteria were recruited to the study:

1. between the ages of 18-75;
2. diagnosis of vestibular dysfunction;
3. fluent in Hebrew;
4. own an Android smart-phone

Exclusion Criteria:

Exclusion criteria for the study group will be as follows:

1. a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment;
2. individuals with dizziness who already have been given a home vestibular rehabilitation exercise program;
3. diagnosis of central vestibular disorder due to brain structural damage.
Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.

There are a number of disorders where blood flow is inadequate to provide nutrients and oxygen to tissues. Under some circumstances, surgery is required to either improve the blood flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood supply to an organ is temporarily or permanently performed to minimize blood loss during a surgical procedure.

Additionally, there are disorders where the location of certain blood containing structures is important but not immediately obvious to surgeons during an operation. Knowledge of where those structures are is very important and could greatly improve the safety of various surgical procedures.

Patients of the investigator who are scheduled for foot surgery will be provided the opportunity to participate in this research. After giving informed consent, hyperspectral images will be obtained at various points during the surgical procedure.

As this technology is non-invasive, it is not expected to interfere with or change the procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved to a disk for later evaluation.

100 subjects will participate in this study.

The hyperspectral imager will be turned on at various time points during surgery, to measure the spectral wavelengths of tissues. The surgery being performed will in no way be altered by the imaging device and post surgical follow-up of patients will be standard of care appropriate to the surgical procedure.

Patients will have HSI performed only during their surgery. They will not receive additional medications and will have no additional follow up. Participating in this study will not add extra appointments, procedures, or time requirements for the patient. The patient's medical record may be referenced for information after the surgery for up to one year. There are no costs to the patient for participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* 18 years or older undergoing foot surgery
* Speak and read English or Spanish.
* Able to provide written informed consent.

Exclusion Criteria:

* Patients unable to give written informed consent
* Patients who cannot speak and read English or Spanish will be excluded.
Misoprostol for the Treatment of Incomplete Abortion

This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.

Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:

In Tanzania and Mozambique:

1. 600 mcg of oral misoprostol in one dose, or
2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

1. 600 mcg of oral misoprostol in one dose, or
2. 400 mcg of sublingual misoprostol in one dose.

In Burkina Faso and Vietnam:

1. 400 mcg of sublingual misoprostol in one dose.

We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.


Eligibility Criteria:
Inclusion Criteria:

* If no ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. Open cervical os.
* If ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. Evidence of incomplete abortion with substantial debris in the uterus.

All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.

* Willing to provide contact information for purposes of follow-up.

  * In Tanzania: 18 years of age or over or parental permission
  * In Mozambique: 21 years of age or over or parental permission
  * In Moldova: 18 years of age or over
  * In Madagascar: 18 years of age or parental permission
  * In Vietnam: reproductive age

Exclusion Criteria:

* Contraindications to the study drug;
* Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
* Signs of severe infection, defined as at least one of the following of:

  1. foul smelling discharge,
  2. fever \> 39 degrees C ,
  3. pulse \>110/min;
Usability, Safety and Efficacy of AspivixTM (Comparative Study)

Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up.

AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber.

The aim of our comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).

Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding pilot study is registered separately.


Eligibility Criteria:
Inclusion Criteria:

* Participants older than 18 years
* Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
* Participants able to provide informed consent as documented by signature with at least 24 hours of reflection time
* Good understanding of written and oral speaking used at the centre where the study will be carried out.

Exclusion Criteria:

* Participants who are contraindicated for the insertion of the IUD Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
* Participants under use of excessive alcohol, narcotics or benzodiazepines prior to procedure
* Participants who do not wish to be informed of a chance discovery
* Participant receiving anaesthetics prior to IUD insertion procedure
* Participants on anticoagulant medication
* Participants under use of an analgesic (\< 12 hours)
* Previous cervical operation
* Severe vaginal bleeding of unknown origin
* Participant previously enrolled in this study
* Cervix diameter smaller than 26 mm
* Nabothian cyst
* Cervical myomas
* Cervical condylomas
* Squamous intraepithelial lesion (Cervical dysplasia)
* Cervical endometriosis
* Cervical tears
* A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
* Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
* Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
* Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present
Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers.

The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ovarian, colorectal or lung cancer receiving bevacizumab therapy
* Male or female (aged ≥18 years old)
* Performance Status (PS) between 0 and 2
* Expected life\> 3 months
* Ability to answer a self-questionnaire
* Obtaining the non-opposition of patient participation

Exclusion Criteria:

* Pregnant or lactating woman
* Rapid evolution of neoplastic pathology
* Major cognitive disorders that do not allow filling of the self-questionnaire
* Impossibility to submit to medical monitoring for social, psychological or geographical reasons
* Patients under guardianship or curatorship
Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia

In myotonia congenita (MC), mutations in the CLCN1 gene coding a key chloride channel expressed in muscle cells cause myotonia. On examination, the myotonia can be demonstrated as delayed muscle relaxation of muscle contractions after mechanical stimulations. Existing literature describe no muscle weakness in MC patients, however a recent muscle MRI study in non-dystrophic myotonia patients found structural abnormalities in affected muscles when examined using T1 and STIR imaging. The question remains whether the signs of structural changes in the muscle are merely due to the myotonia, or long-term effects of elevated stress of the tissue, and if so, whether those changes lead to clinically significant loss of contractile properties of the muscle.

This study examines if the contractile properties of myotonic muscles are impaired in MC patients. 40 patients with Thomsens disease (n=20) and Beckers disease (n=20), respectively, will be included along with 20 healthy controls. Peak muscle torque is measured in the hand by hand dynamometer and in the thigh and calf muscles with a Biodex System 4 Pro Dynamometer and the cross-sectional area of the muscles are examined on T1-weighed and Dixon-MRI-scan. With the obtained data peak torque in strength tests, muscle hypertrophy, fat fraction in muscle tissue and contractility of the muscles, compared with healthy controls, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years
* Molecularly verified MC (Thomsens or Beckers disease)

Exclusion Criteria:

* Conditions that may impair results of the study, evaluated by the investigator
* Clausphobia
* Pregnancy or breastfeeding
* Metallic objects in and around the body that are not MR-compatible
Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.

Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18
* Systemically healthy patients
* Need for periodontal surgical treatment in the mandibular anterior region
* Scoring 15 or above on the modified dental anxiety scale

Exclusion Criteria:

* Having a history of seizures or a convulsive disorder
* Balance disorders such as nystagmus, vertigo
* Use of psychotropic drugs
* Getting treatment for anxiety
* Presence of dermatological lesions on the face, especially around the eyes
* A lesion in the eye that will prevent the use of virtual reality glasses
* Systemic disease and medication use that contraindicate periodontal surgery
Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)

Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.

The multi-centre COVIDOC study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside Intensive care unit with pneumonia caused by infection by the SARS-CoV2 virus in France.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
* Beginning of COVID-19 symptoms \< 10 days at the time of randomization
* Presence of symptom(s) of COVID-19 : fever (température \> or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
* Presence of TDM/radiographic signs or pneumonia
* Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)

Exclusion Criteria:

* Absence of signed informed consent
* SpO2 \< 90 % ambient air or \< 94 % with oxygenotherapy \> or = 3l/min
* Need of oxygenotherapy \> 6 l/min or mechanical ventilation
* Need of hospitalization in ICU
* ALAT/ASAT \> 5 LSN
* Renal failure (eGFR \< 40 ml/min ) or dialysis
* Pregnancy or breastfeeding
* Retinopathy
* Known deficit in G6PD
* Cardiac rythm / lengthening QT disorders
* QT space lengthening on ECG with QTc \> 450 ms
* Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA \& III, antidepressive drugs,..
Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency

In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* symptoms suggestive of COVID-19
* positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2

Exclusion Criteria:

* Bacterial community acquired pneumonia
Surgicel® Fibrillar for Delayed Bleeding After ESD

The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer

   * Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
   * Anti-platelet agents
2. Method

(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result

1. Primary endpoint: rate of delayed bleeding after ESD
2. Secondary endpoint: follow-up hemoglobin after ESD

Eligibility Criteria:
Inclusion Criteria:

* ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

* Coagulopathy: liver cirrhosis, thrombocytopenia
* Anti-platelet agents