cyrilzakka/clinical-trials huggingface dataset:
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or more.
* Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations).
* Active disease as defined by clinical biological and/or morphological assessment.
* Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease.
* Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.

Exclusion Criteria:

* Patients under guardianship / curators
* Following Situations

  * Persons unable to understand, read and / or sign an informed consent
  * Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
  * Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
  * No affiliation to a social security scheme, a universal medical coverage or any similar plan.
* Pregnant or lactating women.
Effect of Music on Mental and Physical Performance in Young Tennis Players

Optimal athletic performance is the result of a synergy between physical abilities and mental skills. Faced with increasing pressure in the world of tennis, athletes are constantly seeking new methods to optimize their performance. Music is a non-pharmacological tool that has demonstrated its effectiveness in reducing anxiety and improving sports performance. This innovative study explores the use of music as a tool to enhance the physical and mental abilities of young Tunisian tennis players. The results of this research could revolutionize training practices and offer new tools to help athletes reach their full potential.

Work objectives: Evaluate the impact of a musical intervention on the physical and mental performance of athletes, particularly young tennis players.


Eligibility Criteria:
Inclusion Criteria:

* Competitive category : Participants must be regular tennis players (number of hours per week) who engage in organized tennis activities (e.g., regular training or participation in competitions).
* Agreement to participate: Participants (players and/or their legal representatives) who agree to participate in the study.

Exclusion Criteria:

* Player's age \<10 and \> 18 years.
* Non-regular young tennis players (Recreational category): Participants who do not engage in tennis practice regularly.
* Diagnosed psychiatric disorder
* Hearing disorder Severe hearing impairments and certain types of tinnitus. Severe neurological disorders: auditory epilepsy and musicogenic epilepsy (audiogenic seizures are a rare neurological condition characterized by seizures triggered by auditory stimulation).

Amusia and musical deafness (a neurological anomaly where rhythm, melody, and musical chords are not perceived).

Specific psychological issues. Personal sensitivities to certain types of music. History of trauma related to music (intense emotional reactions to certain types of music).

* Refusal to participate: Participants (players and/or their legal epresentatives) who refuse to participate in the study.
A Study in Participants With Rheumatoid Arthritis

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA of more than 6 months and less than 15 years
* At least 8 tender and swollen joints
* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
* Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
* Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
* Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

* Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
* Steroid injection or intravenous (IV) infusion in the last 6 weeks
* Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
* History of a serious reaction to other biological DMARDs
* Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
* Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
* Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
* Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
* Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
* Hepatitis or human immunodeficiency virus (HIV)
* A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
* Symptoms of herpes zoster or herpes simplex within the last month
* Active or latent tuberculosis (TB)
* Current symptoms of a serious disorder or illness
* Use of an investigational drug within the last month
Evaluation of an Ostomy Leakage Detection System

This study will evaluate the safety and efficacy of an ostomy leakage detection system.

Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or Older
2. Currently resides in the United Kingdom
3. Has an ileostomy, colostomy, or urostomy
4. Has a stoma diameter within the following range: 15 mm - 70 mm
5. Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).
6. Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days
7. Willing to use their typical ostomy pouching system together with the study product for duration of study
8. Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS):

   * a. Android Devices:

     * i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel
     * ii. Operating System: Android OS 9.0 (Pie) and later
   * b. Apple iPhones:

     * i. Compatible Models: iPhone X and later
     * ii. Operating System: iPhone Operating System (iOS) 15 and newer
9. Is willing to download the phone application for use during the study
10. Is willing to follow protocol procedures, as indicated by signing the informed consent
11. Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)

Exclusion Criteria:

1. Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
2. Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
3. Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
4. Reports as legally blind and/or deaf
5. Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
6. Subject reports currently having an abdominal fistula or abdominal wound
7. Subject has more than one stoma
8. Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
9. Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility.
10. Is currently involved in another research study involving use of ostomy study products or accessories
11. Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories
Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab

Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.

This trial is for a single subject with juvenile idiopathic arthritis unresponsive to all licensed treatments for JIA, and some licensed only for rheumatoid arthritis. He is currently wheelchair bound and completely dependent for activities of daily living and self-care. He is in constant pain, has abundant warmth and swelling of nearly all joints including TMJs, neck, shoulders, elbows, wrists, MCP and finger joints (even some DIP joints), hips, knees, ankles, subtalar and intertarsal joints, MTP and IP joints of the toes.

Drug at a dose of 8 mg/kg would be administered IV every 2 weeks, with close safety and monitoring studies.

Treatment would be monitored every 2 weeks. Efficacy will be measured using the ACR Pedi 30, 50 and 90 definitions as previously published, based on: 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate.

Eligibility Criteria:
Inclusion Criteria:

* Subject X, polyarticular JIA, not responding to any other drug

Exclusion Criteria:

* Not identified subject
Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity

This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
* A positive skin prick test to dust mite at or within the 12 months before study start
* Demonstrate symptomatic worsening after graded nasal allergen challenge

Exclusion Criteria:

* Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
* Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
* Any known contraindications for methacholine challenge testing

Other protocol-defined inclusion/exclusion criteria may apply.
Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit
* Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit
* Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

Exclusion Criteria:

* History of type 1 diabetes mellitus and/or diabetic ketoacidosis
* Severe infection, surgery, or severe trauma within 6 months prior to the screening visit
* Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit
* Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study
* Subject determined by the principal investigator to be ineligible for study conduct for other reasons
Turkish Adaptation, Validity and Reliability Study of the Athlete Disability Index Questionnaire

This survey study aims to analyze the cultural adaptation, validity, and reliability of a scale originally in English and currently being translated into Turkish, which allows athletes with low back pain to assess their functional disabilities in sports and exercise activities as well as their disabilities in daily living activities. Athletes with low back pain will be asked to fill out 3 questionnaires.

In the study, firstly, the translation of the Athlete Disability Index Questionnaire (ADI) into the target language, comparison of the two translated versions of the scale, back translation of the preliminary version, synthesis, pilot test of the pre-final version and psychometric test studies will be carried out by 3 independent translators and 2 linguists in 6 stages.

Then, 120 athletes with low back pain will be asked to fill out the ADI, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Low Back Pain Disability Index (ODI). 7 days later, the ADI will be filled out again by 60 athletes.

After the surveys are completed, the structural validity of the scale will be tested, and reliability will be measured by performing test-retest reliability and internal consistency analyses.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain that has persisted for at least 6 weeks
* Pain that worsens with changes in posture, movement, or physical activity
* Elite athletes with a regular training/match schedule of more than 10 hours per week

Exclusion Criteria:

* Not knowing Turkish
* Acute inflammatory conditions
* Acute musculoskeletal trauma
* Long-term corticosteroid use
A Phase IIA Study of MK0457 in Patients With Cancer of the Lung (0457-006)

This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting)

Exclusion Criteria:

* Patients who have had treatment with any investigational therapy within the past 30 days are not eligible.
* Patients who have had a disease or medical condition that is not controlled will not be eligible.
* Patients who are pregnant or breastfeeding are not eligible.
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents

Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or Pazopanib).

The objective is to analyze the predictive impact of circulating MMP2 and MMP9 on the progression-free survival of patients with metastatic kidney cancer treated with anti-angiogenic agents (Sunitinib or Pazopanib) in comparison with two untreated cohorts (localized or oligometastatic cancer).

Prospective monocenter, open-label study

In the frame of disease management blood samples will be collected at different times of follow-up regarding disease status (localized, oligometastatic and metastatic) and tissue samples will be collected for patients scheduled for surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient male or female, aged of more than 18 years
2. Patient with any of the following conditions:

   * Kidney cancer localized at diagnosis.
   * Metastatic kidney cancer when anti-angiogenic therapy is initiated by Sunitinib or Pazopanib
   * Oligometastatic kidney cancer without systemic treatment (local treatment)
3. ECOG = 0 to 2
4. Patient affiliated to, or beneficiary of, the national social security.
5. Patient having signed informed consent

Exclusion Criteria:

1. Patient previously treated with anti-angiogenic agents.
2. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
3. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons 4. History of malignant disease in the 5 years prior to inclusion (except basal cell carcinoma of the skin or epithelioma of the cervix in situ, or prostate cancer with a good prognosis (stage T \<3 and Gleason \<7)) accidentally discovered during the histological analysis of the tumor sample.

5- Pregnant or nursing women 6- Contraindications to the procedure of the study
Personalized Treatment of Urogenital Cancers Depends on the Microbiome

This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy verified diagnosis of urological cancer, localized disease

Exclusion Criteria:

* Hospitalization within three months of surgery
* Antibiotics within three months of surgery
* Infectious disease, including UTI's within three months of surgery
* History of cancers of the genitourinary tract
* Diabetes
Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

The aim of this study was to investigate the therapeutic effect of sloped dental implants. It can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.

20 OsseoSpeed ™ Profile EV and 20 OsseoSpeed ™ EV groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. The implantation area will be randomly divided into two groups, One group was treated with OsseoSpeed ™ Profile EV (sloped group) and the other group was treated with OsseoSpeed ™ EV (control group). The same patient had the same implant as the same quadrant.

The patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (Keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (GCF) collection and bone integration measurement.

After six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. In each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, GCF collection and osseointegration measurement.

Eligibility Criteria:
20-80 years old with appropriate oral cleaning ability; the computer tomography shows \> 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks Not pregnant or breastfeeding
Honey and Nigella Sativa in COVID-19 Prophylaxis

Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis


Eligibility Criteria:
Inclusion Criteria:

* Health care professionals Post-exposure COVID-19

Exclusion Criteria:

* Multi-organ failure active COVID-19
Effect of Chronic Mechanical Neck Pain on Isokinetic Characteristics of Rotator Cuff Muscles in Adults

Statement of the problem:Would chronic mechanical neck pain affect isokinetic characteristics of Rotator Cuff muscles in adults? it was assumed that There would be no significant effect of chronic mechanical neck pain on isokinetic characteristics of Rotator Cuff muscles in adults.

Sixty-six participants of both sexes between (18 and 29 years old) were enrolled in this study. Thirty-three participants with Chronic Mechanical Neck Pain(CMNP) , thirty-three participants without CMNP. They were recruited from out-patient clinics of faculty of physical therapy, Cairo University.

instrumentation :neck pain intensity was determined by visual analogue scale , neck pain intensity was determined by neck disability index , isokinetic characteristics of rotator cuff muscles was determined by biodex isokinetic dynamometer .

Eligibility Criteria:
Inclusion Criteria:

Subjects were included according to the following criteria:

* Thirty-three participants with Chronic Mechanical Neck Pain(CMNP) and Thirty-three healthy participants would be assigned into two groups; healthy control group (A) and CMNP group (B).
* Right and left- handed subjects.
* Both sexes between 18-29 years old
* (0-4 mm) no pain, (5-44 mm) mild pain, (45-74 mm) moderate pain, (75-100 mm) severe neck pain on visual analogue scale .
* Chronic neck pain \> 12 weeks .
* They did not take any painkillers for the last 48 hours before assessment.

Exclusion criteria:

Subjects were excluded if they have any of the following:

* Shoulder-related pain.
* The existence of any anomalies in the neck and shoulder areas.
* A history of trauma or severe illnesses such as diabetes, cancer, fibromyalgia, or any kind of tumor.
* Disc herniation; history of identifiable structural injury.
* Past incidents of whiplash injury.
* Prior surgery; fractures.
* Pregnancy.
* Any prior rehabilitative therapy received during the last three months.
Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout

This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.

The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.

Eligibility Criteria:
Inclusion Criteria:

1. Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
2. Acute attack of gout no longer than 2 days.
3. Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
4. Age 18-65 years with informed consent.

Exclusion Criteria:

1. Chronic gouty arthritis.
2. Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
3. Anti-inflammatory medication for the treatment of acute gout.
4. Pregnant or breastfeeding women.
5. History of severe allergy, including diclofenac sodium.
6. Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
7. Fever ( T\>38.5 ℃)