cyrilzakka/clinical-trials huggingface dataset:
Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress

The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress is too intense or prolonged, response to stress may become misfitted and deleterious.

This study is based on the hypothesis that a severe physical or psychological trauma is associated with an intense and misfitted stress that is responsible from an undue immuno-inflammatory activation (through sympathetic activation). The result is a subinvasive state of systemic and tissue inflammation (low-noise inflammation), responsible for the mid-term deleterious consequences of the traumatic event.

The objective of this study is to understand how the dysregulation of intense stress simultaneously generates an initial pathological state and an alteration of mid-term evolution (which is considered as a poor prognosis and/or as responsible for after-effects).

The investigators wish to identify relevant biomarkers of the mechanisms activated during intense stress and influencing the immuno-inflammatory and epigenetic spheres with deleterious consequences on physiological and psychological functions.


Eligibility Criteria:
Inclusion Criteria:

* Fracture of the upper end of the femur
* Cognitive state allowing the understanding of questionnaires

Exclusion Criteria:

* Traumatic Brain Injury
* Chronic inflammatory or immune pathologies
* On anticoagulants
* On neuroleptic or antidepressant treatment
* Pathology or health condition not allowing 1-year survival
Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears

This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.


Eligibility Criteria:
Inclusion Criteria:

* Tendinopathy of the Long Head of the Biceps based on clinical symptoms or SLAP-type lesion
* Partial thickness rupture or absence of rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI.

Exclusion Criteria:

* Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
* Distance between acromion and humeral head measuring 6 mm or less
* Previous shoulder surgery.
* Dementia or inability to complete questionnaires and assessments.
* Pregnant or breast-feeding patient
* Protected adult patient
* Patient not covered by social security.
Cognitive Training and Brain Stimulation in Patients With Post-COVID-19 Cognitive Impairment

The aim of the study is to investigate effects of brain stimulation-assisted cognitive training in patients with persistent subjective or objective cognitive impairment after polymerase chain reaction (PCR)-positive COVID-19 disease.

Long-term persistent symptoms occur in a substantial number of patients diagnosed with coronavirus 2019 disease (COVID-19). First evidence suggests that long-term symptoms develop not only after severe courses of the disease, but also after less serious illness and include various symptoms such as fatigue and impaired memory, concentration or sleep. During recovery, these symptoms present a heavy burden for patients, who then often experience psychological distress and reduced quality of life. The goal of the present study is to assess the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with subjective or objective cognitive impairments following post-COVID disease. Patients will either participate in a three-week cognitive training with concurrent online high-definition tDCS application or placebo ("sham") tDCS or participate in an evidence-based muscle relaxation training combined with placebo tDCS. We hypothesize that cognitive training with sham or active tDCS will result in more pronounced improvement on a transfer task compared to the control group. We also hypothesize that training combined with anodal tDCS will lead to significantly higher performance on a transfer task than training combined with sham tDCS. Additionally, we will determine effects on specifically trained and other untrained cognitive functions immediately after the intervention as well as their maintenance one month later.

Eligibility Criteria:
Inclusion Criteria:

1. History of COVID-19 condition at least 4-6 weeks prior to study inclusion
2. Self-reported concerns regarding cognitive functioning.
3. Age: 18-60 years.

Exclusion Criteria:

1. Acute COVID-19 illness.
2. History of dementia before COVID-19.
3. Other neurodegenerative neurological disorders; epilepsy or history of seizures.
4. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
5. History of severe alcoholism or use of drugs.
6. Severe psychiatric disorders such as severe depression (if not in remission) or psychosis.
7. Contraindication to tDCS application (Antal et al. 2017).
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Eligibility Criteria:
Inclusion Criteria:

1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
2. The age of consent at the time of writing, only men and women under 75 years old over 19 years old
3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

Exclusion Criteria:

1. Known history of Rifampicin or Isoniazid resistance
2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
3. Known History of nontuberculous mycobacteria positive
4. Other pulmonary disease which is impossible to participate in clinical trial except TB
Homocysteine After Laparoscopic Roux-enY Gastric Bypass

Changes in homocysteine values after bariatric surgery remain controversially discussed. This is the first comprehensive summary to depict timeline changes in homocysteine levels following laparoscopic roux-en-Y gastric bypass.

Homocysteine is an independent risk factor for cardiovascular disease. Changes in homocysteine levels following bariatric surgery remain controversially discussed.

708 consecutive patients underwent laparoscopic roux-en-Y gastric bypass over a 6 year period. Throughout their routine follow-up, demographic data as well as homocysteine, folate and vitamin B12 were retrospectively collected at the timepoints: preoperatively, at 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, and 96 months postoperatively.

In order to reveal clinical relevance of the results, patients were sent a special questionnaire accompanied by an informed consent form for participation and asked for cardiovascular disease events (myocardial infarction, stroke, deep venous thrombosis) or any other hospital stay after the surgery and cross checked with two region wide databases which account for approx. 80% of all hospital contacts in the region. Additionally, the database was networked with the statewide death registry in order to reveal deceased subjects and data about their demise through the beforementioned databases was collected.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40kg/m2 or BMI \> 35 kg/m2 including relevant comorbidities
* Age between 18 to 75 years
* suitable for operation, consent
* no contraindications for the operation

Exclusion Criteria:

* BMI \< 35 kg/m2
* age below 18 or above 75 years
* not able to consent to the operation
* severe medical conditions not applicable for general anaesthesia
* non compliance
A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy

To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.

The goal of this clinical trial is to evaluate the efficacy and safety of lithium-containing mouthwash in reducing the incidence, duration, and severity of severe oral mucositis (SOM) , and the incidence of dysgeusia. The main questions it aims to answer are whether lithium-containing mouthwash can effectively prevent and treat radiation-induced oral mucositis and dysgeusia, and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to use lithium-containing mouthwash or placebo mouthwash three times daily from the beginning to the end of RT.

Researchers will compare lithium-containing mouthwash group and placebo group to see if lithium-containing mouthwash are beneficial in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; Aged 18-80 years; Eastern Cooperative Oncology Group performance status of ≤2; Planning to receive definitive RT or postoperative adjuvant RT; Normal liver, kidney and bone marrow function; Sign informed consent.

Exclusion Criteria:

Known to be allergic to lithium or other components of mouthwash or severe allergic constitution; Poor oral hygiene and/or severe periodontal diseases; Any previous RT to the head and neck region, Severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy; Recent use or current use of diuretics or other drugs known to interact with lithium; Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Does Allopurinol Prolong a Treated, Acute Gout Flare?

This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.

Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.

Eligibility Criteria:
Inclusion Criteria requires both of:

* Crystal proven gout, and
* An acute gout attack within 72 hours of first treatment

Plus one of the following:

* At least 2 gout attacks in past 12 months
* Tophus
* Nephrolithiasis
* 24hr urine uric acid greater than 1000mg

Exclusion Criteria:

* Inability to return for examinations
* Glomerular filtration rate (calculated) less than 50 milliliters per minute
* Allopurinol use in past 6 months
* Ongoing cancer therapy
* Concomitant azathioprine or cyclophosphamide
* Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:

  * AST \[Aspartate aminotransferase\]
  * ALT \[Alanine aminotransferase\]
  * alkaline phosphatase
* Pre-gout pain in involved joint of more than 3 on a scale of 1-10
* Neurologic deficit around the involved joint
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 20 years.
* Fasting C-peptide \> 300 pmol/l.

Exclusion Criteria:

* Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure \< 30 mmHg).
* Suspected short lifespan because of malignant disease or end-stage kidney disease.
* Pregnancy or planned pregnancy during the study period.
* Body weight \> 150 kg.
* Physical or mental disability not enabling participation in the study.
Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men

The proposed study is designed to develop and test the effectiveness of a novel web-based HIV intervention to motivate HIV testing among men who have sex with men (MSM). The intervention arm includes the delivery of videos tailored to the reasons MSM have for not getting tested for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging, e-mail or instant messaging. The intervention and assessments will be guided by the Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of Change theory. The control intervention will be a health promotion message (similar in content to other Peruvian websites) with an invitation for free HIV testing. Testing will be offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be determined based on participants' demand. The outcomes evaluated will be intention to get tested and actual HIV testing among MSM of each of the trial arms.


Eligibility Criteria:
Inclusion Criteria:

* be 18 years of age or older,
* be a man and report having had sex with a man within the last 12 months,
* be a resident of metropolitan Lima, Peru,
* have not been tested for HIV within the last 12 months,
* have a valid e-mail address,
* do not report being HIV positive.

Exclusion Criteria:

* Do not meet the inclusion criteria specified above
Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.

This pilot study compares the use of tamoxifen to estradiol to placebo for seven days once a month up to 5 months in contraceptive implant users starting from the time of implant initiation. Participants will record bleeding and satisfaction response in a daily text diary.

Eligibility Criteria:
Inclusion Criteria:

* etonogestrel implant users
* at time of and/or within 21 days of initial use of etonogestrel implant placement
* must agree not to take additional hormonal therapy during the study trial period

Exclusion Criteria:

* within 6 months following vaginal or cesarean delivery
* within 6 weeks following abortion
* currently breastfeeding
* positive pregnancy test
* contraindications to tamoxifen or estrogen
* history of thromboembolism
* undiagnosed abnormal uterine bleeding
* active cervicitis
* bleeding disorder
* use of anticoagulation medications
* an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria
Shenzhen Birth Cohort Study

The Shenzhen Birth Cohort Study was set up to investigate the effect of early life environmental exposures on short- and long-term health consequences in Shenzhen, China.

Shenzhen Birth Cohort (Xinmiao Project) is a scientific research/public health project under the support of Shenzhen city and Nanshan district, which was jointly initiated by Nanshan Maternity and Child Healthcare Hospital of Shenzhen and school of public health, Sun Yat-sen University. The project plans to recruit 10,000 participants in early pregnancy and follow up for seven years in the first stage. Biological samples, questionnaires and data for child growth and development, disease and health will be collected. The study is aimed to provide evidence for DOHaD Hypothesis and find the prevention and control measures for some childhood diseases. The core members of the research team are composed of experts from different disciplines in the field of public health, including 4 professors and 3 associate professors. With the support of an executive sponsor, the project is undertaken by the Birth Cohort Study Center. Currently, the center has 3 staff form hospital (one doctor and two masters ) and 5-7 master candidates from Sun Yat-sen University. It is an energetic and enthusiastic team.

Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant women plan to delivery and participate in child care in our hospital; 2. Pregnant women plan to reside in Shenzhen for at least 7 years; 3. Pregnant women who show interest in the study and agree to provide informed consent; 4. Gestational weeks are less than 20 weeks.Those who will agree that their neonatal will be included in the study and be followed up regularly in our child health clinic until an age of 7 years.

Exclusion Criteria:

* Pregnant women who have been pregnant for more than 20 weeks; refuse to participate; unable to guarantee delivery in our hospital or can't participate in child care in our hospital; mentally incapacitated and need guardians; or be unwilling to sign informed consent.
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.


Eligibility Criteria:
Inclusion Criteria:

* Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion Criteria:

* History of no-response to timolol
* History of trabeculectomy
* History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
IntelliCare in College Students - Implementation (ICCS-I)

This study is a hybrid effectiveness-implementation trial of the smartphone student stress-management app IntelliCare for college students. This intervention will be tested with University of Illinois at Chicago (UIC) and Northern Illinois University (NIU) students. During the study, participants will complete measures of depressive and anxious symptoms, as well as measures of mental health literacy, within the app.

In this study, students will be recruited to use the IntelliCare Hub app and encouraged to use it daily.The overall aim of this study is to pilot the program, evaluation metrics, implementation strategies, data collection and assessment procedures for a larger implementation trial. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At monthly intervals, participants will be prompted within the app to complete the Depression Literacy Questionnaire and Anxiety Literacy Questionnaire to measure mental health literacy, the Knowledge and Beliefs about Services scale to measure knowledge of campus mental health services, the Barriers to Mental Health Help-Seeking questionnaire to measure treatment barriers, and the Cognitive and Behavioral Response to Stress Scale to measure cognitive and behavioral coping skills. Counseling center utilization data will be extracted from the participating counseling centers' electronic medical records.

Eligibility Criteria:
Inclusion Criteria:

* Participant is a student at the University of Illinois in Chicago or Northern Illinois University. \*Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
* Participant is 18 years of age or older

Exclusion Criteria:

\*None
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy

This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy. The trial was randomized into two groups: Mavacamten group and Non-Mavacamten group. Over the 30-week treatment period, patients underwent a series of assessments at predefined time points, including transthoracic echocardiography, electrocardiogram (ECG), Holter monitoring, NYHA functional classification, Kansas City Cardiomyopathy Questionnaire (KCCQ), and cardiac biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Weight greater than 45 kg.
3. Adequate acoustic windows to allow for accurate transthoracic echocardiograms (TTEs).
4. Diagnosis of latent obstructive hypertrophic cardiomyopathy, in accordance with the current guidelines of the American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology.
5. Left ventricular ejection fraction (LVEF) ≥55% at rest, confirmed by the echocardiography core laboratory.
6. New York Heart Association (NYHA) Class II or III symptoms at the time of screening.
7. Resting oxygen saturation ≥90% at the time of screening.

Exclusion Criteria:

1. Any acute or severe comorbidities (e.g., severe infections or hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction).
2. Currently using or having used prohibited medications within 14 days prior to screening, such as cytochrome CYP2C19 inhibitors (e.g., omeprazole or esomeprazole) or strong CYP3A4 inhibitors.
3. Life expectancy of less than 1 year.
4. Pregnant or breastfeeding women.
5. History of syncope or sustained ventricular tachyarrhythmia during exercise within the past 6 months.
6. Atrial fibrillation (AF).
7. Patients currently receiving or planning to receive treatment with disopyramide, cibenzoline, ranolazine, or a combination of beta-blockers with verapamil or diltiazem.