cyrilzakka/clinical-trials huggingface dataset:
Human Research Program Flight Thigh Cuff

Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.


Eligibility Criteria:
Inclusion Criteria:

* Astronauts participating in missions that are ≥2 months

Exclusion Criteria:

* Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
* Use of ethinyl estradiol Combined Oral Contraceptive (COC) pills precludes participation in this study
* Having increased risk of venothromboembolism (VTE) based on preflight thrombosis/clotting related biomarkers precludes participation in this study
Late Night Snack and Insulin Glargine

Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.

The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Basal insulin substitution with insulin glargine at least 3 month

Exclusion Criteria:

* Severe disorders
* Severe and clinical significant gastroparesis
* History of pancreatitis or pancreatic cancer
* Severe Liver disorder (liver enzymes \> three times upper normal limit)
* Pregnancy
* Drug- or alcohol abuse
Acute Hamstring Strains in Danish Elite Soccer - Diagnosis and Biomechanical Tests

A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain. In addition to the frequency of injury, hamstring injuries are also the most recurrent soft tissue injury occurring in sport. There is a need for further research concerning diagnosis and different prognostic parameters for the rehabilitating process.

The aims for this study are:

A longitudinal comparison of sonographic and MRI assessments of acute and healing hamstring injuries.

A study investigating different biomechanical parameters in the process of determining whether a former hamstring injured soccer player is fully rehabilitated. We hypothesize that it is possible to use electromyography, muscle strength measurements and different tests on a force platform to help determine this issue.


Eligibility Criteria:
Inclusion Criteria:

* Acute hamstring strain caused during soccer activities (match or training)

Exclusion Criteria:

* A hamstring strain at the time for inclusion
STUDY00015328: Sepsis Endotypes

Determine the utility of biomarkers measured in blood and body fluid (stool, saliva, tracheal aspirate) when combined with clinical data, for predicting sepsis phenotypes that are associated with poor clinical outcomes. We hypothesize that resistin is a biomarker which provides critical prognostic information when used in conjunction with standard clinical data, in patients with sepsis and septic shock.

Day 1 Sample Collection: 20ml of blood for chemical and genetic biomarker analysis. ≤1ml of saliva, stool, and tracheal aspirate for inflammatory marker analysis. Quadratus lumborum muscle size measurement and CT abdomen correlation. If not part of routine care, additional blood tests for cell differential, procalcitonin, and inflammatory markers.

Electronic Medical Records (EMR) Data: APACHE II and SOFA severity scores. Demographics, vital signs, inflammatory markers, organ dysfunction markers, and various blood chemistry values.

Days 2-3 Daily Documentation: Record the most abnormal value for the same parameters as Day 1.

Days 3-5 (Once) Sample Collection: Repeat of blood, saliva, stool, and tracheal aspirate collection. EMR data access for severity scores and other clinical parameters.

Days 5-6 Daily Documentation: Continued recording of the most abnormal values for clinical parameters.

Days 7-10 (Once) Sample Collection: Repeat of blood, saliva, stool, and tracheal aspirate collection. Measurement of muscle size and CT correlation. EMR data access for the same parameters as earlier.

Day 14 (or Discharge) Final Sample Collection: 20ml of blood and other samples, with no more than 1 ml/kg of blood collected over the entire study.

EMR and Clinical Data: Collection of severity scores, vital signs, inflammation markers, organ dysfunction markers, and other clinical variables.

Day 30, 3 Months, 6 Months, and 1 Year Long-term Outcomes: EMR review for clinical outcomes such as date of death, re-hospitalization, persistent critical illness. Phone interviews to gather subjective data about the post-hospitalization course and complications.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18 )
2. gender: male or female
3. Cognitively intact or impaired patients, given that sepsis may cause a certain degree of cognitive dysfunction in patients. All patients in the control group (no sepsis) will be cognitively intact
4. Clinical suspicion for sepsis (except for control/comparison group for whom infection is NOT a current concern)

Exclusion Criteria:

1. Patients with hematologic malignancies
2. Pregnant women
3. Patient/surrogate is not fluent in English and no translation services are available
4. Long-term immunosuppressive therapy
5. Prisoner
Electrical Stimulation for Erector Spinae Plane Catheter Insertion

The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.


Eligibility Criteria:
Inclusion Criteria:

* elective total or total reverse shoulder arthroplasty

Exclusion Criteria:

* inability to provide consent
* history of active opioid use
* emergency procedures
* shoulder arthroscopy
* partial shoulder replacement
* shoulder resurfacing
* any revision shoulder surgery
* any indwelling deep brain stimulator, pacemaker, and/or other neurostimulators
A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer

1. To determine the association between LVD and clinico-pathologic variables in archived colorectal cancer and Nasopharyngeal carcinoma specimens
2. To determine the association between VEGF-C,-D expression with COX-2 expression and clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma
3. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma Lymphangiogenesis and factors modulating lymphangiogenesis are associated with clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer. Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal carcinoma tumor specimens will be obtained from the Department of Pathology. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the investigators intend to analyze archived specimens collected in a previously conducted study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be examined for MVD, LVD and growth factor expression using established haematoxylin and eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be performed by two pathologists blinded to clinico-pathological variables using standardised methods.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients are eligible
* Patients 21 years or older

Exclusion Criteria:

* None
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.

There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).

Eligibility Criteria:
Inclusion Criteria:

* smoke ≥5 cigarettes per day for the past year
* read, write, and speak in English
* report at least minimal interest in switching to an alternative product (\> "not at all" on a Likert scale)
* participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.

Exclusion Criteria:

* \<21 years old
* report NRT use or making a quit attempt within the last 7 days
* current daily use of an e-cigarette over last month.
* unstable or significant medical condition such as respiratory, kidney, or liver disease
* unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* history of cardiac event or distress within the past 6 months
* currently pregnant, planning to become pregnant, or breastfeeding.
* currently enrolled in a contradictory study.
* cohabitates with a currently enrolled participant in the REACH study
* reaction to using patch medication or adhesive tape
* known allergy to propylene glycol or vegetable glycerin
Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia

We will use information technology to integrate the 2004 American Academy of Pediatrics guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn bilirubin test results to improve physician adherence to the guidelines and quality of care.

In 2004, the American Academy of Pediatrics disseminated clinical practice guidelines for the management of neonatal hyperbilirubinemia. Using the infant's age in hours, serum bilirubin levels are applied to hour-specific nomograms to assess risk of developing significant hyperbilirubinemia as well as the necessity for treatment. Prior guidelines did not include nomograms for either. A systems approach to managing neonatal hyperbilirubinemia, including use of the nomograms, has been shown to improve outcomes and patient safety.

Despite the existence of these guidelines, decision support does not exist within MGH clinical information systems for managing neonatal hyperbilirubinemia. We propose to create BiliCurves, an application that integrates perinatal information from the obstetrical health record with that of the newborn's, providing seamless reporting of neonatal bilirubin results in the context of the practice guidelines and relevant obstetrical data. BiliCurves will graphically superimpose bilirubin results onto hour-specific guideline nomograms that providers can view when viewing bilirubin results. We propose to randomize BiliCurves access to pediatric providers, and study its effects on management of hyperbilirubinemia both during birth hospitalization as well as in the outpatient setting after discharge. We hypothesize infants treated by physicians with BiliCurves access will receive birth hospitalization phototherapy at a higher rate and readmission for hyperbilirubinemia at a lower rate than that of the control group. We also hypothesize that physicians with BiliCurves access will report greater ease and confidence in nomogram use and providing evidence-based care as BiliCurves obviates the provider having to have access to paper based versions of the nomogram (usual care) as well decreases potential errors in plotting test results on the nomograms.

Eligibility Criteria:
Inclusion Criteria:

* Providers who care for infants in the newborn nursery.
* All newborns in the newborn nursery that are 35 weeks or more weeks of gestation will be study eligible.

Exclusion Criteria:

* Infants less than 35 weeks gestation.
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.

The main questions it aims to answer are:

1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?
2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?


Eligibility Criteria:
Inclusion Criteria:

* Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).
* Age ≥1 year and \<18 years.
* Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.

Exclusion Criteria:

* Age \<1 year or ≥18 years.
* Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.
* Secondary leukemia or second tumor, CML blast phase ALL.
* Other tumors or immunodeficiency diseases present.
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix

Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.

Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.

But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score \<4).

The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).

The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy over 37 weeks
* Singleton pregnancy
* Vertex presentation
* Previous caesarean section with unique Transversal segmentary incision
* Medical indication of induction of labor
* Unfavorable cervix with Bishop score \< 4
* No Premature Rupture Of Membranes
* Informed consent

Exclusion Criteria:

* Before 18 years old
* Placenta Praevia
* Premature Rupture Of Membranes
* Uterine scar other than transversal segmentary incision
* Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
* Multiple pregnancy
* Fetal malpresentation
* Cesarean indication
* Latex allergy
* No informed consent
Comparison of Qigong Exercises on Two Different Digital Platforms

Mild effort requiring, body-mind oriented, effective on multiple physical fitness parameters, ancient exercise method Qigong would be beneficial for a great number of people by using popular technological mediums in order to increase overall physical activity and wellbeing. Our aim is to evaluate the effects of Qigong exercises on endurance, muscle strength, sleep quality, level of anxiety and stress by using two different tele-rehabilitation methods.

Physical inactivity and sedentary behavior is a serious public health problem which categorized as a pandemic. One of the common risk factors for cardiovascular diseases, cancers, chronic respiratory diseases and diabetes, known as chronic non-communicable diseases, is physical inactivity. Mild effort requiring, body-mind oriented, effective on multiple physical fitness parameters, ancient exercise method Qigong would be beneficial for a great number of people by using popular technological mediums in order to increase overall physical activity and wellbeing. Based on reasons as previously described, our aim is to evaluate the effects of Qigong exercises on endurance, muscle strength, sleep quality, level of anxiety and stress by using two different tele-rehabilitation methods.

Eligibility Criteria:
Inclusion Criteria:

* • Categorized as "inactive (\<600 metabolic equivalent-min/hf)" with respect to International Physical Activity Questionnaire

  * Ability to read and talk in Turkish
  * In order to join online sessions, participants should have internet access
  * All answers of the Physical Activity Preparation Survey should be selected as "No"

Exclusion Criteria:

* • Lack of cooperation

  * Uncontrolled hypertension and uncontrolled arrhythmia patience
  * People with serious neurological and respiratory conditions
  * Having a pacemaker and/or percutaneous transluminal coronary angioplasty
  * Stroke, myocardial infarction history
  * Amputee
  * People with serious major musculoskeletal problems
  * Chronic kidney failure
  * Chronic Liver failure
  * Hip or knee prosthesis in last five years
  * Lower extremity injuries in last 6 months
  * Diabetic ulcer or neuropathy
  * Pregnant or planning to get pregnant in 1 year
  * Breastfeeding
  * Taking sleep pills or taking medicines as part of psychological treatment and/or working on shifts
Relationship Between EBV and PTLD

The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.

The relationship between Epstein-Barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. Over the past several years a quantitative EBV PCR lab test has been established. Unfortunately, the significance of an elevated test remains unclear. The relationship of a particular EBV PCR value and the risk of developing PTLD is unknown. The primary aims will be to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD. The study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including Quantitative EBV PCR results, the presence / absence of PTLD and the treatment of PTLD and results of EBV PCR with treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients undergone pediatric heart transplant
* followed by pediatric heart transplant program

Exclusion Criteria:

-
An Open-label Pilot Study of Coenzyme Q10 in Steroid-Treated Duchenne Muscular Dystrophy

This study will help to determine the safety and efficacy of the nutritional supplement Coenzyme Q10 when added to steroids as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are enrolled in this study will should be on a stable dose of steroids for at least six months, and will remain on their usual dose throughout the study. They will complete two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with Coenzyme Q10. Once Coenzyme Q10 therapy is started, participants will have their strength tested monthly for six months. Following the six month treatment period, participants will be given the option to remain on Coenzyme Q10 until the study is completed.


Eligibility Criteria:
Subject Inclusion Criteria

1. Age: 5 - 11 years old
2. Ambulant
3. Diagnosis of DMD confirmed by at least one the following:

   * Positive X-linked family history for typical Duchenne muscular dystrophy in older male relatives (onset by age 5 yr., wheelchair-bound by age 12 yr.) OR
   * Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical Duchenne dystrophy OR
   * Gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out-of-frame', and clinical picture consistent with typical Duchenne dystrophy.
4. On Glucocorticosteroids: Children must be on a steady dose of prednisone or deflazacort, on any schedule (Daily, alternate days, 10 days on, 10 days off or twice a week), for the last 6 months before starting the clinical trial. Dose of steroid or schedule cannot be altered during the study.
5. Evidence of muscle weakness by MRC score or clinical functional evaluation
6. Ability to provide reproducible repeat QMT bicep score within 10% of first assessment score.
7. Ability to swallow tablets

Subject Exclusion Criteria

1. Failure to achieve one or more of the diagnostic inclusion criteria cited above.
2. Symptomatic DMD carrier
3. Previous (6 months or less) or current use of Coenzyme Q10 (for DMD or any other disease)
4. Use of carnitine, other amino acids, creatine, glutamine, or any herbal medicines within the last 3 months.
5. History of significant concomitant illness or significant impairment of renal or hepatic function.