bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis
Condition: Abdominal Pain; Duodenitis
MeSH terms: Duodenitis; Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the addition of Biofeedback-Assisted
      Relaxation to standard medication treatment improves outcomes for children with a specific
      type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).
    

Detailed description: 
      Recurrent abdominal pain (RAP) is the most common type of pain in school age children and
      young adolescents. Previous studies suggest that stress plays an important role in the
      activation of specific cells that can produce pain within the stomach and intestines.
      Medication is the standard approach to the treatment of RAP in children. Although medication
      is helpful for many children, medication alone is not always enough. Biofeedback trains
      individuals to use relaxation strategies effectively to relieve emotional and physical
      symptoms, and has been used successfully for stress and pain reduction with both children and
      adults. It has shown promising results when used alone in the treatment of children with RAP.
      Research is needed, however, to determine whether biofeedback training is helpful when used
      in conjunction with medication. Information about how biofeedback training affects the
      central nervous system and the cells that produce pain also would be useful in refining
      treatments for this large group of children. The current research will be done in three
      steps, with Phase 1 designed to evaluate the time, resources, technical support, and sample
      size needed for successful completion of the full research study. Twenty children (ages 8-18)
      with eosinophilic duodenitis, a specific form of RAP, will be enrolled and randomly assigned
      to one of two groups: 1) Standard of Care; or 2) Biofeedback (standard medical care plus 10
      sessions of biofeedback training). Measures of pain, functional disability, quality of life,
      physiological arousal, and global treatment response will be collected pre- and
      post-intervention, as well as 3 and 6 months later. Data collected will be used to determine
      how many participants will be needed for the full research study. If biofeedback training is
      ultimately found to be a positive addition to standard medical treatment, this could lead to
      improved health outcomes for children with RAP. This information also could result in greater
      treatment efficiency and reduced health care costs for families, insurance providers, and the
      hospital system.
    

Intervention name(s): Biofeedback-assisted relaxation training
Intervention type(s): Behavioral
Intervention description(s): 10 sessions BART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biofeedback
Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
Condition: Endocarditis, Bacterial; Opioid-use Disorder; Buprenorphine; Outpatient Parenteral Antibiotic Therapy
MeSH terms: Endocarditis, Subacute Bacterial; Endocarditis, Bacterial; Endocarditis; Opioid-Related Disorders
Study type: Interventional

Summary: 
      Hospitalizations for severe infections associated with opioid use disorder (OUD), such as
      infective endocarditis (IE), have doubled in the US over the past decade and are frequently
      prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug
      use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with
      IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more)
      largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD
      infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine
      or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug
      use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT
      (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional
      outpatient care program supporting MAT, may support provision of outpatient IV antibiotic
      therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to
      evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due
      to opioid use disorder in the hospital for the full duration of antibiotic treatment)
      compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically
      stable).
    


Intervention name(s): Outpatient parenteral antibiotic therapy
Intervention type(s): Behavioral
Intervention description(s): Subjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.
Other intervention name(s): OPAT
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous
      ligands have been identified as long-chain fatty acids. Recently, it has been shown that
      GPR120 expression in human adipose tissue is higher in obese than in lean individuals.
      Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a
      high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found
      in type 2 diabetes (T2D).

      Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified
      that inhibits GPR120 signaling activity.

      The investigators now want to investigate if GPR120 expression in adipose tissue may be
      altered in patients with T2D compared to non-diabetic subjects and might contribute to
      diabetes-associated metabolic changes. Additionally, the investigators want to assess the
      frequency of the R270H mutant in T2D.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age-
        and weight-matched normoglycemic controls
      
Biospecimen description: 
      SNP Genotyping of GPR120
    
Keywords: GPR120; Adipose tissue; Type 2 diabetes
The Accumulative Effect of Cold Water Immersion in Football Athletes
Condition: Athletic Performance
Study type: Interventional

Summary: 
      Football is a sport with congested calendars, which requires muscle recovery strategies such
      as cold water immersion (CWI). This recovery technique is well spread through football clubs,
      although it lacks a profound physiologic investigation to understand its effects on athlete's
      body. Objectives: The main objective of this study is to evaluate the effect of a long-term
      CWI exposure in football athlete's.

      Study Hypothesis:

      H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph
      signal, power and perceived of recover when compared with control sample.

      H1: The application of Cold water immersion amends the biomarkers, electromyograph signal,
      power and perceived of recover when compared with control sample.
    

Detailed description: 
      In order to answer this question, the investigators performed a randomized clinical trial in
      23 sub-20 football athletes. All subjects were randomly divided into two groups; a control
      group (10 minutes seated rest) and a CWI group (10 minutes in a 10 degree C) during seven
      days in a row. The investigators evaluated creatine kinase (CK) and lactate dehydrogenase
      (LDH) as molecular biomarkers for muscle damage. The blood samples were collected on the
      first, second, ninth and tenth days. Yet, the investigators assessed the peak of muscle
      activity and isometric strength of the knee flexors and extensors, potency of lower limbs,
      perceived exertion (PE) and total quality recovery perceived (TQRPer) in order to understand
      the treatment physiological effect on the subjects on the first and last day of experiments
      (before and after training).
    

Intervention name(s): cold water immersion; Control group
Intervention type(s): Other; Other
Intervention description(s): The volunteers stayed immerged up to the iliac crest, in the water with water. The temperature utilized was 10 degree C and the time was 10 minutes; The volunteers stayed in rest about 10 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial
Condition: Early Amniotomy, Unfavorable Cervix
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effectiveness and safety of early amniotomy after vaginal
      prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early
      active phase of labor for early amniotomy group ( half of participants) when the cervix will
      dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other
      half of participants) until the membranes rupture spontaneously.
    

Detailed description: 
      During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is
      commonly used in combination with induction of labor. However, there is a lack of data on
      both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable
      cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin
      works efficiently in cervical ripening and labor induction. So dinoprostone surely performs
      quite well in promoting cervical ripening and labor induction since its main component is
      prostaglandin E2 (PGE2).
    

Intervention name(s): PGE2
Intervention type(s): Drug
Intervention description(s): 10 mg PGE2 vaginal ovul(Propess)
Other intervention name(s): dinoprostone
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Infections; Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center study using induced blood stage malaria infection to characterize
      the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
    

Detailed description: 
      The primary objective of the study was to characterize the activity of ACT-451840
      administered orally on clearance of Plasmodium falciparum blood stage parasites from the
      blood in healthy subjects .The inoculum used for blood stage Plasmodium falciparum challenge
      (BSPC) contained an estimated 1,800 viable parasite-infected erythrocytes diluted into 2 mL
      of normal saline for injection. Blood was collected for malaria parasitemia assessment by
      polymerase chain reaction (PCR). Parasitemia ≥ 1,000 parasites/mL indicated that the subjects
      should be treated with ACT-451840 . If PCR counts were > 5,000 parasites/mL and symptomatic
      they were dosed within 24 hours. Subsequent PCR blood sampling were performed prior to
      ACT-451840 dosing and at 2, 4, 8, 12, 16, 20, 24, 30, 36, 48, 60, 72, 84, 96, 120, 144 hours
      post-dosing and then approximately times per week until 2 consecutive negative samples, until
      Riamet® rescue treatment and at the final visit.
    

Intervention name(s): ACT-451840:; Plasmodium falciparum-infected human erythrocytes:; Artemether 20 mg and lumefantrine 120mg combination tablet:; Primaquine:
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): ACT-451840 500 mg was provided in 100 mL amber glass bottles formulated as a powder for oral suspension. The ACT-451840 suspension was prepared extemporaneously by addition of 25 mL of water and administered orally under fed condition.; Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously.; Rescue treatment to ensure clearance of Plasmodium falciparum comprising six doses of four tablets (total course of 24 tablets) given over a period of 60 hours. Each dose of tablets administered orally was immediately followed by food or drinks rich in fat (e.g., milk).; Rescue treatment to ensure clearance of Plasmodium falciparum, to be taken as a single oral 45 mg dose with food only if gametocytes were identified after administration of Riamet® rescue medication.
Other intervention name(s): Riamet®; Primacin™
Intervention MeSH terms: Lumefantrine; Artemether; Primaquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Malaria; ACT-451840
Treadmill Training for Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a trial to test whether treadmill training can be used to improve the "walking" of
      patients with partial spinal cord injury. While on the treadmill, patients will be partially
      supported through the use of a specially designed harness attached to an overhead lift (also
      called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study
      will be randomly assigned to either the experimental group, which receives 12 weeks of this
      specialized treadmill training with regular physical therapy, or to the control group, which
      receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be
      measured before and after treatment as well as 6 and 12 months later, using standard tests
      that examine mobility independence and speed of ambulation. The trial takes place across five
      sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal
      cord injury within 8 weeks of trial entry.
    

Detailed description: 
      This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for
      acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training
      (BWSTT), partially supports the weight of the patient via an overhead lift attached to a
      harness. Therapists train the patient to walk on a treadmill by correcting gait deviations
      and manipulating sensory input that enhance control of the stance and swing phases of walking
      at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from
      below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to
      12 weeks of conventional therapy programs for mobility versus the same intensity and duration
      of a combination of conventional therapy plus BWSTT. The primary outcome measures are the
      level of independence for ambulation and the maximal speed for walking 50 feet. Patients will
      be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months
      after entry into the study.
    

Intervention name(s): body weight-supported treadmill training
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Keywords: Spinal Cord Injury; Body Weight Supported Ambulation Training; Treadmill Training; Physical therapy; Gait; Assisted Ambulation
To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test
Condition: Skin Care
Study type: Interventional

Summary: 
      To assess the irritation potential of four prototype daily defense serum formulations after
      24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.
    

Detailed description: 
      This is an evaluator (single) blind, test site randomized and intra-subject comparison patch
      test study to evaluate the cutaneous irritation potential of four experimental daily defense
      serum formulations, including a saline solution as a negative control.
    

Intervention name(s): Experimental Daily Defense Serum A; Experimental Daily Defense Serum C; Experimental Daily Defense Serum G; Experimental Daily Defense Serum N; Saline Solution Sodium Chloride
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).; Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).; Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).; Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).; Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK)
      of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam
      (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and
      fexofenadine (P-gp substrate), in healthy participants.
    


Intervention name(s): BMS-986419; Caffeine; Bupropion; Flurbiprofen; Omeprazole; Midazolam; Fexofenadine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Fexofenadine; Flurbiprofen; Midazolam; Caffeine; Bupropion; Omeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy; pharmacokinetics; BMS-986419
LungPoint ATV for Biopsy in Patients Undergoing Lobectomy
Condition: Lung Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and performance of the LungPoint ATV
      System.
    

Detailed description: 
      The LungPoint ATV System is an image-guided navigation system used to access tissue samples
      in the lungs. This feasibility study is being conducted to assess the ability of the
      investigator to access and sample tissue using this system in patients undergoing lobectomy
      or pneumonectomy. Navigation to and sampling of the patient's lung cancer tumor is conducted
      immediately prior to the scheduled lobectomy or pneumonectomy.

      Note: This study was conducted as a single-center feasibility clinical trial to determine the
      feasibility of this device. The primary outcome measures related only to feasibility and not
      to health outcomes. Therefore it was not registered on clinicaltrials.gov prior to the start
      of enrollment. Subsequently, it was determined that the results were compelling and therefore
      it was registered to facilitate publication.
    

Intervention name(s): LungPoint ATV System
Intervention type(s): Device
Intervention description(s): The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients
Condition: Interstitial Cystitis; IC
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators believe that this study is of importance of several aspects:

        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the
           current instillation mode.

        2. It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel in
           IC patients

        3. If proved effective or partially effective, this mode of treatment will serve as a basis
           for large feasibility study exploring its safety and efficacy aspects.
    

Detailed description: 
      American Urology Association (AUA) considers intradetrusor injection of BTX as a fifth-line
      treatment of interstitial cystitis due to the seriousness and of adverse events, including
      dysuria, large post-void residuals, and the need for intermittent self-catheterization. An
      appealing alternative for BTX injection is intravesical instillation of BTX since the recent
      studies suggest that intravesically applied BTX acts through the afferent neuropathway
      involving sensory mechanism in the urothelium rather than the smooth muscle. TheraCoat core
      technology is based on a reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel
      appearance at body temperature) for drug retention in the urinary bladder. Intravesical BTX
      instillation using TheraCoat gel is expected to increase treatment efficiency due to
      prolongation of treatment duration and consequently improving bladder exposure to BTX.

      Prior to instillation, the TC-3 hydrogel, in a liquid state, is mixed with BTX.TC-3 mixed
      with BTX is instilled to the bladder by a catheter. Following gel insertion to the bladder,
      the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the
      gel dissolves and is cleared out from the bladder Post instillation, patients followed at 2,
      6, 12 weeks thereafter.
    

Intervention name(s): TC-3 Gel mixed with Botox (BTX)
Intervention type(s): Device
Intervention description(s): TC-3 gel mixed with Botox (BTX). Single intravesical instillations of 40 ml of TC-3 mixed with 200 units of preconstitued BTX, using catheter
Other intervention name(s): botulinum toxin; BTX; TC-3 Gel
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interstitial cystitis; PBS/IC; IC; Botox; Botulinum toxin; TC-3 Gel; TCGel; TheraCoat