bioihbjkbjnl/mcl2 huggingface dataset:
BEATS 2: Music Therapy in Sickle Cell
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of the BEATS music therapy program on
      the self-efficacy, trust, knowledge, and adherence of young adult patients with SCD.

      Primary Hypotheses:

      Compared to baseline, young adult patients with SCD who receive the music therapy
      interventions will report:

      Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),
      Higher trust in health care providers as measured by the Wake Forest Trust in the Medical
      Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge
      Quiz.

      Secondary Hypotheses Compared to the one year prior to the study period, young adults with
      SCD who receive the music therapy interventions will have a higher rate of adherence to
      clinic appointments during the one-year study period.

      Additional Questions Do music therapy interventions influence the rate of hospital
      utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during
      the study period compared to the previous year? Do music therapy interventions influence
      adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in
      mean corpuscular volume (MCV) during the study period? Do music therapy interventions
      influence adherence to iron chelation therapy for patients receiving iron chelation therapy
      as measured by ferritin count during the study period? Does the schedule of music therapy
      interventions in this study improve outcomes more significantly than the schedule of music
      therapy interventions from [IRB# 03-15-30]?
    


Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment via a prerecorded video. The Music Therapist will then engage the patients in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults
Condition: Obese; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the efficacy and safety of the GOLO for Life®
      Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic
      parameters in overweight and obese adults. The change from baseline at Days 90 and 180
      following the G4LP and supplementation with Release in weight (kg and % of total weight) and
      fat mass (percent and kg) will be assessed by Dual X-Ray Absorptiometry (DEXA). The weekly
      change in weight (kilograms and percent change) will also be assessed from baseline to day
      180 following the G4LP and Release supplementation. Additionally, the safety and tolerability
      of the G4LP and Release supplementation will be measured by the occurrence of and/or changes
      in pre-emergent and post-emergent adverse events (AEs).
    


Intervention name(s): Release
Intervention type(s): Dietary Supplement
Intervention description(s): One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obese; weight loss; body composition; cardiometabolic parameters
Desflurane in Children With Laryngeal Mask Airway
Condition: Desflurane Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the airway responses to desflurane during
      maintenance of and emergence from anesthesia in children whose airways were supported with
      laryngeal mask airways (LMAs).
    


Intervention name(s): Sevoflurane/Desflurane; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane; Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane
Other intervention name(s): suprane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and
      preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable,
      locally advanced pancreatic cancer.

      Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of
      intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs).

      Secondary objectives include determining the adverse events (AEs) profile, effects on
      clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor
      resectability after 4 intratumoral administrations of DTA-H19.
    

Detailed description: 
      DTA-H19, is a doubled stranded DNA plasmid that carries the gene for the diphtheria toxn A
      (DT-A) chain under the regulation of the H19 promoter sequence. This is a Patient-Oriented,
      Targeted Therapy as DT-A chain expression is triggered by the presence of H19 transcription
      factors that are upregulated in tumor cells. The selective initiation of toxin expression
      results in selective tumor cell destruction via inhibition of protein synthesis in the tumor
      cell, enabling highly targeted cancer treatment.
    

Intervention name(s): DTA-H19
Intervention type(s): Biological
Intervention description(s): Cohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks
Other intervention name(s): BC-819
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H19 gene, plasmid, diphtheria toxin, pancreatic cancer; inodiftagene vixteplasmid; BC-819
A Survey of the Indications for Esophagogastroduodenoscopy (EGD) in Children's Hospital of Fudan University
Condition: Digestive System Abnormalities
MeSH terms: Digestive System Abnormalities
Study type: Observational

Summary: 
      Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology
      diseases. The investigators want to find which symptoms can support for positive endoscopic
      findings.
    

Detailed description: 
      Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology
      diseases. And there are indications for EGD. Here, investigators want to find which symptoms
      can strongly support for positive endoscopy findings. So, investigators design the study to
      record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of
      endoscopic findings.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All of the patients need esophagogastroduodenoscopic procedures
      
Keywords: esophagogastroduodenoscopy; paediatric
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Condition: Acute Pain; Ankle Sprain
MeSH terms: Acute Pain; Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess the effectiveness of once daily application of
      a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle
      sprains when applied to the painful area.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, parallel group study will be conducted in
      patients with mild or moderate ankle sprains.

      Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with
      either the diclofenac topical patch or a matching placebo patch to be applied once daily for
      7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up
      assessment will be conducted on Day 14. Patients will complete an electronic diary in which
      assessments including pain intensity, pain relief and functional disability will be recorded
      twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and
      the use of study treatment and rescue medication will be recorded in the diary each day.
    

Intervention name(s): Diclofenac Sodium; Matching Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Topical diclofenac patch applied once daily to area of pain; Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diclofenac; ankle sprain; acute pain; topical; patch; Acute Pain due to Mild to Moderate Ankle Sprain
Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls
Condition: Vitamin D Deficiency; Insulin Resistance; Insulin Sensitivity; Obesity
MeSH terms: Insulin Resistance; Vitamin D Deficiency; Hypersensitivity
Study type: Observational

Summary: 
      The purpose of the study is to assess the relationship between vitamin D status and insulin-
      glucose dynamics in obese Adolescents. The study is intended to assess the difference in the
      insulin sensitivity before and after correction of vitamin D deficiency.
    

Detailed description: 
      The vitamin D deficient subjects are identified initially through an existing study. Those
      identified with vitamin D deficiency are notified and subsequently treated with standard
      therapy for vitamin D deficiency as part of their clinical care. Patients who self report
      that they have taken the treatment are enrolled in this study. Patients will be evaluated in
      this study with measurement of serum 25 OH D level, PTH and oral glucose tolerance test. The
      study will assess if there is improvement in glucose- insulin sensitivity dynamics once the
      serum 25OH D level is normalized
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female adolescents who are menarchal BMI is 95th centile, for age and sex
      
Keywords: Vitamin D deficiency; Insulin resistance; Glucose- Insulin dynamics; Obese adolescents
Steady State Study of Codeine Sulfate
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterize the steady-state pharmacokinetics of codeine and its metabolites
      morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral
      administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15
      mg Q4H x 5 days.
    


Intervention name(s): Codeine Sulfate
Intervention type(s): Drug
Intervention description(s): 15 mg tablet
Intervention MeSH terms: Codeine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fat Distribution and Glucose Metabolism in Williams Syndrome
Condition: Williams Syndrome
MeSH terms: Williams Syndrome; Syndrome
Study type: Observational

Summary: 
      Williams Syndrome (WS) is a genetic syndrome with features that may include vascular
      stenoses, neuro-developmental changes, and a variety of endocrine and metabolic
      abnormalities, including impaired glucose metabolism and abnormal body composition.
      Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral
      glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data
      suggest increased overall body fat in these individuals, as well as a relative increase in
      fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain
      incompletely characterized. The purpose of the current study is to carefully describe glucose
      metabolism and lipid parameters in people with WS.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adults with Williams Syndrome (WS), and "control" individuals without WS.
      
Keywords: Williams Syndrome
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl
      Tablets
    

Detailed description: 
      To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg
      buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In
      addition, the bioavailability of the Par product was compared under fed and fasting
      conditions.
    

Intervention name(s): Buspirone HCl; Buspirone HCl; Buspar
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 30 mg, single-dose, fasting conditions; Tablets, 30 mg, single-dose, fed conditions; Tablets, 30 mg, single-dose, fed conditions
Other intervention name(s): Buspar; Buspar; Buspirone HCl
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; buspirone HCl; fed
Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors predict how well patients will respond to treatment.

      PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent
      head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and
           PTEN-expressing cancers.

      Secondary

        -  Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient
           and PTEN-expressing cancers, by treatment arm.

      OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with
      PTEN antibody and analyzed with AQUA.
    

Intervention name(s): cetuximab; cisplatin; gene expression analysis; microarray analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Biological; Drug; Genetic; Genetic; Other; Other
Intervention MeSH terms: Cetuximab
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E5397 from who samples were submitted for research
      
Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVA squamous cell carcinoma of the larynx; stage IVA squamous cell carcinoma of the lip and oral cavity; stage IVA squamous cell carcinoma of the oropharynx; stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVB squamous cell carcinoma of the larynx; stage IVB squamous cell carcinoma of the lip and oral cavity; stage IVB squamous cell carcinoma of the oropharynx; stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVC squamous cell carcinoma of the larynx; stage IVC squamous cell carcinoma of the lip and oral cavity; stage IVC squamous cell carcinoma of the oropharynx; stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity; untreated metastatic squamous neck cancer with occult primary
Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with
      treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized
      study. Assessments will be made before and after MRgFUS for adverse events related to
      treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain
      chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e
      'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms.
      Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the
      evolution of the lesion in the anterior limb of the internal capsule. Patients will be
      clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At
      every follow-up visit, patients will be evaluated for general health, neurological changes,
      as well as for device/procedure related adverse events. Imaging will also be performed with
      positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure.
      Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of
      the procedure for patients, and the technical ability of heating the ALIC to lesional
      temperatures.
    


Intervention name(s): Focused Ultrasound
Intervention type(s): Device
Intervention description(s): MR-guided Focused Ultrasound (MRgFUS) offers the possibility of lesioning deep brain targets, while obviating the need for open surgical approaches. There is no radiation, incision, or burr hole, and lesions are generated in real-time under MR image guidance. Intracranial FUS for other applications, essential tremor most notably, has been shown to be safe and effective, recently receiving Health Canada approval for this indication. The technology, methods and procedures used in this study are identical to those in essential tremor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effects of Hip Abductors Strengthening In Knee Osteoarthritis
Condition: Osteoarthritis Knees Both
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of my study is to determine the effects of hip abductors strengthening and quadriceps
      strengthening in comparison with quadriceps strengthening alone in patients with knee
      osteoarthritis.
    

Detailed description: 
      As the quadriceps strengthening is a keystone of exercise therapy for knee osteoarthritis.
      Thus is the hip abductors strengthening along with quadriceps strengthening would be added to
      the treatment protocol of osteoarthritis it might give more positive results, decrease pain
      and increase the recovery rate as well as helpful to improve the functional outcomes.
    

Intervention name(s): Hip Abductor Strengthening; Traditional Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Elastic resisted training of Hip Abductors (5-10 seconds hold) 10 repetitions x 3 sets, 3 alternate days per week.
Elastic resisted training of Quadriceps (5-7 seconds hold) 10 repetitions x 3 sets, 3 alternate days per week.
Static Stretching of 5 seconds hold (Calf, Hamstrings, Gluteal muscles and Iliotibial band) 10 repetitions x 3 sets, 3 alternate days per week.
Patellar Mobilization in all four directions 10 repetitions x 3 sets, 3 alternate days per week.
Total 18 sessions were given in 06 weeks.; Elastic resisted training of Quadriceps (5-7 seconds hold) 10 repetitions x 3 sets, 3 alternate days per week.
Static Stretching of 5 seconds hold (Calf, Hamstrings, Gluteal muscles and Iliotibial band) 10 repetitions x 3 sets, 3 alternate days per week.
Patellar Mobilization in all four directions 10 repetitions x 3 sets, 3 alternate days per week.
Total 18 sessions were given in 06 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups are formed. Control group and Experimental group.
Masking: Single (Participant)
Primary purpose: Treatment
Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
Condition: Performance; Energy; Gait; Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Investigators investigated that the effects of kinesilogy taping on performance, energy
      consumption and gait characteristics in patients with Duchenne Muscular Dystrophy
    

Detailed description: 
      Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional
      Classification were included in the study. Performance was assessed by measuring the distance
      in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption
      by Physiological Consumption Index (PCI), and gait characteristics by footprint method on
      powdered ground at baseline. Kinesiology taping with facilitation technique was applied on
      bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour
      after application. The comparison between before and after taping was analyzed.
    

Intervention name(s): Kinesiology Taping
Intervention type(s): Device
Intervention description(s): Kinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping. KT is applied by specialized physiotherapists and physicians. This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries. Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: kinesiology taping; performance; energy consumption; gait; Duchenne Muscular Dystrophy