bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find the efficacy of treating the trigger points located
      around the shoulder in patients suffering from chronic shoulder pain.
    

Detailed description: 
      Chronic shoulder pain is a common condition which should be treated by surgery only wen
      conservative approaches have been tried. in the present trial the authors intend to find the
      effectiveness of treating the triggers points located in muscles, ligaments and tendons
      surrounding the shoulderin patients suffering from chronic shoulder pain.

      The technique used in this trial is ischemic compression(thumb tip pressure) on the trigger
      points
    

Intervention name(s): ischemic compression
Intervention type(s): Procedure
Intervention description(s): Active Comparator, ischemic compression, 3 times a week,5 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chiropractic; myofascial trigger points; ischemic compression; shoulder pain
Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm
Condition: Asthma, Exercise Induced
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Observational

Summary: 
      This research is being conducted to help us better understand what causes exercise induced
      asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and
      adenosine, play an important role. The investigators will be measuring these chemicals in the
      exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic
      exercise induced asthma. The investigators will determine how the levels of these chemicals
      change in association with how lung function changes before, during and after an episode of
      exercise induced asthma.
    


Intervention name(s): Hyperpnea challenge
Intervention type(s): Procedure
Intervention description(s): 5 minutes of dry air hyperpnea to induce bronchospasm
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatics with exercise induced bronchospasm
      
Keywords: Asthma; Exercise induced bronchospasm; Hyperpnea induced bronchospasm; leukotrienes; adenosine; exhaled breath condensate
Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability of 500 mg Divalproex Sodium
      Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1
      x 500 mg tablets) in healthy subjects under non-fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): divalproex sodium; Depakote®
Intervention type(s): Drug; Drug
Intervention description(s): delayed-release 500 mg tablet; delayed-release 500 mg tablet
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The Automated Insulin Delivery (AID) System is an investigational insulin delivery device
      being developed for use for participants with diabetes. The purpose of this study is to
      assess the safety of the AID system during meal challenges.
    


Intervention name(s): AID System; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): AID System; Individualized doses of insulin lispro administered via the AID system to maintain glycemic control except during meal challenges.
Other intervention name(s): LY8888AU; LY275585
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Condition: Type 2 Diabetes; Obesity; PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose
      profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.
    

Detailed description: 
      The GI is a method of classifying foods based on the food's ability to raise the blood
      glucose level. Low GI foods are recommended as they have a lower impact on blood glucose
      concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose
      profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese
      males will be recruited. There will be two sessions (consisting of three days for each
      session) where they will consume either a high or low glycaemic index dinner at home and a
      high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter).
      There will be at least five days in between the two sessions. Their glycaemic response will
      be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while
      substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch
      and snack). This study specifically attempts to see whether the inclusion of a low GI
      sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in
      Asians. The study is important in that it will enable us to compute the rate of fat oxidation
      and how it is influenced when subjects are fed a mixed meals modulated to be high GI
      (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians.
      Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is
      no exception. Devising ways and means to staunch the escalation is therefore a priority. The
      findings of the research will contribute towards the long-term objectives of developing
      dietary guidelines for weight and glycaemic control. The study data will also be important
      for the provision of practical food-based advocacy for better weight and glycaemic control in
      Asians.
    

Intervention name(s): low glycaemic index intervention; high glycaemic index intervention
Intervention type(s): Other; Other
Intervention description(s): Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.; High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
Masking: Double (Participant, Investigator)
Primary purpose: Other
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This multi-center parallel study is designed to study the efficacy and safety of fixed doses
      of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo
      group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are
      between 6 and 18 years old.
    

Detailed description: 
      This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose,
      phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride
      (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity
      Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

      The primary objective was to assess the efficacy of Biphentin compared to placebo, in the
      clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

      Subjects who met study entry criteria were enrolled in the Double-blind Phase and were
      randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule
      taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that
      included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The
      open-label period following the one double-blind fixed dose week provides additional
      opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose
      optimization visits are allowed as needed for additional dose titration visits during the
      open-label period.

      The safety and tolerability, and efficacy assessments will be conducted throughout the study.

      Biphentin® is designed to be a single daily dose alternative to separate doses of immediate
      release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more
      similar to immediate release methylphenidate.
    

Intervention name(s): Methylphenidate Hydrochloride Extended Release Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Biphentin Methylphenidate ER Once-A-Day Capsules; Placebo capsules
Other intervention name(s): Biphentin; Placebo capsules
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inattention; impulsivity; hyperactivity; ADHD
Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion
Condition: Family Planning
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral
      hyoscine butyl bromide during intrauterine device insertion.
    


Intervention name(s): diclofenac sodium (cataflam); hyoscine butyl bromide (buscopan)
Intervention type(s): Drug; Drug
Intervention description(s): The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure; The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure
Intervention MeSH terms: Diclofenac; Scopolamine; Bromides; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate,
      gastroparesis symptoms and health-related quality of life in diabetic patients with
      gastroparesis.
    


Intervention name(s): TZP-102; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: gastroparesis; diabetes mellitus; delayed gastric emptying
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the antibody response and reaction rates in children
      age 6-23 months when they are given either the currently recommended schedule of two 0.25ml
      doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month
      apart.
    


Intervention name(s): Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)
Intervention type(s): Biological
Intervention description(s): Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.
Other intervention name(s): VAXIGRIP®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Vaccines; Infant; Dose-Response Relationship, Immunologic
Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of transcranial Electrical Stimulation (tES)
      on emotion processing of healthy participants. Meanwhile, the investigators evaluate the
      effect of tES on electroencephalography (EEG) of both resting and task-related signal. The
      hypothesis of this study is that tES can improve the cognitive function of emotion by
      modulating brain activity.
    

Detailed description: 
      This is a randomized, single-blind, sham-controlled study using transcranial Electrical
      Stimulation (tES) for 7-day treatment. Participants were randomly assigned to transcranial
      alternating current stimulation (tACS) group, transcranial direct current stimulation (tDCS)
      group or sham-control group. Active tES comprised 20 min sessions of 1.5 mA peak-to-peak
      current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days. Sham group
      was administered similarly, but with current turned off after 30s. Apart from studying the
      effects of tES on physiology signals, subjective scale assessments and behavioral data are
      performed before and after the treatment.
    

Intervention name(s): Transcranial alternating current stimulation (tACS) -active; Transcranial direct current stimulation (tDCS)-active; Transcranial electrical stimulation (TES)-sham
Intervention type(s): Device; Device; Device
Intervention description(s): Transcranial alternating current stimulation (tACS) is a non-invasive neuromodulation technique of the brain with an AC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.; Transcranial direct current stimulation (tDCS) is a non- invasive neuromodulation technique of the brain with a DC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.; Transcranial electrical stimulation (TES) is a non-invasive neuromodulation technique of the brain with micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive sham stimulation over the dorsolateral prefrontal cortex, with current turned off after 30 second. The session last 20 min for 7 consecutive days.
Other intervention name(s): tACS active; tDCS active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: transcranial Electrical Stimulation (tES)
A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to assess efficacy, safety, and tolerability of a single-dose intra-articular
      administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis
      (OA).
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single-dose, parallel-group study to
      assess the efficacy, safety, and tolerability of a single-dose intra-articular (IA)
      administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis
      (OA).

      Approximately 180 patients will be randomized (1:1:1:1) to one of four treatment groups
      (three dose levels of UBX0101 and Placebo; approximately 45 patients per group), all
      administered by IA route at Week 0. The four treatment groups will be enrolled concurrently.

      The primary objective of the study is to evaluate the effect of IA administration of UBX0101
      on the change from baseline to Week 12 of pain in the target knee.
    

Intervention name(s): UBX0101; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug intra-articular injection; Placebo intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence
Cardiac Output Monitoring With Estimated Continuous Cardiac Output (esCCO) vs. Transpulmonary Thermodilution (TPTD)
Condition: Pulse Wave Analysis [E01.370.370.680]
Study type: Interventional

Summary: 
      The main goal of our study is to assess the accuracy and reproducibility of continuous
      beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients
      undergoing off-pump coronary artery bypass grafting.
    

Detailed description: 
      Using appropriate statistical methods the cardiac index values obtained via pulse wave
      transit time with esCCO system will be compared with traditional transpulmonary
      thermodilution technique.
    

Intervention name(s): Fluid responsiveness tests
Intervention type(s): Other
Intervention description(s): After the end of surgery in ICU the positive end-expiratory pressure (PEEP) test of 15 cm H2O for 300 seconds will be performed. Following PEEP test, the two-step fluid load test of 6 ml/kg balanced crystalloid solution will be performed sharing in two portions: Initial mini FLT (mFLT) of 1.5 ml/kg within 1 min (approximately 100 mL) followed by the registration of continuous CI and traditional fluid responsiveness parameters and the rest of standard FLT (4.5 mL/kg) within 5 minutes (approximately 350 mL) followed by transpulmonary thermodilution, registration of continuous cardiac index (CI) and classic fluid responsiveness parameters.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cardiac output; coronary artery bypass grafting; minimally invasive hemodynamic monitoring; fluid responsiveness
Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose,
      dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy
      volunteers.
    


Intervention name(s): D-0120; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo; Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Barriers to Adherence to Asthma Controller Meds in Low Income Urban Minority Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Poor adherence to appropriate asthma medications is an important risk factor contributing to
      high asthma morbidity and mortality in urban African American adolescents. As part of the
      ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a
      focus group was developed specifically to explore existing barriers to adherence among inner
      city African American adolescent asthmatics.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        four low income urban adolescents with uncontrolled moderate persistent asthma
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Condition: Pancreatic Cancer
Study type: Interventional

Summary: 
      This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue
      from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and
      cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional
      Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in
      which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
    

Detailed description: 
      This is a single-blinded randomized controlled trial with paired evaluation of conventional
      FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus
      pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all
      the lesions. After each pass of needle, the on-site cytopathologists will evaluate the
      adequacy and the degree of the pathological changes in the obtained material. Based on the
      information provided by the onsite cytopathologists, the endosonographer will repeat the FNA
      until enough histological material is obtained to confirm a diagnosis. Patients will be
      assessed immediately after procedure and during the first 30 days with a follow-up.
    

Intervention name(s): Fine Needle Biopsy (FNB); Fine Needle Aspiration (FNA)
Intervention type(s): Device; Device
Intervention description(s): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.; Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
Other intervention name(s): Shark Core Fine Needle Biopsy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic