bioihbjkbjnl/mcl2 huggingface dataset:
Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal
      sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal
      incisions (belly area cuts), by using an endoscope to create a small cut at the most inner
      layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of
      the esophagus. The investigators are studying whether subjects who undergo Endoscopic
      Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar
      formation and wound infection than with laparoscopic or open surgery.
    

Detailed description: 
      The purpose of this research study is to find out more about a less invasive way of doing the
      surgical procedure (esophageal myotomy) to treat Achalasia.

      Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax,
      causing difficulty in swallowing.

      Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal
      sphincter to allow passage of food into the stomach.

      Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic
      surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera
      and surgical instruments to be introduced into the abdominal cavity to perform the myotomy.
      In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal
      cavity to perform the myotomy.

      Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal
      sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal
      incisions.

      The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it
      works. Additionally, the researchers will assess the level of pain and the amount of scarring
      subjects has after this surgery.
    

Intervention name(s): Endoscopic Esophageal Myotomy
Intervention type(s): Procedure
Intervention description(s): Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.
Other intervention name(s): POEM; Trans-esophageal endoscopic myotomy; Per-oral endoscopic myotomy; Endoscopic Heller Myotomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achalasia; Dysphagia; Endoscopic; Myotomy; Heller; NOTES; POEM
To Study the Effect of β-glucans on Wound Healing
Condition: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of β-glucans on wound healing.
    

Detailed description: 
      The structure of βeta-glucan (β-glucans) is a pathogen associated molecular patterns
      (pathogen-associated molecular patterns, PAMPs), widely present in the cell walls of plants,
      bacteria, yeasts, fungi, mushrooms and algae. Modern has been reported in the literature that
      β-glucan can enhance the immune system of animals, and to enhance the function of the animal
      against bacterial, fungal and viral infections, and cancer.In this study, the use of β-glucan
      to enhance the biological characteristics of the non-specific immunity, to explore the impact
      of postoperative patients with wound healing and infection rates.The observation of the
      healing process to take the Leather District wounds (5 ~ 200 cm2). The experiments were
      carried out for 18 months, were observed record the following three: (1) the rate of wound
      healing, (2) The rate of infection assessment: record length of time and the point in time at
      all levels of antibiotic use also observe the wound change (redness, swelling, heat,
      pain).(3) days of hospitalization, and spend statistics. Using unpaired student's t-test
      analysis, group data whether the differences between groups of experimental data. represents
      a statistically significant when p <0.05.
    

Intervention name(s): oral beta-glucans; oral sugar powder
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.; 30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.
Other intervention name(s): D-glucose polysaccharides; placebo, sugar, glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: burn, wound healing, skin graft
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate the effectiveness of adding etanercept to disease
      modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid
      Arthritis (RA).
    


Intervention name(s): etanercept; Placebo; DMARD Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection once weekly.; Placebo subcutaneous injection; Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RA; Enbrel; DMARD; Joint Count; Rheumatoid Arthritis; Etanercept; disease modifying anti-rheumatic drug
Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
Condition: Synbiotics; Healthy Humans; Composition of Gut Microbiota; Short and Branched-chain Fatty Acids
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week
      clinical trial on healthy volunteers. Following a two week run-in-period, subjects were
      randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a
      3-week wash-out period before the second treatment period, followed by a another wash-out
      period. Volunteers completed questionnaires for each period on overall health and well being,
      stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to
      collect fecal samples for investigation of microbiological and microbial metabolites before
      and after three treatment periods. The primary objective of the study is tan increase in
      fecal butyrate concentration. Secondary objectives are changes in microbiota composition and
      short-chain fatty acids.
    


Intervention name(s): Combination of Lactobacillus acidophilus NCFM and cellobiose
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Ninety patients suffering from active rheumatoid arthritis despite continued treatment
           with methotrexate will be evaluated for improvement of disease activity when taking
           GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.

        -  During the course of the study, patients will also be examined for any side effects that
           may occur, and the amount of GLPG0634 present in the blood as well as the effects of
           GLPG0634 on disease- and mechanism of action-related parameters in the blood will be
           determined.
    


Intervention name(s): GLPG0634; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methotrexate insufficient responders
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Standard placebo-controlled, double-blind study design (TEV-50717 [low dose and high dose]
      vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in
      a statistically significant effect on the tics in participants with TS.
    


Intervention name(s): TEV-50717; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6-, 9-, 12-, 15-, and 18 mg oral tablets; Placebo matched to TEV-50717 tablets will be taken BID.
Other intervention name(s): AUSTEDO, Deutetrabenazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III multicenter randomized, open-label study comparing the efficacy of a combined high
      dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell
      transplant in frontline multiple myeloma patients, non-progressive after induction therapy.
    


Intervention name(s): Bortezomib-Melphalan; Melphalan
Intervention type(s): Drug; Drug
Intervention description(s): Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.; Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Intervention MeSH terms: Bortezomib; Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of
      Treatment A, Treatment B, and Treatment C
    

Detailed description: 
      A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study,
      Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C)
      in Healthy Adult Subjects
    

Intervention name(s): SPN-817, Treatment B; SPN-817, Treatment C; BIS-001, Treatment A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor; SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor; BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
Other intervention name(s): Huperzine A; Huperzine A; Huperzine A
Intervention MeSH terms: Huperzine A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in two Parts to confirm the acceptability/selection of a tablet
      formulation for future clinical development of GSK2838232. Part 1 of the study will assess
      single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing
      approximately 30% fat) against the reference capsule formulation also given with food and
      then will assess the impact of fasted conditions on the tablet performance. In Part 2,
      non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate
      group of subjects, assuming the tablet performance is considered acceptable from Part 1.
      Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects
      through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at
      least 8 evaluable subjects through the single study period in Part 2. The maximum duration of
      study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part
      2.
    


Intervention name(s): GSK2838232 100 mg tablet; GSK2838232 50 mg capsule; Ritonavir 100 mg tablets; Placebo for GSK2838232 tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): It is a white to slightly colored tablet. It will be supplied as prefilled tablets in bulk for dispensing to subjects at the site according to the treatment code.; It is a pink unmarked capsule. It will be supplied as prefilled capsules in bulk for dispensing to subjects at the site according to the treatment code.; It is a white film-coated ovaloid tablets.; It is a white to slightly colored tablet. The placebo tablets supplied will not be identical to GSK2838232 tablets. It will be administered by site staff via an opaque card or paper tube.
Intervention MeSH terms: Ritonavir; GSK-2838232
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The randomization number will determine the allocation of treatment sequences (ABC or BAC) for Part 1, and of treatment (GSK2838232 without RTV or placebo) for Part 2. Allocation to treatment for Part 1A or Part 1B (with Part 2 being fixed) will be according to a predetermined random order.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2838232; safety; food effect; capsule; healthy; PK; tablet
STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
Condition: Overweight and/or Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of formulation on relative bioavailability
      of PF-06882961.
    


Intervention name(s): PF-06882961 100 mg
Intervention type(s): Drug
Intervention description(s): PF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D).
Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy of DLBS1033 in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study are:

        1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject

        2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject
    

Detailed description: 
      This study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a
      fixed dose regimen. The study will involve twenty (20) healthy subjects. The study will be a
      comparative study of safety and efficacy of DLBS1033 with placebo. Each study period will
      consist of 14 days treatment with a 2-week wash-out period in between. The evaluation of
      safety parameters will be performed at Day 1 (baseline), 7, and 14; while the efficacy
      parameters will be performed at Day 1, 2, 7, and 14.
    

Intervention name(s): DLBS1033; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 490 mg DLBS1033 daily; 3 x 1 tablet daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBS1033; safety; fibrinolytic; fibrinogenolytic; antiplatelet
Diffuse Myocardial Fibrosis in Fontan Patients
Condition: Congenital Heart Disease; Single Ventricle; Myocardial Fibrosis
MeSH terms: Heart Diseases; Heart Defects, Congenital; Univentricular Heart; Fibrosis
Study type: Observational

Summary: 
      The purpose of this protocol is to measure the relaxation of the heart in subjects with
      single ventricles who have undergone the surgical Fontan procedure. We will do this by
      measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to
      blood levels that measure heart scarring. We will also measure relaxation before and after
      boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid
      in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram,
      and cardiac catheterization for each patient and compared to blood markers of heart scarring.
      We aim to compare all of these measurements to see if we can accurately identify heart
      scarring and, if present, how much it correlates with impaired heart relaxation.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a single ventricle palliated with a Fontan procedure
      
Biospecimen description: 
      Blood samples
    
Keywords: Congenital heart disease; Myocardial fibrosis; Diastolic dysfunction
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the amount of bronchial tube relaxation from the Formoterol medicine
      contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a
      steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison
      will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time
      for breathing in the medication. Breathing tests will be measured over a 12 hour period for
      the comparison.
    

Detailed description: 
      Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort
      160/4.5 two inhalations in the manner prescribed in the approved package insert. The second
      intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved
      holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at
      various time periods over a 12-hour time frame in each intervention. Comparison will be made
      of the two periods to demonstrate that the use of the valved holding chamber does not
      adversely affect the bronchodilation of the formoterol component of the combination drug.
    

Intervention name(s): pMDI budesonide/formotrol 160/4.5 is in group 1; Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Intervention type(s): Drug; Device
Intervention description(s): The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.; Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.
Other intervention name(s): Symbicort; Symbicort; Aerochamber plus
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Formoterol; Long Acting Beta Adrenergic Bronchodilator; Symbicort; Aerochamber
Pistachios, Performance, Metabolomics
Condition: Inflammation; Oxidative Stress; Immune Dysfunction
MeSH terms: Immune System Diseases; Inflammation
Study type: Interventional

Summary: 
      Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling
      intensely for 75 kilometers will support substrate utilization during exercise (as determined
      through metabolomics) and improve performance compared to water only, and attenuate
      inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.
    


Intervention name(s): Pistachios
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inflammation; Oxidative stress; Immune dysfunction; Metabolites
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation
Condition: Patients With Postoperative Mechanical Ventilation After Liver Transplantation
Study type: Observational

Summary: 
      Mechanical ventilatory lung care is essential for postoperative care in liver transplantation
      recipients, for such patients are under massive fluid challenge and hemodynamic alterations
      perioperatively. Some of the recipients experience difficulty in weaning off from the
      mechanical ventilator due to various causes. This study is to investigate the relationship
      between the inflammatory gene polymorphism, known for acute lung injury, and the duration of
      mechanical ventilatory care for such liver transplantation recipients.
    


Intervention name(s): Mechanical ventilatory lung care
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20-65 years old, scheduled for liver transplantation.