bioihbjkbjnl/mcl2 huggingface dataset:
Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy
Condition: Epidural Anesthesia; General Anesthesia
Study type: Interventional

Summary: 
      Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided
      into two groups, T and G, randomly. In Group T all patients underwent laparoscopic
      cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1%
      lignocaine plain whereas in group G all patients underwent surgery under general anesthesia.
      Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid
      consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of
      respiratory complication and duration of hospital stay as secondary outcome.
    


Intervention name(s): Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine); general anesthesia effect on heart rate in Laparoscopic Cholecystectomy
Intervention type(s): Drug; Drug
Intervention description(s): patients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure; patients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
Other intervention name(s): Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy; general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy
Intervention MeSH terms: Lidocaine; Bupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia
Masking: Single (Participant)
Primary purpose: Other
Keywords: headache; blood pressure
A Study of LY3074828 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828, when given as a
      solution formulation in different devices. The tolerability of LY3074828 will also be
      evaluated and information about any side effects experienced will be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 13 weeks, not including
      screening.
    


Intervention name(s): LY3074828
Intervention type(s): Biological
Intervention description(s): Administered SC
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
Condition: Bioequivalence; Ethinylestradiol; Gestodene; Harmonet
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the
      Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify
      through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene
      0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under
      fasting conditions.
    

Detailed description: 
      Bioequivalence Study
    

Intervention name(s): Reference Drug; Test Drug
Intervention type(s): Drug; Drug
Intervention description(s): Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose; Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; study; ethinylestradiol; gestodene
Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
Condition: Pulmonary Alveolar Proteinosis; Bronchiectasis; Cystic Fibrosis; Acute Respiratory Distress Syndrome
MeSH terms: Cystic Fibrosis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Bronchiectasis; Pulmonary Alveolar Proteinosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple
      ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male
      and female subjects (on non-child bearing potential) will be enrolled to investigate single
      inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose
      levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered
      once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is
      the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The
      Clinical trial will involve 42 healthy participants. The trial is expected to last
      approximately 4 months.
    


Intervention name(s): Molgramostim; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Granulocyte Macrophage-Colony Stimulating Factor (rhGM-CSF); Nebuliser solution
Intervention MeSH terms: Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Help Arthritis With Exercise in West Virginia
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this project is to determine if an evidence-based, community-delivered
      physical activity program, EnhanceFitness, yields benefits for participants with arthritis.
      The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for
      adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a
      randomized, controlled (wait list) design, and 3) disseminate the results to community and
      public health partners. It is anticipated that participation in the EnhanceFitness program
      will result in reduced pain, improved physical function and physical activity levels for
      adults with arthritis.
    


Intervention name(s): 12-weeks EnhanceFitness; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.; Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis; Osteoarthritis; Rheumatoid Arthritis; Fibromyalgia; Lupus
An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form
      of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such
      therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using
      third party human cultured cells will be safe and effective
    


Intervention name(s): Mesenchymal stromal cells (MSC) for infusion
Intervention type(s): Drug
Intervention description(s): MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
Other intervention name(s): No other names
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stromal cells; ileitis; colitis
Dietary Protein Requirements in Hemodialysis Patients
Condition: Chronic Renal Failure; End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional

Summary: 
      The primary purpose of this study is to assess dietary protein requirements in clinically
      stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary
      protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a
      safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.
    

Detailed description: 
      A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition
      (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation
      may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The
      usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend =
      1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of
      insufficient duration, that were usually carried out with obsolete types of dialysis therapy.

      We will examine the response to different levels of dietary protein intake (0.6-1.3 g
      protein/kg/day) under classical balance techniques with carefully controlled dietary intakes,
      living, conditions, and collection of nitrogen outputs and carefully measured nitrogen
      intakes and outputs.
    

Intervention name(s): Protein Diet
Intervention type(s): Other
Intervention description(s): Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic Renal Failure; End-Stage Renal Disease; Nitrogen Balance; Dietary Protein Intake
A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and
      safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function
      impairment compared to healthy subjects
    


Intervention name(s): ID-085
Intervention type(s): Drug
Intervention description(s): Hard capsules for oral administration formulated at a strength of 200 mg
Intervention model: Sequential Assignment
Intervention model description: Single-center, open-label, single-dose study is conducted in male and female subjects with renal function impairment and in healthy subjects. Groups A (mild), B (moderate), C (severe) and D (healthy subjects) will be studied in a staggered way, starting with the group with mild renal function impairment
Masking: None (Open Label)
Primary purpose: Other
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
Condition: Amputation
Study type: Observational

Summary: 
      The study investigated the perceived-mobility of patients with unilateral lower limb
      amputations by means of patient-reported outcome measures (PROMs). Such aspect may play an
      important role in evaluating the patient impairment and addressing forensic-medical issues.
      However, to this concern, the use of PROMs has not been extensively investigated yet. Among
      the validated PROMs, the study assessed self-perceived mobility and quality of life by
      administering the Trinity Amputation Prosthetic Evaluation Survey (TAPES) and the more recent
      Prosthetic Mobility Questionnaire (PMQ). The aim of this observational study was to improve
      the estimation of the physical and psychological impairment caused by the amputation,
      focusing on the impact of the limb loss on social participation, quality of life and daily
      living activities.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Subjects with a unilateral lower limb amputation either trans-femural or trans-tibial

          -  Age:18-65 years old
Physical Therapy on Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ
      prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be
      randomly assigned to one of these groups: Experimental group: physical therapy + training in
      lifestyle advice; Control group: just training in means of lifestyle advice. In both groups
      several physical therapy assessments will be undertaken: 1st before intervention; 2nd
      immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24
      months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by
      their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is
      no contraindication for physical therapy, and after reading, understanding and freely signing
      an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study
      (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the
      variables, as well as bivariate analysis in order to find all the possible relationships
      between the variables. A confidence level of 95% (p<0.05) will be established for all the
      cases. Effectiveness will be evaluated by comparing between the two groups of the change in
      outcome variables between visits.
    


Intervention name(s): Physical therapy + educational strategy; Educational strategy
Intervention type(s): Other; Behavioral
Intervention description(s): See arm/group descriptions; See arm/group descriptions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: Experimental group and Control group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Venlafaxine PK Following Bariatric Surgery
Condition: Roux en Y Gastric Bypass; Sleeve Gastrectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to evaluate how the body absorbs and processes the immediate
      release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are
      1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate.
      Non-surgical controls will also be enrolled based on a matching criteria to post gastric
      bypass subjects. Participants will be asked to complete two 12-hour study days approximately
      11 days apart. This study will enroll up to 30 participants.
    


Intervention name(s): Venlafaxine IR and Venlafaxine XR
Intervention type(s): Drug
Other intervention name(s): Effexor and Effexor XR
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
Condition: Risk Factors for or a Diagnosis of Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerated concentration (MTC) of
      bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate
      without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at
      MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20
      to bisphosphonate alone.
    


Intervention name(s): rHuPH20; zoledronic acid
Intervention type(s): Drug; Drug
Intervention description(s): recombinant human hyaluronidase PH20 injection; subcutaneous injection
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pharmacokinetics; rHuPH20
Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being
      developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This
      open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral
      doses of immediate release (IR) and modified release (MR) tablets in healthy, adult
      participants under fasted conditions. This is an open label, single dose, randomized, 2
      period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy
      participants.
    


Intervention name(s): PF-06700841 Immediate release tablets; PF-06700841 Modified release tablets
Intervention type(s): Drug; Drug
Intervention description(s): Small molecule tablets in immediate release form; Small molecule tablets in modified release form
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to investigate the efficacy and safety of three weekly
      intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle
      Osteoarthritis (OA).
    

Detailed description: 
      Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established
      treatment option in knee osteoarthritis. Previous studies reported that five weekly
      hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis.
      However, the effect of three weekly injections has rarely been investigated. Besides, no
      study to date has assessed whether balance function would change after HA injections in
      patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of
      three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle
      osteoarthritis. Pain, physical function and balance will be assessed as parameters for the
      effectiveness.
    

Intervention name(s): sodium hyaluronate
Intervention type(s): Drug
Intervention description(s): 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankle joint; Balance; Hyaluronic acid; Osteoarthritis
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets
      40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were
      separated by a washout period of 7 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg
      (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets
      containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc., USA) in Healthy Human
      Volunteers Under Fed Condition.
    

Intervention name(s): Torrent's Olmesartan Medoxomil Tablets 40 mg; Daiichi Sankyo Inc's Benicar Tablets 40 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults
Condition: Blood Glucose; Blood Insulin
Study type: Interventional

Summary: 
      Blood sugar and insulin levels after a meal may be altered by the food and beverages a person
      consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and
      related diseases. This study will look at how drinking different common beverages (milk,
      low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar
      and insulin levels.
    

Detailed description: 
      The broad aim of the proposed research is to evaluate the effects of consuming milk and
      non-milk beverages with a breakfast meal on postprandial glucose and insulin responses in
      overweight and obese adults with varying levels of glucose tolerance (normal, pre-diabetic,
      type 2 diabetes). The investigators expect the consumption of fluid milk with breakfast to
      decrease the postprandial glucose response relative to other non-milk beverages (orange juice
      and sweetened coffee). Furthermore, the investigators expect that there will be no difference
      in the postprandial glucose or insulin response between varieties of fluid milk (skim,
      low-fat, and whole).
    

Intervention name(s): Acute beverage (water) consumption; Acute beverage (Black Coffee) consumption; Acute beverage (Orange Juice) consumption; Acute beverage (Whole Milk) consumption; Acute beverage (2% Milk) consumption; Acute beverage (Skim Milk) consumption
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Acute beverage consumption includes water.; Acute beverage consumption includes black coffee.; Acute beverage consumption includes Orange Juice..; Acute beverage consumption includes whole milk; Acute beverage consumption includes 2% milk; Acute beverage consumption includes skim milk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
Condition: Immune Response to MMR Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study planned to determine and compare immunogenicity and reactogenicity of MMR
      vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or
      disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.
    

Detailed description: 
      This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical
      study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL
      delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in
      total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for
      seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps
      and rubella at 35 days after administration of a single dose of MMR vaccine of Serum
      Institute of India.
    

Intervention name(s): MMR vaccine
Intervention type(s): Biological
Other intervention name(s): Tresivac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention