bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to determine the maximum tolerated dose of an investigational drug in subjects with
      schizophrenia
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single
      ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of
      lurasidone injectable suspension in subjects with schizophrenia. This study will determine
      the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable
      suspension, and characterize the PK profiles of lurasidone and its metabolites in serum
      (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and
      ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone
      injectable suspension and its metabolites will also be evaluated when applicable.
    

Intervention name(s): DSP-1349M; placebo
Intervention type(s): Drug; Drug
Intervention description(s): DSP-1349M injectable; placebo injection
Other intervention name(s): lurasidone
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Condition: Neurodermatitis
MeSH terms: Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the efficacy of dupilumab on itch response in participants with prurigo
      nodularis (PN), inadequately controlled on topical prescription therapies or when those
      therapies are not advisable.

      Secondary Objectives:

      To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with
      PN, inadequately controlled on topical prescription therapies or when those therapies are not
      advisable.

      To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in
      health-related quality of life. To evaluate safety outcome measures. To evaluate
      immunogenicity of dupilumab.
    

Detailed description: 
      The duration of study for each participant included 2-4 weeks of screening period, 24 weeks
      of treatment period and 12 weeks of post treatment period.
    

Intervention name(s): Dupilumab SAR231893; Placebo; Moisturizers; Low to medium potent topical corticosteroids; Topical calcineurin inhibitors
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical
Intervention MeSH terms: Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether there is a drug-drug interaction between
      multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive
      containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin
      will also be assessed in healthy volunteers.
    

Detailed description: 
      This study will be an open-label (all volunteers and study staff know the identity of the
      assigned treatment), single-center, fixed-sequence study (all volunteers receive the same
      medication on the same days), to determine how canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics (ie,
      how the body affects the drug) of an oral contraceptive containing ethinyl estradiol and
      levonorgestrel. The study will consist of 3 phases; a screening phase, an open-label
      treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in
      the study for approximately 33 days.
    

Intervention name(s): Oral contraceptive; Canagliflozin (JNJ-28431754)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9.; One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
Other intervention name(s): Levora; JNJ-28431754
Intervention MeSH terms: Canagliflozin; Contraceptive Agents; Contraceptives, Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Contraceptives, Oral; Ethinyl Estradiol; Levonorgestrel; LEVORA
Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to investigate the effect of supplement containing L-arabinose and
      indigestible dextrin on dietary glycemic index.
    


Intervention name(s): L-arabinose and indigestible dextrin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum
Condition: Genu Valgum
MeSH terms: Genu Valgum
Study type: Observational

Summary: 
      Many patients with genu valgum present with postural changes, such as: internal rotation of
      the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis,
      thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere
      with lumbar range of motion. Investigators of this study try to answer the following
      question: is there a relationship between sacral angle and lumbar range of motion in women
      with bilateral genu valgum. the results of this study will help professionals to plan a
      proper treatment program for patients with genu valgum.
    

Detailed description: 
      Sixty four female participants were under the following procedures:

        -  Screening for genu valgum via postural assessment from frontal view, then measuring the
           Q angle bilaterally.

        -  Patients with Q-angle >20 degress were under the following procedures:

      A. Full-Length AP standing X-ray,then the investigators measured the hip-knee angle (the
      angle between the mechanical axis of the femur and the tibia). It will be obtained by
      connecting the center of the femoral head to the midpoint of the tibial eminential spine in a
      line tangential to the femoral condyles, and another line from here to the centre of the
      trochlea tali.

      B-Lumbo-sacral X-ray lateral view was done at the time and the sacral angle was the measured
      by Ferguson´s technique in degrees using a protractor and this was the sacral angle.

      C- During the same session, trunk range of motion was measured by Modified schober test D-
      Collected data were taken for statistical analysis.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female with bilateral genu valgum with age range 18-25 and BMI≥ 30 (kg/m2)
Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects.

      Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study

      Part 2: Single dose 2-way comparator PK Study
    


Intervention name(s): Tricaprilin; Tricaprilin; Placebo; Tricaprilin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1; Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1; Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1; Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1
Other intervention name(s): AC-SD-03; AC-LMP-01; AC-SD-03P; AC-1202
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bioimpedance and Arterial Distension
Condition: Hypertension
MeSH terms: Dilatation, Pathologic
Study type: Observational

Summary: 
      The overall objectives were to investigate if characteristic dimensions for tissue and
      vessels determined from measured bioimpedance spectra would provide the same values as
      dimensions determined from MR images of the upper arm and verify that temporal variations of
      impedances could be converted to blood pressure.
    

Detailed description: 
      It is emphasized that measurements of pulse wave velocity was not a part of this trial, which
      implies that only uncalibrated blood pressures could be measured. The specific objectives
      were:

        1. To determine conductivities and permittivities in the spectral region from 1 KHz to 1
           MHz for persons with: (a) a normal distribution of fat and muscles, (b) exceptionally
           thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat.
           Both sexes should be represented.

        2. To verify that temporal variations synchronous with the heartbeat could be measured on
           all three groups.

      Hypotheses:

      A. That experimentally in vivo determined electrical parameters for tissues would differ
      considerably from theoretical values and from values measured in vitro experiments.

      B. That the variations of the electrical parameters would exhibit little variation from
      person to person.

      C. Those simple experimental relations can be established for the electrical parameters by
      including a simple vascularization model.

      D. That it is possible to measure temporal variation of the impedance, which are synchronous
      with the heartbeat.

      E. That the measured values would facilitate the calculation of the differential blood
      pressure with accuracies better than 10 mmHg.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Equal number of females and males. Large variations of BMI Large variations of BP
      
Keywords: Impedance; Electrical; Tissue; Excitation frequency; arterial distension; distension wave form
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
Condition: Insomnia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and
      ethanol
    


Intervention name(s): Placebo ethanol; Ethanol; Placebo; Gabapentin; Ethanol; Placebo; Gabapentin; Placebo ethanol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint; Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint; Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint; Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint; Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint; Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint; Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint; Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
Intervention MeSH terms: Ethanol; Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment
Condition: Retinal Detachment; Proliferative Vitreoretinopathy
MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Dissociative Disorders
Study type: Interventional

Summary: 
      EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN
      PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL
      DETACHMENT
    

Detailed description: 
      After informed consent, children under 14 years of age with high-risk PRRD underwent pars
      plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in
      prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml)
      and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was
      occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best
      corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.
    

Intervention name(s): Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml).; After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group B received infusion of normal saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pediatric retinal detachment; proliferative vitreoretinopathy; 5-Fluorouracil; Low molecular weight heparin
Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain
Condition: Cold Exposure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Physiotherapy offers a range of therapeutic modalities for pain management including
      Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and
      Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS,
      CI and Acupuncture in a cold-induced pain model.
    


Intervention name(s): Transcutaneous Electric Nerve Stimulation; Interferential Current; Manual Acupuncture
Intervention type(s): Device; Device; Procedure
Intervention description(s): Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil); Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil); Manual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200
      mg on the single-dose pharmacokinetics of tadalafil 10 mg
    


Intervention name(s): Tadalafil; Tipranavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administered days 1, 8 and 16; administered days 8-18; administered days 8-18
Intervention MeSH terms: Ritonavir; Tipranavir; Tadalafil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses
      ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in
      patients with type 2 diabetes. Eligible patients will be those who have completed study
      BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will
      continue on the same treatment regimen (mono or combination therapy) as they received in the
      initial study. The anticipated time on study treatment is 3-12 months, and the target sample
      size is 100-500 individuals.
    


Intervention name(s): GK Activator (2); Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses bid; As prescribed, in patients who were in study BM18249
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rhinitis, Cognition and Driving Performance
Condition: Seasonal Allergic Rhinitis; Driving Ability; Cognition
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory
      functions. Our group has previously shown that patients suffering from AR symptoms perform
      less well on tasks requiring sustained attention compared to non symptomatic controls. Car
      driving is a typical behavior that is susceptible for changes in sustained attention and
      might therefore become worse under conditions when patients suffer from AR symptoms. We will
      compare the driving performance of untreated, symptomatic AR patients with the performance of
      symptomatic patients that have been treated with either a systemic AR medication (a pill) or
      a topical medication (nasal spray)
    


Intervention name(s): cetirizine 10 mg; fluticasone furoate; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): cetirizine 10 mg over encapsulated; nasal spray 25ug per dose; a placebo nasal spray and placebo capsule are available for double dummy treatment
Intervention MeSH terms: Fluticasone; Xhance; Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: driving, memory, cognition
Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet
      of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg
      tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty
      Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence,
      two-period, single-dose, crossover, bioavailability study comparing Cyclobenzaprine
      hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.)
      with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) manufactured by
      Merck & Co Inc., USA and distributed by McNeil Consumer & Speciality Pharmaceuticals, in
      healthy, adult, male, human subjects under fasting condition.

      Following an overnight fast of at least 10 hours, A single oral dose of one Cyclobenzaprine
      hydrochloride 10 mg tablet was administered with 240 mL of drinking water at ambient
      temperature during each period of the study under supervision of a trained Study Personnel.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study.

      A total of forty (40) subjects were enrolled in the study. Out of which thirty-four (34)
      subjects completed both the periods of the study.
    

Intervention name(s): Cyclobenzaprine hydrochloride 10 mg tablet
Intervention type(s): Drug
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Cyclobenzaprine hydrochloride 10 mg tablet fasting conditions
Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome
Condition: Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study looked at the role of cardiac CT in improving risk factor control in those with
      diabetes.
    

Detailed description: 
      This study examined whether doing a cardiac screening test, the cardiac CT, would result in
      patients paying more attention to controlling their risk factors.
    

Intervention name(s): Cardiac CT; Usual medical care
Intervention type(s): Diagnostic Test; Behavioral
Intervention description(s): A cardiac CT involves a non-invasive test of the coronary arteries.; Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
Other intervention name(s): Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research