bioihbjkbjnl/mcl2 huggingface dataset:
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety,
      and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
    

Detailed description: 
      This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be
      conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis.
      After obtaining informed consent, subjects will be randomized to active or vehicle treatment
      arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all
      affected areas of psoriasis on the trunk and/or extremities for 4 weeks.
    

Intervention name(s): SB414 6%; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily; Vehicle Comparator
Other intervention name(s): NVN1000; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess
      the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg)
      and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal
      allergic rhinitis.
    


Intervention name(s): GSK835726 10mg; GSK1004723 1000mcg; Cetirizine 10mg; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK835726 10mg tablet; GSK1004723 1000mcg nasal spray solution; Cetirizine 10mg active comparator; placebo to match actives
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Proof of concept
Motivational Interviews for Incarcerated Teens - 1
Condition: Alcoholic Intoxication; Marijuana Abuse
MeSH terms: Marijuana Abuse; Alcoholic Intoxication
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of an individual motivational interview for
      reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in
      incarcerated teens.
    

Detailed description: 
      The objective of this research is to investigate ways to enhance motivation for treatment and
      effectively reduce substance abuse among juvenile offenders. Motivational intervention (MI)
      as preparation for residential treatment and for persons (including teens) with little
      motivation to change has been effective in reducing substance abuse. Thus, MI designed for
      delinquent youths who are required to attend substance abuse treatment may prove efficacious.

      In this proposed randomized trial, a one-way design (MI + Standard Care [SC] v. Attention
      Control [AC] + SC) will be used to determine whether MI enhances subsequent treatment
      participation and reduces substance-related problems post discharge in substance using,
      delinquent youths. Teens will also receive a booster session of MI or AC prior to discharge.
      Primary outcome variables include alcohol and marijuana use, as well as related behaviors
      (illegal activity, sex or injuries while drunk or high). It is hypothesized that in
      comparison to teens receiving AC, youths receiving MI will participate more (by therapist and
      teen ratings) in SC and will show the lowest levels of heavy substance use and related
      problems after discharge. It is hypothesized that these effects will be mediated by stage of
      change, drug effect expectancies and self-efficacy.

      This study will extend previous research by evaluating the use of MI with substance abusing
      teens in a correctional facility, and by expanding outcome measures to include alcohol and
      marijuana-related risk behavior (such as injuries and illegal activity when drunk or high) in
      this population. The development of effective interventions for substance using juvenile
      offenders has the potential to reduce substance abuse and crime in this population.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: alcohol, marijuana
A Study for Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily
      injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections)
      on lowering the blood sugar level
    


Intervention name(s): Insulin lispro low mixture; Insulin glargine; Insulin lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.; Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks; Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Other intervention name(s): LY275585[P]; LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Observational

Summary: 
      Aim of the project is to validate and functionally characterize the combined impact of
      candidate genes and stress exposure on drinking in adolescents. Lifetime and recent stress
      experiences and drinking are recorded in a sample of healthy young adults who are genotyped
      for polymorphisms in candidate genes related to alcoholism. All participants undergo a
      standard laboratory psychosocial stress test. Our hypothesis is that specific genes can be
      identified which influence drinking by modulating stress response.
    


Intervention name(s): Trier Social Stress Test
Intervention type(s): Behavioral
Observational model: Defined Population
Time perspective: Other
Keywords: Alcoholism; Risk factors; Adolescence; Stress test; HPA system; Family adversity; Candidate genes; Cortisol; Adrenocorticotrophin
Single Dose Study of SHR4640 in Healthy Subjects
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic
      and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
    


Intervention name(s): SHR4640; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: urate transporter 1; SHR4640; single ascending dose; pharmacokinetics; pharmacodynamics
Study of Tolerance to Oral Peanut
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy
    

Detailed description: 
      Background Peanut allergy is severe and rarely resolves.

      Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut
      allergy.

      Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be
      administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5
      peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30
      weeks maintenance.
    

Intervention name(s): Peanut oral immunotherapy
Intervention type(s): Dietary Supplement
Intervention description(s): Daily doses of peanut flour
Other intervention name(s): Daily doses peanut flour
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peanut; food allergy; anaphylaxis; immunotherapy
Injury Prevention Among Conscripts
Condition: Back Problems and Other Musculoskeletal Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to study the effect of neuromuscular training program
      and regular safety counselling on the risk of musculoskeletal injuries in adolescent
      conscripts.

      800 voluntary participants are recruited from the four army companies in western Finland
      during the years 2007 and 2008.
    


Intervention name(s): physical training and counselling
Intervention type(s): Other
Intervention description(s): Neuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: low back pain; physical fitness; injury; prevention; conscripts
Time-Restricted Eating and Muscle Hypertrophy
Condition: Muscle Hypertrophy; Healthy and Well-Trained Men and Women
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The purpose is to examine the effects of time-restricted eating (TRE; consuming all calories
      within an 8-hour period each day) vs. normal eating (CON; consuming same kcals and protein as
      TRE, but during a 10-13 hr eating window each day) during 8 weeks of resistance exercise on
      body composition and muscle mass (whole muscle and single fiber), muscular performance,
      anabolic protein signaling, single muscle fiber characteristics, and the gut microbiome in
      well-trained young men and women.
    

Detailed description: 
      The primary goal pertains to muscle hypertrophy (not fat loss), thus all participants will be
      placed in a 10% caloric surplus.
    

Intervention name(s): Time Restricted Eating; Normal Feeding; Resistance Training; Whey Protein
Intervention type(s): Other; Other; Other; Dietary Supplement
Intervention description(s): Diet will be tracked and reported every day to a qualified dietitian.; Diet will be tracked and reported every day to a qualified dietitian.; 8 weeks of supervised and programmed whole body resistance training, performed 4x per week; Consumed on all exercise days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Hypertrophy; Intermittent Fasting; Time Restricted Eating; Protein Signaling; Anabolic
Phase 3 Alogliptin Pediatric Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg)
      once daily compared to placebo when administered as monotherapy, or when added onto a
      background of metformin alone, insulin alone, or a combination of metformin and insulin, as
      measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric
      participants with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat
      children 10 to 17 years of age who have T2DM and are experiencing inadequate glycemic
      control. This study will look at HbA1c fluctuations in children who take alogliptin in
      addition to their background antidiabetic therapy.

      The study will enroll approximately 150 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Alogliptin 25 mg

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the tablet containing
           alogliptin 25 mg but has no active ingredient (that is, has no alogliptin).

      All participants will be asked to take one tablet at the same time each day throughout the
      study in addition to their current background antidiabetic therapy (metformin and/or insulin)
      if applicable.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is approximately 56 weeks. Participants will make multiple visits to the clinic, and
      will be contacted by telephone 2 weeks after the last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Alogliptin Benzoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alogliptin benzoate tablets.; Alogliptin placebo-matching tablets.
Other intervention name(s): SYR-322; Nesina; Vipidia
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Condition: Obstetric Labour, Premature
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 2

Summary: 
      Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity
      and mortality and is frequently associated with long-term disability. Oxytocin is a hormone
      produced by the body during labor. GSK221149A is an experimental drug that will be used to
      block the effects of oxytocin, and therefore pause or prevent contractions. In this study,
      patients with preterm labor will be given an intravenous infusion of GSK221149A over
      approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study,
      patients with preterm labor will be give an intravenous infusion of GSK221149A over
      approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously
      and to investigate the pharmacokinetics of GSK221149A administered orally to healthy,
      pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation
    

Intervention name(s): GSK221149A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6mg/h and 12 mg/h; Matched Placebo to Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Premature Labor; Pre Term Labor; intravenous; fetal fibronectin
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship
Condition: Cervicobrachial Neuralgia
MeSH terms: Neuralgia; Brachial Plexus Neuritis
Study type: Interventional

Summary: 
      Study Design: Longitudinal Experimental Study

      Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and
      cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing
      model based on Least Square Approximation.

      Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and
      brachial plexus displacement within their interface structures. No studies were conducted
      about ULNTT1 and cervico-thoracic spine motion patterns relationship.

      Methods: 12 subjects with ULNTT1 asymmetry > 10° (AS group) and 11 subjects with ULNTT1
      symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be
      analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one
      patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be
      collected with motion-capturing technique and data will be analyzed with Least Square
      Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will
      undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility
      will be so re-evaluated with same methods.
    


Intervention name(s): Spinal Manipulation
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neurodynamics
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Total knee replacement is associated with severe post-operative pain. The purpose of this
      study is to compare two methods of treatment for pain control following Total Knee
      Replacement with an accelerated physical therapy protocol to aid the achievement of rehab
      milestones.
    

Detailed description: 
      A total of 106 patients undergoing total knee arthroplasty will be randomized into two
      groups: one to receive only Periarticular injections and the other periarticular injections
      AND adductor canal block.

      Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48
      hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24
      and 48 hours.

      Time to reach discharge criteria based on physical therapy assessments will also be measured.
    

Intervention name(s): Bupivacaine; Morphine; Methylprednisolone; Cefazolin; Normal saline; Midazolam; Propofol; Dexamethasone; 8 MHz. Chiba needle, 22 G / 4 inches
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Device
Intervention MeSH terms: Cefazolin; Dexamethasone; Methylprednisolone; Midazolam; Morphine; Bupivacaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nerve Block; Rehabilitation; Knee Replacement, Total
Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter
      sensors and compared against the hemoglobin measurement from the subject's blood sample under
      controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the
      device's 8-17 g/dL specification range.

      The purpose of the study was to evaluate a change in the sensor component and to assess
      performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not
      uniform across the accuracy range.
    


Intervention name(s): Rainbow DCI and R1-25 sensor
Intervention type(s): Device
Intervention description(s): Noninvasive Measurement of SpHb
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Performance of Two Silicone Hydrogel Toric Contact Lenses
Condition: Vision Correction
Study type: Interventional

Summary: 
      Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked
      (subject), daily wear, randomized, bilateral, parallel group study.
    


Intervention name(s): senofilcon A toric; balafilcon A toric
Intervention type(s): Device; Device
Intervention description(s): silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement); silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Other intervention name(s): ACUVUE OASYS; PureVision Toric
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: toric contact lenses; vision; comfort; toric fit characteristics; slit lamp findings
Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism
Condition: Graves Disease
MeSH terms: Graves Disease; Hyperthyroidism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether higher doses of radioiodine increase
      treatment efficacy in severe Graves' disease.
    

Detailed description: 
      Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women
      aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the
      treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is
      considered a first line therapy in the United States. However, treatment failure occurs in
      about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of
      radioiodine usually present severe hyperthyroidism, characterized by large goiter, high
      24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have
      previously shown that large goiter (≥48ml) is an independent predictor of treatment failure.
      In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter
      was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of
      radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between
      radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no
      published studies evaluating cure rates with different radioiodine doses in severe GD.
    

Intervention name(s): Radioiodine; Radioiodine
Intervention type(s): Radiation; Radiation
Intervention description(s): A unique dose of 200µCi of ¹³¹I/ml/24-RAIU; A unique dose of 250µCi of ¹³¹I/ml/24-RAIU
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graves Disease; Hyperthyroidism; Radioiodine; Clinical trial