bioihbjkbjnl/mcl2 huggingface dataset:
Abuse Potential Study of PF-00345439
Condition: Opioid Users
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the relative abuse potential of intact and chewed PF-00345439
      (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release
      (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.
    


Intervention name(s): Capsule; PF-00345439; PF-00345439; oxycodone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Taken once; 40 mg capsule swallowed whole, taken once; 40 mg capsule chewed, taken once; 40 mg solution, taken once
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Abuse potential; PF-00345439; drug abuse
Identification and Semi -Quantification of ER/PR Proteins Expression
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is the identification and quantification of proteins expression
      level in breast cancer tissues.

      The imaging system is intended for diagnostic use as an aid to the pathologist in the
      detection, counting and classifying ER/PR IHC stained samples.
    

Detailed description: 
      The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the
      progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human
      breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the
      assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the
      antibodies that offer direct visualization and semi-quantification of the protein expression
      through a brightfield microscope, the GenASIs GoPath system is designed to complement the
      routine workflow of the pathologist in the review of immunohistochemically stained histologic
      slides.
    

Intervention name(s): Breast Cancer patient; Cancer patients
Intervention type(s): Procedure; Procedure
Intervention description(s): Samples; Samples
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Breast cancer patients
      
Keywords: Immunohistochemical (IHC); ER/PR; Breast cancer
Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic
      effects of aspirin administered intravenously with aspirin administered orally.
    


Intervention name(s): Rho-11; aspirin 325mg
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered 325 mg aspirin by rapid IV push; Subjects will be administered 325 mg aspirin orally
Other intervention name(s): Intravenous aspirin
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Condition: Jet Lag Disorder
MeSH terms: Jet Lag Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With
      Jet Lag Disorder
    


Intervention name(s): Tasimelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule; capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety of SB-656933 following repeat dosing for 14 days.
    

Detailed description: 
      A randomised, double-blind, placebo controlled, dose ascending, parallel group study to
      evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of
      SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic
      interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also
      be assessed.
    

Intervention name(s): SB-656933-AAA; Matching placebo; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.; SB-656933-AAA matching placebo tablets will be administered orally.; Simvastatin will be provided as a 40 mg tablet.
Other intervention name(s): SB-656933
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: COPD,; CD11b,; CXCR2,; safety,; repeat dose,; tolerability.; SB-656933,
A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study involves GLQ223 administration to patients who have not previously been exposed to
      it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will
      include survival, opportunistic infections, T4 cell count, and assessments of viral load.
    

Detailed description: 
      The study will involve the randomization of patients with 200-500 T4 cells and AIDS or ARC to
      one of three treatment arms: zidovudine alone, GLQ223 alone, or GLQ223 plus zidovudine.
      Patients randomized to receive GLQ223 will receive an infusion every three weeks for 45
      weeks.
    

Intervention name(s): Trichosanthin; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Trichosanthin
Allocation: Randomized
Primary purpose: Treatment
Keywords: Trichosanthin; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; Zidovudine
Myofascial Release in Shoulder Pathologies
Condition: Humerus Fracture; Rotator Cuff Injuries
MeSH terms: Humeral Fractures; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Shoulder pathology has a high prevalence in the field of musculoskeletal diagnoses, as well
      as being a common etiology in cases of disability. Passive and active-assisted kinesitherapy
      are used in the physiotherapy protocol. These techniques sometimes lead to feedback of fear
      and increased sensation of pain on the part of the patient that can slow or hinder the
      optimal recovery. A randomized clinical trial is intended to demonstrate that techniques for
      myofascial release of muscles important in the biomechanics of the shoulder, it is more
      effective than kinesitherapy in improving myofascial and also by eliminating the
      aforementioned unwanted effects and, therefore, improving the recovery of these processes.
    

Detailed description: 
      The purpose of this study was to compare the efficacy of myofascial therapy and kinesitherapy
      in improving function in shoulder pathology with prolonged immobilization. Design
      Prospective, single-blind randomized controlled trial. Setting Inpatient department of a
      secondary university hospital. Participants Shoulder pain patients (N=44) were consecutively
      recruited and randomly assigned to an intervention or control group. Interventions Patients
      were randomly assigned to a Control Group, to which conventional kinesitherapy was applied,
      or to the intervention group to which a Myofascial therapy protocol was applied. Both groups
      completed a therapeutic exercise program based on specific mobilization and strengthening
      exercises. Main Outcome Measures The QuickDash questionnaire was the primary outcome, visual
      analog scale and the passive range of motion of the shoulder joint, grades were the secondary
      outcomes. The outcomes were evaluated at baseline (T0) and at 4 (T2),
    

Intervention name(s): Treatment
Intervention type(s): Other
Intervention description(s): Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled longitudinal experimental study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder; Pathology; Myofascial release; Clinical trial
Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
Condition: Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      The aim of the study is to determine the factors affecting the bioavailability of iron and
      folic acid during the simultaneous use of iron supplements and folic acid supplements in
      non-pregnant women of childbearing age.
    

Detailed description: 
      Scientists in the field of nutrition and gynecology and obstetrics have been paying attention
      to the need of use iron and folate supplements in women of childbearing age. Increased intake
      of micronutrients in the diet or the use of supplementation does not always bring the
      expected results, what depends on factors that affect the bioavailability of minerals and
      vitamins. On the one hand these factors are related to the properties of food intake, e.g. to
      the presence of other nutrients that can increase or decrease the absorption of folates and
      iron (eg vitamin C, phytates), and on the other hand the functioning of the body itself,
      which to a certain extent is determined by genetic factors (e.g., genetically determined
      reduced activity of methylenetetrahydrofolate reductase [MTHFR], which reduces the
      bioavailability of folic acid).

      The study aims:

        -  assessment of the effect of simultaneous supplementation with iron and folate on:

             -  parameters of the iron metabolism

             -  parameters of the folate metabolism

        -  the estimation of gene polymorphisms encoding proteins transporting iron and folate

        -  obtaining information whether the polymorphism of genes encoding proteins transporting
           iron and folate is related to the effectiveness of the iron and folic acid
           supplementation used in non-pregnant women of childbearing age.

      In 200 non-pregnant women of childbearing age a blood level of iron and folic acid will be
      determined. Subjects with low level of blood iron and folic acid will be supplemented with
      oral iron and folic acid for 3 months. Subjects with proper level of blood iron and folic
      acid will be a control group. At baseline and at completion of the study (after 3 months)
      fasting blood will be collected and abovementioned parameters will be estimated.
    

Intervention name(s): Folic acid and iron supplementation; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months; Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
Intervention MeSH terms: Folic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: iron; folate; childbearing age; bioavailability
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month
      formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse
      of the symptoms of schizophrenia.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double blind (neither physician
      nor patient knows the treatment that the patient receives), parallel group (each group of
      patients will be treated at the same time), placebo-controlled (an inactive substance is
      compared with a drug to test whether the drug has a real effect in a clinical trial)
      multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a
      17-week flexible dose open-label Transition Phase (open-label phase means that all people
      know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase;
      and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase
      (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria
      will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1
      ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of
      variable duration; patients will remain in the study until they experience a relapse event or
      meet discontinuation criteria.
    

Intervention name(s): PP3M 175 mg eq.; PP3M 263 mg eq.; PP3M 350 mg eq.; PP3M 525 mg eq.; Placebo (20% Intralipid emulsion)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; R092670; Paliperidone Palmitate; Paliperidone palmitate 3 month formulation (PP3M)
Atomoxetine, Placebo and Parent Management Training in Autism
Condition: Autism; Pervasive Development Disorder; Asperger's Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Asperger Syndrome; Child Development Disorders, Pervasive; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent
      Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive
      Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention
      Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where
      the atomoxetine will have a dose titration over a 6 week period. All children will be seen
      weekly during this titration period, with additional visits at Week 8 and Week 10. Families
      assigned to the PMT arm will have an additional weekly meeting with a clinician for a total
      of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with
      their children. Subjects who are clinical responders (ADHD Responders and Compliance
      Responders) from the 10 week study period will be followed every 4 weeks in a 24-week
      extension study. Subjects who are clinical nonresponders will continue in PMT if they
      received PMT during the double-blind phase, and they will receive an open trial of
      atomoxetine if they were on placebo during the double-blind phase. All subjects (responders
      and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for
      24 weeks after the completion of the double-blind phase.
    


Intervention name(s): atomoxetine; Placebo; Parent Management Training
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): atomoxetine; Placebo + parent management treatment
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; PDD NOS; Attention Deficit Hyperactivity Disorder; Parent Management Training
Decrease in Temperature as a Pagtonomic Sign by Scorpion Sting
Condition: Scorpion Stings
MeSH terms: Bites and Stings; Scorpion Stings
Study type: Observational

Summary: 
      The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes
      patients do not know the animal that causes these symptoms; the bibliography marks the
      decrease in temperature as a sign to be presented.
    

Detailed description: 
      The scorpion sting is a medical emergency where 184 patients from the state of Guanajuato
      were divided into 2 groups according to the type of antivenom administered, the dose of
      antivenom were at the discretion of the attending physician, Birmex (n = 117) and Alacramyn
      (n = 67) for the temperature record of the site of sting and other vital signs, this to
      compare it with the bibliography as a pathognomonic sign.
    

Intervention name(s): Vital signs
Intervention type(s): Diagnostic Test
Intervention description(s): Axillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Person who has been scorpion sting and present signs and symptoms of poisoning to will
        applied a treatment in the city of León, Guanajuato
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will perform a randomised controlled trial of the provision of food
      designed for rehabilitation of malnourished children that is supplemented with n-3 fatty
      acids compared to usual composition. The investigators want to see whether the provision of
      such a food normalises the deficiencies in essential fatty acids observed in severely
      malnourished children faster than standard composition.
    

Detailed description: 
      Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for
      Severe Malnutrition.

      Description of Study Design: Randomized Controlled Trial

      Study Duration: 6 months (Trial); 12 months (All trial-related activities)

      Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed
      oil, with or without fish oil, compared to conventional-composition RUTF. Interventional
      product will be given until nutritional recovery to a maximum of 12 weeks.

      Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil
      allocation is randomised within those receiving flax-enriched RUTF and is open label.

      Location: Kilifi District, coastal Kenya.
    

Intervention name(s): RUTF/Flax Oil; RUTF/Flax Oil plus additional Fish Oil; Standard RUTF
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ready to Use Therapeutic Food; Ready to Use Therapeutic Food; Standard formulation RUTF given according to National Guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Essential Fatty Acid; Seed oil; Fish oil; Dietary deficiency
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects
Condition: Phase 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human
      (FIH), sequential single ascending dose (SAD) study.
    

Detailed description: 
      GBS-101 is a single center Phase 1, placebo-controlled, randomized, double blind,
      first-in-human (FIH), sequential single ascending dose (SAD) study to evaluate the safety,
      tolerability and PK of GV101 in healthy subjects. 8 healthy subjects wills be enrolled
      cohorts 5 - 7 cohorts of the study. Cohorts 1-4 were previously completed with a tablet form
      of the study drug at 50 mg, 100 mg, 200 mg, and 400 mg. Planned cohorts 5 - 7 will be dosed
      400 mg (liquid), 800 mg (liquid), 1600 mg (liquid) or matched placebo.. Participants will be
      randomized in a 3:1 ratio, 1:1 for 2 sentinel subjects and 5: 1 GV101 drug to matching
      placebo thereafter. Subjects in each cohort will receive a single oral dose of GV101 or
      matching placebo under fasting conditions. A staggered schedule will be used for each dose
      level, where 2 sentinel subjects (1 active and 1 placebo) will be dosed first, with the
      remaining 6 subjects (5 active and 1 placebo) dosed at least 24 hours after the sentinel
      subjects.

      This study of GV101 will provide safety, tolerability, and plasma pharmacokinetic data in
      healthy individuals. The PK component will characterize the PK of GV101 to inform dosing and
      may help to correlate exposures treatment-related AEs.
    

Intervention name(s): GV101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GV101 administered once orally.; Matched placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 3:1 GV101 (study drug) to placebo. (1:1 for sentinel 2 subjects and 5:1 thereafter)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Adult; Volunteers