bioihbjkbjnl/mcl2 huggingface dataset:
Diurnal Testosterone Concentration
Condition: Testosterone Deficiency
Study type: Observational

Summary: 
      In this case-controlled, observational study, 24 subjects will participate in a 12-hour blood
      collection with a single blood draw at +24 hours. 12 men will have low testosterone levels
      (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn
      every 2 hours and later analyzed for total testosterone and calculated free testosterone. The
      primary objective of this study is to assess the degree of diurnal variation in men with
      testosterone deficiency.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        24 male subjects (12 with TD and 12 without TD)
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of the new influenza
      vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)
      in children 6 to 35 months of age.
    

Detailed description: 
      The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to
      explore response to vaccination.
    

Intervention name(s): FluLaval® Quadrivalent; Fluzone®
Intervention type(s): Biological; Biological
Intervention description(s): 1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.; 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.
Other intervention name(s): GSK2282512A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Children; Immunogenicity; Fluzone®; 6 to 35 months of age; Seasonal influenza; Safety
Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses
      in current multifocal contact lens wearers with symptoms of end of day discomfort compared to
      their habitual multifocal contact lens correction.
    


Intervention name(s): Delefilcon A multifocal contact lenses; Habitual multifocal contact lenses
Intervention type(s): Device; Device
Intervention description(s): Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning); Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
Other intervention name(s): DAILIES TOTAL1® multifocal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myopia; presbyopia
Scleroderma Registry
Condition: Systemic Sclerosis; Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Observational

Summary: 
      Scleroderma is likely caused by a combination of factors, including an external trigger
      (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will
      conduct genetic analyses for disease-related genes in patients with scleroderma and their
      family members (parents, brothers, and sisters).
    

Detailed description: 
      Scleroderma refers to a group of diseases that involve the abnormal growth of connective
      tissue, which supports the skin and internal organs. Scleroderma can affect the skin, making
      it hard and tight; it can also damage the blood vessels and internal organs such as the
      heart, lungs, and kidneys. Estimates for the number of people in the United States with the
      systemic (body-wide) form of scleroderma range from 40,000 to 165,000. The number of people
      with all scleroderma-related disorders is between 250,000 and 992,500.

      Researchers believe that several factors interact to produce scleroderma, including abnormal
      immune activity, potential environmental triggers, and genetic makeup. Scleroderma is not
      passed on from parents to child, but certain genes may make a person more likely to develop
      the disease. The goals of this project are to identify the genes that influence disease
      susceptibility and expression in systemic scleroderma and to establish a repository of DNA,
      plasma, and serum samples from single case scleroderma families, multicase families, and
      healthy unrelated volunteers for the use of researchers interested in studying this disease.

      Participants in the Registry will have a phone interview regarding disease characteristics
      and family history. Participants will be sent a blood kit to get a blood sample drawn locally
      for shipment to the Registry lab. Blood samples will be made available (anonymously) for
      studies by researchers around the country. In some cases, participants will be asked to sign
      a release of medical information so that medical records can be obtained to verify the
      diagnosis.

      As of May 2009, this study is no longer enrolling family members.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Systemic Sclerosis or family member of patients with systemic
        sclerosis

        or

        Healthy volunteer with no autoimmune disease and without a first degree relative with a
        systemic autoimmune disease.
      
Biospecimen description: 
      Serum, Plasma, DNA
    
Keywords: Genetic Study; Transmission Dysequilibrium Testing; Genome Wide Scan; Family Study
A Study to Assess the Effect of SB 659032 on Platelet Function
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single dose, single period study. Approximately 14 subjects will
      receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.
      This study will evaluate whether SB-659032 has an effect on platelet function as determined
      by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK
      analysis and measurement of Lp-PLA2 activity will also be collected
    


Intervention name(s): SB659032
Intervention type(s): Drug
Intervention description(s): single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: platelet function; atherosclerosis,; SB-659032
Prone-position CT for Diagnosing Inguinal Hernia
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Background: The aim of this study was to investigate the efficacy of prone-position computed
      tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT
      before laparoscopic inguinal hernia repair.

      Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal
      preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients
      diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine
      and prone positions for preoperative assessment. The anatomy of the right and left inguinal
      regions was confirmed during the surgery and compared with the preoperative CT findings.
    


Intervention name(s): supine- and prone-position Computed Tomography
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Condition: Epilepsy; Generalized Tonic-Clonic Seizures
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      Prospective study of an electromyography (EMG) based seizure detection and warning system for
      detecting generalized tonic-clonic (GTC) seizures.
    

Detailed description: 
      This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a
      Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal,
      prospective study of an electromyography (EMG) based seizure detection and warning system
      (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized
      tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is
      intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure
      activity. This is to facilitate a faster intervention to the GTC seizure, and to more
      accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.
    

Intervention name(s): Brain Sentinel Seizure Detection and Warning System
Intervention type(s): Device
Intervention description(s): The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
Other intervention name(s): SPEAC System
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and Adults with GTC seizures, either primary GTC or partial onset seizures with
        secondary generalization
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
Condition: Children; Under-nutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess compliance with dietary recommendations, in conjunction with a
      nutritional supplement to meet the nutritional requirements in children and the effects of
      the compliance on promoting growth in children who are at risk of under-nutrition.
    

Detailed description: 
      This study will assess compliance with dietary recommendations, in conjunction with an oral
      nutritional supplement to meet the nutritional requirements in children older than 36 (>36)
      to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting
      catch-up growth and normal healthy growth in children who are at risk of under-nutrition.
    

Intervention name(s): nutritional supplement
Intervention type(s): Other
Intervention description(s): 2 servings per day
Other intervention name(s): Pediasure S229
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures
Condition: Forearm Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Comparing the rate of complications between buried and exposed intramedullary implants after
      fixation of pediatric forearm fractures.
    

Detailed description: 
      comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm
      fracture in rate of complications such as infection,malunion,nonunion and refracture.
    

Intervention name(s): buried intramedullary K-wire; exposed intramedullary K-wire
Intervention type(s): Device; Device
Intervention description(s): Using of buried kirschner wire in pediatric forearm fixation; Using of exposed kirschner wire in pediatric forearm fixation
Other intervention name(s): buried intramedullary kirschner wire; exposed intramedullary kirschner wire
Intervention model: Single Group Assignment
Intervention model description: Using of buried and exposed intramedullary k-wire in pediatric forearm fixation.
Masking: None (Open Label)
Primary purpose: Screening
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of
      the product Dermacyd PHDETINBACK Sweet Flower.
    


Intervention name(s): Dermacyd PH_DETINBACK (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Duloxetine - Warfarin Pharmacodynamic Study
Condition: Anticoagulant Effect of Warfarin When Taken With Duloxetine.
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the blood clotting effects of multiple doses of warfarin at steady state when
      taken at the same time as multiple doses of duloxetine as measured by changes in the
      International Normalised Ratio. All subjects will begin dosing with warfarin, then after
      approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either
      continue dosing at 60 mg or have a dose increase to 120 mg.
    


Intervention name(s): Duloxetine; Warfarin
Intervention type(s): Drug; Drug
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Warfarin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess
      safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is
      given at the same dose 7 days apart, and the impact this medication has on various substances
      in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of
      any side effects.
    


Intervention name(s): GSK716155 subcutaneous injections; placebo injection
Intervention type(s): Drug; Biological
Intervention description(s): albiglutide subcutaneous injection; placebo injection
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GSK716155; albiglutide; pharmacodynamics; pharmacokinetics
Indomethacin Use in Pain Relief During Intrauterine Device Insertion
Condition: Family Planning
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the investigators study is to test the analgesic effect of rectal indomethacin
      during Intrauterine device insertion.
    


Intervention name(s): indomethacin suppositories; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure; The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Epidemiological Study of Quality of Life in Osteopathy
Condition: Muscle Skeletal Disorders
Study type: Interventional

Summary: 
      Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life
      in a large sample of naive patients undergoing osteopathic manipulative treatment.
    


Intervention name(s): Osteopathic Manipulative Treatment
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic manipulative treatment; muscle-skeletal disorder; quality of life
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
Condition: Peripheral Neuropathy; Antineoplastic Combined Chemotherapy Protocols
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain
      in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with
      cancer.
    

Detailed description: 
      To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of
      chemotherapy-induced neuropathic pain.

      This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID
      in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A
      pretreatment phase and a treatment phase.
    

Intervention name(s): Cesamet™ (nabilone)
Intervention type(s): Drug
Intervention MeSH terms: Nabilone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy-induced; neuropathy; cancer
A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix
Condition: Squamous Cell Carcinoma of Cervix
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare two different brachytherapy treatment option in
      locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is
      effective in locoregional control and more convenient in terms of cost and time than 7 Gy
      brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.
    

Detailed description: 
      Cervical cancer is the second most common cancer among women worldwide and is the commonest
      form of gynecolgic malignancy in Bangladesh.Radiotherapy in the form of external beam
      radiotherapy combined with intracavitary Brachytherapy is the accepted definitive mode of
      treatment.Limiting the number of high dose rate(HDR) Brachytherapy has the potential benefit
      of improving patient compliance and reducing treatment cost and duration.The aim of this
      study is to compare the treatment outcome and acute complications following treatment with 9
      Gray (Gy) in two fractions of brachytherapy with standard EBRT in locally advanced carcinoma
      of cervix.

      EBRT will be delivered by a cobalt 60 teletherapy unit to a prescribed dose of 50 Gy in 25
      fractions of 2 Gy per fraction and 5 days a week over a period of 5 weeks concurrent with
      inj. Cisplatin 40 mg/meter square weekly for 5 weeks.The patients will be then randomised
      into two arms of HDR brachytherapy,either 9Gy in 2 fractions or 7 Gy in 3 fractions.All
      patients will be followed up as per guideline for 6 months.The treatment related toxicity
      will be measured by Common Toxicity Criteria(Common terminology criteria for adverse events
      v.3.0).

      All the relevant collected data will be compiled on a master chart and then statistical
      analysis of the results will be obtained by using SPSS 17.The data will be analysed using Chi
      square test and T test.Significant value will be decided at a level of 0.05 in two tailed
      tests.
    

Intervention name(s): HDR Brachytherapy of 9 Gy in 2 fractions; HDR Brachytherapy of 7 Gy in 3 fractions
Intervention type(s): Radiation; Radiation
Intervention description(s): Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix; Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Carcinoma cervix; RCT(randomised controlled trial); 9 Gray; Brachytherapy
A Trial of Echinacea in Children
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized trial to determine if echinacea is effective in shortening the length
      and/or lessening the severity of colds in children 2 through 11 years old.
    

Detailed description: 
      Upper respiratory tract infections (URI's) are a significant health burden in childhood.
      URI's are a major reason for visits to health care providers, and up to 35 percent of young
      children at any given time are taking some over-the-counter cold medication. Unfortunately,
      data suggest that most of these medications have limited effectiveness. Alternative medical
      therapies are growing in popularity; in a recent survey of parents of children being seen by
      pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen
      by an alternative medicine health care provider, and 53.3 percent received therapies for the
      treatment of URI's in children. The proposed study is a randomized, double blind, placebo
      controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims
      of the project are: to determine if Echinacea shortens the duration and/or lessens the
      severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate
      of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11
      years old is associated with any significant side effects. A two-year study of 600 children
      is planned. Not only will the results of this study determine if Echinacea, the most popular
      medicinal herb sold in the United States, is an effective therapy for URI's in children, the
      study will provide a design framework for further assessment on the efficacy of other
      complementary and alternative medicines in children.
    

Intervention name(s): Echinacea
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment