bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
Condition: Tuberculosis; Tuberculosis Vaccines
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the protective efficacy of two doses of GSK
      Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy
      will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because
      pulmonary TB occurs frequently in these countries and age range. In addition, the safety and
      immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of
      volunteers.
    

Detailed description: 
      Case Definitions:

      • First case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
      complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert
      MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB
      diagnosis.

      • Second case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
      complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert
      MTB/RIF and confirmed HIV-negative at the time of TB diagnosis.

      • Third case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
      complex identified from a sputum specimen, taken up to four weeks after initiation of TB
      treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the
      time of TB diagnosis.

      • Fourth case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
      complex identified from a sputum specimen, taken up to four weeks after initiation of TB
      treatment, by Xpert MTB/RIF and/or microbiological culture.

      • Fifth case definition: A subject for whom a clinician has diagnosed TB disease and has
      decided to treat the patient with TB treatment.
    

Intervention name(s): GSK Biologicals' investigational TB vaccine (GSK692342); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses administered intramuscularly in the deltoid region of the arm.; 2 doses administered intramuscularly in the deltoid region of the arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Positive Interferon-γ release assay; Efficacy; Adults; Tuberculosis vaccine; Endemic region
A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible
      dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A
      binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male
      volunteers.
    

Detailed description: 
      This will be an open-label (volunteers and study staff will know the identity of assigned
      treatment), dose-ranging study to determine 5-HT2A receptor engagement by JNJ-40411813 as a
      function of dose and time in healthy male volunteers. The study will consist of an
      eligibility screening examination, an open-label treatment period and a follow-up examination
      (approximately 10 days after dose administration, a follow-up examination will be performed).
      Initially, 4 volunteers (Cohort 1) will be included to determine 5-HT2A receptor occupancy
      following single dose administration of JNJ-40411813. Dependent on the results, doses for the
      remaining 8 volunteers (Cohort 2 and 3) will be selected to further characterize 5-HT2A
      receptor occupancy within the feasible dose range up to maximally 700 mg JNJ-40411813.The
      maximal study duration for a volunteer will be 6 weeks. In this study, [11C]-MDL 100,907 will
      be used as positron emission tomography (PET) ligand to investigate the concentration-related
      binding of 40411813 to the 5-HT2A receptor in the brain. JNJ-40411813 (200 mg to 700 mg) will
      be taken orally (by mouth). If multiple capsules have to be taken, the actual intake may be
      spread over a 15-minute period. Study drug will be administered to each volunteer just after
      completion of a meal and within 30 minutes after the start of the meal.
    

Intervention name(s): JNJ-40411813; JNJ-40411813
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: Type=2 to 3, unit=mg, number=200 to 300, form=capsule, route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.; Cohort 2: Type=up to 7, unit=mg, number=up to 700 mg, form=capsule, route=oral use. Capsule(s) taken in the fed state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: JNJ-40411813; Positron Emission Tomography (PET); Serotonin-2A (5-HT2A) receptor antagonist; Male Volunteers
Colorado Adult Joint Assessment Scale (CAJAS) Validation
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment
      Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a
      population of adults with moderate to severe hemophilia A treated with coagulation factor
      VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.
    


Intervention name(s): Colorado Adult Joint Assessment Evaluation
Intervention type(s): Other
Intervention description(s): Physical evaluation of 6 joints, ankles, knees and elbows
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Hemophilia
Changes in mRNA Expression Following Exposure to Naproxen
Condition: Healthy
Study type: Interventional

Summary: 
      Using tissue samples obtained from a previous study, the effect of naproxen on the gene
      expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will
      be distinct changes in the gene expression profiles of samples taken from individuals treated
      with naproxen versus samples taken from individuals treated with placebo.
    

Detailed description: 
      We will use microarray technology to quantify the transcriptome-wide changes in gene
      expression in said-samples.
    

Intervention name(s): Naproxen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg naproxen, twice daily for 7 days; 1 tab,twice a day for a seven days
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a single blind, randomized controlled trail. condition/disease: acute low back
      pain treatment/intervention: motion style acupuncture treatment
    

Detailed description: 
      "Motion Style Acupuncture Treatment(MSAT)" is a therapeutic technique using acupuncture
      needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain
      to move the part of their body actively during acupuncture treatment under physicians'
      observation. This treatment is known to relieve the pain and increase the range of
      motion(ROM). However, there has been no specific value for the effect of this treatment.

      So, the investigators will conduct a randomized controlled trials to verify the efficacy and
      safety of Lumbar MSAT. From March 2021 to December 2021, the investigators will collect 96
      inpatients who are suffered from Low back pain with the numeric rating scale(NRS) over 5
      after injury by acute traffic accident(TA). For experimental group(n=48), the investigators
      will conduct MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean
      medical treatment. For control group(n=48), just Korean medical treatment except MSAT will be
      conducted. For these two groups, the investigators will compare NRS, Visual Analogue
      Scale(VAS), Range Of Motion(ROM), Oswestry Disability Index (ODI) and EuroQol 5-Dimension
      (EQ-5D), Patient Global Impression of Change (PGIC)."
    

Intervention name(s): Lumbar motion style acupuncture treatment; Korean medical treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation; acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump
Condition: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). This is an in-patient trial
      investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week
      out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the
      final clinic visit. A subject's participation in this trial would be expected to be up to 16
      weeks.
    


Intervention name(s): pump; insulin aspart
Intervention type(s): Device; Drug
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pump; Diabetes
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Condition: NAFLD (Non-Alcoholic Fatty Liver Disease); Resistance Training
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in
      patients with NAFLD.
    

Detailed description: 
      Background: Non Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent liver disease in
      developed countries with a prevalence rate of 20-30 % of adults. About 10-25% of these
      individuals are estimated to meet the current diagnostic criteria for Non Alcoholic
      Steatohepatitis (NASH) and some may progress to Cirrhosis and liver failure. NAFLD is now
      recognized as the hepatic manifestation of the metabolic syndrome. Recent data shows that
      NAFLD might also predict the tendency to develop diabetes mellitus and coronary artery
      disease. The drug of choice for NAFLD is yet to be found. The recommended treatment of NAFLD
      includes weight reduction and Physical Activity (PA), but the data of the effect of
      Resistance Training (RT) PA on NAFLD is scant.

      Aim of the study: To evaluate the effect of RT on clinical and metabolic parameters in
      patients with NAFLD. Study design: Randomized Clinical Trial. Patients will be randomly
      allocated to 2 arms (intervention and control). The intervention arm will perform RT, whereas
      control arm will be advised to perform home stretching. Medical examination will be performed
      at week 0 (baseline) and at week 13 using uniform protocols.
    

Intervention name(s): Resistance Training
Intervention type(s): Behavioral
Intervention description(s): Supervised Resistance Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of
      QuickClot.
    

Detailed description: 
      The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting
      process. This dressing will be applied for one minute to the area where the tonsils/adenoids
      were. The investigators are hoping to develop a standard of practice where Quickclot is a key
      addition for tonsillectomy surgery.
    

Intervention name(s): QuickClot
Intervention type(s): Device
Intervention description(s): 1 application of treatment to each tonsil/adenoid removal area
Intervention model: Single Group Assignment
Intervention model description: Quickclot
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tonsillectomy; adenoidectomy; obstructive sleep apnea
Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to see if creatine, which is a naturally occurring chemical in
      the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.

      The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate
      for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr)
      concentrations.
    

Detailed description: 
      The purpose of this study is to see if creatine, which is a naturally occurring chemical in
      the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.
      Creatine may have effects of interest in the brain. The reason for the MRI component of this
      study is to learn about new ways to see inside the brain. The investigators will use magnetic
      fields and radio waves to look at the brain and chemicals in the brain. The investigators
      hope that this technique will have medial use in the future.

      The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate
      for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr)
      concentrations. A secondary hypothesis is that decreased depressive symptoms measured with
      the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery Asberg Depression Rating
      Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.
    

Intervention name(s): Creatine monohydrate or placebo
Intervention type(s): Drug
Intervention description(s): Placebo, 2g, 4g, and 10g of creatine monohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
RA-2 13-cis Retinoic Acid (Isotretinoin)
Condition: Male Infertility; Klinefelter's Syndrome; Y-chromosome Microdeletions
MeSH terms: Infertility; Infertility, Male; Klinefelter Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Men with infertility and normal hormone levels have few options for fertility treatment.
      Previous research work has suggested that men with infertility may have low levels of the
      active form of Vitamin A, called retinoic acid, in their testes. We think that giving men
      with low sperm counts retinoic acid may increase their sperm counts and improve their chances
      of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks
      can increase sperm production and help infertile men become fathers without the need for In
      vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see
      if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.
    

Detailed description: 
      This is a 20 week, unblinded, two-arm pilot study to determine the impact of therapy with
      13-cis retinoic acid and calcitriol on sperm indices in infertile men. Twenty infertile men,
      ages 21-60 with abnormal sperm analyses will be enrolled for 20-week and given 20 mg 13-cis
      retinoic acid, twice daily. Subjects#11-#20 will also be administered calcitriol to see if
      adding calcitriol with Accutane will improve sperm motility. All subjects will be closely
      followed for side effects related to treatment. The impact of treatment on indices of
      spermatogenesis will be determined by monthly seminal fluid analyses.
    

Intervention name(s): 13-cis retinoic acid; Calcitriol
Intervention type(s): Drug; Drug
Intervention description(s): Accutane is used for the treatment of severe acne; Calcitriol is a form of vitamin D given twice daily (BID)
Other intervention name(s): Accutane; Isotretinoin; 1,25-dihydroxyvitamin D3
Intervention MeSH terms: Calcitriol; Dihydroxycholecalciferols; Tretinoin; Isotretinoin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility
Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
Condition: Menopause; Fracture; Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young
      individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA
      approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating
      bone formation. The investigators hypothesize that teriparatide will significantly increase
      bone density (BMD) and improve bone structure in premenopausal women with IOP.
    

Detailed description: 
      Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young
      individuals sustain one or more low-trauma fractures. In studies of IOP in men,
      histomorphometric indices of bone formation are depressed, and affected men respond to
      PTH(1-34) with robust increases in lumbar spine (LS) bone mineral density (BMD). This is the
      beginning of the third year of an R01 (AR4989603) investigating the etiology and
      pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in
      premenopausal women. There is evidence of markedly decreased bone formation and
      microarchitectural deterioration with decreased mechanical competence/strength.

      Teriparatide [PTH(1-34)] is an anabolic agent that stimulates bone formation and improves
      bone microarchitecture. Based on findings, the investigators hypothesize that teriparatide
      will significantly increase BMD and improve microarchitecture in premenopausal women with
      IOP.

      This is an open-label study of carefully characterized premenopausal women with IOP who are
      participating in a NIH-funded study and who have fragility fractures or very low bone
      density. Participants in the study will receive 18-24 months of teriparatide and the effects
      on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed. In
      order to assess whether teriparatide stimulates bone formation to the same extent in women
      with IOP as it does in normal women, the study will compare the short-term changes (2 and 4
      weeks) in biochemical markers of bone formation in response to teriparatide between women
      with IOP and normal women who are participating in another NIH-funded study as controls.
    

Intervention name(s): Teriparatide (PTH 1-34)
Intervention type(s): Drug
Intervention description(s): 20 micrograms subcutaneous injection daily
Other intervention name(s): Forteo
Intervention MeSH terms: Teriparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Teriparatide; Forteo; Osteopenia; Osteoporosis; Fracture; Low Bone Density; Premenopausal women
A Possible Effect of Oxytocin During Interaction Between Humans and Animals
Condition: Animal Assisted Therapy
Study type: Interventional

Summary: 
      The purpose of this pilot study is to investigate the possible change of Oxytocin level in
      human blood after positive interaction with farm animals.
    

Detailed description: 
      The purpose of this pilot study is to investigate the possible change of Oxytocin level in
      human blood after positive interaction with farm animals and filling in instruments measuring
      anxiety and stress.
    

Intervention name(s): Measuring oxytocin level in blood
Intervention type(s): Other
Intervention description(s): Blood sampling and instruments measuring anxiety and stress
Other intervention name(s): Oxytocin
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oxytocin; Animal Assisted therapy; Farm animals; Healthy nursing students
Placental Volume, Flow, and Vascularity Study
Condition: Pre-Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this preliminary study is to implement an automated and standardized
      computer-based method that accurately measures placental volume, blood flow, and vascularity.
      This will be accomplished by using the digital data obtained at the time of a first-trimester
      3D image volume. This information will then be used to further investigate whether placental
      volume, blood flow, and vascularity can be used to predict the risk of preeclampsia in
      conjunction with maternal history and serum blood markers obtained at the time of their
      ultrasound.
    

Detailed description: 
      Preeclampsia is defined as a multi-system disorder typically characterized by hypertension,
      proteinuria, and/or end organ damage. Preeclampsia can develop rapidly at any time after 20
      weeks gestation and into the postpartum period and can at times lead to systemic
      complications and even death. Preeclampsia continues to be a leading cause of maternal
      morbidity and mortality secondary to the development of hypertensive disorders, systemic
      inflammatory changes affecting the endothelium, and hemorrhagic complications. It also
      contributes indirectly to neonatal morbidity and mortality by leading to premature delivery.
      Our current ability to screen patients for the risk of developing preeclampsia relies on
      clinical factors as recommended by ACOG and the USPHS. At this time, if a patient is deemed
      high risk, our only intervention for prevention of preeclampsia is to prescribe low-dose
      aspirin. Being able to identify the population at higher risk for preeclampsia would allow
      for implementation of new management options among these persons. The purpose of this
      preliminary study is to implement an automated and standardized computer-based method that
      accurately measures placental volume, blood flow, and vascularity. This will be accomplished
      by using the digital data obtained at the time of a first-trimester 3D image volume. This
      information will then be used to further investigate whether placental volume, blood flow,
      and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal
      history and serum blood markers obtained at the time of their ultrasound.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are pregnant adults in the first trimester of gestation who are receiving an
        ultrasound at one of the qualifying study sites.