bioihbjkbjnl/mcl2 huggingface dataset:
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Disease
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial evaluated the use of a tetravalent vaccine against dengue.

      Primary objectives:

        -  To describe the humoral immune response to dengue before and after each vaccination with
           tetravalent dengue vaccine in adults, adolescents, and children.

        -  To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age
           cohorts.

        -  To evaluate the persistence of antibodies against dengue during 5 years after the first
           vaccination with tetravalent dengue vaccine in the 4 age cohorts.
    

Detailed description: 
      Safety assessments included solicited reactions within 7 or 14 days after each injection,
      unsolicited adverse events within 28 days after each injection, and serious adverse events
      during the study period.
    

Intervention name(s): CYD dengue vaccine serotypes (1, 2, 3, 4).; Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; Each at 0.5 mL, Subcutaneous, respectively
Other intervention name(s): ChimeriVax™; Meningococcal Polysaccharide Vaccine A+C; NaCl; Typhim Vi®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue virus; Dengue fever; Dengue hemorrhagic fever; Dengue diseases; Dengue vaccine
Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate
      450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg
      extended release tablet under fed conditions using a single-dose, randomized,
      three-treatment, three-period, six-sequence crossover design.
    


Intervention name(s): Lithium
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA
      measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the
      pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete
      response to current lamivudine therapy
    


Intervention name(s): Entecavir
Intervention type(s): Drug
Intervention description(s): Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Other intervention name(s): Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
Condition: Erosive Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority
      design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
    

Detailed description: 
      This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy,
      multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is
      assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the
      non-inferiority of YYD601 40mg to Nexium 40mg.
    

Intervention name(s): YYD601 40mg; Nexium 40mg; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients should take druges 30 minutes before breakfast.; Patients should take druges 30 minutes before breakfast.; The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Glutamine and Intestinal Protein Metabolism
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Gut barrier plays a major role in defence of the organism. During catabolic states, like
      major surgery or inflammation, gut barrier could be altered. It has been reported that
      preoperative nutritional support may have beneficial effects on clinical outcome in patients
      with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino,
      have been reported to modulate inflammatory, antioxidant responses and protein metabolism in
      intestine. In addition, glutamine supply improves clinical outcome in critically ill
      patients. Antioxidant micronutrients may also have some beneficial effects in intestine by
      improving antioxidant response and might also regulate protein expression. Nevertheless,
      effects of glutamine combined to antioxidant micronutrients have not been evaluated.

      Thus, the aim of this study will be to assess the influence of glutamine and
      glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.
    


Intervention name(s): Glutamine; Glucose; glutamine-antioxidants containing solution
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
Condition: Condition of Patient 3 Years After FESS-operation
Study type: Observational

Summary: 
      State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS)
      provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and
      chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can
      alleviate symptoms associated with AR and RS, and most patients with RS benefit from
      endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR
      and CRS continue to experience bothersome symptoms despite adequate treatment. This group
      with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge
      (3).
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        rhinosinusitis patients
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Uterine Fibroid
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a
      day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared
      with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
    

Detailed description: 
      This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy
      and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with
      low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by
      12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B)
      compared with 24 weeks of placebo (Group C).

      All participants completing the Week 24 visit, including women randomized to placebo, were
      offered the opportunity to enroll in an open-label extension study in which all eligible
      participants will receive relugolix co-administered with low-dose E2 and NETA. Participants
      who did not enroll into the extension study had a follow-up visit approximately 30 days after
      the end of treatment (that is, after the participant's last dose of study medication).

      Safety will be assessed throughout the study by monitoring adverse events, vital signs,
      physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments
      of bone mineral density.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Relugolix (40 mg) tablet administered orally once daily.; E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.; E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Other intervention name(s): TAK-385; MVT-601; E2/NETA; low-dose hormonal add-back
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Relugolix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Uterine Fibroid; Heavy Menstrual Bleeding; Menstrual Blood Volume
Functional Magnetic Resonance Imaging (fMRI) of Anosognosia in Amnestic Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
Condition: Anosognosia; Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Agnosia; Cognitive Dysfunction
Study type: Observational

Summary: 
      This is a three year fMRI study conducted at the University of Wisconsin (UW) Hospital and
      the William. S. Middleton VA Hospital. This study is guided by the hypothesis that reduced
      fMRI activity and connectivity cortical midline structures (i.e., medial frontal and ventral
      posterior cingulate cortex) are physiologic abnormalities that relate strongly to the
      compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals
      with amnestic MCI (aMCI) and AD. Further, the investigators hypothesize that these regional
      changes in fMRI activity are predictive of faster progression from aMCI to AD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MCI and AD patients are referred from memory clinics at the UW hospital, William S.
        Middleton Memorial Veterans Hospital (Madison, WI) and the statewide clinics offered
        through the Wisconsin Alzheimer's Institute (WAI).
      
Keywords: anosognosia fMRI amnestic MCI Alzheimer; anosognosia in AD and MCI
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a
      combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.
    


Intervention name(s): Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: contraception
Employment and Quality of Life in Patients With Malignant Melanoma
Condition: Malignant Melanoma of Skin; Quality of Life; Work Ability
MeSH terms: Melanoma
Study type: Observational

Summary: 
      Within the first year after diagnosis, data on employment and quality of life will be
      collected and evaluated in patients with malignant melanoma
    


Intervention name(s): Quality of Life, status of employment
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with malignant melanoma
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE
Condition: Immediate Type Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Pollen allergen extracts are prepared locally and checked for efficacy by comparison to
      imported allergens and specific IgE.
    

Detailed description: 
      Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen
      sensitization. Local allergen extracts are cheaper and more available but need
      standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally
      prepared and compared mean wheal diameter of skin prick test to imported allergens and also
      to specific IgE.
    

Intervention name(s): Pollen sensitization
Intervention type(s): Biological
Intervention description(s): Skin prick test with local and imported Bermuda, Johnson and careless weed allergen extracts at concentration of 10,000, 3,000, 1,000 and 300 AU/mL and measure specific IgE levels
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        People 18-60 years of age who recently have positive skin prick test to grass pollen or
        careless weed are pricked with local and imported Bermuda grass, Johnson grass and careless
        weed allergen extracts. Specific IgE levels are also measured at the same day.
      
Keywords: skin prick test; grass and weed pollens
Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational [Patient Registry]

Summary: 
      Objectives:

      Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on
      cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension
      (RH).

      Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its
      association with OSA, and to identify if long term blood pressure control and number of
      antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii)
      to identify epigenetic profiles and clinical, biological and polygraphic variables with a
      predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the
      HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in
      women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA
      diagnosis and treatment in patients with RH.

      Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood
      pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and
      subclinical organ damage variables and biological samples at baseline will be collected from
      all the subjects included. A sleep study will be performed in all the subjects at the study
      inclusion date. Subsequently, the OSA subjects will be managed as per local standard
      practice. Follow-up variables will be annually collected (including blood samples). On the
      basis of OSA and its treatment, three cohorts of RH subjects will be defined: control
      (non-OSA), OSA-treated and OSA nontreated.
    

Detailed description: 
      A minimum follow-up of 5 years has been established. During the follow-up, an annually
      programmed visit will be carried on to all patients, collecting variables from subjects'
      interview in the office.The baseline and follow-up variables will be collected using
      questionnaires.

      The variables that will be collected are:

      BP variables; Anthropometric variables; Compliance with CPAP in the case of CPAP-treated OSA
      patients; blood samples extraction; outcomes (heart disease, cerebrovascular disease, kidney
      disease, vascular disease). All the cardiovascular events will be independently evaluated by
      two doctors to establish a diagnostic. In case of discordance a third external doctor will
      assess the case. The date of each event will be recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Resistant Hypertension
      
Biospecimen description: 
      -  2 tubes EDTA

        -  2 tubes with gel for serum

        -  1 tube for RNA extraction

        -  1 tube for urine
    
Keywords: Hypertension; Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Cardiovascular Diseases
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients with at least moderate persistent allergic asthma controlled with inhaled
      steroids, omalizumab(administered per US product label), when compared to placebo, will
      provide the participants with significantly improved tolerability of specific allergen
      immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
    

Detailed description: 
      Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is
      designed to give omalizumab 13 weeks prior to administering rapid build up of specific
      allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster
      therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.
    

Intervention name(s): Xolair; Xolair
Intervention type(s): Drug; Drug
Intervention description(s): Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.; Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Other intervention name(s): Omalizumab (Xolair); Omalizumab (Xolair)
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic; Asthma; Immunotherapy
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Condition: Leukemia; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
MeSH terms: Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Bone marrow transplantation may allow the doctor to give higher
      doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor
      bone marrow transplantation in treating patients who have hematologic cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies
      after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose
      chemotherapy.

      OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide
      IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days
      -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone
      is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6
      months for 1 year and then annually thereafter.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
    

Intervention name(s): busulfan; cyclophosphamide; methylprednisolone; allogeneic bone marrow transplantation; in vitro-treated bone marrow transplantation
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Busulfan; Prednisolone hemisuccinate; Prednisolone phosphate
Primary purpose: Treatment
Keywords: refractory multiple myeloma; chronic phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; acute undifferentiated leukemia; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes
Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose relative bioavailability study of
      Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.
    

Detailed description: 
      This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study
      in healthy adult male volunteers under fasting conditions with a washout period of 7 days.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Keppra® 750 mg Tablets
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Levetiracetam