bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The present trial is a follow-up of AL203 study (NCT00343889).

      Primary Objectives:

      To describe the antibody persistence at 15 to 18 months of age and the booster effect of a
      dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine
      [OPV]).

      Secondary Objective:

      To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when
      administered concomitantly with OPV in each vaccine group.
    

Detailed description: 
      Study participants will receive a booster vaccination of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™
      either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose
      primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given
      concomitantly with OPV. Participants will receive a booster dose of the vaccine they had
      received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).
    

Intervention name(s): DTaP-HB-PRP~T vaccine; Tritanrix-HepB/Hib™; Oral Polio Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Oral
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b
Paediatric Safety Study in Cat-PAD
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
    


Intervention name(s): Cat-PAD; Placebo
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Cat Allergy; Rhinoconjunctivitis
A Trial of SHR2285 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open-label study
    

Detailed description: 
      This is a phase 1 open-label study. The objective of this study is to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR2285 in healthy
      subjects
    

Intervention name(s): SHR2285
Intervention type(s): Drug
Intervention description(s): SHR2285 is a selective inhibition of human FXIa small molecule compound.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Three different cohorts can enroll healthy Caucasian participants; males and females in each cohort separately.
Masking: None (Open Label)
Primary purpose: Treatment
Engaging HIV Patients in Primary Care by Promoting Acceptance
Condition: HIV
Study type: Interventional

Summary: 
      Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public
      health concern because reduced commitment to care puts PLWHA at risk for illness progression,
      death, and transmission of HIV to others. This project will develop a novel treatment, brief
      acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a
      pathway to reducing engagement barriers. The clinical and public health impact of this
      project will be the development of a simple, low-cost, disseminable intervention that
      enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments
      that will prolong survival and improve quality of life. We hypothesize that individuals
      randomized to brief ABBT will showed increased longitudinal attendance of primary care
      appointments.
    


Intervention name(s): ABBT; TAU
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HIV; Primary care; Engagement; Acceptance; Disclosure; Stigma
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 28-day, placebo controlled clinical study assessing the safety, tolerability
      anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic
      Obstructive Pulmonary Disease).
    


Intervention name(s): SB681323
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: P38 map kinase; CRP; COPD; safety
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether a dosing adjustment is needed in patients with
      renal impairment.
    


Intervention name(s): Maraviroc; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Maraviroc; Maraviroc
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Maraviroc 300 mg (150 mg x 2 tablets) x single dose; Maraviroc 150 mg tablet twice daily x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 150 mg tablet once daily x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 150 mg tablet once every 48 hours x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 300 mg (150 mg x 2 tablets) x single dose; Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis; Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
Intervention MeSH terms: Ritonavir; Saquinavir; Maraviroc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maraviroc, pharmacokinetics, renal impairment
A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the potential for a drug interaction between GDC-0853
      and midazolam, itraconazole, rosuvastatin, and simvastatin.
    

Detailed description: 
      This will be a 4-part study, with each part being an open-label fixed-sequence evaluation
      conducted in healthy adult participants. Approximately 64 participants will be enrolled in
      this study.
    

Intervention name(s): Midazolam; GDC-0853; Midazolam and GDC-0853; Rosuvastatin; Rosuvastatin and GDC-0853; Simvastatin; Simvastatin and GDC-0853; GDC-0853; Itraconazole; GDC-0853 and itraconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose midazolam; Multiple doses GDC-0853 for 6 days; Multiple doses GDC-0853 and single dose midazolam; Single dose rosuvastatin; Multiple doses GDC-0853 and single dose rosuvastatin; Single dose simvastatin; Multiple doses GDC-0853 and single dose simvastatin; Single dose GDC-0853; Multiple doses itraconazole for 6 days; Multiple doses itraconazole and single dose GDC-0853
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Midazolam; Rosuvastatin Calcium; Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Condition: Newly Diagnosed Type 2 Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiovascular complications account for the highest mortality in type 2 diabetic patients,
      mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread
      in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong
      predictor of cardiovascular events and all-cause mortality .

      Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular
      mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .
    


Intervention name(s): Sitagliptin and acarbose
Intervention type(s): Drug
Intervention description(s): Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.
Intervention MeSH terms: Sitagliptin Phosphate; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; left ventricular mass; inhibitor of dipeptidyl peptidase-4
Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may
      prevent this from happening.

      PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in
      preventing early menopause in premenopausal women who are receiving chemotherapy for stage I,
      stage II, or stage III breast cancer that has been removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women
           undergoing adjuvant chemotherapy in combination with vs without triptorelin for
           previously resected stage I-III breast cancer.

      Secondary

        -  Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy
           alone.

      OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone.

        -  Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy
           and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of
           chemotherapy. The last dose of triptorelin is given before the last course of
           chemotherapy.

      Patients with hormone-sensitive tumors who resume ovarian function after stopping
      chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2
      years.

      Patients undergo menopausal status assessment, using follicle-stimulating hormone,
      luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12
      months after the last course of chemotherapy.

      After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.

      PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
    

Intervention name(s): cyclophosphamide; docetaxel; doxorubicin hydrochloride; epirubicin hydrochloride; fluorouracil; methotrexate; paclitaxel; triptorelin; adjuvant therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Fluorouracil; Methotrexate; Epirubicin; Triptorelin Pamoate
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Observational

Summary: 
      The goal of this prospective observational study is to investigate whether whole brain
      radiation leads to measurable xerostomia from parotid gland toxicity.
    

Detailed description: 
      The parotids have not been traditionally considered an organ at risk / avoidance structure in
      whole brain radiation. However, patients receiving whole brain radiation sometimes complain
      of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an
      acute measurable increase in xerostomia at one month post-radiation, and that the severity of
      xerostomia is related to the dose received by the parotids. In this study, investigators will
      use the validated University of Michigan Xerostomia Questionnaire to prospectively collect
      baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation
      dose to the parotids will be evaluated to assess whether there is a dose-toxicity
      relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48
      evaluable patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer
        Center.
STAGES Trial: Study of Adiposity, Growth and Endocrine Stages
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The investigators propose to conduct a cross-sectional study of 60 participants who are 18-30
      years of age to undergo research PET/CT. The purpose of this study is to investigate the
      relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and
      components of the metabolic syndrome in young adults.
    

Detailed description: 
      We propose to conduct a cross-sectional study of 60 participants who are 18-30 years of age
      to undergo research PET/CT. The purpose of this study is to investigate the relationships
      between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and components of the
      metabolic syndrome in young adults. This study is part of a larger study aimed at
      understanding the mechanism of brown adipose tissue as a potential protective factor against
      metabolic dysfunction.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy, obese young adults
      
Biospecimen description: 
      Buffy coat in -80F long-term storage
    
Keywords: Metabolic dysfunction; Insulin resistance; Brown adipose tissue; Dyslipidemia
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
Condition: Primary Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids
      reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:
      demonstrate potential to reduce total blood cholesterol more than 10% and/or total
      triglycerides more than 15%, as required by State food and drug administration (SFDA)
      regulation.
    

Detailed description: 
      The proposed clinical trial is a pilot randomized, double-blind, placebo controlled,
      parallel, multicenter study with three treatment groups.

      The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.

      Subjects will be randomized into one of the following 3 groups:

        -  milk without sterols and hawthorn powder

        -  milk with 1.2g/d sterols and 8g/d hawthorn powder

        -  milk with 1.8g/d sterols and 8g/d hawthorn powder

      The trial population will consist of female or male volunteers aged 18 - 65 years of age with
      primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L
      AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central
      laboratory in the past 2 weeks prior to recruitment.
    

Intervention name(s): sterols and hawthorn powder
Intervention type(s): Dietary Supplement
Intervention description(s): there are two dose level of sterols (1.2g/d; 1/8g/d)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in
      the treatment of Parkinson's disease.
    

Detailed description: 
      CERE-120 is an experimental drug that consists of an adeno-associated virus (AAV) that was
      engineered to carry the human gene for neurturin, a neurotrophic (growth) factor. Similar to
      other growth factors (such as GDNF), neurturin is capable of restoring function and
      protecting brain cells from further damage. The virus used in CERE-120 is not known to cause
      disease in people.

      CERE-120 is delivered directly to the brain cells most affected in Parkinson's disease - the
      dopamine producing neurons. CERE-120 is injected during brain surgery. Once in place,
      CERE-120 continuously produces neurturin.

      During the first, open-label, part of the study (Phase 1), subjects with Parkinson's disease
      received CERE-120 at one of two dose levels. In the second part of the study (Phase 2),
      subjects were randomized 1:1 to receive CERE-120 or a "sham" surgery where no medication was
      injected.

      Participants in both phases of the study were followed for up to five years after surgery.
    

Intervention name(s): CERE-120: Adeno-Associated Virus Delivery of Neurturin; Sham Surgery
Intervention type(s): Biological; Procedure
Other intervention name(s): AAV2-Neurturin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the first part of the study (Phase 1), 2 escalating dose cohorts received CERE-120.
In the second part of the study (Phase 2), subjects were randomized 1:1 to receive CERE-120 or Sham Surgery.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Movement Disorders; Gene Therapy; Neurotrophic Factors; GDNF; Neurturin; DBS; Dopamine
Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major
      depressive disorder (MDD) patients with inadequate response to current antidepressant
      treatment.
    


Intervention name(s): Vortioxetine 10-20 mg; Escitalopram 10-20 mg
Intervention type(s): Drug; Drug
Other intervention name(s): Brintellix®; Lu AA21004
Intervention MeSH terms: Vortioxetine; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vortioxetine; Cognition
Ginsenoside-Rd for Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute
      ischemic stroke.
    

Detailed description: 
      A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its
      toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a
      purified component from total saponins of Panax notoginseng, has a molecular formula of
      C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit
      receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) ,
      attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve
      brain functioning in animal models of acute ischemic stroke.
    

Intervention name(s): ginsenoside-Rd 10 mg; placebo; ginsenoside-Rd 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days; infusion placebo (group B)once a day and continued for 14 days; infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized trial; ischemic stroke; Ginsenoside-Rd
A Study of OsrHSA in Adult Healthy Male and Female Volunteers
Condition: Ascites Hepatic
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of
      OsrHSA in adult healthy male and female volunteers
    

Detailed description: 
      This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation
      study to evaluate safety, tolerability, PK, and immunogenicity of OsrHSA in healthy
      volunteers.
    

Intervention name(s): OsrHSA 20 mg/kg IV; OsrHSA 40 mg/kg IV; OsrHSA 80 mg/kg IV; OsrHSA 140 mg/kg IV; OsrHSA 200 mg/kg IV; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min; Normal Saline (0.9% Sodium Chloride)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study in healthy volunteers to evaluate safety, tolerability, PK, PD and immunogenicity of OsrHSA.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: OsrHSA