bioihbjkbjnl/mcl2 huggingface dataset:
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
Condition: Drug-Related Side Effects and Adverse Reactions
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body,
      and by itself, has no pharmacological action. A pharmacologically active drug can be attached
      to GSK3128349 with the goal of changing the distribution and/or duration of action of the
      attached drug. This study will determine the distribution and pharmacokinetics (duration) of
      GSK3128349 itself after a single intravenous infusion. GSK3128349 has been labeled with and
      the radioisotope 89Zirconium allowing it to be visualized in the organs of the body using a
      PET scanner at multiple time points after GSK3128349 dosing. The data from this study will
      help predict the distribution of future drugs attached to GSK3128349. The total duration of a
      subject's participation is about approximately 10 weeks, including the screening period.
    


Intervention name(s): 89Zr-GSK3128349 1 mg
Intervention type(s): Drug
Intervention description(s): 89Zr-GSK3128349 is a mixture of unlabelled and zirconium-labelled GSK3128349, in the form of solution for IV administration, and is associated with about 15 MBq of radioactivity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: 89Zirconium; Open label; Pharmacokinetics; Radioactive; Clearance; Biodistribution
A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a randomized, double-blind, placebo-controlled phase I clinical trial of
      TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects.

      The main purpose was to evaluate the safety and tolerance of different doses of TQH3821 or in
      combination with methotrexate tablets after single and multiple administration in healthy
      subjects.
    


Intervention name(s): TQH3821 tablets; TQH3821 tablets (Placebo); Methotrexate tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase.; TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase.; Methotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of African American Women's Hair Care Practices and Hair Attitudes on Exercise Habits
Condition: Hair and Scalp Health
Study type: Observational

Summary: 
      The purpose of this research study is to better understand African American women's hair and
      hair styling practices and how these practices affect attitudes and viewpoints regarding
      exercise.
    


Intervention name(s): Survey of exercise practices
Intervention type(s): Other
Intervention description(s): detailed questionnaire regarding the subject's race, income level; type(s), frequency, intensity, and amount of exercise; attitudes about exercise; hair style; hair care practices; attitudes about hair; hair and scalp health; and attitudes about exercise with regards to hair
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        African American females between the ages of 21 and 60.These subjects will be recruited
        from Wake Forest University Health Sciences Dermatology clinic and our Institutional Review
        Board (IRB) approved advertising.
      
Keywords: African American females between the ages of 21 and 60
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
Condition: Metastatic Colorectal Cancer; Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Recurrent
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, single-dose, parallel-group study comparing
      pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008
      (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody
      Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.
    


Intervention name(s): LY01008; Avastin
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous injection; Single intravenous injection
Other intervention name(s): Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection; Bevacizumab
Intervention MeSH terms: Bevacizumab; Endothelial Growth Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the effectiveness and tolerability/safety of
      aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also
      have a parent with bipolar disorder and other family member with a mood disorder.
    

Detailed description: 
      This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that
      will last up to 12 weeks.

      This placebo-controlled portion will be followed by a 6-week open label
      extension/stabilization phase. In order to be eligible for participation in the
      extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no
      dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated
      in the blinded portion of the clinical trial for a minimum of 4 weeks.
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Addressed in arm description.; Addressed in arm description.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder
A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
Condition: Nalbuphine; Idiopathic Pulmonary Fibrosis; Cough
MeSH terms: Pulmonary Fibrosis; Cough; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of Nalbuphine ER (NAL ER) tablets in subjects
      diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and evaluate it's treatment of cough in
      these patients. This is a two-treatment, 2-period crossover study. Subjects will be
      randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluated for
      approximately 21 days. After completion of the first phase, subjects who received NAL ER will
      crossover to placebo and subjects who received placebo will crossover to NAL ER to complete
      Treatment Period 2.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover
      efficacy and safety study in IPF subjects with NAL ER tablets for the treatment of cough. The
      study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2
      weeks.

      Treatment Period 1: During Treatment Period 1, eligible subjects will be randomized (1:1) to
      one of the following treatment arms:

        -  Arm 1: Active NAL ER followed by crossover Placebo in Treatment Period 2

        -  Arm 2: Placebo followed by crossover NAL ER in Treatment Period 2

      Following 3 weeks of dosing in Treatment Period 1, subjects will complete a 2-week washout
      period before entering Treatment Period 2. Subjects assigned to Arm 1 will receive placebo
      and subjects assigned to Arm 2 will receive NAL ER during Treatment Period 2. A final 2-week
      washout period will occur at the completion of Treatment Period 2.

      NAL ER Dosing Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54
      mg twice a day (BID) over a 5-day period and then maintained at 54 mg twice a day (BID) for
      approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg twice a
      day (BID) over 1 week and then to 162 mg twice a day (BID) over 6 days.
    

Intervention name(s): NAL ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID over a 3 week period.; Participants will receive Placebo tablet (matching NAL ER BID) over a 3 week period.
Other intervention name(s): Nalbuphine; Nalbuphine
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled, 2-Treatment, 2-Period Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nalbuphine; Cough; Idiopathic Pulmonary Fibrosis; Pharmacokinetics
An Internet-Based Smokeless Tobacco Cessation Program for Teens
Condition: Smokeless Tobacco Use
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco
      cessation website to a website with more static information that is similar to websites that
      can be found through a typical Internet search.
    


Intervention name(s): Tailored, enhanced condition; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.; The Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smokeless tobacco
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Adolescent Behavior
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study evaluates the short-term effects of incorporating the structured care of a pet
      fish into a diabetes self-care routine on glucose control in early adolescents with type 1
      diabetes.
    

Detailed description: 
      Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to
      self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time
      for the deterioration of glycemic control in patients with T1DM. In particular, parental
      monitoring declines during early adolescence. This often occurs before the child has
      developed self-efficacy and competence in independently performing diabetes-related tasks,
      including blood glucose monitoring. Consequently, there is a great need for innovative
      strategies in early adolescents that promote self-efficacy development and facilitate
      parental involvement.
    

Intervention name(s): Pet Fish
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:
feed fish one pellet in the morning after waking; check and record BG reading at that time
feed fish one pellet in the evening before dinner; check and record BG reading at that time
feed fish one pellet at night before bedtime; check and record BG reading at that time
every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.
Each child will also receive two books intended to supplement and enrich their pet fish experience.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Prematurity on Renal Function in 5 Years Old Children
Condition: Prematurity of Fetus
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Purpose of the study:

        1. To evaluate the effect of prematurity on renal function in 5 years old children

        2. To compare former premature children treated by ibuprofen in the neonatal period to
           controls
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children from a previous trial followed at 3, 4 and 5 years of age
      
Biospecimen description: 
      Blood and urine samples
    
Keywords: premature renal function; ibuprofen; blood pressure; Renal function
Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol
      Ointment in sequential therapy
    

Detailed description: 
      1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group
      were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were
      respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea
      Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12
      weeks after the beginning of treatment.
    

Intervention name(s): Calcipotriol Betamethasone ointment and Calcipotriol ointment; Calcipotriol Betamethasone ointment; Calcipotriol Betamethasone ointment and Urea Cream
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
Condition: Pneumonic Plague; Preventive Therapy
MeSH terms: Plague
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule
      of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular
      (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to
      evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in
      healthy volunteers who have previously been vaccinated with the same concentration of rF1V
      vaccine.
    

Detailed description: 
      The Phase 1 clinical trial is designed as an open-label, single-center, dose-escalation study
      to evaluate the safety, tolerability, and immunogenicity of a two-dose regimen of rF1V in
      healthy volunteers at four dose-levels (20 ug, 40 ug, 80 ug and 160 ug rF1V) in four
      sequential cohorts. The protocol was amended 26 January 2006 to recruit volunteers from
      Cohort 4 to participate in an Extension. Cohort 4 Extension volunteers will receive a third
      vaccination at day E-0. Day E-0 (-1) should not exceed Day 240 of the Phase 1 study.
    

Intervention name(s): rF1V vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plague; recombinant plague vaccine; vaccine; plague vaccine; Protection against pneumonic plague
Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
Condition: Adolescent Obesity; Eating Behavior; Dietary Intake
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery
    

Detailed description: 
      The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are
      virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake
      and eating behavior before and after bariatric surgery. The consortium, however, provides a
      unique opportunity to investigate these issues in a large and diverse sample through the
      context of the proposed ancillary study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will assess changes in dietary intake and eating behavior in 110 extremely obese
        adolescents who undergo bariatric surgery as part of the main Teen-LABS study. These
        individuals will be recruited from one of 4 Teen-LABS sites: Baylor College of Medicine,
        Cincinnati Children's Hospital Medical Center, University of Alabama at Birmingham, and the
        University of Pittsburgh Medical Center. Changes in bariatric surgery patients will be
        compared to those of 110 obese adolescents treated with a lifestyle modification program
        designed to produce an 8% weight loss. These individuals will be recruited from a study at
        the Children's Hospital of Philadelphia (PI: Robert Berkowitz, M.D.) which will be ongoing
        at the same time and will include the same measures as those proposed in this application.
      
Keywords: adolescent obesity; eating behavior; dietary intake
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
Condition: Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked Agammaglobulinemia; Hyper-IgM Syndrome; Wiskott-Aldrich Syndrome
MeSH terms: Wiskott-Aldrich Syndrome; Agammaglobulinemia; Hyper-IgM Immunodeficiency Syndrome; Hyper-IgM Immunodeficiency Syndrome, Type 1; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to determine the efficacy of Gammaplex by measuring the number of
      serious acute bacterial infections during treatment with Gammaplex over a 12 month period.
      The secondary objectives are to assess the safety and tolerability of Gammaplex and to
      compare the data collected from adult subjects with PID from the GMX01 study
    


Intervention name(s): Gammaplex
Intervention type(s): Biological
Intervention description(s): GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked agammaglobulinemia; Hyper-IgM syndrome; Wiskott-Aldrich Syndrome; Immunoglobulins; Bacterial Infections
Effect of Genetic Polymorphism on Calcineurin Inhibitors Levels in Egyptian Renal Transplant Patients
Condition: Renal Transplantation
Study type: Observational

Summary: 
      Renal transplantation is the treatment of choice for patients with end-stage renal disease
      (ESRD). Calcineurin Inhibitors tacrolimus and cyclosporine are the principle
      immunosuppressive agents administered to solid organ transplant recipients to prevent and
      treat allograft rejection.

      The aim of the present study is to detect the incidence of some selected genetic polymorphism
      in Egyptian renal transplant population and investigate the influence of these genetic
      polymorphism (SNPs )on Cyclosporine and Tacrolimus blood concentration. In addition to detect
      the association between these genetic polymorphism variants and patients' clinical outcome
      after transplantation.
    

Detailed description: 
      Tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid
      organ transplant recipients to prevent and treat allograft rejection.They both exert their
      immunosppressive action by inhibiting the calcinurein in T-lymphoctes.
      Subsequently,Cyclosporin and tacrolimus are both metabolic substrates for cytochrome P450
      (CYP) 3A enzymes - in particular, CYP3A4 and CYP3A5 - and are transported out of cells by the
      P-glycoprotein (ABCB1) efflux pump. Different expression of CYP3A4, CYP3A5 and P-glycoprotein
      causes patient to-patient variability in the absorption, metabolism and tissue distribution
      of calcineurin inhibitors. This different expression is likely to be at least partially the
      result of mutations in the genes encoding for these enzymes and drug transporter. This may
      lead to variable drug concentrations within the systemic circulation and at target sites,
      influencing drug efficacy. Moreover, it will influence the individual's susceptibility to
      drug interactions and drug toxicity
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Renal Transplant Patients
      
Biospecimen description: 
      Peripheral blood samples will be collected and stored in - 80°C environment for DNA
      extraction by DNA extraction kit according to manufacturer recommendation
    
Keywords: Renal Transplantation; Genetic Polymorphism; CYP3A5; CYP3A4