bioihbjkbjnl/mcl2 huggingface dataset:
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Condition: Common Variable Immunodeficiency; X-linked Agammaglobulinemia; Autosomal Recessive Agammaglobulinemia
MeSH terms: Agammaglobulinemia; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the efficacy, tolerability, safety and
      pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
    

Detailed description: 
      This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy
      period. During the 28-week efficacy period, subjects visited the study site at least every 4
      weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20
      dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters
      were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28
      ± 1).
    

Intervention name(s): Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
Intervention type(s): Biological
Intervention description(s): IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.
Other intervention name(s): Hizentra; SCIG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subcutaneous immune globulin; SCIG
S&B Heat Stress Pilot Protocols
Condition: Thermal Discomfort
Study type: Interventional

Summary: 
      The purpose of this study is to develop a heat stress program for the construction industry
      and evaluate its feasibility and appeal.
    


Intervention name(s): Group A; Group B
Intervention type(s): Device; Device
Intervention description(s): The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group A will be fitted with a cooling and bio-harness. At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.; The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group B will wear a bio-harness and no cooling vest.At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of
      using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in
      subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug
      therapy.
    


Intervention name(s): biphasic insulin aspart
Intervention type(s): Drug
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Indian Phenotype Registry
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study is a non-interventional, multicentre observational study to be conducted at 1000
      sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients
      per site. The study would enrol Diabetes Mellitus patients who provides written informed
      consent. No study medication will be prescribed or administered as a part of study procedure.
      Patients, who have been treated as per Investigators' routine clinical practice will be
      screened for enrolment in study. The study will be initiated after obtaining written approval
      of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
    

Detailed description: 
      This study is a non-interventional, multicentre observational study to be conducted at 1000
      sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients
      per site. The study would enrol Diabetes Mellitus patients who provides written informed
      consent. No study medication will be prescribed or administered as a part of study procedure.
      Patients, who have been treated as per Investigators' routine clinical practice will be
      screened for enrolment in study. The study will be initiated after obtaining written approval
      of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

      This is a single visit cross sectional study however during site feasibility visit,
      probability of follow-up of these patients will be evaluated. If feasible protocol will be
      amended to continue data collection prospectively for appropriate duration
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Diabetes Mellitus patients
      
Keywords: Diabetes, T2D
Organochlorine Pesticide Exposure in Residents Near Lake Apopka
Condition: Pesticide Exposure
Study type: Observational

Summary: 
      In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine
      pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane,
      toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests
      and to improve crop harvests. For most of those years, the farmworkers were exposed to the
      pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these
      organochlorine pesticides (OCPs) are readily taken up into the body and not readily
      eliminated. Therefore, they can be detected in exposed individuals for many years after the
      exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems
      in sensitive individuals. For example, exposure to some OCPs has been associated with
      development of Parkinsonism. Exposure to other OCPs has been associated with development of
      lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are
      endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may
      have mixed interactions with steroid receptors.

      In this research study the investigators aim is to test the blood from former farmworkers
      during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for
      the auto-antibodies. In addition, questionnaires will provide insight on their health status
      and health concerns.
    

Detailed description: 
      In this research study, a onetime blood test will be collected from former farmworkers during
      the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the
      auto-antibodies. In addition, questionnaires will provide insight on their health status and
      health concerns.

      The investigators will collect existing data from the National Health and Nutrition
      Examination Survey (NHANES) which has monitored the pesticide exposure (with the exception of
      toxaphene) of people older than 8 years, so there is information on the range of
      concentrations of these chemicals in the blood of Americans. This data will be use as the
      control group for comparison with the values found for OCP concentrations.
    

Intervention name(s): Blood Collection
Intervention type(s): Other
Intervention description(s): Onetime blood collection.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants for this study will be recruited from the Florida Farmworker Association of
        Florida, Lake Apopka, FL.
      
Biospecimen description: 
      Blood samples will be collected for analysis of organochlorine pesticides and
      auto-antibodies.
    
Keywords: organochlorine compounds; pesticides
A Study to Determine the Absorption, Metabolism, and Routes of Excretion of (14C) Radiolabeled Ibrutinib in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption, the metabolic pathways and the
      excretion of ibrutinib in healthy male adult participants after administration of a single
      oral dose of 50 mg to 140 mg (5 mg/mL solution) of unlabeled ibrutinib admixed with 14C
      ibrutinib.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      single-dose study in healthy male participants. Six men will be enrolled to allow a minimum
      of 4 participants to complete the study. All participants will receive a single oral solution
      dose of 50 to 140 mg ibrutinib containing 1480 kBq (40 µCi) of 14C labeled ibrutinib,
      constituting a total radiation burden of approximately 0.916 mSv (ICRP risk category IIa).
      The duration of the study is approximately 73 days including screening period of 28 days,
      treatment period of 15 days, and follow-up period of 30 days. Safety will include adverse
      events, laboratory safety, 12 lead electrocardiogram, physical examination, and vital signs.
    

Intervention name(s): Ibrutinib
Intervention type(s): Drug
Intervention description(s): Type=exact number, unit=mg, number=50-140, form=solution, route=oral. Participants will receive a single oral solution dose of 50 mg to 140 mg -ibrutinib containing 1480 kBq (40 µCi) of 14C-labeled ibrutinib, with a total radiation burden of approximately 0.916 mSv.
Other intervention name(s): PCI-32765
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Ibrutinib; PCI-32765; B-cell malignancies; CYP3A4
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      COVID-19 caused by SARS-CoV-2 virus has affected the lives of millions of individuals
      globally and also severely strained the medical community. Pre-symptomatic and asymptomatic
      SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe
      disease. The transmission potential of SARS CoV-2 is potentially greater than earlier viral
      outbreaks of SARS-CoV and MERS-CoV.Routine measures of social distancing, personal hand
      hygiene and limited outdoor contact activities have shown benefits to limit corona virus
      infection. However, the role of vitamin D in SARS-CoV-2 infection is sparingly explored
      despite the knowledge of an immunomodulatory role and protective effect of vitamin D against
      viral infections. Meta-analysis of five clinical trials of vitamin D supplementation found
      that those receiving vitamin D supplementation had fewer respiratory tract infections (odds
      ratio = 0.58 (95%CI, 0.42 - 0.81).Any immune-modulatory effect of vitamin D is likely to be
      observed at levels which are considered higher than that required for normal bone metabolism.
    


Intervention name(s): cholecalciferol 6 lakh IU
Intervention type(s): Drug
Intervention description(s): vitamin D levels and serum calcium will be assessed at day 3,7, 14.
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)
Condition: Pulmonary Arterial Hypertension; Vasodilation; Vasoconstriction
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial
      hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers
      bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan
      blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors.
      Theoretically, selective ETA blockade may be associated with greater vasodilation and
      clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied
      in humans.

      We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and
      sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically
      relevant doses:

        -  Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and
           placebo.

        -  These effects will be confirmed by 2 functional markers of ETB receptor antagonism:
           plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the
           forearm vasodilator response to ET-3.
    


Intervention name(s): Bosentan; Sitaxsentan; Placebo; Endothelin-3
Intervention type(s): Drug; Drug; Drug; Biological
Intervention description(s): Bosentan 125mg tablets, orally, twice daily for 7 days; Sitaxsentan 100mg tablets, orally, once daily for 7 days; Placebo tablets taken twice daily, orally, for 7 days (placebo arm) or once daily for 7 days (sitaxsentan arm); 5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
Other intervention name(s): Tracleer; Thelin
Intervention MeSH terms: Bosentan; Sitaxsentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Forearm Blood Flow; Vasodilation; Vasoconstriction; Endothelin System; Endothelin-1; Endothelin-3; Endothelin antagonists; Bosentan; Sitaxsentan; Endothelin; Regional Blood Flow
Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The purpose of this study is to investigate the change in muscle activity during gait with
      the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.
    

Detailed description: 
      A small group of children with hemiplegic cerebral palsy is investigated by 3D instrumented
      gait analysis. Muscle activity is measured by surface electromyography (sEMG) of selected
      lower limb muscle groups. Kinematic, Kinetic, and sEMG data are compared between both lower
      limbs walking with and without an ankle foot orthosis. Data are also compared with those of
      an healthy control group.
    

Observational model: Defined Population
Time perspective: Other
Keywords: cerebral palsy; ankle foot orthosis; emg; surface electromyography; gait analysis
Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need
      for steroid treatment for Crohn's disease.
    

Detailed description: 
      On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE:
      This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer
      HealthCare, Inc.
    

Intervention name(s): Sargramostim (Leukine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily via subcutaneous injection for up 22 weeks; Once daily via subcutaneous injection for up 22 weeks
Other intervention name(s): BAY86-5326
Intervention MeSH terms: Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional

Summary: 
      This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined
      therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the
      treatment of macular edema associated with branch retinal vein occlusion.
    


Intervention name(s): intravitreal bevacizumab monotherapy; combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection
Intervention type(s): Procedure; Procedure
Intervention description(s): The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.; The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bevacizumab; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: branch retinal vein occlusion; bevacizumab; triamcinolone acetonide
Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets
      compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male
      and female volunteers under fed conditions
    


Intervention name(s): Empagliflozin; Metformin; Empagliflozin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin; Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin; Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin; Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Condition: Coronary Artery Disease Risk High
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease
Study type: Interventional

Summary: 
      This pilot study seeks to compare the change in energy expenditure and fitness levels of
      patients seen in the Children's Hospital Preventive Cardiology program receiving standard of
      care provider exercise counseling to similar patients receiving Frequency, Intensity, Time,
      Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an
      online interactive tool.

      The investigators primary hypothesis is that this interactive technology coupled with support
      from a exercise specialist will increase the energy expenditure of the investigators patients
      over standard of care provider counseling.

      The investigators Secondary hypotheses include greater improvement in measured physical
      fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold
      (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial
      stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group
      compared to control.
    


Intervention name(s): BodyMedia
Intervention type(s): Device
Intervention description(s): Accelerometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: patients at increased risk for atherosclerosis
Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma
Condition: Effect of Drugs; Adverse Effects of Medical Drugs
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It is a randomized controlled trial in which investigators determine the efficacy of
      tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having
      Melasma.
    

Detailed description: 
      In this prospective single blind split face controlled trial.Total 30 patients referred to
      Dermatology Ward were selected. At first, patients were examined under wood lamp for
      determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid
      microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left
      half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy
      technique. This procedure was done total of six times with 2-week intervals. Participants
      were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of
      the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23
      was used for analysis. P value < 0.01 was taken significant.
    

Intervention name(s): Tranexamic Acid; 0.9% Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Tranexamic acid intradermal injections were used for treatment of melasma; Normal saline used for comparision of efficacy of tranexamic acid
Other intervention name(s): Normal saline
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Melasma; Tranexamic acid; Mesotherapy