bioihbjkbjnl/mcl2 huggingface dataset:
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
Condition: Primary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
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: 
      The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month
      treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.
    

Intervention name(s): Human Normal Immunoglobulin for Subcutaneous Administration
Intervention type(s): Biological
Other intervention name(s): Hizentra
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open label, multiple dose study to investigate the pharmacokinetics
      of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of
      [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male
      volunteers. The anticipated time of study treatment is 4 weeks.
    


Intervention name(s): RG1662
Intervention type(s): Drug
Intervention description(s): multiple doses of RG1662
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS
      P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,
      well tolerated and immunogenic. The present study is intended to extend the follow-up of the
      volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and
      cellular immune responses. The results of the present study will be key for the design of
      future phase II trials, particularly for the definition of the optimal schedule for boosting
      immunizations.

      All individuals (27) will be enrolled in a 120-weeks observational study and monitored every
      24 weeks for the following 3 years. During these visits, which are performed within the
      schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to
      the routine virological, hematological and biochemical assessment, the anti-Tat specific
      humoral and cellular immune responses will be evaluated.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein
      
Biospecimen description: 
      Whole blood, serum, PBMCs
    
Keywords: HIV; Tat protein
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The objective of this study is to compare the effectiveness and safety of carbetocin vs.
      oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage
      (PPH)after vaginal delivery.
    

Detailed description: 
      The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is
      general agreement that active management of the third stage of labor is recommended.

      Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that
      is why it is better administered as a continuous intravenous infusion to achieve sustained
      uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with
      prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity
      may theoretically offer advantages over oxytocin in the management of the third stage of
      labor. The side-effect profile of carbetocin was not found to be different from that of
      Oxytocin but may prove to be advantageous when compared to Syntometrine.
    

Intervention name(s): oxytocin; oxytocin plus misoprostol; Carbetocin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patient will be received oxytocin 20 IU by intravenous infusion; The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol; The patient received Carbetocin 100 mic gm
Other intervention name(s): Active comparator; Active Comparator; Active Comparator
Intervention MeSH terms: Misoprostol; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a prospective double-blind randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum Hemorrhage; vaginal delivery; carbetocin; misoprostol; oxytocin
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the
      survival of subjects with COPD and also assess the long term safety profile of this drug.
    

Detailed description: 
      A multicenter, randomized, double-blind, parallel group, placebo controlled study to
      investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and
      fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of
      subjects with chronic obstructive pulmonary disease over 3 years of treatment.
    

Intervention name(s): Salmeterol 50mcg/ Fluticasone Propionate 500mcg
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: mortality; TORCH; SERETIDE; ADVAIR; COPD
Intravenous Streptokinase in Acute Myocardial Infarction
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether the administration of intravenous streptokinase (SK) early in the course
      of acute, transmural myocardial infarction would limit myocardial damage.
    

Detailed description: 
      BACKGROUND:

      Determination of the potential value of thrombolytic therapy in patients with acute
      myocardial infarction was an issue of major importance in 1983. An estimated 1.4 million
      heart attacks occurred each year, of which over 500,000 were fatal. Reduction of mortality
      required an effective means to reduce infarct size. Studies indicated that reperfusion
      represented a potent means of achieving salvage of ischemic myocardium. Pilot clinical
      studies indicated that reperfusion could be achieved in a substantial percentage of patients
      by lysis of coronary thrombosis with both intracoronary and intravenous streptokinase
      administration. Intracoronary thrombolysis was receiving widespread clinical applications but
      had many limitations. The intracoronary route took 90-120 minutes longer to administer than
      the intravenous route. Because intracoronary therapy required the availability of a
      catheterization laboratories and highly skilled invasive cardiologists, this treatment was
      not available to large numbers of patients who were hospitalized in smaller community
      hospitals.

      DESIGN NARRATIVE:

      Randomized design with two groups and fixed sample size. Control patients received routine
      coronary care. The treatment group received intravenous streptokinase plus conventional care.
      This was followed with intravenous heparin and warfarin. The primary endpoint was 14 day
      mortality. Secondary endpoints included angiographic patency of the involved coronary artery
      at 10 to 14 days, left ventricular function, segmental wall motion analysis, and myocardial
      infarction size at 30-45 days.
    

Intervention name(s): streptokinase
Intervention type(s): Drug
Intervention MeSH terms: Streptokinase
Allocation: Randomized
Primary purpose: Treatment
A Bioequivalence Study of Glibenclamide From Glibesyn 5 mg Tablets (Medochemie LTD Cyprus) and Daonil 5 mg Tablets (Sanofi-Aventis Cyprus Ltd. )
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Glibenclamide from Glibesyn 5 mg tablets (Manufactured by Medochemie LTD
      Cyprus) and Daonil 5 mg tablets (Sanofi-Aventis Cyprus Ltd. ) after a single oral dose
      administration of each to healthy adults under fasting conditions
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically
      transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Glibesyn; Daonil
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 5 mg Glibenclamide; 1 tablet contains 5 mg Glibenclamide
Other intervention name(s): Glibenclamide; Glibenclamide
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
Condition: Diabetes Mellitus Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the investigators study was to compare for the first time efficacy and safety of
      intravenously administered GLP-1 with an established intravenous insulin regimen in
      hyperglycaemic type 2 diabetic patients.
    

Detailed description: 
      Intervention studies in patients with acute myocardial infraction or cardiac surgery, using
      intravenously administered human insulin, suggest that normalization of hyperglycemia can
      reduce morbidity as well as mortality in these patients. Insulin-based regimens require
      frequent blood glucose measurements and adjustments of infusion rate to achieve
      normoglycemia.

      In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1
      (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in
      a glycemia-dependent manner and therefore does not cause hypoglycemia.

      The aim of our study was to compare for the first time efficacy and safety of intravenously
      administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2
      diabetic patients.
    

Intervention name(s): GLP-1; Human regular insulin intravenously
Intervention type(s): Drug; Drug
Intervention description(s): Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.; Human regular insulin intravenously according to the Munich-registry.
Other intervention name(s): GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland); Insulin Actrapid, NovoNordisk, Denmark
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus type 2, GLP-1, insulin infusion
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Condition: Bone Density; Bone Loss; Anorexia Nervosa; Eating Disorder; Atypical Anorexia Nervosa
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to
      investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators
      hypothesize that 12 months of denosumab administration will result in an increase in bone
      mineral density, decrease in markers of bone resorption and improvement in bone
      microarchitecture in osteopenic women with anorexia nervosa compared with placebo.

      An optional extension study will offer subjects 12-month administration of open-label
      alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab
      or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label
      alendronate will result in a greater increase in BMD compared to 12 months of placebo
      followed by 12 months of open-label alendronate. Within the group of women who receive
      sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we
      hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.
    


Intervention name(s): Denosumab 60 MG [Prolia]; Placebo Injection; Alendronate 70Mg Tab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Denosumab 60mg injection at baseline and 6 months; Placebo Injection at baseline and 6 months; Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Intervention MeSH terms: Denosumab; Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cerebral and Peripheral Perfusion Pilot Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic,
      adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will
      beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in
      the brain, improving cerebral perfusion, increasing brain activity patterns, and improving
      blood vessel function.
    

Detailed description: 
      Treatment with cholesterol-lowering medications, specifically statins, is associated with up
      to a 73% reduction in the prevalence of AD, suggesting a potentially promising role for
      statins in the prevention of AD. In order to better understand the mechanisms through which
      statins may possibly modify blood AD risk, this study evaluated whether administration of
      atorvastatin favorably altered blood flow in the brain (measured by magnetic resonance
      imaging (MRI)) and blood vessel function (measured by ultrasound).

      Participants attended 3 visits over the course of the 4-month study. At the initial visit,
      participants completed a short questionnaire about their past medical history and medication
      history. At the baseline visit, participants were randomized in a 1:1 ratio to receive
      atorvastatin 40 mg nightly vs. matching placebo. At baseline and follow-up visits,
      participants provided an update on medical problems and medications, reviewed any potential
      side effects, and had fasting blood tests collected for safety monitoring, including liver
      and muscle enzyme monitoring. In addition, all participants had MRI and ultrasound measures
      collected.
    

Intervention name(s): atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg daily for 4 months; Matching placebo daily for 4 months
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cerebral blood flow
Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae
Condition: Vaginal Delivery
Study type: Interventional
Phase: Phase 4

Summary: 
      A case control study conducted on 120 women coming to Cairo University Maternity Hospital
      .Patients who meet the inclusion criteria were asked to participate in the study and a verbal
      consent was obtained from each patient. Patients will be divided into three equal groups (A,
      B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected
      intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in
      bed. Vaginal examination will be conducted every two hours. The duration of the first stage
      was calculated from the time of cervical dilatation of three to four centimeters in active
      labour until a fully dilated cervix will be observed
    

Detailed description: 
      A case control study conducted on 120 women coming to Cairo University Maternity Hospital
      .Patients who meet the inclusion criteria were asked to participate in the study and a verbal
      consent was obtained from each patient. Patients will be divided into three equal groups (A,
      B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected
      intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in
      bed. Vaginal examination will be conducted every two hours. The duration of the first stage
      was calculated from the time of cervical dilatation of three to four centimeters in active
      labour until a fully dilated cervix will be observed
    

Intervention name(s): hyoscine butylbromide; saline
Intervention type(s): Drug; Drug
Intervention description(s): 20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor; 0.9%normal saline
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Normal labour; Augmentation of labour; Hyoscine butylbromide
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Observational

Summary: 
      This is a descriptive prospective community-based seroprevalence study.

      Primary objective:

        -  To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against
           dengue in healthy 5 to 10 year-old children in India.

      Secondary objectives:

        -  To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies
           in positive (IgG) samples

        -  To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in
           healthy 5 to 10 year-old children in India.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants aged between 5 and 10 year-old that are registered in health centers in India.
      
Keywords: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period
      2, after a washout period of at least 5 days, each subject will receive oral doses of
      tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3
      to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared
      between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy
      subjects.
    


Intervention name(s): tafamidis; rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 61 mg capsule; 10 mg tablet
Other intervention name(s): Vyndaqel; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science