bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Condition: Myocardial Diseases; Parvovirus B19, Human
MeSH terms: Parvoviridae Infections; Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective randomized double-blind placebo-controlled trail to investigate the effect of
      high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of
      patients with chronic symptomatic ICM and a high PVB19 load in the heart.
    

Detailed description: 
      Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with
      progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.

      Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin
      (IVIg) in addition to conventional heart failure therapy in patients with idiopathic
      cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in
      conjunction with virus elimination.

      Study design: All patients will undergo routine diagnostic work-up (including physical
      examination, coronary angiogram, transthoracic echocardiogram, blood studies and
      endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients
      will be randomized to either receive IVIg or placebo on top of their standard heart failure
      regimen.
    

Intervention name(s): Intravenous Immunoglobulins; plasma volume expander
Intervention type(s): Drug; Drug
Intervention description(s): 2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days; 10 ml/kg BW will be administrated on four consecutive days.
Other intervention name(s): Nanogam; G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing"); Albuman 40 g/l
Intervention MeSH terms: Plasma Substitutes; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immunoglobulins, Intravenous; Cardiomyopathies; Parvo B19, Human
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of pyronaridine-artesunate and
      artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in
      Kenyan children.
    


Intervention name(s): Pyronaridine-artesunate; Artemether-lumefantrine combination
Intervention type(s): Drug; Drug
Other intervention name(s): Pyramax; Coartem
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
Condition: Chronic Hepatitis
MeSH terms: Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      WRITE study aim at identifying the effectiveness of an innovative individualized schedule of
      treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.
    

Detailed description: 
      The investigators are going to compare weight-based dosages of ribavirin, in combination with
      Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at
      week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will
      discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week
      4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24,
      whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in
      arm B will be treated till week 48.

      A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon
      alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.
    

Intervention name(s): Peginterferon alpha-2a + Ribavirin
Intervention type(s): Drug
Intervention description(s): Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight < or > 75 kg for 24 weeks (Arm A).
Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B).
These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C)
Other intervention name(s): Peginterferon alpha-2a (40 kD) PEGASYS; Copegus or Rebetol, Ribavirin Teva
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: genotypes 2 and 3; combination treatment; individualized treatment
A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study on the effectiveness, tolerability and safety of oral ziprasidone as
      monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD
      will be treated with either ziprasidone or placebo for 12 weeks.

      Hypothesis: There will be a statistically significant difference in the magnitude of
      response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale
      (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be
      greater in the ziprasidone monotherapy group than in the placebo group.
    

Detailed description: 
      Exploratory hypothesis 1: There will be a statistically significant difference in the
      percentage of responders in the two treatment groups; response rates will be significantly
      higher for the ziprasidone monotherapy compared to the placebo group.

      Exploratory hypothesis 2: The change in 6-VAS-D scores during the trial will be highly
      correlated to the change in HAM-D-17 and QIDS-SR during the trial.
    

Intervention name(s): Ziprasidone; Ziprasidone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.; 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.; 0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo
Other intervention name(s): Geodon; Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Major Depression; Depression; Geodon; Ziprasidone
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day
      quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected
      patients were randomly assigned to a 7-day standard triple therapy (pantoprazole,
      clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and
      amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a
      further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and
      metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter
      pylori eradication rates between three groups.
    

Detailed description: 
      The purpose of this study is to compare the effectiveness of three H. pylori eradication
      regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7
      days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by
      pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple
      therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

      A total of 306 subjects are enrolled into this study.

      H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day
      sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a
      follow-up endoscopy with rapid urease test and histological examination eight weeks after the
      H. pylori therapy. The eradication rates of three groups will be compared.
    

Intervention name(s): 7-day quadruple therapy; 10-day sequential therapy; 7-day standard triple therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days; pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days; pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Other intervention name(s): Pantoprazole, amoxicillin, clarithromycin, metronidazole; sequential group; pantoprazole, clarithromycin, amoxicillin
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori infection
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan
      for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
    

Detailed description: 
      The study will include 116 patients who are planned for hip or knee replacement. Patients
      will randomized in 2 groups. 1-st group will receive BCD-080 at dose 30 mg every 12 hours
      during 14 days after surgery, 2-d group will receive Clexane at the same dose. Efficacy
      assessment will include frequency of deep vein thrombosis (DVT) (proximal and/or distal;
      symptomatic or asymptomatic), symptomatic nonlethal thromboembolia of the pulmonary artery
      (PATE) and venous thromboembolism death. Safety assessment will include frequency of "big",
      "small" and other bleedings and frequency of heparin induced thrombocytopenia.The assessment
      of efficacy and safety parameters will be made during the treatment and follow-up period
      (till 60 day).
    

Intervention name(s): Sodium Enoxaparine
Intervention type(s): Drug
Intervention description(s): 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
Other intervention name(s): Clexane (Sodium Enoxaparine); BCD-080 (Sodium Enoxaparine)
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Deep vein thrombosis; Prophylaxis; Sodium enoxaparin
Evaluation of Vitamin D Status in Children With Acute Burns
Condition: Burns; Bone Demineralization
MeSH terms: Bone Demineralization, Pathologic; Burns
Study type: Interventional
Phase: Phase 1

Summary: 
      To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
    

Detailed description: 
      The purpose of this study is to follow up our descriptive observations with a prospective
      randomized double blinded study to verify our clinical perception that hypovitaminosis D is
      prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific
      primary outcome measures during burn convalescence.
    

Intervention name(s): Vitamin D2; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily enteral dose of 100IU/kg; Daily enteral dose of 100IU/kg
Other intervention name(s): ergocalciferol; cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D
The Effect of General Anesthesia on the Middle Ear Pressure
Condition: Ear Deformities, Acquired
MeSH terms: Ear Deformities, Acquired
Study type: Interventional

Summary: 
      The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in
      patients who do not have any ear pathology and undergo surgery under general anesthesia, on
      the MEP.
    

Detailed description: 
      Studies reported that inhalation agents are more likely to have impacts on the middle ear
      pressure compared to intravenous anesthetic agents. Despite numerous studies comparing the
      effects of inhalation agents on the middle ear pressure, this is the first clinical trial in
      which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other
      anesthetic analgesic agents used, on the middle ear pressure were compared. Our purpose in
      this study was to investigate the effect of sevoflurane and desflurane, inhalation agents
      used in patients who do not have any ear pathology and undergo non-ear surgery under general
      anesthesia, on the middle ear pressure.
    

Intervention name(s): desflurane,; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Patients were divided into two groups according to inhalation agent administered for the surgery; Sevofluran, Group S (n=25) and Desfluran, Group D (N=25).; For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).
Other intervention name(s): suprane; sefoflurane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: middle ear pressure; sevoflurane; desflurane
Effect of Piroxicam on Ovulation
Condition: Contraception, Postcoital
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam
      will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone
      which triggers ovulation).

      Additionally blood levels of endogenous hormones (hormones produced by your body) will be
      measured and transvaginal ultrasound examinations will be conducted at regular intervals. In
      addition the concentration of piroxicam in blood will be determined in regular intervals.

      With regards to the tolerability of the study drug subjects will be asked regularly how they
      feel.
    


Intervention name(s): Piroxicam ( BAYl1902); Piroxicam ( BAYl1902); Placebo; Piroxicam ( BAYl1902)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule); Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule); Single dose of placebo (i.e., 4 placebo capsules); Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Emergency contraception; Contraception
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects
Condition: Glucose Homeostasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a
      single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT)
      in 16 healthy males
    

Detailed description: 
      Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1
      is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to
      rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of
      GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An
      oral delivery system would mimick the physiological path of endogenous secretion. Objective:
      We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2
      mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy
      males.
    

Intervention name(s): Oral GLP-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLP-1 tablet (2mg); Control tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLP-1; insulin; glucose
A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu® 75 mg Caps (Hoffmann-La Roche, Switzerland)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and
      Tamiflu® 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences
      ,California ,USA after a single oral dose administration of each to healthy adults under
      fasting conditions.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (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): Oseltamivir; Tamiflu®
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 75 mg oseltamivir; 1 tablet contains 75 mg oseltamivir
Other intervention name(s): Tamiflu®
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg
      dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients
      suffering from vulvovaginal candidiasis, to assess safety of the two medications during the
      treatment, and to evaluate women's satisfaction with the two treatments.
    


Intervention name(s): Fluomizin vaginal tablets; Canesten vaginal tablets
Intervention type(s): Drug; Drug
Intervention description(s): One vaginal tablet for 6 days and 1 placebo tablet on day 7; one vaginal tablet for 7 days
Other intervention name(s): 10 mg dequalinium chloride vaginal tablets; Donaxyl vaginal tablets; Naxyl vaginal tablets; 100mg clotrimazole vaginal tablets
Intervention MeSH terms: Clotrimazole; Dequalinium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vulvovaginal candidiasis; vulvovaginal candidosis; mycotic vaginal infection; dequalinium chloride; Fluomizin; clotrimazole; canesten
Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity
Condition: Sepsis; HBP
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      the aim of the study is to correlate between the severity of sepsis and serum heparin binding
      protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic
      biomarker in sepsis
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult confirmed septic patients
      
Biospecimen description: 
      serum blood sample
Effect of Metabolaid® on AMPK Activation for Weight Loss
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The objective of this study was to establish a formulation, containing both Hibiscus
      sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant
      capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the
      hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in
      light-to-moderate-overweight subjects under risk of developing metabolic syndrome.
    

Detailed description: 
      AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the
      amelioration of obesity-related diseases, where most therapeutic approaches have failed.
      Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic
      disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS)
      and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride
      accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary
      supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and
      randomized trial in 56 overweight subjects for two months. Anthropometric and circulating
      biochemical parameters were determined.
    

Intervention name(s): Metabolaid®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg per day, in fasting conditions.; 500 mg per day, in fasting conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention