bioihbjkbjnl/mcl2 huggingface dataset:
Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to investigate the impact of the oral contraceptive YASMIN
      (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral
      contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on
      factors of blood coagulation and fibrinolysis in female subjects
    


Intervention name(s): Yasmin (DRSP 3mg/EE 0.03 mg); Microgynon (LNG 0.15 mg/EE 0.03 mg)
Intervention type(s): Drug; Drug
Intervention description(s): The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).; The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Contraception; Hemostasis; Blood Coagulation
Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome; Dyslipidaemia
MeSH terms: Metabolic Syndrome; Dyslipidemias; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial
      dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial
      hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation
      and the risk of atherosclerosis.
    


Intervention name(s): nicotine acid; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication; 16 weeks treatment with placebo
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). It is demonstrated that
      intensive insulin therapy resulting in good glycaemic control can reduce or delay the
      incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an
      ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin
      injection (CSII) therapy in the pediatric and adolescent age population. This trial compares
      the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered
      by CSII in children and adolescents with type 1 diabetes.
    


Intervention name(s): insulin lispro; insulin aspart
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes, Type 1
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere
      alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.
      Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either
      1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle
      or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study
      treatment is until disease progression, and the target sample size is 500+ individuals.
    


Intervention name(s): capecitabine [Xeloda]; Taxotere; Taxotere
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 825mg/m2 po bid on days 1-14 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle; 100mg/m2 iv on day 1 of each 3 week cycle
Intervention MeSH terms: Capecitabine; Docetaxel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Double Blind Atorvastatin Amlodipine Study
Condition: Angina
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the
      combination in patients with symptomatic myocardial ischemia.

      Amlodipine's use in angina has been well documented in clinical trials such as the Circadian
      Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical
      practice has not been tested. Furthermore, the potentially synergistic benefit of
      atorvastatin and amlodipine on inflammation ischemic activity has not been studied.
    


Intervention name(s): amlodipine; atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
Condition: Visceral Leishmaniasis; Malnutrition
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral; Malnutrition
Study type: Observational

Summary: 
      The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess
      the association between malnutrition and visceral leishmaniasis (VL). It was conducted in
      Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical,
      anthropometric, biochemical, immunological, parasitological and sociodemographic data of
      school age children from VL high prevalence communities were collected in December 2009, May
      2010 and February 2011.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        School age children from VL high prevalent communities of Libo Kemkem and Fogera districts
        in Amhara Regional State, Ethiopia
      
Keywords: Visceral leishmaniasis; kala azar; malnutrition; stunting; thinness; Leishmania donovani
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia (TD)
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
      persistence of effect of valbenazine 40 mg and 80 mg.
    


Intervention name(s): Valbenazine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Other intervention name(s): Ingrezza, NBI-98854
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual
      misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
    

Detailed description: 
      Uterine atony is the main cause of PPH; therefore, active management of the third stage of
      labor has emerged as a most actual tool in its prevention. The previous study in Egypt
      recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an
      antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin.
      Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced.
      In previous studies, its safety has been confirmed for use in non-pregnant women, with no
      thromboembolic complications. TA is an inexpensive, widely available medicine that has been
      shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
    

Intervention name(s): misoprostol; Carbetocin; TA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patient receive 600mic gm sublingual misoprostol; Patient receive 100 mic gm carbetocin IV; The patient receives 1gm oral tranexamic acid
Other intervention name(s): Active comparator; Active Comparator; Active Comparator
Intervention MeSH terms: Misoprostol; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a prospective double-blind randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum Hemorrhage; vaginal delivery; tranexamic acid; misoprostol
The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
Condition: Asthma; Obesity; Inflammation
MeSH terms: Asthma; Overweight; Inflammation
Study type: Interventional

Summary: 
      Background: In recent years, the prevalence of both asthma and obesity has risen dramatically
      among children and adolescents in the United States. Given the concurrent rise in the two
      epidemics, there may be an underlying link. Obesity contributes to asthma severity and
      control, and may play a role in its underlying cause. Obesity is associated with a state of
      heightened inflammation that may lead to an increase asthma symptoms and severity. Obese
      adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better
      asthma control than those treated with other standard asthma medications. The use of
      montelukast in obese children and adolescents has not been specifically studied.

      Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and
      objective markers of asthma to a greater degree in obese, as opposed to non-obese children
      and adolescents. The investigators would like to determine if the use of montelukast will
      improve objective asthma scores, pulmonary function, markers of inflammation and medication
      use to a greater degree in obese as opposed to non-obese children/adolescents.

      Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a
      tailored approach focused on obese asthmatic children may help reduce the burden of this
      disease, health care costs and potential long-term complications as these children enter
      adulthood. Furthermore, this study may help clarify the underlying mechanisms that link
      asthma and obesity. Although this proposal is focused on one medication, it provides an
      example of how certain medications may have differential efficacy in the obese asthmatic.
    


Intervention name(s): Montelukast; Placebo; Montelukast; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Age-dependent dose, nightly, 24 weeks; Age-dependent dose, nightly, 24 weeks; Age-dependent dose, nightly, 24 weeks; Age-dependent dose, nightly, 24 weeks
Other intervention name(s): Singulair; Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Obesity; Pediatric; Inflammation; Leukotriene; Montelukast
Modafinil for Atypical Depression
Condition: Atypical Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil
      in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of
      atypical depression. The hypothesis is that modafinil is safe and effective in the treatment
      of atypical depression.
    

Detailed description: 
      This study on the safety and efficacy of modafinil on atypical depression has an initial
      12-week open label treatment period with modafinil that is followed by a 12-week
      double-blind, randomized parallel treatment period with either modafinil or matching placebo.
      Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to
      either continuing treatment at their current dose or switched to matching placebo for 12
      weeks.
    

Intervention name(s): modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: atypical depression; psychostimulants; modafinil
The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects
Condition: Antineutrophil Cytoplasmic Antibody Associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability,
      Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
    


Intervention name(s): STSA-1002 subcutaneous injection; STSA-1002 subcutaneous injection
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single low dose on day 1 following protocol requirements.; Subjects will receive a single high dose on day 1 following protocol requirements.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)
Condition: Asthma, Bronchial
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of montelukast, an approved medication,
      on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the
      lower leg length (LLL) growth rate for children treated with montelukast compared to placebo
      will be established.
    

Detailed description: 
      This is a crossover study that consists of a 2-week placebo run-in period, then a first
      3-week treatment period, then a 2-week washout period, and then a second 3-week treatment
      period. Participants will be randomized to treatment with either montelukast and placebo or
      budesonide and placebo. The duration of treatment is 6 weeks.
    

Intervention name(s): Montelukast chewable tablets; Budesonide inhaler; Placebo to montelukast chewable tablets; Placebo to budesonide inhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Montelukast sodium 5 mg chewable tablets; Budesonide 200 mcg inhalation powder; Placebo chewable tablets; Placebo inhalation powder
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effects of Risperidone and Olanzapine on Thinking
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this research is to find ways to maximize the benefits of antipsychotic
      medications for cognition.

      Hypothesis: Risperidone and olanzapine will show greater benefits than conventional
      medications on assessments of social cognition, particularly affect perception and social
      perception.
    


Intervention name(s): Risperidone; Olanzapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; cognition; antipsychotic medication; information processing; social cognition; Psychotic
Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.
Condition: Breast Cancer Metastatic; Breast Cancer Female; Breast Cancer Recurrent
MeSH terms: Breast Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal
      growth factor Receptor). HER2 receptor plays an important role in cell growth and
      differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive
      malignance exacerbates pathology and worsens clinical outcome, such as shortened overall
      survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30%
      overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression
      tumor have disease progression and poor prognosis in metastatic process (8), (9).

      Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth
      of cancer cells has been approved. One of these products is Trastuzumab.

      The study processed on 50 females aged between 18 and 65, recurrent or metastatic breast
      cancer patients with positive HER2.

      The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® +
      docetaxel, in blocks of 4 in a 1:1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be 2
      patients in the experimental group and 2 patients in the control group.

      Primary endpoint is serum peak concentrations (Cmax), area under the curve from 0 to t
      (AUC0-t).

      This trial is intended to assess the biosimilarity of pharmacokinetic parameters, safety
      between Faceptor (experimental drug) and Herceptin (reference).
    


Intervention name(s): Faceptor; Herceptin; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.; Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.; The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.
Other intervention name(s): NNG-TMAB; Trastazumab; Trastuzumab; Taxotere
Intervention MeSH terms: Docetaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group: study drug and reference
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN:
      bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in
      inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The
      purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021
      compared to Avastin. Also study includes pharmacokinetics assessment.
    


Intervention name(s): Bevacizumab; Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).; Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally); Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).
Other intervention name(s): Avastin; BCD-021; Taxacad
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NSCLC; bevacizumab; pharmacokinetics
Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants
Condition: Hypoxic-Ischemic Encephalopathy; Sepsis; Kidney Diseases; Metabolic Disease; Twin to Twin Transfusion Syndrome; Cardiac Disease; Pulmonary Disease
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Kidney Diseases; Heart Diseases; Fetofetal Transfusion; Metabolic Diseases
Study type: Observational

Summary: 
      Historically, CKRT and hemodialysis were performed in small infants and newborns with devices
      developed for adults with high rates of complications and mortality.

      We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use
      and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new
      device in a population of neonates and small infant. Compared to adult's device continuous
      renal replacement therapy with an adapted machine allowed successful blood purification
      without severe complications even in low birth weight neonates.
    


Intervention name(s): CARPEDIEN
Intervention type(s): Device
Intervention description(s): Continuous renal replacement therapy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The population will be selected in a department of pediatric and neonatal unit intensive
        care and whom need a renal replacement therapy