bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Evacetrapib in Healthy Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if two different dosing strategies for evacetrapib
      will have essentially the same effect on the body. The study will also explore the effect of
      a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,
      not including screening. Screening is required within 28 days prior to the date of first
      dosing.
    


Intervention name(s): Evacetrapib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of
      ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter
      ablation of AF. Integration of a previously acquired image of the left atrium into the
      electroanatomical (EA) map offers several potential advantages, including visualisation of
      the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results .
      The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM,
      etc). Although both systems have been independently validated, their clinical utility has not
      previously been directly compared in a randomised trial
    

Detailed description: 
      Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter
      ablation procedure and data is collected. Both systems are routinely used in our clinical
      practise. This is a comparison trial of 2 mapping technologies.
    

Intervention name(s): NavX Fusion; Cartomerge
Intervention type(s): Procedure; Procedure
Intervention description(s): Using NavX Fusion to guide catheter ablation; Guidance of catheter ablation using Cartomerge guidance
Other intervention name(s): NavX Fusion (St Jude) - electroanatomic mapping; Cartomerge (Biosense Webster) - electroanatomic mapping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3D mapping; Image integration; Atrial fibrillation; Catheter Ablation
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
Condition: B-cell Non Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether SCT400 is safe and effective in the
      treatment of B-cell Non Hodgkin's lymphoma
    


Intervention name(s): Chimeric anti-CD20 monoclonal antibody
Intervention type(s): Biological
Other intervention name(s): SCT400
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chimeric anti-CD20 monoclonal antibody(SCT400); escalating doses; safety; pharmacokinetics and pharmacodynamics
Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study
Condition: Heterotaxy Syndrome
MeSH terms: Heterotaxy Syndrome; Syndrome
Study type: Observational

Summary: 
      Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along
      the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly
      associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA).
      Advances in cardiac surgery have improved HS mortality such that there is increasing
      attention to IRA and their management. The objective of this research project is to
      prospectively observe a cohort of infants with HS and IRA and evaluate their long term
      outcomes. Specifically, the investigators would like to determine what is the natural history
      of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to
      an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators
      plan a prospective, multi-center, observational study to follow this complicated group of
      patients. This will be a web-based database collected from major cardiac tertiary care
      centers in both Canada and the United States. Patients with HS will be recruited by their
      primary site and clinical data will be collected by their primary site prospectively
      throughout childhood until they are at least five years of age. This patient population will
      be followed by their own clinical care givers; this is not an interventional study. No
      additional clinic visits will be required and the patients will not have to be contacted.
      Patient medical records will be accessed by a member of the study team at the primary site at
      least once per year or more frequently if interventions are required or complications
      develop.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All infants with heteterotaxy syndrome whose families provide written informed consent.
      
Keywords: Pediatrics; Congenital heart disease; Heterotaxy syndrome; Intestinal malrotation
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
Condition: Type 1 Diabetes; Lipoatrophy
MeSH terms: Lipodystrophy; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether a zinc-free insulin is an effective
      treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump
      (CSII, continuous subcutaneous insulin infusion) therapy.
    

Detailed description: 
      Randomized, controlled, open-label parallel study. Clinical Study Phase IV After being
      included in the study, subjects are getting an extensive dermatological examination by a
      pediatric dermatologist familiar with cutaneous complications of T1D, additionally
      pathological results will be documented by photography and, if necessary, videodermoscopy.
      Additionally, an evaluation of their lipoatrophic areas using imaging methods like ultrasound
      (USG) and MRI will be performed. After randomization, half of the included children switch
      their pump insulin into insulin glulisine (intervention group) for 6 months. The others
      continue their current treatment (control group) and switch to insulin glulisine 6 months
      later. Both groups are followed-up until month 12. Hence, after the 4th visit at 6 months,
      all enrolled patients are on insulin glulisine pumps for a further period of 6 months.
    

Intervention name(s): Apidra; current insulin
Intervention type(s): Drug; Drug
Intervention description(s): Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.; Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.
Other intervention name(s): Glulisine; short-acting analog insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Lipoatrophy; children; adolescents; adults; insulin therapy
Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans
Condition: Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans
      (PIBO) patients aged 5 years and older of both sexes were enrolled.
    

Detailed description: 
      Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic
      obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI)
      with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea,
      tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest,
      persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation,
      atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on
      pulmonary function test.

      Patients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules
      of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients
      whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and
      Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to
      randomization to active drug or placebo. Pulmonary function and number of exacerbations were
      evaluated. Spirometry and plethysmography were performed at baseline and at 6 months.
      Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first
      second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw).
      Patients had been clinically stable over the previous three weeks.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Placebo with the same color and size than azithromycin tree days a wek for 6 months
Other intervention name(s): placebo
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, double-blind, randomized study
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bronchiolitis obliterans; Azithromycin
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
Condition: HER2-positive Early Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab
      Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab)
      approved in the CN in combination with Docetaxel and Carboplatin in patients with operable
      HER2 positive, with early or locally advanced HER2-positive breast cancer. The hypothesis to
      be tested in this study is the tpCR of patients with Cycle 6 of SIBP-01 is similar to
      CN-approved trastuzumab, using a 90% bilateral confidence interval between 0.74 and 1.5.
    


Intervention name(s): SIBP-01; Herceptin; Docetaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IBP-01: injection; strength: 150mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles; Herceptin: injection; strength: 440mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles; Docetaxel: injection; dose 75mg/m2, 75mg/m2 once every 3 weeks (intravenous infusion, not less than 60 minutes, on the 1st day of each cycle), totaling 6 cycles;; Carboplatin: injection; dose AUC6, AUC6 once every 3 weeks (intravenous infusion, not less than 30 minutes, on the 1st day of each cycle), totaling 6 cycles;
Other intervention name(s): Herceptin Biosimilar; Trastuzumab; Docetaxel Injection; PARAPLATIN®，Carboplatin Injection
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, randomized, single-blind, positive drug parallel controlled equivalence clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
Condition: Urothelial Cancer
Study type: Observational

Summary: 
      This is observational clinical trial to study adult urothelial cancer patients treated with
      cisplatin-based neoadjuvant chemotherapy.

      Hypothesis: Identification of genetic and molecular "cisplatin susceptibility" biomarkers
      will allow identification of urothelial cancer patients most likely to benefit from
      cisplatin-based neoadjuvant chemotherapy.
    

Detailed description: 
      In this trial patients will submit germline (blood) and tumor tissue samples as part of two
      existing sample collection protocols for analysis of genetic and molecular markers governing
      response to chemotherapy. Pathologic review of tissue samples after neoadjuvant therapy will
      allow determination of the complete response rate (pT0 rate) and this will be compared
      between patients with "susceptible" and "resistant" genetic/molecular cisplatin
      susceptibility variants.

      Primary Endpoint: Analysis of whether a small set of previously-identified germline
      "cisplatin susceptibility" polymorphisms associate with achievement of a complete pathologic
      response to neoadjuvant cisplatin-based chemotherapy in urothelial cancer patients.

      Secondary Endpoints: To perform companion genetic or molecular analyses of other
      previously-identified gene, SNP, or microRNA "cisplatin susceptibility" candidates in these
      patients, using tumor and/or germline tissue.

      Exploratory Endpoints: To perform unbiased, hypothesis-generating SNP, gene, or microRNA
      array studies to identify novel germline or tumor determinants which may predict response to
      cisplatin-based chemotherapy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eligible patients who are about to begin neoadjuvant cisplatin-based chemotherapy for
        urothelial cancer and who have consented to IRB approved protocols #15550B and/or TRIDOM
        (IRB #14104B).
      
Biospecimen description: 
      Blood (germline) and tumor tissue samples will be used to perform genetic analysis. The
      purpose of this analysis is to determine whether a set of "cisplatin susceptibility"
      polymorphisms predict complete pathologic response to cisplatin-based chemotherapy and to
      identify novel determinants which may predict response to cisplatin-based chemotherapy.

      Samples will be biobanked for future analysis of genetic determinants.
    
Keywords: Urothelial, cancer, cisplatin, neoadjuvant, chemotherapy, germline
Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol
Condition: Nursing Caries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency
      and salivary cortisol level among the 1st Year Nursing Students.

      This is a randomized controlled study using pre-post-test design with control group. The
      population of our research; Ankara University Faculty of Health Sciences Nursing Department
      consisting of 202 students studying at the First Year.
    

Detailed description: 
      The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency
      and salivary cortisol level among the 1st Year Nursing Students.

      This is a randomized controlled study using pre-post-test design with control group. The
      population of our research; Ankara University Faculty of Health Sciences Nursing Department
      consisting of 202 students studying at the First Year. A descriptive question form will apply
      to the entire population of the research.191 students fulfilling the criteria of this study
      will be included. Eleven students who have not fullfilled this criteria the inclusion
      criteria will be excluded from the study. Power analysis has been performed and the required
      sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of
      error. Sample of the study consistsof 75 students considering the possibility of students
      leaving the research. This 75 students will be divided into two groups as intervention group
      (n=38) and control group (n=37). Intervention and control group have been randomly selected
      among Ankara University Faculty of Health Sciences Nursing Department.
    

Intervention name(s): Laughter yoga
Intervention type(s): Behavioral
Intervention description(s): 440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cortisol; Laughter Yoga; Mental Symptom; Nursing; Student
RW Effectiveness of Lurbinectedin in Extensive Stage SCLC
Condition: Small-cell Lung Cancer
MeSH terms: Small Cell Lung Carcinoma
Study type: Observational

Summary: 
      LURBICLIN cohort will describe the demographic and clinical characteristics of patients who
      received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate
      effectiveness and safety of lurbinectedin in real-world conditions.
    

Detailed description: 
      LURBICLIN cohort will describe the demographic and clinical characteristics of patients who
      received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate
      overall survival, real world progression-free survival, best response and duration of
      treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received
      lurbinectedin as part of the French Early Access Program (ATU). Previous and subsequent
      treatments (treatment delivered immediately after treatment with lurbinectedin) will be
      recorded. Those outcomes will be correlated to clinical, pathological, and radiological
      characteristics of patients.
    

Intervention name(s): Lurbinectedin
Intervention type(s): Drug
Intervention description(s): Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with histologically or cytologically confirmed extensive stage Small Cell Lung
        Cancer who received at least one dose of treatment with lurbinectedin as part of the French
        Early Access Program (ATU program).
      
Keywords: IFCT; Small-cell Lung Cancer; Lurbinectedin; Real-world study
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)
      on the levodopa pharmacokinetics when administered in combination with a single-dose of
      controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).
    

Detailed description: 
      Single centre, double-blind, randomized, placebo-controlled, crossover study with four
      consecutive single-dose treatment periods. The washout period between doses was to be at
      least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after
      completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly
      with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to
      be discharged 72 h post-dose.
    

Intervention name(s): BIA 9-1067; Placebo; Madopar® HBS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OPC, Opicapone; PLC, Placebo; controlled-release levodopa 100 mg/benserazide 25 mg
Other intervention name(s): OPC, Opicapone; PLC, Placebo
Intervention MeSH terms: Opicapone; Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); Opicapone; BIA 9-1067
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and evaluate the single-dose oral bioavailability and
      to monitor the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral
      bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg
      Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fasting
      conditions.
    

Intervention name(s): Atorvastatin Calcium Tablets, 80 mg
Intervention type(s): Drug
Intervention description(s): Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other intervention name(s): Lipitor 80 mg Tablets
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Atorvastatin calcium; crossover