bioihbjkbjnl/mcl2 huggingface dataset:
Study on the Bioavailability of SHR0302 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety, and the relative bioavailability of
      SHR0302 tablets with three different formulations in healthy subjects.
    


Intervention name(s): SHR0302; SHR0302; SHR0302; SHR0302; SHR0302; SHR0302
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Group A subjects were given oral F1 、F2 and F3 version SHR0302; Group B subjects were given oral F1 、F3 and F2 version SHR0302; Group C subjects were given oral F2 、F1 and F3 version SHR0302; Group D subjects were given oral F2 、F3 and F1 version SHR0302; Group E subjects were given oral F3 、F1 and F2 version SHR0302; Group F subjects were given oral F3 、F2 and F1 version SHR0302
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The relative bioavailability of SHR0302 tablets with three different formulations
Masking: None (Open Label)
Primary purpose: Other
Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      The purpose of this study is to develop and validate a questionnaire to assess the quality of
      life when the recipients of kidney transplantation switched their medication from tacrolimus
      twice daily (BID regimen) to Advagraf (once daily (QD) regimen of modified release
      tacrolimus).
    

Detailed description: 
      This study will develop and validate a questionnaire to assess the health-related quality of
      life when switching from tacrolimus twice daily (b.i.d) regimen to once daily (q.d) regimen
      after kidney transplantation.

      In-depth interviews are conducted to develop questionnaire items, and the interviewees are as
      follows: participants who have received tacrolimus b.i.d for a minimum of 6 months to a
      maximum of 12 months, and who are within 1 month of switching to Advagraf (q.d regimen of
      modified release tacrolimus).

      The time required for the in-depth interview is approximately 30 minutes to one hour.

      After questionnaire items are developed, survey participants for validation are as follows:
      the first survey is conducted on participants who have received tacrolimus b.i.d for a
      minimum of 6 months to a maximum of 12 months during the period. The second survey is
      conducted within one month after switching to Advagraf (q.d regimen of modified release
      tacrolimus).

      At the validation stage, the survey using the developed questionnaire is conducted twice,
      once during the b.i.d. regimen and once after switching to the q.d. regimen.
    

Intervention name(s): Qualitative interviews with participants
Intervention type(s): Behavioral
Intervention description(s): For the development and validation of a questionnaire.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who underwent kidney transplantation
      
Keywords: Behavioral; Questionnaire development; Questionnaire; Interview with patients; Observational; Tacrolimus; Patient reported outcome tool; Validation; Kidney transplantation
R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the combination of efficacy of the combination of rituximab, bendamustine,
      mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
    

Detailed description: 
      Assess the combination of efficacy and safety of the combination of rituximab, bendamustine,
      mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are
      refractory or in relapse.
    

Intervention name(s): Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Intervention type(s): Drug
Intervention description(s): Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
Other intervention name(s): R-BMD
Intervention MeSH terms: Dexamethasone; Rituximab; Bendamustine Hydrochloride; Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type
      psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites
      in North America and Europe.
    


Intervention name(s): M1095 (Sonelokimab); Placebo; Secukinumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.; Placebo contains no active drug.; Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Other intervention name(s): Sonelokimab; Cosentyx®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the
      meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of
      the two vaccines given separately in healthy adolescents and young adults.
    


Intervention name(s): Meningococcal vaccine GSK134612; Boostrix®
Intervention type(s): Biological; Biological
Intervention description(s): One dose administered intramuscularly (IM) in the deltoid muscle of the arm.; One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Other intervention name(s): MenACWY-TT; Nimenrix; Tdap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Young adults; Adolescents; Reactogenicity; Diphtheria; pertussis; Immunogenicity; Tetanus; Meningococcal vaccines; Safety; Neisseria meningitidis; Healthy
Daily Protein Intake Distribution and MPS (ARCIII)
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      To determine whether a balanced total daily dietary protein distribution supplemented with
      whey protein during a weight-loss intervention will result in increased muscle protein
      synthesis
    


Intervention name(s): whey protein; placebo
Intervention type(s): Other; Other
Intervention description(s): whey protein.; placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypotheses under test are that alcohol dependent subjects treated with
      mifepristone will report decreased craving for alcohol following alcohol exposure in the
      laboratory and report significantly less drinking under naturalistic conditions, than those
      treated with placebo.
    


Intervention name(s): Korlym (mifepristone); Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg/day, oral pill, 7 days; 600 mg/day, oral pill, 7 days
Other intervention name(s): Mifepristone; C-1073; Mifeprex; RU-486; Placebo
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Alcohol; Relapse
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion; Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      It is not unusual for several children operated for severe adenoid hyperthrophy causing
      breathing problems to have otitis media with effusion simultaneously. It is unknown whether
      adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy
      alone in terms of otitis media related quality of life and recurrence of otitis media several
      months after the operation. For this purpose a randomized trial is conducted including
      children operated for adenoid hyperthrophy and whose otitis media with effusion had caused
      minimal or no symptoms so far
    


Intervention name(s): adenoidectomy, myringotomy, tubes insertion; A-M
Intervention type(s): Procedure; Procedure
Intervention description(s): adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M); adenoidectomy and myringotomy alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
Nourishing the Community Through Culinary Medicine
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to adapt existing Nourish Program curriculum for synchronous
      virtual delivery,to implement adapted virtual Culinary Medicine (CM)curriculum among target
      population, to assess if program participation improves participant dietary behaviors,
      nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if
      program participation improves patient levels of HbA1c, Body Mass Index, Blood Pressure, HDL,
      LDL and Triglycerides above standard of care and to determine the feasibility and
      reproducibility of virtual synchronous CM classes in patients with diabetes.
    


Intervention name(s): Virtual Culinary Medicine
Intervention type(s): Behavioral
Intervention description(s): The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly). Participants will cook and engage virtually (with video and sound on) from their home kitchens via the digital platform. Participants will also be expected to shop for groceries ahead of the sessions to participate in the program. A gift card will be provided for groceries ($20 per class = $100 total).Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions. Recipes will provide enough food for a family of four. clinic patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to compare the effectiveness of three combination treatments for
      uncomplicated malaria when given in operational settings, without supervision of doses other
      than the first dose.
    

Detailed description: 
      Children aged 0.5-10 years presenting at health centres with fever or history of fever and
      other symptoms suggestive of malaria will be screened; children found to have uncomplicated
      Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or
      SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will
      be given to the child's parent to be administered at home, unsupervised by the study team.
      Patients will be visited at home three days later. Unused medication will be counted and the
      mother will be asked about the number of doses the child received and any side effects.
      Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for
      packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by
      day 28. Analysis will be by intention to treat.
    

Intervention name(s): Amodiaquine plus artesunate (AQ/AS); Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ); Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Artesunate; Chloroquine; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria treatment; artemisinin based combination therapy; Plasmodium falciparum; pragmatic trial; effectiveness
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery
Condition: Gastric Cancer; Anastomotic Leak
MeSH terms: Stomach Neoplasms; Anastomotic Leak
Study type: Observational

Summary: 
      We investigate whether the intravenously administered human albumin is beneficial to prevent
      anastomotic leakage after gastric cancer surgery.
    

Detailed description: 
      Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical
      postoperative complication. Anastomotic leakage severely compromises the recovery after
      surgery. It increases the overall burden of patients and hospital resources. Postoperative
      mortality is higher in patients with anastomotic leakage.

      Human albumin is routinely administered after surgery with a unproven hypothesis that the
      human albumin is beneficial to prevent anastomotic leakage. We investigate whether the
      intravenously administered human albumin is beneficial to prevent anastomotic leakage after
      gastric cancer surgery.
    

Intervention name(s): Human albumin
Intervention type(s): Biological
Intervention description(s): Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.
      
Keywords: Gastric Cancer; Anastomotic leakage; Human albumin
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential
      treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who
      have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to
      one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po
      daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study
      treatment is 3-12 months.
    


Intervention name(s): entecavir; entecavir; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5mg po daily for 8 weeks; 0.5mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Painless Myocardial Ischemia in Diabetic Patients.
Condition: Painless Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      This study aims to investigate the relationship between the concentrations of blood orphanin,
      norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes
      mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for
      screening high risk patients in the diabetes sufferers to prevent the painless myocardial
      ischemia.
    


Intervention name(s): ELISA Test
Intervention type(s): Diagnostic Test
Intervention description(s): The levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Allergens in Inner-City Schools and Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14
      million missed school days per year, and is the number one cause of school absences in
      America. Elementary school children spend 6 to 10 hours a day in school, and most of that
      time is spent in one classroom. The goals of this project are to provide an understanding of
      exposure risk factors specific to the classroom. This is critical, because the classroom
      environment could potentially be considered as an effective target for prevention of
      inner-city asthma morbidity by reducing exposures to many symptomatic children through an
      intervention in the school classrooms.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        elementary school students with asthma
      
Keywords: pediatric; childhood; allergy
Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Study is a 12-week Double blind,controlled experiments designed to examine the possible
      effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative
      stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.
    

Detailed description: 
      In a 12-week randomized controlled trial ( double-blind study), based on data on serum
      25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in
      circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week
      intervention period, the sample size was calculated 40 individuals per treatment group.
      Considering 3 polymorphic variant groups and one control group which receives plain yogurt
      drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a
      total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day
      of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group
      receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and
      oxidative stress markers are evaluated at the beginning and in the end of the interventional
      period.
    

Intervention name(s): Fortified Yogurt Drink; Plain Yogurt Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks; Daily intake of unfortified yogurt drink(500 ml)for 12 weeks
Other intervention name(s): FYD; PYD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Vitamin D fortification; Yogurt Drink; Efficacy
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
Condition: Dose Schedule Study
Study type: Interventional

Summary: 
      To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1
      of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months),
      results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are
      similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2,
      6 months.
    

Detailed description: 
      OBJECTIVES:

      Primary objective:

      To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age
      according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24
      months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are
      similar to those obtained when the vaccine is administered on the standard 3-dose schedule of
      0,2,6 months.

      Secondary objectives:

        1. To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of
           age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or
           0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3
           that are similar to those obtained when the vaccine is administered on the standard
           3-dose schedule of 0,2,6 months.

        2. To describe the safety profile of the administration of Gardasil® according to each of
           the four schedules by assessing:

           (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii)
           solicited (local reactogenicity and fever) and unsolicited events occurring during the
           first 7 days following each vaccination; (iii) serious adverse events occurring up to
           one month following the last dose of vaccine; (iv) deaths or adverse events occurring at
           any time determined to be vaccination-related.
    

Intervention name(s): Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Intervention type(s): Biological
Intervention description(s): Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gardasil; Human Papillomavirus; HPV vaccine; Cervical cancer