bioihbjkbjnl/mcl2 huggingface dataset:
The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program
Condition: Obesity; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The WORLD study is a single-center, year-long randomized controlled trial in free-living
      women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a
      moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the
      study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1).
      During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with
      the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through
      12, participants shifted into weight maintenance. It was hypothesized that a weight-loss
      intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines
      would be equally effective for weight loss while achieving comparable nutrient adequacy.
      Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate,
      based on the Healthy Eating Index.
    


Intervention name(s): Moderate-fat; Lower-fat
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 35% of calories from fat; 20% of calories from fat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight loss; Weight maintenance; Weight management; Cardiovascular disease risk; Dietary Guidelines; Diet and exercise; Prevention
Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to
      compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.

      Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
    

Detailed description: 
      In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug"
      at Day1/Day43 and "study drug" at Day22/64.

      In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at
      Day1/Day43 and "comparator drug" at Day22/64.
    

Intervention name(s): Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg; Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
Intervention type(s): Drug; Drug
Intervention description(s): White colored oval three-layer tablet; White and pink colored oval two-layer tablet
Other intervention name(s): Study drug; Comparator drug
Intervention MeSH terms: Amlodipine; Telmisartan; Chlorthalidone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim of this study is to further understand the memory response to HPV vaccination
      in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory
      responses can be detected shortly after immunization, the best approach to measure the
      long-lasting anamnestic response is to challenge with a booster dose years (> 5) after the
      original exposure.
    

Detailed description: 
      This is a single center, interventional study to evaluate long term memory response to Q-HPV
      vaccination and to natural infection. Memory response will be assessed by measuring
      seroprotection 8-10 years post Q-HPV vaccination and to challenge with a booster dose years
      after the original exposure to measure the long-lasting anamnestic response.
    

Intervention name(s): Human Papillomavirus 9-valent Vaccine, Recombinant
Intervention type(s): Biological
Intervention description(s): All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
Other intervention name(s): Gardasil9
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a
      Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.
    


Intervention name(s): PF-04965842; Placebo; PF-04965842; Placebo; PF-04965842; Placebo; PF-04965842; Placebo; PF-04965842; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single doses of 3, 10, 30, 100, 200, 400, or 800 mg of PF-04695842 (solution or suspension) in a dose escalation format.; Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.; Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.; Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.; Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.; Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.; Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.; Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.; Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.; Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.
Intervention MeSH terms: Abrocitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Double Blind; Placebo-Controlled; Single- & Multiple Dose Escalation; Safety; Tolerability; PK; PD; Pf-04965842
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose open-label comparative pharmacokinetic study to assess the
      pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra
      (tablet) in healthy male subjects.
    


Intervention name(s): HIP0908; viagra
Intervention type(s): Drug; Drug
Intervention description(s): SINGLE DOSE , CROSS OVER; single dose, cross over
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti erectile dysfunction agent
Evaluation of Astigmatic Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate
      that the investigational contact lens meets the design requirements related to corneal
      staining, lens fit, visual acuity and rotational performance as well as subjective comfort
      and handling. Subjects will wear the contact lenses for a total of 28-36 days.
    


Intervention name(s): Investigational Contact Lens; Marketed Contact Lens
Intervention type(s): Device; Device
Intervention description(s): Senofilcon C Toric; Air Optix for Astigmatism
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-center, open-label, 3 part study. The study is designed to determine
      the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting
      conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980
      tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the
      presence or absence of a high-fat meal.
    


Intervention name(s): GDC-0980; GDC-0980; GDC-0980; GDC-0980; GDC-0980; GDC-0980; rabeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet dose; Oral capsule dose; Oral tablet dose in fed state; Oral repeating dose in fasting state; Oral repeating dose in fed state; Oral tablet in a fasting state; Oral repeating dose
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study was to investigate safety, tolerability, pharmacokinetics
      and pharmacodynamics of BI 1356 BS.
    


Intervention name(s): BI 1356 BS - Powder in bottle (PIB); BI 1356 BS - Tablet; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      A pharmacokinetics and pharmacogenetics study to complement the current knowledge of
      tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at
      steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on
      tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after
      renal transplantation.

      Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus
      immediate release (Prograf®)
    

Detailed description: 
      Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to
      compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84)
      systemic exposure.

      Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies
      (LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of
      CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve
      the optimal dose of Advagraf® for kidney transplant patients.
    

Intervention name(s): Advagraf Capsule; Prograf Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Other Names:
FK506E
MR4
tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent; Other Names:
FK506E
MR4
tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-market Study to Capture Information Regarding Performance of Lyric2
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Randomized post market study comparing Lyric to Lyric2 capturing information regarding
      comparative performance and safety.
    

Detailed description: 
      Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing
      information regarding comparative performance and safety.
    

Intervention name(s): Lyric; Lyric2
Intervention type(s): Device; Device
Intervention description(s): Extended wear hearing instrument; Extended wear hearing instrument
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Mild to moderate hearing loss
A Study Evaluating the Efficacy and Safety of HSK3486
Condition: Sedation and Anesthesia for Adult Colonoscopy Procedures
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, randomized, active controlled, multi-center, parallel group study comparing
      HSK3486 with Propofol, in patients undergoing a colonoscopy.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old; Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to produce information on the pharmacokinetic characteristics (uptake
      into and elimination from the body) of two new patch formulations of the analgesic
      buprenorphine as compared to the reference patch Transtec (Registered Trademark) 35
      micrograms per hour (μg/h) in order to assess the suitability of the test formulations for a
      later confirmatory bioequivalence study.

      In addition to a reduced buprenorphine load, the new patch formulations may potentially
      provide improved wearing properties. A placebo patch formulation of the respective test or
      reference patch will be applied simultaneously to explore the skin tolerability and skin
      adhesiveness of the patch formulations. Furthermore, the safety and tolerability of the
      treatments will be assessed.
    


Intervention name(s): Test Product T1: Buprenorphine patch (9 mg); Test Product T2: Buprenorphine patch (3.8 mg); Reference Product R: Transtec patch (20 mg); Matching placebo patch to T1; Matching placebo patch to T2; Matching placebo patch to R
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Buprenorphine transdermal patch formulation, containing 9 milligrams buprenorphine in an active surface area of 25 square centimeters.; Buprenorphine transdermal patch formulation, containing 3.8 milligrams buprenorphine in an active surface area of 10 square centimeters.; Transtec (Registered Trademark) transdermal patch containing 20 milligrams buprenorphine in an active surface area of 25 square centimeters, release rate 35 micrograms per hour.; Placebo patch to T1.; Placebo patch to T2.; Placebo patch to R.
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-way cross-over (three periods, three treatments and six sequence groups) with single application each. There will be a wash-out period between administrations, i.e., between removal of previous patch and application of new patch of at least 10 days.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
Condition: Mental Disorder
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief
      versus short psychotherapy in subjects with substantial mental complaints.
    

Detailed description: 
      Running evaluations of the brief intervention (BI) at our outpatient clinic preceding to this
      study had given us the impression that the patients obtained a more active coping style
      towards their health problems with consequential enhanced work participation (WP). These
      evaluations, in addition to our experiences in BI for low back pain (LBP) has generated the
      current hypothesis of this study towards WP. Yet, the sustainability of WP and long-term
      effects on mental health remained questionable. In this pragmatic RCT the objective was to
      compare brief psychotherapy with focus on normalization and coping (Brief-PsT) with
      short-term psychotherapy of standard duration with more extended focus (Short-PsT), as
      otherwise used at the Mental Health services. The primary aim of this study was to assess
      differences in effect on WP and the secondary aim was to assess differences in clinical
      response. The investigators hypothesized that in the short term, Brief-PsT could facilitate
      or sustain WP in a superior fashion to Short-PsT in persons who are on, or at risk of sick
      leave due to mental health problems. Although the investigators expected a substantial
      long-term rate of clinical recovery and reduction in mental health-related symptoms in both
      groups, the investigators had no specific hypothesis regarding the extent and direction of
      possible group differences in these clinical measurements.
    

Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pragmatic randomized controled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Return to Work; Brief Intervention
Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The current standard for locally advanced cervical cancer is concurrent cisplatin-based
      chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play
      an important role in cancer progression by silencing growth regulatory genes and there is now
      evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and
      chemotherapy effects.

      Objective. To determine response rate, safety and biological effects of hydralazine and
      magnesium valproate when added to cisplatin chemoradiation.

      Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase
      the clinical complete response rate to 95% as compared to 75% as seen in historical controls
      treated with cisplatin chemoradiation in FIGO stage IIIB patients.

      Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical
      carcinoma with no previous treatment will be included. Patients will be typed for acetylator
      status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at
      40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical
      response rate, safety and transcriptome changes will be analyzed.
    

Detailed description: 
      Eligible patients after signing informed consent will undergo study evaluation and then typed
      for acetylator phenotype before receive either 182 or 83 mg of hydralazine, and magnesium
      valproate at 30mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy.
      External beam radiation will be delivered by megavoltage equipment for a dose of 50gy (2Gy
      fraction from monday to friday) concurrently with cisplatin at 40mg/m2 for six weeks. Within
      one to two weeks, intracavitary brachytherapy (low-dose rate, Cesium sources) will be
      delivered to achieve at least 85Gy to point A. A punch biopsy from the primary tumor will be
      taken at entering the study and at day 8 of hydralazine and valproate treatment (before the
      first dose of cisplatin and radiation)to assess global gene expression profiling by
      microarray analysis. Blood samples will be taken to assess global DNA methylation, histone
      deacetylase activity and plasma levels of hydralazine and valproic acid.

      Clinical response and toxicity will be assessed.
    

Intervention name(s): Hydralazine and magnesium valproate; Punch biopsy of the primary tumor
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Hydralazine; Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical carcinoma; Epigenetic therapy; Hydralazine; Valproate; Microarray analysis
Convalescent Plasma for Patients With COVID-19: A Pilot Study
Condition: Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy
      when there is no vaccine or treatment available for infectious diseases. In the latest viral
      epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization
      issued a document outlining a protocol for the use of whole blood or plasma collected from
      patients who have recovered from the Ebola virus disease by transfusion to empirically treat
      local infectious outbreaks.
    

Detailed description: 
      The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia,
      and through a donation of plasma from the recovered, the subsequent transfusion of this to
      patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific
      evidence regarding the application of convalescent plasma for emergency viral outbreaks and
      has recommended the following protocol
    

Intervention name(s): Plasma
Intervention type(s): Drug
Intervention description(s): Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Other intervention name(s): Convalescent Plasma COVID-19
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus Disease 2019