bioihbjkbjnl/mcl2 huggingface dataset:
A First Time in Human Study of GSK586529 in Healthy Volunteers
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male
      subjects. Subjects will be divided into two cohorts with alternate panel design. The study is
      investigating the safety, tolerability and pharmacokinetics of single oral escalating doses
      of GSK586529.
    


Intervention name(s): GSK586529 capsules; GSK586529 tablets; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.; GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.; Placebo tablets and capsules will be provided to subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Prevention
Keywords: Depression
Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I single center, open-label, non-randomized study in healthy male subjects,
      designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability
      of single oral doses of PCO371. It is planned to enroll 12 subjects, with 6 subjects in each
      of 2 study parts. Subjects in Part 1 will receive a single oral dose of [14C]PCO371 Oral
      Solution. Subjects in Part 2 will receive a single oral dose of PCO371 capsules, followed by
      a single intravenous infusion of [14C]PCO371 Solution for Infusion over 10 min, starting 2 h
      post-oral dose. The study parts may be dosed in any order for logistical reasons (e.g. Part 2
      may be dosed before Part 1). No subject will be permitted to take part in both study parts.
    


Intervention name(s): PCO371; [14C]PCO371; [14C]PCO371
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PCO371 Capsule; [14C]PCO371 Oral solution; [14C]PCO371 Solution for infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home Treatment for Acute Psychiatric Care
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study aims to evaluate whether psychiatric home treatment is an effective and efficient
      alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of
      psychiatric patients in need of hospitalization are randomly assigned to either treatment at
      inpatient wards (treatment as usual) or a new care model with the additional option of
      treating patients at their homes by mobile care teams. The primary focus is on checking
      whether optional home treatment leads to a reduction of inpatient days during a two-year
      follow-up period. In addition, the two service models will be compared regarding treatment
      cost and outcomes as well as satisfaction of patients and their relatives with psychiatric
      care.

      Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be
      examined by a highly trained clinical assessor to test and verify the diagnoses and the
      clinical ratings made by the staff members of the mental hospital under routine everyday
      conditions.
    

Detailed description: 
      This study aims to evaluate whether psychiatric home treatment is an effective and efficient
      alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of
      psychiatric patients in need of hospitalization are randomly assigned to either treatment at
      inpatient wards (treatment as usual) or a new care model with the additional option of
      treating patients at their homes by mobile care teams. The primary focus is on checking
      whether optional home treatment for crisis intervention leads to a reduction of inpatient
      days during a two-year follow-up period. In addition, the two service models will be compared
      regarding treatment cost and outcomes as well as satisfaction of patients and their relatives
      with psychiatric care.

      Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be
      examined by a highly trained clinical assessor to test and verify the diagnoses (SCID-I and
      SCID-II) and the clinical ratings (HoNOS) made by the staff members of the mental hospital
      under routine everyday conditions.
    

Intervention name(s): Home treatment; Treatment As Usual
Intervention type(s): Other; Other
Intervention description(s): Patients are treated at home whenever possible and appropriate; Patients are treated at a mental hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to
      cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK
      Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): HPV-16/18 VLP/AS04 vaccine (Cervarix TM); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
Other intervention name(s): GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cervical neoplasia; AS04; Randomized; Cervical cancer; HPV-16/18 L1 VLP AS04; Phase IIIb; Korea; HPV; Double-blind; Controlled
Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection
Condition: Postoperative Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Acute kidney injury (AKI) is a severe complication after liver resection and is associated
      with morbidity and mortality. The incidence of postoperative AKI is significantly higher in
      elderly patients, especially in those with comorbidities.

      There is currently limited evidence on the incidence and associations of postoperative AKI in
      elderly patients following liver resection.

      This study will evaluate the incidence and associations of AKI in elderly patients after
      liver resection and its impact on postoperative mortality.
    

Detailed description: 
      The occurrence of postoperative AKI is independently associated with increased morbidity and
      mortality. Advanced age reduces renal autoregulatory capacity due to physiological and
      functional changes, thus render the elderly to suffer postoperative AKI and probably the
      consequent chronic kidney disease.

      Although elderly patients account for approximately 25% of surgical procedures, the incidence
      and associations of AKI in this group of patients are rarely understood.

      Thus, it is essential to identify those patients at high risk to develop postoperative AKI to
      optimize perioperative prevention and protection strategies.

      This study is a retrospective cohort study, aim to access risk factors of postoperative AKI
      and its association with outcomes. The investigators will develop and validate a predictive
      model for postoperative AKI.

      The principal clinical outcome of the study is postoperative AKI, defined as an absolute
      increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from
      preoperative baseline within seven days after surgery, according to the Kidney Disease:
      Improving Global Outcomes (KDIGO) criterion.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Elderly patients (aged ≥ 65 years) with benign and malignant liver diseases of the Chinese
        PLA General Hospital HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from
        2012-2019
      
Keywords: acute kidney injury; predictive nomogram; elderly; liver resection
Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and potential efficacy of a new drug,
      OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of
      patients with open angle glaucoma or ocular hypertension. It will be compared with commercial
      timolol and placebo eye drops.
    

Detailed description: 
      Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to
      damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with
      glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents,
      which can have undesirable side effects on the cardiac and respiratory systems.

      The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop,
      metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being
      studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or
      ocular hypertension. It will be compared with a well known beta blocker, timolol maleate
      ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP
      without the typical side effects of other beta blockers.
    

Intervention name(s): OT-730 ophthalmic solution; timolol maleate ophthalmic solution; OT-730 placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one eye drop twice daily; one eye drop twice daily; one eye drop twice daily
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure
MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      The aim of the study is to test whether the distal radius bone marrow show significant
      difference in the fat fraction in young women compared to post menopausal women with and
      without osteoporosis.
    

Detailed description: 
      Patients of the Department of Endocrinology, who routinely perform bone density tests, DXA
      (Dual Energy X-ray absorpiometry) test on the lumbar spine, proximal femoral and distal
      radius, will be invited for a visit, and after signing the informed consent form, the
      following data will be collected: age, BMI, first menstrual period and last menstrual period,
      family history of osteoporosis, history of osteoporotic fractures, smoking, alcohol use and
      exercise habits. In addition, blood tests will be performed: calcium phosphate, albumin,
      alkaline phosphatase, vitamin D level, thyroid function, LH (Luteinizing Hormone) FSH
      (Follicle Stimulating Hormone), Estradiol, and serum bone turnover index (CTX P1NP). Amount
      of blood taken: 12 ml The patients will then be sent to the Alfredo Federico Strauss Center
      for Computerized Neuroimaging at Tel Aviv University for an MRI study of the distal radius.
      The study results will be analyzed by an expert bone radiologist from the Sourasky Medical
      Center to reject any kind of pathology (such as a fracture, inflammation, tumor), and further
      analyzed for bone marrow fat fraction by Tel Aviv University researchers. In the case of
      abnormal findings, they will be mentioned in the report and the participants will receive
      recommendations from the appropriate expert.
    

Intervention name(s): MRI scans of distal radius
Intervention type(s): Device
Intervention description(s): MRI scans to monitor the fat fraction in the bone marrow of the distal radius
Intervention model: Single Group Assignment
Intervention model description: 3 groups of women: Group 1: Healthy young women Group 2: Postmenopausal women without Osteoporosis Group 3: Postmenopausal women with Osteoporosis All will undergo the same MRI scans
Masking: None (Open Label)
Primary purpose: Other
Keywords: Osteoporosis; MRI; distal radius; postmenopausal
Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of a new interdental cleaning device
      (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote
      the establishment of a hygienic routine of cleaning interproximal spaces.
    

Detailed description: 
      The Soft-Picks Advanced has a new curved design allowing a user to easily access to difficult
      interdental sites, such as spaces between premolars and molars. This study is a single center
      with parallel design, single blinded, which will randomize eligible subjects into two
      treatment groups.
    

Intervention name(s): Soft-Picks Advanced; Floss
Intervention type(s): Device; Device
Intervention description(s): Soft-picks Advanced will be used once a day to clean interdental sites at home.; Floss will be used once a day to clean interdental sites at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis; Symptomatic Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance
      training program with concurrent application of partial blood flow restriction (PBFR) to the
      exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in
      women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be
      change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators
      will test the following hypotheses. In comparison with low-intensity resistance training
      without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:

      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee
      extensor strength

      Secondary Hypotheses:

        1. Increase quadriceps muscle volume assessed by MRI

        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed
           stair climb

        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and
           Osteoarthritis Outcome Score (KOOS) questionnaire
    


Intervention name(s): partial blood flow restriction (PBFR); low intensity resistance training
Intervention type(s): Other; Other
Intervention description(s): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.; low intensity resistance training without partial blood flow restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: knee osteoarthritis; symptomatic knee osteoarthritis; isotonic leg-press strength; isokinetic knee extensor strength; quadriceps volume
Evaluate IMG-007 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics
      (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-controlled, sequential ascending, single
      dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy
      participants. The study is comprised of 3 phases: screening phase, treatment phase, and
      safety follow-up phase.
    

Intervention name(s): IMG-007 or placebo
Intervention type(s): Drug
Intervention description(s): intravenously administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans
Condition: Opioid Use; Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an educational patient-centered presentation
      reduced the amount of opioid pills requested and utilized by patients compared to standard of
      care group.
    


Intervention name(s): Educational Shared-Decision Making Tool
Intervention type(s): Behavioral
Intervention description(s): Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: orthopedics; hand surgery; opioid use; counseling; education
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of
      therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration
      of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
    

Detailed description: 
      This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be
      randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or
      Lansoprazole 30 mg).
    

Intervention name(s): CJ-12420 50 mg QD; CJ-12420 100 mg QD; Lansoprazole 30 mg QD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.; CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.; Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.
Other intervention name(s): Not yet decided; Not yet decided; Lanston cap.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tofacitinib Bioequivalence Study Comparing Tablets And Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aim of the study is to establish bioequivalence between commercial tofacitinib
      tablet formulations with the tofacitinib capsule formulation.
    


Intervention name(s): tofacitinib 10 mg; tofacitinib 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1 will consist of 2 periods and 2 sequences. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 10 mg tofacitnib tablet under fasting conditions in period 1, followed by a 10 mg tofacitinib capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.; Cohort 2 will consist of 2 periods and 2 sequences. A total of 24 healthy subjects will be enrolled for this cohort. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 5 mg tablet under fasting conditions in period 1, followed by a 5 mg capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Deglutition Disorders; Parkinson Disease; Dysarthria
Study type: Observational

Summary: 
      The investigators prospectively enrolled 64 early PD patients (less than 3 years after the
      first symptom) in order to prospectively assess the natural history of non-dopaminergic
      symptoms.
    

Detailed description: 
      Patients were evaluated at baseline and after 2 years in off drug condition. Clinical,
      psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing
      video fluoroscopy, dysarthria, gait and axial disorders.
    

Intervention name(s): observational study
Intervention type(s): Other
Intervention description(s): natural history of non dopaminergic signs
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )
      
Keywords: Idiopathic early; Parkinson's Disease