bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effects of single therapeutic and supratherapeutic oral doses
      of ACP-196 on the heart rate-corrected QT interval using Fridericia's formula (QTcF).
    

Detailed description: 
      This is a single-dose, randomized, double-blind, double-dummy, placebo- and
      positive-controlled, 4-period, balanced crossover study under fasting conditions.
      Participants will be randomized to 1 of 4 treatment sequences: ABCD, BDAC, CADB, or DCBA. On
      4 different occasions (4 periods), each participant will receive Treatment A (a single
      therapeutic oral dose of 100 mg ACP-196), Treatment B (a single supratherapeutic oral dose of
      400 mg ACP-196), Treatment C (a single oral dose of 400 mg moxifloxacin) or Treatment D (a
      single oral dose of ACP-196 and moxifloxacin matching placebos) according to a randomization
      scheme. The washout period will be >= 5 days between each dose. The clinic attempted to
      contact participants using their standard procedures approximately 14 days after the last
      study drug (or placebo) administration to determine if any adverse events (AEs) had occurred
      since the last dose of study drug(s). An adverse event is any untoward medical occurrence in
      a participant who received study drug without regard to possibility of causal relationship.
    

Intervention name(s): ACP-196; Moxifloxacin 400 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme.; Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme.; Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.
Other intervention name(s): Acalabrutinib
Intervention MeSH terms: Moxifloxacin; Acalabrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACE-HV-005; ACP-196; Healthy participants; Volunteers; Adults; QTc Interval; Pharmacokinetics; PK
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Condition: Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced
      day-to-day function and significant discomfort. Tear substitutes are an important part of the
      treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often
      remains very irregular due to poor surface healing.

      The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal
      surface and has been studied in patients with recalcitrant corneal ulcers and erosions with
      significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May,
      2010).

      The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface
      healing, may be able to promote healing of the corneal surface allowing for more conventional
      modalities to take over and maintain a smooth and regular ocular surface. The investigators
      hope to be able to demonstrate an improvement in visual acuity, surface healing and a
      reduction in dry-eye related symptoms.
    

Detailed description: 
      See above
    

Intervention name(s): Thymosin Beta 4 eye drops; Vehicle Control
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.; Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
Other intervention name(s): Tβ4; Vehicle
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease; Rheumatoid arthritis; Systemic lupus erythematosus; Scleroderma
Dreaming During Anaesthesia and Anaesthetic Depth
Condition: Anaesthesia
Study type: Observational

Summary: 
      Patients commonly report that they have been dreaming when they awaken from general
      anaesthesia. Our hypothesis is that patients who report dreaming are less deeply
      anaesthetised during anaesthesia than patients who do not report dreaming. Depth of
      anaesthesia will be determined using a processed electroencephalographic monitor (called the
      BIS monitor).
    

Detailed description: 
      In this study, we will record the depth of anaesthesia during surgery with the BIS monitor
      and then interview patients immediately upon emergence to determine whether they recall
      dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting for elective non-cardiac surgery
      
Keywords: dreaming; anaesthesia; electroencephalography; bispectral index; awareness
Efficacy of Internet-delivered Strengths Use Intervention
Condition: Mental Health Wellness; Professional Burnout
MeSH terms: Burnout, Professional
Study type: Interventional

Summary: 
      The aim of the study will be to test the efficacy of a novel online-delivered
      gamification-based intervention for the identification, development, and use of strengths in
      the workplace. The program will be addressed to young employees and will have the aim of
      boosting their well-being and performance.
    


Intervention name(s): Internet-delivered strengths use intervention; Waiting-list
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The online strengths use intervention program follows the theorized five stages of strengths use interventions: (1) preparation and commitment, (2) identification, (3) integration, (4) action, and (5) evaluation. To increase participant engagement and motivation, gamification components are embedded in several stages.
The intervention was previously tested through a feasibility and acceptability trial (NCT05474807).
The entire intervention will be delivered online via an LMS software solution.; The waiting-list arm will serve as the control group, filling in only the outcome measure at the same time as the intervention group participants.
After the intervention group finishes participating in the intervention, the waiting-list participants will benefit from the same internet-delivered strengths use program.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Two-armed randomized trial with waiting-list control and pre-, mid-, and post-intervention measurements.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison
      of AR-13324 to latanoprost
    


Intervention name(s): AR-13324 Ophthalmic Solution 0.01%; AR-13324 Ophthalmic Solution 0.02%; Latanoprost ophthalmic solution 0.005%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered to study eye, once daily (QD) in the evening (PM) for 28 days; Administered to study eye, QD in the PM for 28 days; Administered to study eye, QD in the PM for 28 days
Other intervention name(s): Netarsudil; Latanoprost
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glaucoma
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
Condition: Grade B aGVHD; Grade C aGVHD; Grade D aGVHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The study plans to treat at least 60 pediatric participants, male and female, between the
      ages of 2 months and 17 years inclusive with aGVHD following allogeneic hematopoietic stem
      cell transplant (HSCT) that has failed to respond to treatment with systemic corticosteroid
      therapy. Participants may have Grades C and D aGVHD involving the skin, liver and/or
      gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI tract, with or
      without concomitant skin disease.
    

Detailed description: 
      Remestemcel-L will be evaluated in pediatric participants with aGVHD following allogeneic
      HSCT that has failed to respond to treatment with systemic corticosteroid therapy.
    

Intervention name(s): remestemcel-L
Intervention type(s): Drug
Intervention description(s): Participants were treated with IV remestemcel-L at a dose of 2 x 10^6 MSC/kg (actual body weight at screening) twice per week for each of 4 consecutive weeks. Infusions were administered at least 3 days apart and no more than 5 days apart for any infusion.
Intervention MeSH terms: Remestemcel-l
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GVHD
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the ability of a repeated high-frequency
      site-based computerized cognitive assessment to evaluate the potential treatment effects of
      donepezil (MK-0000) compared with placebo among participants with mild cognitive impairment
      (MCI) or mild Alzheimer's Disease (AD). The primary study hypothesis is that the average
      percentage of correct responses on one card learning (OCL) task will be ≥2 percentage points
      in participants receiving donepezil compared with participants receiving placebo.
    


Intervention name(s): Donepezil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.; Dose matched placebo capsule QD, orally for Days 1-56.
Other intervention name(s): MK-0000; Donepezil hydrochloride; Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tomotherapy for Leptomeningeal Metastases
Condition: Leptomeningeal Metastasis
MeSH terms: Neoplasm Metastasis; Meningeal Carcinomatosis
Study type: Interventional

Summary: 
      This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy
      for leptomeningeal metastases.
    

Detailed description: 
      This is a single-arm, single center, phase II trial to investigate the feasibility and
      toxicity of tomotherapy for leptomeningeal metastases, which are defined as leptomeningeal
      metastases with or without brain metatstases.
    

Intervention name(s): tomotherapy
Intervention type(s): Radiation
Intervention description(s): the prescription of tomotherapy: whole brain radiation (WBRT) with 40Gy in 20 fractions and concurrent boost of 60Gy of the leptomeningeal metastases;
WBRT of 50Gy in 25 fractions, with dose limitation of hippocampus and brain stem; c.TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
d. Some patients received intrathecal chemotherapy (MTX+AraC+Dex) based on the cytology of cerebrospinal fluid (CSF).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tomotherapy; leptomeningeal metastases; fractionated stereotactic radiotherapy
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and the United States of America. The aim of this trial is
      to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta
      pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.
    


Intervention name(s): N9-GP; ALPROLIX®
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 50 IU/kg for intravenous (i.v.) injection; A single dose of 50 IU/kg for intravenous (i.v.) injection
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated
      synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type
      1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy
      (DPN).
    


Intervention name(s): CBX129801
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
Condition: Relative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which
      will be only enrolled Chinese male healthy volunteers.
    

Detailed description: 
      27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile
      and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally
      in two different manufacturers after breakfast. All subjects are required to collect PK blood
      samples before and after administration at the following time points: within 1 hour before
      administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after
      administration (16 times point), each collection of venous blood is 2mL.
    

Intervention name(s): Sulfatinib T capsule; Sulfatinib R capsule
Intervention type(s): Drug; Drug
Intervention description(s): Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.; Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
Other intervention name(s): HMPL-012, Surufatinib; HMPL-012, Surufatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Relative bioavailability
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
Condition: Dementias With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to achieve mass balance recovery of [14C]-radiolabel in
      urine and feces and to identify and quantify the main elimination pathways of E2027.
    


Intervention name(s): E2027
Intervention type(s): Drug
Intervention description(s): E2027 oral capsule.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: E2027; [14C]E2027; Dementia with Lewy bodies; Dementia
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study consisting of four periods (screening, run-in, treatment, follow-up). A
      four-week treatment-free, run-in period where the subject will make at least four attempts at
      intercourse on four separate days with at least 50% of the attempts must be unsuccessful.
      During run-in the subjects will be using a stopwatch to measure the time from erection
      perceived hard enough for penetration until withdrawal from the partner's vagina. Next there
      are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to
      visit the clinic on 5 occasions over a period of 4 months.
    


Intervention name(s): LEVITRA (vardenafil); placebo
Intervention type(s): Drug; Drug
Intervention description(s): active comparator; placebo comparator
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile dysfunction, impotence
Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer
Condition: Bone-Metastatic, Castration-Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is
      chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6
      months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to
      delay/prevent disease progression in patients who have not had prior chemotherapy.
    

Detailed description: 
      This is a multi-center, single-arm, open-label, prospective phase II clinical trial
      evaluating the efficacy, safety and pharmacokinetics of orally administered KX2-391 in adult
      male patients with progressive bone-metastatic CRPC. Patients must have 1) documented
      bone-metastatic prostate cancer, 2) castrate levels of testosterone, 3) not received prior
      chemotherapy, and 4) documented disease progression based on rising PSA, progressive
      measurable visceral disease and/or progressive bone lesions (one criteria is sufficient) as
      per the Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines (Scher et al 2008).
    

Intervention name(s): KX2-391
Intervention type(s): Drug
Intervention description(s): KX2-391 will be administered as a 40 mg oral dosing solution, twice daily, for 6 28-day cycles.
Other intervention name(s): KXO1
Intervention MeSH terms: Tirbanibulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPRC
Kuopio Fall Prevention Study.
Condition: Accidental Falls; Health Behavior; Aging
Study type: Interventional

Summary: 
      This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with
      free use of communal recreation facilities in fall prevention.

      Morbidity, use of social services and health outcomes of aging women in province of Kuopio,
      Finland are also monitored. The study combines a six months supervised exercise, followed by
      six months free, but unsupervised, use of recreational facilities and observational period of
      second year into total of 2 year follow up duration.
    

Detailed description: 
      In 2016, a 2-year randomized controlled trial (RCT) will be launched to investigate the
      effect of exercise on fall risk, injuries and subjective well-being (SWB) in aging women
      (n=1078) by using municipal sport services in cooperation with the city of Kuopio. The effect
      of the exercise intervention on functional capacity, muscle strength, bone, body composition,
      cognitive function, the use of health services and its cost effectiveness will also be
      studied.

      The trial will be carried out on women belonging to the Kuopio Osteoporosis Risk Factor and
      Prevention (OSTPRE) Study, which is an ongoing population-based prospective cohort study,
      with a follow-up of 26 years. It investigates life style factors associated with fractures
      falls, bone mineral density and morbidity in a target population of 14 220 women, now aged
      between 75-84 year.

      The study combines combination of a 2-year fall prevention trial with the 26 years of life
      style and medical data from the previous OSTPRE follow up to provide meaningful answers
      whether municipal exercise program can provide cost effective health gain in elderly. In
      addition, the study aims to answer, who will benefit from the exercise the most and what are
      the underlying factors explaining efficacy in the women's previous 26 years of lifestyle and
      medical history. The study will help to develop strategies for societal fall prevention.
    

Intervention name(s): Supervised physical exercise; Health counselling
Intervention type(s): Behavioral; Other
Intervention description(s): Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.; Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postural Balance; Cost-Benefit Analysis; Morbidity; Exercise
Microcurrent for Healing Autogenous Skin Donor Sites
Condition: Burns
Study type: Interventional

Summary: 
      This single-center, prospective, randomized, and controlled study evaluated the efficacy of
      silver-coated dressing with active microcurrent in comparison to silver-coated dressing with
      sham microcurrent on wound-closure time for autogenous skin donor sites.
    

Detailed description: 
      The specific aims of the study are to evaluate the impact of active versus sham direct
      microcurrent application to silver nylon dressings in the treatment of donor sites for
      partial thickness thermal injuries. The primary endpoint is wound-closure time
      (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection.
      Exploratory assessments of clinical outcomes, including inflammation, and pain medication
      (type, dosage, route, timing) will also be conducted.
    

Intervention name(s): Microcurrent stimulator; Silverlon Wound Contact Dressing
Intervention type(s): Device; Device
Intervention description(s): Microcurrent stimulation from 15-50 microamps; Silver coated nylon dressing FDA approved for use on donor sites in burn patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: burns; donor site; healing; microcurrent