bioihbjkbjnl/mcl2 huggingface dataset:
Partnered Multicomponent Exercise for Elderly in Long-term Care Facilities
Condition: Exercise; Long Term Care Facilities; Physical Function; Happiness
Study type: Interventional

Summary: 
      This study aimed to explore the effects of a partnered multicomponent exercise program on
      improving the physical function and sense of well-being of elderly people in Long-term Care
      Facilities (LTCFs).
    

Detailed description: 
      This study is a single-blinded randomized controlled trial. Elderly residents were recruited
      from two LTCFs in Yilan county. The experimental group (N=14) received a 90-minute partnered
      multicomponent exercises intervention once weekly for 12 weeks. The control group (N=14)
      carried out the usual activities without intervention. The Barthel Index (BI), Short Physical
      Performance Battery (SPPB), De Morton Mobility Index(DEMMI), handgrip strength, and Chinese
      Happiness Inventory (CHI) were measured before and after the interventions.
    

Intervention name(s): partnered multicomponent exercises program
Intervention type(s): Other
Intervention description(s): aerobic,strength, flexibility and balance exercises and game
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D is a commonly available essential prohormone humans need to regulate blood calcium
      and has recently emerged as potentially helpful in combating severe COVID-19. Despite its
      importance, some studies estimate as much as 40% of the US population is deficient in vitamin
      D. Most available vitamin D supplements have little absorption data and are nearly all
      softgels or capsules. This clinical trial is designed as a preliminary pharmacokinetics study
      to assess the absorbance of a nano liquid D3 supplement that can be taken as an oral spray
      once daily. Preliminary evidence suggests that this nano liquid D3 may be absorbed more
      readily than commercially available softgel dosage forms of D3. This randomized,
      double-blind, placebo-controlled trial will compare nano liquid D3 to commonly available D3
      oral softgels and a placebo control group over the course of a thirty-one (31) day study
      period.
    


Intervention name(s): Softgel Vitamin D3; Nano Liquid Vitamin D3; 25(OH)D Blood Serum Test; Placebo Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Diagnostic Test; Other
Intervention description(s): 5000IU vitamin D3 taken as single oral softgel once daily for 30 days; 5000IU vitamin D3 taken as liquid oral spray once daily for 30 days; A sample of blood is drawn off and processed for 25(OH)D levels at baseline, after 15 days of supplementation, and after 30 days of supplementation; Liquid oral spray once daily for 30 days. Solution identical in smell, taste, color, and production process to Nano Liquid D3, but containing no Vitamin D3.
Other intervention name(s): Cholecalciferol; Cholecalciferol; Vitamin D Blood Test; Nano Liquid Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
Condition: Epilepsy
MeSH terms: Epilepsy; Arrhythmias, Cardiac
Study type: Observational

Summary: 
      Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death
      in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm
      disturbances could emerge only during seizures. Furthermore, patients could have transitioned
      sinus or AV node blocks which could cause syncopes with brady-related seizures which could be
      treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording
      single-channel ECG for up to 36 months which give an ability to detect these heart
      disturbances.

      The purpose of this study is to look the incidence and types of arrhythmias which occur in
      150 patients with hard-to-treat partial seizures and secondarily generalized seizures
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers
        therapy
      
Keywords: Epilepsy; heart block; sudden cardiac death; loop recorder
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects
      who will be able to enter a long-term study after completing the parent study "A double-blind
      comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension
      for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).
    

Detailed description: 
      NCT00415623 (protocol A0531085)
    

Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Intervention MeSH terms: Amlodipine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
Condition: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Mental Disorders; Neurodevelopmental Disorders
MeSH terms: Autism Spectrum Disorder; Mental Disorders; Autistic Disorder; Neurodevelopmental Disorders; Developmental Disabilities; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics
      (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect
      (FE) of RO6953958 following oral administration in healthy male participants. Part 3
      (Drug-drug interaction (DDI)) will assess the safety, tolerability, and effect of RO6953958
      on the PK of the cytochrome P450 (CYP) 3A substrate midazolam.
    


Intervention name(s): RO6953958; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part 1: RO6953958 will be administered in an adaptive manner. The starting dose is planned to be 5 milligrams (mg).
Part 2: The starting dose is planned to be 45 mg.
Part 3: RO6953958 will be administered QD following a standardized breakfast on Day 3 to Day 14 at the maximum dose QD that was tested in the ongoing Part 2 (MAD).; Part 1: A placebo will be administered in an adaptive manner. The starting dose is planned to be 5 mg.
Part 2: The starting dose is planned to be 45 mg.; Midazolam will be administered as single intervenous (IV) bolus injection of 100 micrograms (ug) on Day 1 and Day 13, and as single oral dose of 300 ug on Day 2 and Day 14.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder
Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project explores the feasibility and utility of remote glucose monitoring for a cohort
      of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).
    


Intervention name(s): Remote Patient Monitoring
Intervention type(s): Behavioral
Intervention description(s): Participants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic).
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Insulin Glargine at Bedtime or in AM Versus NPH
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy and safety of once-nightly insulin glargine versus a single morning
      injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients
      inadequately controlled on combination oral agents.
    

Detailed description: 
      Insulin glargine has a longer action than compared to NPH insulin, but whether this results
      in improved control when used as a once-nightly or morning basal insulin injection in type 2
      diabetic patients who are inadequately controlled on combination oral agents has been
      controversial. Inner city ethnic minority patients with diabetes are a particularly
      challenging population of diabetic patients to treat. This study investigates whether insulin
      glargine may be a more effective or safer first-line basal insulin than NPH in this
      population.
    

Intervention name(s): 1- Insulin glargine QHS; 2 - Insulin glargine QAM; 3 - NPH insulin QHS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL); Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL); NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
Other intervention name(s): Trade name: Lantus; Trade name: Lantus; (Generic)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glargine; Type 2 diabetes; Basal insulin
A Phase I Study of SB26 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, randomized double-blind, placebo-controlled (within a dose group),
      single and multiple rising dose study of the intravenous administration of SB26 in healthy
      volunteers.
    

Detailed description: 
      The study includes two Parts; Part 1 includes the FiH exposure and SRD and Part 2 is the MRD.
      Approximately 58 subjects will be enrolled in the study. New subjects will be recruited for
      each cohort in both Parts. The SRD Part will include 5 or more dose levels and the MRD Part
      will include 3 or more dose levels; additional dose level(s) may be added based on emerging
      safety and PK data from prior cohorts.
    

Intervention name(s): SB26; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB26 administered intravenously; Placebo administered intravenously
Other intervention name(s): TAK-671; SB26/TAK-671 matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine the effect of Coenzyme Q10 supplementation on conventional
      therapy of children with heart failure due to idiopathic dilated cardiomyopathy.
    

Detailed description: 
      This study aims to determine the effect of Coenzyme Q10 supplementation on conventional
      therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a
      prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18
      years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or
      placebo. Echocardiographic systolic and diastolic function parameters are determined for
      every patient at baseline, after three,six and nine months of supplementation.
    

Intervention name(s): Coenzyme Q10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance; dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
Other intervention name(s): Ubiquinone; no brand name
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coenzyme O10; Children; Idiopathic Dilated Cardiomyopathy
Pneumatic Compression and Post-induction Hypotension
Condition: Prostate Cancer
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of pneumatic compression on
      post-induction hypotension in elderly patients undergoing robot assisted laparoscopic
      prostatectomy.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of pneumatic compression of lower leg,
      which is performed during 20 minutes after anesthesia induction period, on post-induction
      hypotension in elderly patients undergoing robot assisted laparoscopic prostatectomy.
    

Intervention name(s): Pneumatic compression
Intervention type(s): Procedure
Intervention description(s): Pneumatic compression with preset pressure and cyclic manner is applied from immediately after anesthesia induction to 20 minutes after anesthesia induction in the both legs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an single-blind, single-center, two-period crossover, PK profile study. Each subject
      will be randomized to one of two treatment sequences. Both treatment sequences will be
      enrolled concurrently.
    

Detailed description: 
      This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of
      BG-00012 given in capsule form supplied by two different manufactures.
    

Intervention name(s): Test product; Reference product
Intervention type(s): Drug; Drug
Intervention description(s): Dimethyl Fumarate (BG00012); Dimethyl Fumarate (BG00012)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: bioequivalence
ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting
Condition: Cardiac Revascularization
Study type: Interventional

Summary: 
      Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications,
      such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently
      performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads
      to a systemic inflammatory response, which may be induced by the contact of circulating blood
      with artificial surfaces of the extracorporeal circuit.[1] To reduce postoperative
      complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical
      practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed
      on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. [1] There
      are many studies and debates about the two approaches to cardiac revascularization via CABG.
      This study aims to answer the question as to difference in the ICU stay of patients with low
      ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary
      artery bypass grafting and better treatment option shall be adopted in future.
    


Intervention name(s): Coronary Artery Bypass Grafting
Intervention type(s): Procedure
Intervention description(s): on-pump vs off pump Coronary artery Bypass Grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Bypass Grafting
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Condition: Infantile Colic; Infantile Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Colic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after
      single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral
      absorption is evaluated through the drug recovery in urine.
    

Detailed description: 
      This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one
      single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks
      old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output
      collected during the 24 hours after oral administration with special diapers.

      Safety and tolerability of the drug will be evaluated by monitoring any changes in
      signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in
      the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant
      administration.
    

Intervention name(s): Nepadutant; Nepadutant
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old); 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Intervention MeSH terms: MEN 11420
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infantile colic; Abdominal Cramps; Colicky Pain; Functional gastrointestinal disorders
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
    


Intervention name(s): Baraclude
Intervention type(s): Drug
Intervention description(s): Specified dose on specified day
Intervention MeSH terms: Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without Subcutaneous Recombinant Human Interleukin-2 (rhIL-2) Following Autologous Stem Cell Transplant for Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will find the highest acceptable treatment dose and timing of infusion of cord
      blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with
      multiple myeloma.

      The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is
      administered after treatment to help the NK cells expand in the body. The safety of this
      treatment will be studied and researchers want to learn if NK cells will help in treating
      multiple myeloma.
    

Detailed description: 
      The primary objective of the study is to assess safety and determine the maximum tolerated
      dose of PNK-007 as well as the feasibility of treating at various timepoints following ASCT
      in subjects with multiple myeloma. The secondary objective is to explore the potential
      clinical efficacy by day 90-100 post ASCT.

      Treatment plan includes ASCT followed by PNK-007 which will be administered IV Day 14 post
      ASCT to determine the maximum tolerated dose. Once the IV Day 14 post ASCT. PNK-007 will be
      followed by up to six rhIL-2 injections to support the NK cells expansion in the body.

      Subjects will be followed for up to 12 months post PNK-007.
    

Intervention name(s): rhIL-2; PNK-007
Intervention type(s): Drug; Biological
Intervention description(s): Human recombinant Interleukin-2; PNK-007 is a culture-expanded cell population derived from human cord blood hematopoietic stem/progenitor cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Plasma Cell Myeloma; Plasma Cell Neoplasm; Relapsed/refractory Myeloma; PNK-007; Recombinant Human IL-2 (RHIL-2); Human IL-2; Bone Marrow Transplant
The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation
      lines in addition to pulmonary vein isolation may improve the outcome in patients with
      persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.
    

Detailed description: 
      This is a prospective, randomized multi center study comparing two catheter ablation
      strategies (pulmonary vein isolation (PVI) versus PVI plus low voltage areas (LVA) guided for
      ablation in patients with symptomatic persistent and long standing persistent atrial
      fibrillation (AF) who were unresponsive to at least one Class I or III antiarrhythmic agents,
      or it is the patient´s decision to receive ablation as first line therapy. Patients with
      documented persistent AF who are eligible for participation in the study, and gave a written
      informed consent, will be randomized between two groups prior to the procedure: PVI and
      PVI+LVAs guided radiofrequency catheter ablation.

      All the patients will receive a high density voltage map in sinus rhythm (SR). All the
      patients will receive circumferential PVI. If LVAs are present, Patients randomized to the
      PVI+LVA group will get additional linear ablation lines to exclude these areas from normal
      voltage atrial myocardium. The patients will be followed for 12 months.
    

Intervention name(s): radiofrequency ablation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment