bioihbjkbjnl/mcl2 huggingface dataset:
Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology
Condition: Cardiac Disease; Pulmonary Disease; Cardiopulmonary Disease
MeSH terms: Heart Diseases; Pulmonary Heart Disease
Study type: Interventional

Summary: 
      This is a randomized controlled trial of the feasibility and utility of implementing a
      smartphone application (MVN) to maintain compliance with a Heart Healthy lifestyle after
      discharge from a cardiac outpatient rehabilitation program. Patients will be randomized into
      one of two groups: usual care (control: UC) or Movn mobile application (intervention: MVN).
      This study will improve and strengthen data collection from this at-risk patient population
      by recording baseline clinical and psycho social measures while gaining insight into
      self-reporting of physical activity and frequency between the UC and MVN groups.
    


Intervention name(s): Usual Care; Movn application (MVN)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Discharge packet of Heart Healthy instructions, with self-report health status, quality of life and psychosocial questionnaires, as well as other educational handouts, exit interview to review exercise progress, receive referrals to additional medical services they might need after discharge from the program, with physician.; Intervention participants will receive the same discharge packet as the UC group along with their exit interview and will receive the following:
Participant individualized Heart Healthy instructions for post-cardiac rehabilitation will be integrated into the MVN application including daily medication reminders, physical activity prompts, educational materials, and patient-reported outcome assessment of behavior and psychosocial status.
Text messages will be used on an ad hoc basis to provide positive feedback to the participant; two-way messaging between the participant and the research coordinator will be available to provide opportunities to answer specific questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics
      and pharmacodynamics of metformin in healthy Korean men.
    


Intervention name(s): Metformin; Metformin and Pantoprazole; Metformin and Rabeprazole
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Diabex; Diabex, Pantoloc; Diabex, Pariet
Intervention MeSH terms: Metformin; Rabeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Proton pump inhibitor; Drug interaction
Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      esketamine is an optical isomer of ketamine. Compared with ketamine, esketamine has the
      characteristics of higher effective value, stronger receptor affinity, less adverse reactions
      of nervous system, and pharmacokinetics is controllable.

      Domestic and foreign studies have focused on the therapeutic effect of esketamine on major
      depression, but less attention has been paid to perioperative depression.This study intends
      to explore the effect of small doses of esketamine on patients with breast
      cancer.Postoperative depression and pain are observed.
    

Detailed description: 
      This study intends to explore the effect of small doses of esketamine on patients with breast
      cancer.WE pay attention to :

        1. Safety of low-dose single intravenous injection of esketamine (1)The influence of
           intraoperative vital signs of patients after medication, such as blood pressure and
           heart rate fluctuation; (2)the duration of recovery after anesthesia; (3)postoperative
           adverse reactions, such as nausea and vomiting, dizziness and diplopia, respiratory
           depression, laryngeal spasm, delirium agitation, etc

        2. Effect of single intravenous injection of low-dose ketamine on postoperative depression
           in patients undergoing radical mastectomy (1) 1 day before surgery, 2 days, 5 days, 30
           days, 90 days after surgery Hamilton Depression Scale scores; (2) The serum leptin level
           1 day before surgery, 2 days after surgery and 5 days after surgery; (3) Correlation
           between depression scale score and leptin level

        3. Effects of low dose esketamine on acute and chronic pain in patients undergoing radical
           mastectomy

             -  visual analogue scale scores at 6, 12 and 24 hours after surgery;

                  -  visual analogue scale scores at 3, 5, 30 and 90 days after surgery;

                       -  the number of analgesic remedies
    

Intervention name(s): Esketamine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction; The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 180 patients will be divided into two groups according to the random number table method: control group (normal saline group),treatment group (esketamine group), 120 cases in each group.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Esketamine; Depression; pain; leptin
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

      - to evaluate the efficacy of phenobarbital in reducing seizure frequency.

      Secondary:

        -  to confirm dose response relationship,

        -  to assess the effects on Type I seizures,

        -  to assess the safety of phenobarbital

        -  to assess the drug tolerability.
    

Detailed description: 
      Primary:

      -to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg
      phenobarbital, in reducing seizure frequency in participants with partial onset seizures
      (Type I seizures; complex or simple with motor symptoms only) not fully controlled despite
      treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve
      Stimulator (VNS)

      Secondary:

        -  to confirm dose response relationship of 60 and 100 mg phenobarbital doses,

        -  to assess the effects of phenobarbital on Type I seizures,

        -  to assess the safety of phenobarbital

        -  to assess the tolerability of phenobarbital
    

Intervention name(s): Phenobarbital; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Intervention MeSH terms: Phenobarbital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: partial onset seizures
Study of Gralise to Treat Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      To determine Gralise in treating fibromyalgia pain:

        -  efficacy

        -  safety
    

Detailed description: 
      Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology
      (ACR) criteria for fibromyalgia

        -  Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name:
           Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack
           of efficacy.

        -  Patient who had allergic reaction or serious adverse reactions will not be included in
           this study.

        -  Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800
           mg per day by end of 2 weeks.

        -  Drug is to be taken with meal, once a day in the evening; once patient has reached the
           therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will
           evaluate the patient and may increase or decrease the dosage, but patient may not
           increase or decrease the dose of medication at his /her discretion.

        -  During study, patient will have total of 5 visits, 4 of which will be for duration
           patient will be on Gralise, and the last visit will be for tapering off the medication.

        -  During study, patient is asked keep a paper diary on which patient will record the
           numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication,
           and any side effects.
    

Intervention name(s): Gabapentin ER
Intervention type(s): Drug
Intervention description(s): Patient who are on gralise will report efficacy by rating his or her pain rating on a digital pain scale (11 points) from 0 to 10 on each scheduled clinical visits, which will be compared to their pain level at baseline.
In addition, patients will also record the doses and any adverse effects that might arise during the trial in a diary provided by the study. All information will be recorded in a paper diary that will be followed by coordinator during each follow up visits.
Other intervention name(s): Gralise
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: side effects; safety; efficacy; Gralise; Fibromyalgia; gabapentin
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in
      India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV)
      or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a
      treatment period and a 2 year follow-up period.

      Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of
      vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days
      after completing vaccination.
    


Intervention name(s): ChimeriVax™-JE; Japanese Encephalitis Inactivated Mouse Brain Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously; Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
Condition: Immunoglobulin A Nephropathy; IgAN - IgA Nephropathy; IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study
      of IV VIS649 in healthy subjects.

      VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor
      APRILL.

      The study will enroll up to 45 subjects and will be conducted in up to 5 sequential dosing
      cohorts at four different dose levels, enrolling 9 subjects per cohort. Subjects will be
      randomized to VIS649 or placebo in a ratio of 7:2 (7 active, 2 placebo). Safety,
      pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.
    

Detailed description: 
      On Day 1, a single dose of VIS649 or placebo will be administered IV. Pharmacokinetics
      sampling will start with a collection prior to the start of infusion and at multiple
      timepoints throughout the study. Pharmacodynamics sampling will occur at baseline and
      multiple timepoints throughout the study.

      Sentinel subjects will be utilized; the first two subjects in each cohort will be randomized
      to receive either VIS649 or placebo and will receive study drug at least 24 hours before the
      remaining subjects in the cohort are dosed.

      The safety profile of these subjects over the 24 hour post-administration period will be
      reviewed to determine whether it is appropriate to proceed with enrollment of the remaining
      subjects in the cohort as planned. This will occur for each dose escalation.

      The maximum duration of participation (Screening through End-of-study) for individual
      subjects will be approximately 20 weeks (5 months). The scheduled final visit will occur 16
      weeks post-dosing (112 days).
    

Intervention name(s): VIS649; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single IV dose of study product on Day 1 of study; Singe IV dose of placebo administered via IV on Day 1 of study
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: phase 1, randomized, placebo-controlled, double-blind, single ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic glomerular disease; autoimmune glomerulonephritis
Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
Condition: Corneal Ectasia
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      comparison between standard cross-linking protocol and accelerated and transepithelial
      cross-linking
    

Detailed description: 
      comparison between standard cross-linking protocol and accelerated and transepithelial
      cross-linking for treatment of documented pediatric keratoconus progression. The study
      patients are divided into 3 groups. Group A patient treated with standard cross-linking.
      Group B patients treated with accelerated cross-linking. Group C patients treated with
      transepithelial cross-linking.
    

Intervention name(s): Standard CXL; Accelerated CXL; Transepithelial CXL
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.; Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.; Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if favipiravir is effective in reducing the time to
      resolution of influenza symptoms.
    

Detailed description: 
      The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time
      to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects
      with uncomplicated influenza compared to no treatment (e.g. placebo).
    

Intervention name(s): favipiravir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered twice daily over 5 consecutive days for a total of 10 doses.
Day 1: 1800 mg twice daily (loading doses)
Days 2 through 5: 800 mg twice daily; Administered twice daily over 5 consecutive days for a total of 10 doses.
Other intervention name(s): T-705
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: influenza; flu; fever; cough; body aches; headache; nasal congestion; body pains; sore throat; fatigue; T-705; favipiravir; favor; flu symptoms
Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON
Condition: White Spot Lesions
Study type: Interventional

Summary: 
      Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a
      continuous pathological process with loss of tooth minerals, demineralization, which involves
      the destruction of tooth structure from acids. The first sign of early active
      demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface
      active mineral decomposition.
    

Detailed description: 
      Deposition of minerals depends on the equilibrium between demineralization and
      remineralization which may happen as a natural repair mechanism. The aim of this trial is to
      comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat
      coating material against the Icon resin infiltration in the ability to improve the caries
      lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two
      materials to evaluate the caries progression. PRG Barrier Coat group showed immediate
      significant improvement in LF scores in demineralization progress and inhibition of caries
      progression with a significant improved effect. S-PRG Barrier Coat was clinically successful
      strategy in inhibition of caries and improve remineralization.
    

Intervention name(s): surface pre-reacted glass filler coating material
Intervention type(s): Combination Product
Intervention description(s): the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia
Condition: Bilateral Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The
      aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of
      bilateral primary inguinal hernia
    

Detailed description: 
      This prospective study included 180 patients with bilateral primary inguinal hernia;
      randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by
      laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II
      treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral
      Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative
      complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.

      .
    

Intervention name(s): Laparoscopic Trans-Abdominal Pre-Peritoneal; Open pre-peritoneal repair; Bilateral Lichtenstein repair
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers; Open pre-peritoneal single mesh repair with suture fixation; Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pill Swallow Study
Condition: Not Determined
Study type: Interventional

Summary: 
      A prospective, single-center, open-label, single-arm, observational study assessing
      participant experience with swallowing the Mock-RP
    


Intervention name(s): Mock-RP
Intervention type(s): Other
Intervention description(s): Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to determine whether 30 minutes of treatment playing an interactive computer
      game weekly for 6 weeks, improves visual acuity. The game has been specially configured to
      ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses
      which manipulate the image seen by each eye in order to provide more information to the
      amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM
      technology, play the computer game but without the I-BiTTM technology, or watch a DVD using
      the I-BiTTM technology.
    


Intervention name(s): I-BiTTM game; Non-I-BiTTM game; I-BiTTM DVD
Intervention type(s): Device; Device; Device
Intervention description(s): 30 minutes intervention weekly for 6 weeks.; 30 minutes intervention weekly for 6 weeks.; 30 minutes intervention weekly for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amblyopia; I-BiT TM; Interactive games; Binocular
A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess absorption, distribution, metabolism, excretion and absolute
      bioavailability of AG-348 in healthy male participants. Potential participants will be
      screened within 29 days prior to dose administration to determine eligibility. Eligible
      Participants will be admitted into the Clinical Research Unit (CRU) one day prior to
      administration of AG-348 and will be confined to the CRU until at least Day 8. If
      participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day
      11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous
      (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine
      position for 1 hour post-dose and avoid water for 2 hours post-dose.
    


Intervention name(s): AG-348; [13C6]AG-348
Intervention type(s): Drug; Drug
Intervention description(s): 120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled [14C]AG-348.; IV microdose of approximately 100 micrograms (mcg), single dose.
Intervention MeSH terms: Mitapivat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science