bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs
      has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a
      treatment modality for Fibromyalgia is limited, however small trials have demonstrated its
      efficacy. No head to head comparisons between escitalopram and duloxetine have been
      undertaken. We aim to conduct a single blind, randomized control trial to assess the
      comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly
      diagnosed Fibromyalgia.
    

Detailed description: 
      180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016
      criteria shall be enrolled by consecutive sampling after taking written informed consent.
      Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact
      Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups.
      The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The
      second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients
      shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms
      shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall
      change in the FIQ-R from baseline shall be assessed and the difference between both groups
      will be analyzed.
    

Intervention name(s): Duloxetine; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily; Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily
Other intervention name(s): DUPREX; EXAPRO
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibromyalgia treatment; Duloxetine; Escitalopram
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Patient Population: Patients with AF that is symptomatic and refractory to at least one
      antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6
      months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months
      terminated by cardioversion or drug).

      Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based
      technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
    

Detailed description: 
      Interventions: Patients will be randomized to either wide circumferential pulmonary vein
      isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF
      ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be
      performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will
      be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based
      ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed
      within 6 months. A 2 month blanking period will be allowed after each procedure during which
      early recurrences will not be counted.

      Outcomes:

        -  Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months
           post-initial procedure.

        -  Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins

        -  Occurrence of adverse events in each group post-procedure.

        -  Quality of life assessment at 6 and 12 months post-initial procedure.

      Followup:

        -  3, 6, and 12 months post-initial procedure.

        -  Clinical data, ECG, Holter, loop recorder at baseline and at each visit.

        -  QOL at baseline, 3, 6 and 12 months post-initial procedure.
    

Intervention name(s): Ablate AF triggers via PVI; Substrate via CFAEs; Combined approach for AF ablation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Trigger-based ablation guided by pulmonary vein antrum isolation; Substrate-based ablation using an approach targeting CFAEs; Combined trigger and substrate based approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paroxysmal atrial fibrillation; persistent atrial fibrillation; high burden of atrial fibrillation; atrial fibrillation ablation; Pulmonary vein isolation; AF trigger; complex fractionated electrograms; CFE; CFAE; complex fractionated atrial electrograms; refractory antiarrhythmic medication; PVAI; Ensite NavX; NavX; CoolPath catheter; irrigated ablation catheter; high burden of paroxysmal or persistent atrial fibrillation; candidates for AF ablation; symptomatic AF; AF is refractory to at least one antiarrhythmic medication
RDEA3170 Bioavailability Study
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and
      pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative
      bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)
      and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat
      and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
    


Intervention name(s): RDEA3170 10 mg; RDEA3170 2.5 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis
Condition: Autoimmune Hepatitis; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Study type: Interventional

Summary: 
      Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune
      response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and
      liver failure.

      There are few studies on dietary management in hepatitis and most of theme have focused on
      micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of
      other diseases associated, but few recommendations have been made regarding a complete
      dietary approach. Fiber has been proven to increase the excretion of nitrogen products and
      consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to
      decrease endogenous catabolism in cirrhotics patients.

      The implementation of a high protein high fiber nutrition plan and improves nutritional
      status of patients with autoimmune cirrhosis.
    

Detailed description: 
      Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary
      plan. The monitoring of adherence to the diet will be once a month for the duration of the
      study period.

      There will be an nutritional assessment by anthropometric techniques: arm circumference,
      triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking
      the standard for cirrhotic patients. Body composition was measured by bioelectric impedance
      to obtain fat mass, lean and total fluid content.

      The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied
      three times during the study and the quality of life questionnaire SF-36 CLDQ and will be
      held in direct interview at the first visit and at study end.

      Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin,
      angiotensin and aldosterone.
    

Intervention name(s): High protein high fiber diet
Intervention type(s): Dietary Supplement
Intervention description(s): A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.
Each participant will receive nutritional counseling once month during six months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK,
      study of the way a drug enters and leaves the blood and tissues over time) of
      single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.
    

Detailed description: 
      This is a single-center, randomized (study medication assigned to participants by chance),
      double-blind (neither Investigator nor participant knows which treatment the participant
      receives), placebo controlled (placebo is an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial), study of a single-ascending
      dose of JNJ-54861911 in participants between 55 to 75 years of age. The duration of study
      will be approximately 2 to 6 weeks per participant. The study consists of 3 periods:
      Screening period (28 to 2 days prior to dose administration); Double-blind Treatment period
      (participants will receive either a single oral dose of JNJ-54861911 or placebo as tablets
      under fasted conditions); and a Follow-up visit period (7 to 14 days after dose
      administration). All the eligible participants will be assigned to any of following 3
      cohorts: Cohort A (single oral dose of JNJ-54861911, 25 milligram [mg] or placebo); Cohort B
      (single oral dose of JNJ-54861911, 50 mg or placebo); Cohort C (single oral dose of
      JNJ-54861911, 100 mg or placebo). Each cohort will include 8 participants. Participants in
      each cohort will be randomly assigned to receive either a single oral dose of JNJ-54861911 (n
      = 6) or placebo (n = 2). Blood samples will be collected pre-dose and over 96 hours (that is
      up to Day 5) after dosing for understanding the PK characteristics of JNJ-54861911.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54861911 (25 mg); JNJ-54861911 (50 mg); JNJ-54861911 (100 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of JNJ-54861911, 25 mg on Day 1.; Single oral dose of JNJ-54861911, 50 mg on Day 1.; Single oral dose of JNJ-54861911, 100 mg on Day 1.; Single oral dose of placebo matched to JNJ-54861911 on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54861911; Alzheimer's disease
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with
      an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in
      detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary
      aim is to assess the efficacy of PVI during a two years follow-up and to assess the
      reliability of the implantable loop recorder in detecting atrial fibrillation.

      50 patients will be enrolled into the study. After enrollment an implantable loop recorder
      will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24
      months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic
      monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography
      will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life
      will be assessed at baseline, and 6 and 12 months after PVI.
    


Intervention name(s): Implantable loop recorder (ILR)
Intervention type(s): Device
Intervention description(s): The ILR will be implanted subcutaneous following standard surgical procedure.
Other intervention name(s): All patients in the group get an ILR implanted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Atrial fibrillation; Monitoring; Pulmonary vein isolation; Implantable loop recorder
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for
      the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses
      Pulse laser system provide for improved energy delivery which may decrease blood loss and
      operative time. We seek to evaluate Moses technology for enucleation of the prostate in the
      setting of BPH.
    

Detailed description: 
      This is a single-center, prospective, double-blinded, randomized controlled trial comparing
      MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation
      with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a
      1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e.
      alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start
      of each case, a laser technician would be notified of randomization via envelope and
      randomize the settings to either Moses or traditional mode. The surgeons and patients were
      blinded to which mode was used. All surgeries will be performed using a two lobe technique
      and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood
      loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow
      parameters, and complications postoperatively at 6 weeks.
    

Intervention name(s): Moses laser enucleation of prostate
Intervention type(s): Procedure
Intervention description(s): Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
Condition: Snoring; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring
Study type: Interventional

Summary: 
      This study evaluates the efficacy, the tolerance and the acceptability/compliance of the
      nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in
      European adult patients without cardiovascular and/or respiratory comorbidities/disorders.
    


Intervention name(s): nastent™
Intervention type(s): Device
Intervention description(s): Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, non-randomized, single-dose, open-label study conducted in male and
      surgically sterile or post-menopausal female participants with stable chronic hepatic
      impairment and in healthy participants matched by age, gender, and body weight to assess the
      effect of hepatic impairment on the pharmacokinetics of alectinib.
    


Intervention name(s): Alectinib
Intervention type(s): Drug
Intervention description(s): Participants will receive alectinib as per the dosage schedule mentioned in arm description.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; Alectinib; Hepatic impairment
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic
      control on metformin alone, have a similar, or not inferior, glycemic response when treated
      with the combination of muraglitazar and metformin compared to pioglitazone and metformin.
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the
      efficacy in the sleep difficulties associated with insomnia
    


Intervention name(s): GR205171; GW597599
Intervention type(s): Drug; Drug
Intervention description(s): 10 milligrams (mg); 15 mg
Intervention MeSH terms: Vofopitant; Vestipitant
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Primary Insomnia Adults
Vaginal Misoprostol and Foley Catheter for Induction of Labor
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 2

Summary: 
      to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter
      for induction of labor
    

Detailed description: 
      two groups of patients who are eligible for labor induction were randomized to either
      sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal
      misopristol plus foleys catheter.
    

Intervention name(s): Misoprostol; Foley Catheter
Intervention type(s): Drug; Device
Intervention description(s): vaginal Misoprostol Plus Foley Catheter
Other intervention name(s): cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open label study is to characterise the absorption, metabolism,
      excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male
      participants.
    

Detailed description: 
      The study is designed as an open label, single-dose study in healthy adult participants for
      the following reasons:

        -  Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN
           will be given as a single dose.

        -  A comparator is not necessary for the evaluation of the objectives.

        -  Blinding of the study treatment is not required as there is no comparator.

        -  Conducting the study in healthy participants mitigates the potential confounding effects
           of the disease state and concomitant medications.
    

Intervention name(s): [14C]IDV184001AN
Intervention type(s): Drug
Intervention description(s): [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension
Other intervention name(s): [14C]-IDV184001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; ADME; OUD; radiolabel; metabolism
Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      randomized, open-label, single dose, replicate crossover clinical trial to compare the
      pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of
      telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
    


Intervention name(s): TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5); TWYNSTA(Telmisartan+Amlodipine besylate); Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once; TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once; Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)
Condition: Growth Disorder; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases; Growth Disorders
Study type: Observational

Summary: 
      This study is conducted in Europe and the United States of America (USA). The aim of the
      study is to validate two measures for growth hormone deficiency in children, the Treatment
      Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment
      Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): No treatment given.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The 2 populations (child and parent/guardian) will each be divided into a Treatment Naïve
        group and a Maintenance group.