bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients
Condition: Anesthetics, Local
Study type: Interventional

Summary: 
      The clinical trial will compare pain perception during dental local anesthesia injections
      with and without using soft tissue vibration device prior to injection. The primary goal is
      to test the effectiveness of such devices in pain/discomfort reduction during intraoral local
      anesthesia injections in various techniques (infiltration and block anesthesia).
    


Intervention name(s): DentalVibe® Comfort Injection System; Lidocaine Epinephrine
Intervention type(s): Device; Drug
Intervention description(s): Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.; Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other intervention name(s): DentalVibe; Xylocaine 2% with Epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in
      child and adolescent patients with bipolar I disorder, manic or mixed episode with or without
      psychotic features.
    


Intervention name(s): Aripiprazole; Aripiprazole; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.; Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.; Placebo tablet
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aripiprazole; Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
Condition: Migraine Disorder
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on
      the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility,
      acceptability, compliance and maintenance of Tai Chi exercise among this population.
    

Detailed description: 
      Migraine is a disabling neurological condition, characterized by attacks of headache and
      associated symptoms such as photophobia, nausea, and vomiting. In Hong Kong, the overall
      prevalence is around 12.5%. People with repeated migraine attacks are pain and personal
      suffering, have impaired social and personal life, and increased financial cost of
      medication. More nonpharmacologic prophylactic treatments are needed to reduce the high
      disease burden. As a body-mind exercise, Tai Chi's potential therapeutic efficacy on the
      prophylaxis of migraine has caught our attention. The investigators propose to conduct a
      two-arm individual level randomized controlled trial. Local women diagnosed with episodic
      migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi
      training ("TC"); or 2) a waiting list control group ("control"). The control group will
      receive a "delayed" Tai Chi training at the end of the trial. A total of 60 participants will
      be randomized and the intervention period will be 12 weeks with another 12-week follow-up.
      Number of attacks per month (frequency of attack), intensity and duration of headache,
      stress, sleep quality and quantity, fatigue, HRQoL, and body composition will be measured at
      baseline and at 12 weeks and 24 weeks. The primary outcomes are the difference in frequency
      of attack from baseline to the 12 weeks after randomization, and the proportion of patients
      with at least a 50% reduction of the number of attacks per month. The intervention effect
      will be estimated by calculating the differences of outcomes from baseline to the end of the
      trial between the intervention and control groups using intention-to-treat analysis.
    

Intervention name(s): Tai Chi training; Waiting list control group
Intervention type(s): Behavioral; Other
Intervention description(s): The 12-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice sessions per week. A modified 32-short form Yang-style Tai Chi Chuan will be adopted. The instructor-led sessions will be operated by qualified Tai Chi masters. The training activity will be delivered in group. The group size is 15 to 18 persons.; At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Tai Chi; Prophylaxis; Randomized controlled trial
A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of different
      formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35
      months of age.
    

Detailed description: 
      Safety and immunogenicity of different formulations administered as a 2-dose schedule in
      children 6-35 months of age will be evaluated. In addition, the quality of the 2-dose priming
      will be assessed through the anamnestic response elicited by an antigen challenge
      (unadjuvanted H5N1) administered 12 months later. The persistence of the immune response
      approximately 12 months (Day 385) after dose 2 will also be evaluated.

      Subjects from each group will be enrolled into the CMI sub-cohort comprising of approximately
      100 subjects. Within the participating country(ies), these subjects will be enrolled in only
      selected/qualified sites.
    

Intervention name(s): Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
Intervention type(s): Biological
Intervention description(s): All subjects will receive intramuscularly a two-dose primary series (adjuvanted) at a 21 day interval, and a booster dose (unadjuvanted) at Day 385 of GSK1557484A vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: children; H5N1; observer-blind; Influenza; dose-ranging
Pilot Feasibility of Rice Bran Supplementation in Children
Condition: Dietary Rice Bran Supplementation
Study type: Interventional

Summary: 
      The purpose of this study is to assess feasibility of rice bran consumption in weaning
      children and to identify dietary rice bran mediated changes to the stool microbiome and stool
      metabolome.
    

Detailed description: 
      Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial
      nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent
      diseases. The investigators will determine if dietary rice bran intake can modulate the
      infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing
      diarrheal diseases that increase risk for malnutrition and stunting.

      The investigators hope to learn about the feasibility of dietary supplementation of
      heat-stabilized rice bran in weaning children living in regions with increased susceptibility
      to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool
      microbiome and metabolome.
    

Intervention name(s): Vitamin A; Rice Bran + Vitamin A
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.; 100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. Dietary rice bran consumed daily and amounts increase throughout the 3 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 3 g/day)
Other intervention name(s): whole food dietary intervention
Intervention MeSH terms: Vitamins; Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: rice bran; infants; stool metabolome and microbiome; dietary intervention
Filgrastim for the Promotion of Collateral Growth in Patients With CAD
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study in humans with stable coronary artery disease (CAD) treatable by
      PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of
      subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF
      (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
    

Detailed description: 
      The purpose of this study in humans with stable coronary artery disease (CAD) treatable by
      PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of
      subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF
      (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
    

Intervention name(s): Filgrastim (rG-CSF)
Intervention type(s): Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CAD; G-CSF; Collaterals; CFI; perfusion
Pilot Study of High Risk Lung Cancer Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study is a prospective trial of 200 individuals at high risk for lung cancer who are not
      eligible for lung cancer screening under current screening guidelines.
    

Detailed description: 
      This study is a prospective trial of 200 individuals at high risk for lung cancer who are not
      eligible for lung cancer screening under current screening guidelines. Potential subject's 6
      yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will
      undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in
      excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set
      the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other
      competing risks of death and this may potentially limit screening benefit in these older
      individuals.
    

Intervention name(s): Screening
Intervention type(s): Diagnostic Test
Intervention description(s): Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Pilot Study; High Risk; Prospective; Screening
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Condition: Dermatitis; Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate
      dry syrup in the change in the severity of pruritus after the treatment period.
    

Detailed description: 
      This is a randomized, double-blind, parallel-group comparative study to demonstrate the
      noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis,
      as assessed by the primary endpoint of the change from baseline in pruritus score after
      2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to
      investigate the safety, and plasma concentrations of TAU-284.
    

Intervention name(s): Bepotastine besilate; ketotifen fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day; Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Other intervention name(s): TALION 5mg tablets; ketotifen fumarate dry syrup
Intervention MeSH terms: Ketotifen; Bepotastine besilate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a non-randomized, open label study in healthy male and female volunteers. A single
      intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1
      and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone
      propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of
      Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7,
      and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study
      medical was performed within 7 days of study completion.

      The objective of this study was to assess the effects of chronic administration of
      fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and
      female subjects.
    


Intervention name(s): Ketorolac tromethamine; Fluticasone Propionate
Intervention type(s): Drug; Drug
Intervention description(s): A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.; Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6
Intervention MeSH terms: Fluticasone; Xhance; Ketorolac; Ketorolac Tromethamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of
      risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a
      sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior
      and thoughts). The study duration is about 6 to 7 weeks.
    

Detailed description: 
      Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. On enrollment,
      subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral
      risperidone tablets 1 to 3 mg, or oral risperidone tablets 4 to 6 mg), which will be
      administered daily for 6 weeks. Study medication will be increased to within the target
      dosage range during the first 7 days and then further increased until the maximum tolerated
      dose is achieved by day 14. The maximum tolerated dose will be maintained for the last 4
      weeks of the study, unless dose adjustments are agreed with the Sponsor. Risperidone (1 to 3
      mg or 4 to 6 mg) or placebo given orally as 0.5, 1, 2, 3, or 4 ,g tablets (or matching
      placebo) each day for 6 weeks.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Adolescents
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the
      Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan
      160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
    


Intervention name(s): Cilnidipine/Valsartan; Cilnidipine+Valsartan; Cilnidipine/Valsartan; Cilnidipine+Valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle; Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle; Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle; Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
Intervention MeSH terms: Valsartan; Cilnidipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Condition: Colonic Neoplasms; Rectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Rectal Prolapse
MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis; Rectal Prolapse; Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      After resection of diseased segments of the large intestine, the continuity of the intestine
      has to be restored. This can be done by suturing or with so called stapling devices. In
      addition since 2 centuries compression rings are used to connect the intestine after
      resection. The NITICAR27 device is a novel compression anastomosis device. The investigators
      want to prove if this novel device can be compared to commonly used stapling devices
      concerning anastomotic leakage, bleeding and stenosis.
    


Intervention name(s): Compression Anastomosis Device; follow-up colonoscopy
Intervention type(s): Device; Other
Intervention description(s): Restoring intestinal continuity using the NITI CAR27 device; endoscopic exploration of anastomosis after complete healing
Other intervention name(s): ColonRing; BioDynamix Anastomosis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anastomotic leakage; bleeding from the anastomotic region; anastomotic stenosis
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and
      tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic
      impairment (HI) compared to matched healthy participants.The information obtained in this
      study will help to determine whether dosage adjustment for FIA586 is necessary in patients
      with advanced liver fibrosis who have mild to moderate HI.
    

Detailed description: 
      This is a Phase I, single-dose, open-label, parallel-group study in participants with mild
      (Child-Pugh A; n=8-10) and moderate (Child-Pugh B; n=8-10) hepatic impairment (HI) and
      matched healthy participants with normal hepatic function (n=8-20).

      The study is comprised of an up to 28-day screening period (Days -28 to 2), a baseline
      evaluation (Day -1) prior to dosing on Day 1, and a treatment period of 6 days (Days 1-6).
      Participants will remain domiciled up to Day 6 after the Study Completion procedures have
      been completed.

      On Day 1, participants will be given a single dose of FIA586 following an overnight fast. PK
      (plasma and urine) and biomarker samples will be taken prior to dosing of study treatment and
      up to 120 hours (Day 6) post- dose. On Day 6, after the last PK sample has been taken, Study
      Completion assessments will be performed, and the participant will be discharged, provided
      there are no safety or tolerability concerns as judged by the investigator.

      All participants will have a post-study safety contact conducted approximately 30 days after
      administration of study treatment.
    

Intervention name(s): FIA586
Intervention type(s): Drug
Intervention description(s): FIA586 capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; NASH; Child-Pugh classification; FIA586