bioihbjkbjnl/mcl2 huggingface dataset:
Intragastric Balloon in Obese Adolescents With Comorbidities
Condition: Obesity
Study type: Interventional

Summary: 
      The reason we are doing this research is to get information about the ORBERA™ Intragastric
      Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are
      overweight will lose weight and if their other medical problems will get better. ORBERA™ is a
      special balloon approved by the FDA for overweight adults, and we would like to try using it
      for overweight teenagers.
    

Detailed description: 
      After obtaining consent and determining that participants meet the inclusion and exclusion
      criteria, participants will have baseline tests and initial visits with a physician,
      dietitian, and psychologist. Next, the ORBERA™ Intragastric Balloon (IGB) will be inserted
      into the stomach and then removed after 6 months. Participants will continue to be followed
      for 6 months after the balloon is removed. Throughout the year, participants will have
      additional tests along with ongoing visits with a physician, dietitian, and psychologist.
    

Intervention name(s): ORBERA™ Intragastric Balloon
Intervention type(s): Device
Intervention description(s): The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery
Condition: Airway Extubation
Study type: Interventional

Summary: 
      The investigators examined the effect of dexmedetomidine on the emergence agitation and
      postoperative quality of recovery in nasal surgery
    

Detailed description: 
      Emergence agitation during the immediate postanesthetic period is common. It may lead to
      serious consequences for the patient, such as injury, increased pain, hemorrhage,
      self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The
      aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and
      postoperative quality of recovery in adult patients undergoing nasal surgery.
    

Intervention name(s): Dexmedetomidine; Normal saline 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation; Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Naturopathic Treatment for the Prevention of Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test the ability of a comprehensive naturopathic approach to reduce
      important risk factors for the development of cardiovascular disease. Treatment will take
      place over the course of one year and the comparator/control group will be followed by their
      medical doctors and be given conventional care.
    

Detailed description: 
      Interventions will consist of an individualized treatment approach guided by an expert panel
      of clinicians who treat patients with cardiovascular disease. These interventions will
      consist of a combination of dietary, lifestyle and specific recommendations for
      supplementation. As this is a pragmatic study, blinding will not be attempted nor is
      appropriate.
    

Intervention name(s): Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise; Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)
Intervention type(s): Other; Other
Intervention description(s): Individualized according to needs of each participant and willingness to comply. Intervention to include lifestyle modification, dietary changes and supplementation using natural health products as recommended by naturopathic practitioner.; Will vary according to individual - not standardized and likely to include statins.
Other intervention name(s): Naturopthic Medicine; Diet; Natural Health Products; Alternative Medicine; Fish oil; Plant sterols; Soluble fiber; CoQ10; Cinnamon; Exercise; Cholesterol lowering drugs; Atorvastatin; Fluvastatin; Lovastatin; Pravastatin; Rosuvastatin; Simvastatin
Intervention MeSH terms: Coenzyme Q10; Ubiquinone; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin; Lovastatin; L 647318; Dihydromevinolin; Anticholesteremic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular disease; naturopathic medicine; natural health products; lifestyle intervention; dietary advice; coronary heart disease
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Condition: Genital Herpes
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional

Summary: 
      To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV)
      shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a
      history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to
      receive episodic acyclovir 400mg orally three times daily or matching placebo three times
      daily for 5 days and who are followed for a total of 13 days.
    


Intervention name(s): acyclovir; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400mg taken orally three times daily for 5 days; matching placebo taken orally three times daily for 5 days.
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: herpes simplex virus; acyclovir; HSV shedding; women; Africa
The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate
      the PK, safety and tolerability of SR750 in healthy subjects.
    


Intervention name(s): SR750 tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of SR750 orally; Ascending single and multiple doses of placebo orally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran
      etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days)
      in healthy male subjects between Japanese and Caucasians
    


Intervention name(s): Dabigatran high dose; Dabigatran low dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC
Condition: Advanced Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Hepatic arterial infusion chemotherapy (HAIC) deliver high concentration of chemotherapeutic
      agents directly to the liver tumor, was proved to be effective for intrahepatic and perihilar
      cholangiocarcinoma. Based on the potential synergistic effect of bevacizumab, chemotherapy
      and PD-1 inhibitor, this phase II clinical study want to test the efficacy and safety using
      intra-arterial infusion of oxaliplatin, 5-fluorouracil and bevacizumab combined with
      intravenous infusion of PD-1 inhibitor (Toripalimab) in the treatment of unresectable biliary
      malignant tumors.
    


Intervention name(s): OXA, 5-FU and bevacizumab plus Toripalimab
Intervention type(s): Drug
Intervention description(s): concomitant treatment: A. HAIC: oxaliplatin (40 mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for 22 hours) on days 1-3, and arterial bevacizumab 300mg for 2 hours on d1 before oxaliplatin through a percutaneously implanted port-catheter system.
B. Intravenous PD-1 inhibitor (Toripalimab) 240 mg for 30-60 minutes on d1 before the HAIC.
The concomitant treatment repeat every three week, up to 6 cycles.
Maintenance treatment: Bevacizumab (300mg) + PD-1 inhibitor (Toripalimab 240mg) will be given intravenously, every 3 weeks.
Other intervention name(s): FOLFOX
Intervention MeSH terms: Bevacizumab
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic arterial infusion chemotherapy; oxaliplatin; 5-fluorouracil; bevacizumab; Toripalimab; advanced biliary tract cancer
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The present study aims to evaluate the impact of detecting active initial caries lesions in
      primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and
      satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary
      dentition will be examined and treated in a mobile dental unit, which will temporarily be
      parked in public schools of Sao Paulo. The caries detection will be conducted using the
      International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an
      adjunct criterion for caries activity assessment. Children will be randomized in two groups
      according to the caries threshold to be detected: Group A (only advanced lesions will be
      detected and treated, independently of their activity status) and Group B (all caries
      lesions, including initial ones, will be detected and all active lesions will be treated).
      After this, the treatment plan for each child will be made according to strategies mentioned
      above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction
      of children and quality of life will be collected after diagnosis, after the end of treatment
      and 12 and 24 months from the initial examination. For comparison between groups, multilevel
      regression analyses will be performed. The primary outcome will be sites which need of
      operative treatment during the follow-up periods and the secondary outcomes will be the
      cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the
      impact on quality of life.
    


Intervention name(s): Advanced caries lesions detection (no activity assessment); All caries lesions detection (+activity assessment)
Intervention type(s): Other; Other
Intervention description(s): The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.; The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.
Other intervention name(s): WHO criteria; Advanced caries lesions; Extensive Decays; Caries activity assessment; initial caries lesions; early detection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Dental caries; Primary tooth; Caries Detection
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is
      required in patients with mild or moderate hepatic impairment.
    


Intervention name(s): Lorcaserin
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Chiropractic Force Versus Touch
Condition: Healthy
Study type: Interventional

Summary: 
      The Life University Center for Chiropractic Research is conducting a research study to better
      understand the physiologic and brain-based differences between the touch and force components
      of the chiropractic adjustment. Eligible individuals will either receive a chiropractic
      adjustment with force or a non-force stimulation. Individuals in the force stimulation group
      will receive an active spinal adjustment with a handheld instrument called an Activator.
      Individuals in the non-force stimulation group will have one Activator placed on the spine
      and another Activator clicked away from the spine. This study is not randomized. The first
      participant will receive an active spinal adjustment, and the second participant will receive
      a non-force stimulation at the same locations as the first participant. This pattern repeats
      until all individuals have been recruited (n=30). Outcome assessments include resting state
      electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome
      assessments will be captured prior to the adjustment or non-force stimulation, after the
      adjustment or non-force stimulation, and one week later. Individuals will also undergo a
      standard health history and chiropractic physical exam at the start of participation.
    


Intervention name(s): Chiropractic spinal adjustment; Non-force simulation
Intervention type(s): Other; Other
Intervention description(s): Chiropractic spinal adjustment; Non-force simulation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect
Condition: Unilateral Spatial Neglect (USN)
MeSH terms: Perceptual Disorders
Study type: Interventional

Summary: 
      Investigators hypothesize, based on anecdotal evidence to date, that active music making
      interventions conducted on a patient's neglected side will result in improved attention to
      that side and that this will be measurable within session.
    

Detailed description: 
      An open, single group of ten patients selected will receive a 30 minute music
      therapy/occupational therapy co-treatment intervention. Music interventions will be performed
      by a licensed, Board-Certified Music Therapist while a licensed Occupational Therapist will
      provide support, assistance, and measurements of behavioral attention/inattention. At the
      outset of the first session patients will be briefly, informally interviewed to ascertain
      their musical preferences, which will then be integrated into the music therapist's
      interventions whenever possible to maximize engagement and therapeutic rapport. Live music
      will be provided on the patient's neglected side and patients will be encouraged to play
      music interactively with a focus towards that side whenever possible. An outcome measurement
      tool (Star Cancellation Test) will be focused on measuring hemispheric neglect and
      administered at the beginning and end of each session to measure within session changes.
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): The majority of each study session will be spent engaging in music therapy: playing live music with a music therapist with the help of an occupational therapist. At the beginning and end of each session subjects will complete 2 assessments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Music therapy; sensorimotor cortex; brain injury
Pulses, Satiation, Food Intake and Blood Glucose
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Pulses have the potential to be positioned as a food for body weight and metabolic control
      based on their composition, effects on rate of digestion and absorption of fat and
      carbohydrates, and effects on satiety. However, the role of individual pulses incorporated
      into a mixed meal on regulation of food intake, satiety and glycaemic control remains
      unclear. Therefore, the objective of our study was to determine the effects of ad libitum
      consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food
      intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.
    


Intervention name(s): dietary treatment
Intervention type(s): Other
Intervention description(s): A within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
fMRI and Visceral Perception Upon Capsaicin Infusion
Condition: Irritable Bowel Syndrome; Colonic Diseases, Functional; Dyspepsia; Gastrointestinal Diseases; Abdominal Pain; Visceral Pain
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Colonic Diseases, Functional; Dyspepsia; Abdominal Pain; Visceral Pain
Study type: Interventional

Summary: 
      Brain imaging has shown abnormal brain activations in response to visceral stimulation in
      patients with the Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD). To
      investigate the possible role of the Nucleus of the Solitary Tract (NTS), the primary relay
      station in the brainstem for vagal afferents, its activation in IBS and functional dyspepsia
      patients will be evaluated. Prior to this, an exploratory study in healthy volunteers will be
      conducted. This will be the first high magnetic field fMRI study (7T) evaluating the possible
      role of NTS activation in visceral abdominal pain. Moreover, this will be the first
      pharmacological fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is
      more physiological than mechano-stimulation in the upper gastrointestinal tract.
    


Intervention name(s): Capsaicin; Placebo
Intervention type(s): Other; Other
Other intervention name(s): Capsaicin oleoresina solution infusion into the duodenum.; Saline infusion into the duodenum
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Magnetic Resonance Imaging; Brainstem; Solitary Nucleus; Visceral Nervous System; Transient Receptor Potential Channels
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the safety and effectiveness of the CardioFocus
      Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.
    


Intervention name(s): Endoscopically Guided Ablation
Intervention type(s): Device
Intervention description(s): Visually Guided Ablation using EAS-AC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to characterize the effects of a single-dose of retigabine on
      cortical excitability in healthy subjects, as quantified by means of TMS.
    

Detailed description: 
      Epilepsy is a disorder of brain excitability. Antiepileptic drugs (AEDs) modulate this
      excitability and transcranial magnetic stimulation (TMS) imposed itself as one of the best
      noninvasive methods to study cortical excitability in human subjects.

      Based on several recent studies, we hypothesize that measuring TMS parameters in the patients
      suffering from epilepsy can rapidly predict the effectiveness of the newly given AED and,
      ultimately, guide the optimization of the AED therapy. Characterizing the neurophysiological
      properties of innovative AEDs such as retigabine with TMS will allow 1) to better understand
      how AEDs modulate, in vivo, cortical excitability in humans in relation to their mode of
      action and 2) to establish TMS as a tool for assessing individual responsiveness to a
      particular AED treatment and for antiepileptic treatment monitoring.

      The effects of most AEDs on cortical excitability have been investigated. The modifications
      of the excitability parameters are related to the specific mode of action of each AED. For
      the new AED retigabine, at least two modes of action are known: 1) increase in cellular
      potassium efflux by changing conformation of the KV7.2-7.3 channels and 2) enhancement of
      GABA-A activity.
    

Intervention name(s): retigabine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of a 400 mg tablet.; Single oral administration of a tablet
Other intervention name(s): ezogabine
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: retigabine; cortical excitability; Transcranial Magnetic Stimulation