bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation
Condition: Phototherapy; Autonomic Nervous System; Training
Study type: Interventional

Summary: 
      Recent studies have shown positive results in the application of phototherapy for the
      improvement of performance and acceleration of the healing process of the body homeostasis.
      Among the methods used to assess the recovery post-exercise has cardiac autonomic modulation
      assessed by heart rate variability (HRV), a tool widely used in sports to evaluate medium
      global behavior of the autonomic nervous system. Objective: analyze and compare the effect of
      a special protocol of phototherapy using different light sources interacting with a combined
      training with an autonomic modulation of heart rate in different moments (baseline; tracking
      daily; recovery post-exercise and after training). Method: 45 male participants will be
      allocated from a stratified randomization into three groups: control (n=15), placebo (n=15)
      and group special protocol of phototherapy (n=15). Participants will perform a combined
      training of sprints and squats twice a week for twelve weeks divided into two phases. The
      application of phototherapy and placebo was administered in phase 2, after sprints and just
      before the squat. The phototherapy was used combine different light sources and wavelength
      (red and infrared). Was analyze HRV in five moments: baseline; traking daily; week target of
      phase I and II; after training. The weeks target consist of training sessions with greater
      energy expenditure (largest intensity). The sphericity of the data was tested by Mauchly
      test. In case of violation of the sphericity assumption, the correction of Greenhouse-Geisser
      was performed. The data was analyzed using analysis of variance for repeated measures
      (Bonferroni post-test), which provide information on the effects of time, group and
      interaction. All statistical analyzes assume the significance level of 5%.
    


Intervention name(s): Phototherapy; Placebo; Passive recovery
Intervention type(s): Other; Other; Other
Intervention description(s): Photobiomodulation or photobiostimulation, this technique is the application of monochromatic light that can influence cellular activity through inhibition or stimulation of chemical and biological functions.; The same procedures as in the active phototherapy group was applied to the placebo group; however, the emitter was disabled. The device was emit the same sounds regardless of the programmed mode (active phototherapy).; Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Photobiomodulation; Autonomic nervous system; Heart rate variability; Recovery of function; Super-pulsed laser; Led light
Ileus After Lumbar Spine Surgery
Condition: Lumbar Spine Surgery Postoperative Ileus
MeSH terms: Ileus
Study type: Observational

Summary: 
      Postoperative ileus (POI) after lumbar spine surgery is not uncommon. However, the incidence,
      severity and risk factors of ileus after spine surgery remain uncertain because there is not
      yet a prospective investigation using a subjective grading evaluation tool.
    

Detailed description: 
      This study aims to prospectively investigate the incidence of POI after spine surgery by
      using the I-FEED scoring system. The severity of POI after spine surgery thus could be
      stratified and then an investigation of possible risk factors could be identified.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who undergoing elective lumbar spine surgery
      
Keywords: post-operative ileus,lumbar spine surgery
Evaluation of Pain Measurement Device
Condition: Pain
Study type: Observational

Summary: 
      This longitudinal observational study will attempt to objectively measure pain with an
      experimental, non-invasive device. Patients and volunteers will receive a baseline screening
      with psychophysical tests and questionnaires. Investigators will apply the device to measure
      pain during routine clinical care and correlate patients pain ratings and analgesia
      requirements to that measured by the device. A more standardized approach with experimental
      pain stimuli will be pursued in human volunteer studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women of all ethnicities will be included.
Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury
Condition: Drug Induced Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to try to develop new blood tests that may help doctors identify
      if a drug is hurting a person's liver.
    

Detailed description: 
      Our hypothesis is that there are liver-specific particles, called mRNA, that are identifiable
      in a person's blood sample during liver injury caused by some drugs. The purpose of this
      study is to try to develop new blood tests that may help doctors identify if a drug is
      hurting a person's liver, perhaps early in the process before significant injury or illness
      have occurred.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be identified in emergency rooms or inpatients at the University of North
        Carolina Memorial Hospital.
      
Biospecimen description: 
      blood
Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Condition: Hypertension, Portal
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo
      controlled, double blind study. This study will enroll subjects with portal hypertension
      (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak
      stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and
      those with decompensated cirrhosis.

      Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to
      receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean
      body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over
      a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is
      the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo
      as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week).

      An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will
      be performed before the first infusion and after the final 26th dose of the investigational
      medicinal product (IMP). Additionally, subjects will undergo a FibroScan (if available) prior
      to the first infusion, at Infusion Visit 13, and 14 to 28 days following final 26th infusion,
      an methacetin breath test (MBT), will be performed if available at screening, at Infusion
      Visit 13, and 14 to 28 days after the final infusion, and blood will be collected for
      assessment of biomarkers.

      All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the
      final dose administration and a second will occur 14 days following the first postdose visit.

      Subjects will be offered enrollment into a subsequent separate study, an open label extension
      study, if there is adequate tolerability and no safety issues or signs of clinical
      progression that would recommend discontinuation.

      Subjects who do not enroll in the open label extension study will be contacted via telephone
      every 6 months for 2 years and annually thereafter for a total of 4 years.
    


Intervention name(s): GR-MD-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3; Placebo for GR-MD-02
Other intervention name(s): galactoarabino rhamnogalacturonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liver Cirrhosis
Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment
Condition: Deep Caries
Study type: Interventional

Summary: 
      Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in
      two-step indirect pulp treatment: Randomized clinical trial
    


Intervention name(s): Calcium hydroxide; Calcium silicate
Intervention type(s): Other; Other
Intervention description(s): Pulp capping material; Pulp capping material
Other intervention name(s): Dycal; Theracal
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Children's Amalgam Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only
      such trial in the United States, to address the potential impact of mercury exposure from
      amalgam restorations on neuropsychological and renal function in children.
    

Detailed description: 
      The safety of silver amalgam as a dental restorative material has been controversial since
      its introduction 150 years ago, but until recently it has been assumed that the exposure to
      mercury from dental amalgam is limited to the acute placement phase. However, some recent
      studies have raised safety concerns by demonstrating chronic release of mercury vapor from
      amalgam fillings during chewing and brushing. The Children's Amalgam Trial (CAT) is a two-arm
      randomized trial of safety, comparing amalgam with a mercury-free restorative material. A
      single masking procedure is used to ensure that all investigators and staff measuring
      outcomes are unaware of assigned trial arm. The study follows 534 New England children, aged
      6-10 years at enrollment, for 5 years. The children were recruited from two northeastern U.S.
      communities, one in rural Maine, and one in urban Massachusetts. No trial subjects received
      prior amalgam restorations, and all were in need of at least two posterior occlusal fillings.
      Participants were randomized to receive either amalgam or composite material for all
      posterior restorations at baseline and at subsequent visits. The primary endpoint will be
      5-year change in IQ scores. Secondary endpoints will include measures of other
      neuropsychological assessments and renal functioning.
    

Intervention name(s): Dispersed phase amalgam restoration /composite restoration
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
The Clinical Significance of Biochemical 11 Deoxycortisol Levels
Condition: Retrospective
Study type: Observational

Summary: 
      data from charts regarding clinical characteristics and androgens levels from first to last
      visit were collected
    

Detailed description: 
      data from charts regarding clinical characteristics and androgens levels from first to last
      visit were collected Female patients only ages 10-18 years who were referred to the combined
      gynecology endocrinology adolescents clinic
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All referred to gynecology endocrinology adolescents clinic who underwent an ACTH
        stimulation test
Analysis of Postoperative Bandage Use Protocols in Otoplasty
Condition: Prominent Ears
Study type: Interventional

Summary: 
      The aim of the study is to investigate the possible influence of different durations of use
      of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty.
      We hypothesize that the duration of elastic bandage use has no significant influence on the
      incidence of relapse of prominence of the ears and need for reoperation.
    


Intervention name(s): Use of ear bandage
Intervention type(s): Procedure
Intervention description(s): Elastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: External ear; Ear abnormalities; External ear cartilages
A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals
Condition: Immune Response to Oral Polio Vaccine
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World
      Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study
      will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study
      will also assess lot-to-lot consistency among three lots of BBio bOPV.
    

Detailed description: 
      Bilthoven Biologicals has developed a new bivalent OPV containing WHO approved Sabin strains
      of poliovirus type 1 and type 3. This phase III study will be conducted in two parts:

      Part 1 - 40 children of 60 to 83 months of age will be given single dose of BBio bOPV or
      licensed bOPV in 1:1 ratio. Primary objective is to assess safety of BBio bOPV.

      Part 2 - A total of 1080 infants of 42 to 56 days of age will be randomized to receive three
      doses of either BBio bOPV from one of the three lots or a licensed bOPV in 1:1:1:1 ratio as
      primary immunization series at 6, 10 and 14 weeks of age.

      Primary objective of this study is to assess non-inferiority of bOPV manufactured by BBio to
      that of licensed bOPV in terms of seroconversion. This study also will assess lot-to-lot
      consistency among three lots of BBio bOPV.
    

Intervention name(s): Part 1 study - BBio bOPV; Part 2 study - BBio bOPV Lot 1; Part 2 study - BBio bOPV Lot 2; Part 2 study - BBio bOPV Lot 3; Part 2 study - Licensed bOPV; Part 1 study - Licensed bOPV
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.; Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.; Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.; Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.; Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.; A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Lifestyle Intervention Program in Overweight Medical Students
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study will be a randomized cross-over design over the course of 2 academic years. 40
      subjects -20 overweight women and 20 over weight men will be recruited. Each subject will
      have body composition tested, blood lipid profile, and resting metabolic rate done in the
      beginning of the first academic year and at the end of the first academic year. The
      intervention group will receive activity trackers, diet counseling, and fitness counseling
      for one academic year. The second year, all outcome measures (a body scan, blood lipid
      profile, and resting metabolic rate) will be performed again at the start of the academic
      year 2, except the intervention group will now be the control group and the control group
      will now receive the same intervention. All final outcome measures will be performed at the
      end of the second year.
    


Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
Condition: Huntington Disease; Irritability
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess efficacy and safety of dextromethorphan/quinidine
      20mg/10mg (DM/Q 20mg/10mg) in patients with irritability due to Huntington's disease.
    


Intervention name(s): Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DM/Q 20mg/10mg one capsule once daily for 1 week, followed by DM/Q 20mg /10 mg twice daily for subsequent 4 weeks, and finally DM/Q 20mg/10mg once daily for 7days.; Placebo once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
Other intervention name(s): Nuedexta
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritability
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Interventional
Phase: Phase 2

Summary: 
      Syncope is defined as transient loss of consciousness associated with inability to maintain
      postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the
      effects of sublingual administration of a new medication called CPC on tilt-induced syncope
      in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants were
      randomized at the University of Wisconsin - Madison. Each participant will be in the study
      for 1 day.
    

Detailed description: 
      Vasovagal syncope (VVS) is the most common type of syncope. The mechanism is reflex-mediated
      triggered by various afferent input to the brain. The event is usually preceded by
      diaphoresis, warmth, nausea, and pallor, and is followed by fatigue. While several drugs are
      indicated in the treatment of VVS, to our knowledge, there is no current treatment of an
      impending syncopal attack. In the present study, the investigators hypothesize that a single
      administration of sublingual CPC preparation during the prodromal phase aborts tilt-induced
      syncope or near syncope with SBP less than or equal to 70 mmHg in patients with a history of
      VVS. Patients with an established diagnosis of typical VVS or near syncope will be randomized
      to receive CPC or placebo in 1:1 ratio. Drug or placebo will be administered at the onset of
      prodromes during tilt table testing. In addition to the primary endpoint (syncope or near
      syncope with SBP less than or equal to 70 mmHg), the investigators will be assessing the
      effects of the drug on time to event, incidence of asystole (> 3 sec), and fatigue after tilt
      table testing.
    

Intervention name(s): CPC - Capsaicin, Phenylephrine, Caffeine; Tilt Table Test; Placebo
Intervention type(s): Drug; Diagnostic Test; Drug
Intervention description(s): CPC is a combination of Capsaicin, Phenylephrine and Caffeine; Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).; Placebo for CPC
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Caffeine; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Neurocardiogenic Syncope; Reflex Syncope; Fainting Spells
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult
      subjects.
    

Detailed description: 
      The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A
      total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each
      participant will receive a single IM dose of TNM002 or placebo according to the cohort in
      which they were enrolled. After injection (Day 1), participants remain in the study site for
      observation up to 5 days. Following completion of the safety assessments and sampling for
      PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15,
      29, 43, 64 and 85, participants will return for safety assessments.
    

Intervention name(s): TNM002 Dosage 1 (10 μg/kg); Placebo; TNM002 Dosage 2 (35 μg/kg); Placebo; TNM002 Dosage 3 (100 μg/kg); Placebo; TNM002 Dosage 4 (250 μg/kg); Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once.; placebo to match TNM002 Dosage 1, given once; TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once; placebo to match TNM002 Dosage 2, given once; TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once; placebo to match TNM002 Dosage 3, given once; TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once; placebo to match TNM002 Dosage 4, given once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment