bioihbjkbjnl/mcl2 huggingface dataset:
Strength Training for Injury Prevention
Condition: Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of a strength & conditioning (S & C)
      program on risk factors for injury (Y-balance and Functional Movement Screen scores), as well
      as parent reported injury occurrence in 12-16 year old male and female athletes. Forty girls
      and 40 boys aged 12-16 will be recruited; half will participate in supervised S & C sessions
      2-3x/week while the other half will continue with their regular sports and activities. Risk
      factors for injury and performance indices (20 m sprint and multiple jump test) will be
      assessed before and after the 4 month study. Injury occurrence will be recorded via bi-weekly
      phone calls to the parent and athlete.
    


Intervention name(s): Strength & Conditioning; Control
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Acute Treatment of Migraine Using the CEFALY Device
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as
      an acute treatment for a migraine attack. This open clinical trial will study the acute
      treatment of migraine using the Cefaly® device, prior to development of a sham-controlled
      trial.
    


Intervention name(s): CEFALY
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      Previous work have shown that consumption of foods rich in polyphenols, such as berries and
      cocoa, led to beneficial changes in the gut microbiota composition, as well as improvements
      in biomarkers of cardiovascular disease risk in healthy volunteers. In addition, recent
      studies suggest that pesticide exposure has a detrimental effect on the gut microbiome in
      human populations and laboratory animals.The aim of this pilot study is to investigate the
      effects of short-term consumption of an organic and a non-organic plant rich diet on urinary
      polyphenol and pesticide levels, gut microbiome and selected biomarkers of cardiovascular
      health in a group of young healthy individuals.

      Healthy men and women participants (10) will be recruited for a 2-arm randomised crossover
      controlled trial. Urinary polyphenol and pesticide levels after consumption of an organic and
      non-organic plant rich diet for 4 days will be analysed. Changes in gut microbiome
      composition and biomarkers of cardiovascular disease risk (flow-mediated dilation, blood
      pressure and arterial stiffness) will also be investigated.
    


Intervention name(s): Organic diet; Non-organic diet
Intervention type(s): Other; Other
Intervention description(s): Organic plant-rich foods (2000kcal for women, 2500kcal for men); Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: polyphenols; pesticides; plant based food; organic; microbiome; vascular function
Pediatric Schizophrenia Efficacy and Safety Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety study of Lurasidone in pediatric patients.
    

Detailed description: 
      To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in
      adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of
      Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from
      Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    

Intervention name(s): Lurasidone 40 mg; Lurasidone 80 mg; Placebo 40 or 80 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lurasidone 40 mg once daily; Lurasidone 80 mg once daily; Placebo 40 or 80 mg once daily
Other intervention name(s): Latuda; Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; Lurasidone; Latuda
Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB
Condition: Chronic Hepatitis b
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      In recent years, vitamin D (VD) has received much attention in the fields of host immune
      regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD
      works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells,
      dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI
      (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and
      more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct
      antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical
      cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies
      have been carried out at home and abroad.

      In this study, We will recruit CHB patients with low HBsAg levels. They all will receive
      pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a
      control group. A final assessment will be made to determine whether vitamin D levels would
      affect the clearance rate of HBsAg.
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): Patients take 800 mg vitamin D capsules daily during the whole treatment period
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis B; Vitamin D; Interferon
Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The main objective of the study was to demonstrate the non-inferiority of the efficacy of a
      single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular
      injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral
      osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales
      from D0 to D180.
    

Detailed description: 
      After a period of washout-out for NSAIDs, the patients received a single intra-articular
      injection of OSTENIL PLUS or of SYNVISC-ONE in the most painful knee. The study involved a
      preselection visit at D-7 and five further visits: at D0 (baseline, evaluation before
      intra-articular injection), at D2 ± 2 days (injection), at D30 ± 15 days, at D90 ± 15 days
      and C5 at D180 ± 15 days.

      To enrol the patients as quickly as possible, 129 sites, i.e. general medical or rheumatology
      practices, were open. After verifying the inclusion and exclusion criteria, the evaluating
      investigators assigned a randomisation number based on the chronological order of inclusion
      of patients at their site. The patient was then sent to the injecting investigator so that
      he/she could give the injection of the product corresponding to the randomisation number.
    

Intervention name(s): OSTENIL PLUS; SYNVISC-ONE
Intervention type(s): Device; Device
Intervention description(s): Injection into the joint cavity of the most painful knee; Injection into the joint cavity of the most painful knee
Intervention MeSH terms: Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a multicentre, prospective, double-blind, randomised, controlled non-inferiority study in two parallel groups of patients followed up for six months.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in
      people with a brief psychotic disorder, especially positive symptoms.

      The secondary objectives would be to assess the effect of EMC on metacognition (cognitive
      distortions and deficits in theory of mind), psychosocial functioning and quality of life,
      neuropsychological functioning and gender, as well as determine the changes produced by EMC
      in the insight of each session and the maintenance of the effects of EMC program at six
      months of treatment.
    

Detailed description: 
      The study is a randomized clinical trial in which a group will receive the Meta-Cognitive
      Training (EMC) and a control group will receive a journal workshop.

      The evaluator will be blind to the group that owns the patients included. The total simple
      will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score
      at or above 3 on the PANSS during the last year. Patients should be attended in one of the
      next services: Parc Sanitari Sant Joan de Déu, Corporació Sanitària Parc Taulí, Hospital de
      la Santa Creu i Sant Pau, Hospital Clínic de Valencia, Centre d´Higiene Mental de les Corts,
      Institut d´Assitència Sanitària Girona, Servicio Andaluz de Granada, Málaga y Jaén. The
      assessment was performed at baseline, at the end of treatment and six month follow-up.

      The assessment includes: psychopathology and insight ( PANSS, PSYRATS, PDI, GAF, BDI, BCIS,
      Sumd), meta-cognition (jumping to conclusions, IPSAQ, TCI), neuropsychology (WCST, TMT,
      CPT-II, TAVEC, WAIS) and social functioning and quality of life (EFS, DAS-SV, SLDS). The
      insight will be assessed at the final of each session (BCIS). The treatment and control group
      consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. The
      EMC group material is translated and validated in Spanish by investigators of the team.

      The primary analysis variable is the difference between the scores of experimental and
      control group in the symptoms scales (especially positive). Secondary outcomes will change in
      other assessments of social functioning, metacognition (cognitive distortions and theory of
      mind) and neuropsychological variables. Were analyzed using regression and ANCOVA methods
      with SPSS 19.
    

Intervention name(s): Meta-cognitive Training; Psychoeducational group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: meta-cognition; positive symptoms; early phases; schizophrenia
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and feasibility of vaccination
      with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF
      producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide
    


Intervention name(s): Colon GVAX; cyclophosphamide
Intervention type(s): Biological; Drug
Intervention description(s): Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4; 200 mg/m^2 administered IV on Day 1 of Cycles 1-4
Other intervention name(s): Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line
Intervention MeSH terms: Cyclophosphamide; Molgramostim; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV colon cancer; stage IV rectal cancer
A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the specially prepared study drug,
      LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it
      takes the body to get rid of it.

      Information about any side effects that may occur will also be collected.

      Participants will stay at a clinical research unit (CRU). The study will last about 28 days
      (check in to follow-up) for each participant.

      This study is for research purposes only and is not intended to treat any medical condition.
    


Intervention name(s): [¹⁴C]-LY3202626
Intervention type(s): Drug
Intervention description(s): Administered as solution by mouth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Combination of Cryosurgey and NK Immunotherapy for Recurrent Laryngeal Cancer
Condition: Recurrent Laryngeal Cancer
MeSH terms: Laryngeal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent laryngeal cancer.
    

Detailed description: 
      By enrolling patients with recurrent laryngeal cancer adapted to enrolled criteria, this
      study will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laryngeal cancer; cryosurgery; NK immunotherapy
Vestibular Stimulation in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether caloric vestibular stimulation improves
      symptoms of Parkinson's Disease.
    

Detailed description: 
      Parkinson's Disease (PD) is a nationwide public health problem, inflicting a complex
      constellation of physical and neuropsychiatric symptoms which are shown to progress with
      time. This research will investigate the potential of caloric vestibular stimulation (CVS), a
      non-invasive form of brain stimulation, as a treatment for individuals who suffer from
      Parkinson's Disease. Investigators will investigate whether core cognitive and physiological
      deficits are responsive to stimulation by comparing participants' performance on behavioral
      and physiological measures after baseline and either active or placebo stimulation phases
      with the aim of drawing initial insights into the application of CVS within this population.
      The study design is based on a single-case study that recently demonstrated durable,
      clinically meaningful gains in the motor and nonmotor symptoms of PD.
    

Intervention name(s): Caloric Vestibular Stimulation; Sham Caloric Vestibular Stimulation
Intervention type(s): Device; Device
Intervention description(s): Stimulation of the vestibular nerves; Sham stimulation of the vestibular nerves
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a single
      iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery
      System in healthy adult human volunteers.
    

Detailed description: 
      This is a single center, randomized, single-masked, comparative group, safety and
      tolerability study of single dose levels of citrate buffer delivered through transcleral
      iontophoresis administered via the EyeGate® II Drug Delivery System. The current study will
      also determine the safety and tolerability of the dose ranges of transcleral iontophoresis
      from 2 mA through 7 mA and will determine the safety and tolerability of the application of
      the Eyegate II system on the eye for time ranges of up to 10.5 minutes.
    

Intervention name(s): EyeGate II® Drug Delivery System; Citrate buffer
Intervention type(s): Other; Drug
Intervention description(s): Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System; Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Other intervention name(s): Citrate buffer
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Iontophoresis; Ophthalmology
Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors
Condition: Solid Tumors; Relapsed/Refractory Sarcomas
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find out how safe and effective treatment with a new
      combination of drugs, vorinostat and etoposide, is in treating cancer. The medication
      etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is
      an experimental drug which targets a protein(s) that control the way cancer cells grow and
      divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet
      in children.

      There are two parts to this study. In the first part of this study, the phase I portion, a
      safe dose of the combination, vorinostat and etoposide. The goal of second part of this
      study, the phase II portion, is to see how effective the combination of vorinostat and
      etoposide is in treating cancer.
    


Intervention name(s): Vorinostat and Etoposide
Intervention type(s): Drug
Intervention description(s): Patients will be assessed in 3-week cycles. Escalating doses of vorinostat will be administered orally on a daily x 4 schedule in combination with a fixed dose of etoposide. Etoposide will be administered intravenously daily x 3 days. Cohorts of 3-6 patients will be treated with vorinostat and etoposide. In the phase II component, patients will be treated at the RP2D established in the Phase I component of the study, which was found to be 270 mg/m2/dose of Vorinostat and 100 mg/m2/dose of Etoposide.
Intervention MeSH terms: Etoposide; Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ETOPOSIDE (VP-16); SAHA (SUBEROYLANILIDE HYDROXAMIC ACID) (Vorinostat); Pediatric; 10-096; POETIC; phase II component: the population will be restricted to relapsed/refractory sarcomas.
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative
      Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over
      the first 48 hours (SPID48) in subjects with acute moderate to severe pain following
      unilateral bunionectomy.
    


Intervention name(s): Intranasal Dexmedetomidine; Intranasal Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): DEX-IN
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bunion; Bunionectomy; Pain; Analgesia; dexmedetomidine; intranasal
Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators will test the hypothesis that transcutaneous electrical nerve stimulation
      (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution
      during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary
      Arterial Bypass Graft Surgery (CABG).
    

Detailed description: 
      Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program
      of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4).
      Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction
      (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as
      primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and
      expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical
      parameters. In addition, amount of opioid analgesic and pain intensity also will be measured
      throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).
    

Intervention name(s): Transcutaneous electrical nerve stimulation
Intervention type(s): Device
Intervention description(s): Patients will be treated with conventional TENS (ENDOMED 684 Device, ENRAF-Nonius B.V., Rotterdam, Netherlands) for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). TENS intervention was applied as described elsewhere.
Other intervention name(s): TENS; electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: exercise; neuromodulation; blood flow; exercise capacity
Cleft Palate Technique and Maxillary Growth
Condition: Cleft Palate; Growth
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      comparison of the maxillary growth between cleft palate patients that underwent to repair by
      2 flap palatoplasty versus Furlow with buccinator technique
    


Intervention name(s): 2 flap palatoplasty technique; normal group; Furlow with buccinator technique
Intervention type(s): Procedure; Other; Procedure
Intervention description(s): cleft palate repair by 2 flap palatoplasty technique; control normal group; cleft palate repair by Furlow with buccinator technique
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        5-6ys old child with treated cleft palate