bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
Condition: Spinal Injuries; Low Back Pain
MeSH terms: Low Back Pain; Spinal Injuries
Study type: Interventional

Summary: 
      Contextualization: Trigger points are muscle nodules found in muscles. We can observe five
      different types of trigger point, in clinical practice two of them stand out, the active
      trigger point; Which is painful; And latent; Asymptomatic; Both of which are sensitive to
      palpation. Once the individual present these muscle nodules can develop pain and motor
      dysfunction. Studies indicate that the prevalence of trigger points is 95% of individuals
      with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with
      low back pain.

      Objective: To compare the pain and function levels of patients with acute and chronic low
      back pain who, when asymptomatic, had trigger points compared to the pain and function levels
      of patients with acute and chronic low back pain who, when asymptomatic, had no trigger
      points.

      Study design: Cohort study, two arms, blind evaluator, prospectively enrolled at baseline.

      Location: This research will be conducted in the physiotherapy department at the
      Rehabilitation Center of the Brotherhood of Santa Casa de Misericórdia de São Paulo (ISCMSP).

      Patients: 400 asymptomatic individuals Follow-up: Asymptomatic individuals will be assessed
      at baseline and over 3 years. You will be asked to contact the research department within 6
      weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). Participants
      will be allocated to two groups, trigger point group (n = 200) and group without trigger
      point (n = 200).

      Outcomes: The pain intensity, function level and trigger point pain intensity outcomes will
      be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar
      (acute) and after 12 weeks the pain persists (chronic)
    


Intervention name(s): Evaluation of pain by algometry
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety
Condition: Cancer in Remission (Any Type or Stage); Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is
      associated with high rates of depression and anxiety among its sufferers, and cancer patients
      with depression usually have worse treatment outcomes and long-term survival. Surprisingly,
      many cancer patients with depression do not receive treatment for their depression, perhaps
      because treatments for cancer-related depression are usually adapted from those used in
      non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients
      with depression are more likely to have a long latency of anti-depressant drug action,
      negative drug-drug interactions with cancer chemotherapies and an increased susceptibility
      for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new
      treatment modality for depression that affects the brain directly with no systemic side
      effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared
      by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder,
      and now is being evaluated for a wide array of additional psychiatric indications. This
      randomized, open label, two-arm, pilot study will investigate the safety, tolerability,
      feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided
      rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly
      reduce symptoms of depression and that right-sided slow rTMS will be more effective than
      left-sided fast rTMS for the treatment of severe anxiety.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Other intervention name(s): Neurostar TMS Therapy(R) System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repetitive Transcranial Magnetic Stimulation; Cancer Survivors; Depression; Anxiety
Regenerative Endodontic Therapy (RET) for the Management of Immature Non-vital Permanent Teeth in Children
Condition: Infected Immature Permanent Teeth
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of Antibiotic pastes or Calcium hydroxide disinfection on
      healing of periapical pathology and continued root development of infected non-vital immature
      permanent teeth in children.

      In the test group regenerative endodontic therapy (RET) is performed with antibiotics as the
      disinfecting agent, in the control group RET is performed with Calcium Hydroxide as the
      disinfecting agent.
    


Intervention name(s): RET using antibiotics (Ciprofloxacin and Metronidazole); RET using non-setting Calcium Hydroxide
Intervention type(s): Drug; Drug
Intervention description(s): RET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.; First Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.
Other intervention name(s): Bi-Antibiotics; Calcium hydroxide
Intervention MeSH terms: Calcium, Dietary; Anti-Bacterial Agents; Metronidazole; Ciprofloxacin; Antibiotics, Antitubercular; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regenerative Endodontic Therapy; Infected immature permanent teeth
Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair
Condition: Cleft Palate, Unilateral, Complete
MeSH terms: Cleft Palate
Study type: Interventional

Summary: 
      : Cleft palate is a congenital deformity caused by abnormal facial development during
      intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live
      births.

      The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly
      and inserted onto the posterior edge of the hard palate in cleft palate patients . This
      configuration prevents the muscle from exerting its upward, backward, and lateral pull.

      Various modalities have been described with major refinements over the past 30 years.
      Gradually, cleft surgeons began to appreciate the importance of dissection and
      retro-positioning of the levator muscle on improving speech outcomes.

      Furlow was the first to describe the palatoplasty technique, in which the levator muscle is
      dissected and freely released from its abnormal position and retro-positioned in a Z-plasty
      lengthening technique without dissection on the hard palate. However , among the problems
      that have been raised concerning the Furlow palatoplasty is the limitation of the procedure
      in wide clefts. Furthermore, the possibility of higher fistula rate associated with the
      technique.

      These considerations have led to modified palatal lengthening by buccinator myomucosal flaps
      which is this study working on.
    


Intervention name(s): furlow z plasty with buccinator myomucosal flap
Intervention type(s): Procedure
Intervention description(s): using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determinants of Gestational Weight Gain in Obese Pregnant Women
Condition: Energy Intake; Energy Expenditure
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Observational

Summary: 
      The purpose of this study is to measure energy intake and energy expenditure during and after
      pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the
      Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but
      no evidence for changes in energy expenditure after adjustment for the weight gained when
      compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally,
      the investigators will measure the babies born to the pregnant women enrolled in MomEE at one
      time point before 10 days of life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        75 obese, pregnant women
      
Biospecimen description: 
      Placenta, Cord Blood, fasting Urine, fasting Maternal plasma and serum (during pregnancy and
      postpartum).
    
Keywords: Pregnancy; Postpartum
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      Clinical follow-up survey of the Norwegian material of paediatric patients who received
      therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life,
      education, work, family and children, delayed effects of tumour disease and treatment,
      endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Those children and adolescents who were younger than 18 years of age and who recived
        treatement for medulloblastoma or CNS-PNET in southern part of Norway between 1974 and
        2013.
Mesenchymal Stem Cell and Islet Co-transplantation
Condition: Chronic Pancreatitis; Diabetes
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells
      (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human
      component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently,
      the investigators intend to test whether infusion of MSCs immediately after islet autograft
      can reduce onset of diabetes and improve glycemic control after total pancreatectomy and
      islet autotransplantation.
    

Detailed description: 
      This is a Phase I study evaluating safety and tolerability of autologous BM-MSCs in chronic
      pancreatitis patients who undergo total pancreatectomy and islet autotransplantation
      (TP-IAT). CCT-BMMSC will be infused at one of the following doses: (Tier 1), 20x10^6 cell per
      patient, (Tier 2), 50x10^6 cell per patient, and (Tier 3), 100x10^6 cell per patient.

      Primary objective: To describe and compare the safety and tolerability of infusion of fresh
      autologous bone marrow-derived Mesenchymal stromal cells after islet transplantation in
      chronic pancreatitis patients who undergo TP-IAT. The investigators plan to enroll 24
      patients for the whole study. The duration of this study is 12 months. The investigators
      anticipate that this study will be completed within 2 years of commencement.

      Secondary objective: Efficacy of infusion of fresh autologous bone marrow-derived Mesenchymal
      stromal cells together after islet transplantation in chronic pancreatitis patients who
      undergo TP-IAT as assessed through onset of diabetes, glycemic control, pain relief and
      quality of life index.

      Safety variables: Adverse events (AEs), Laboratory parameters (hematology, biochemistry,
      urinalysis), Vital signs
    

Intervention name(s): autologous mesenchymal stromal cell
Intervention type(s): Biological
Intervention description(s): Islet transplantation patients will receive autologous MSCs following islets infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Probiotics on Intestinal Inflammation in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and
      gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI
      tracts is influenced by both genetic and environmental factors. Children with CF may harbor
      an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane
      conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes
      and acid suppressors). The investigators previously demonstrated that intestinal inflammation
      is highly frequent in CF children, being a major feature of intestinal involvement. In
      addition, specific probiotics significantly improved airway and GI inflammation in a
      preliminary trial. The aim of the study is to characterize intestinal and respiratory
      microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG)
      supplementation on both GI and airway microflora and the eventual relationship between
      probiotic assumption and clinical and inflammation markers. The aim is to study the effect of
      microflora modification on intestinal and extraintestinal inflammation to eventually improve
      the quality of life of CF patients, who often suffer from intestinal and respiratory
      progressive disease, through a non invasive intervention consisting in the supplementation of
      probiotic bacteria.
    


Intervention name(s): Lactobacillus rhamnosus GG; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 capsule/die for 1 month; Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 cps/die for 12 months
Other intervention name(s): LGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: intestinal inflammation; intestinal microflora; children
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to test whether adalimumab can induce clinical remission in
      subjects with active Crohn's disease who have been initially treated with infliximab and
      either lost response or discontinued its use as a result of intolerance to the drug.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
Condition: Infant, Premature; Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha
      hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton
      pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and
      neonatal outcomes.

      Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal
      progesterone administered intramuscularly versus vaginally in women with singleton pregnancy
      and a history of prior preterm birth.
    

Detailed description: 
      This study is intended as a randomized controlled trial. Women with singleton pregnancies
      between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

      Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha
      hydroxyprogesterone caproate every week in the clinic between randomization and delivery for
      those delivery preterm or 36 weeks 6 days.

      While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily
      at home. Vaginal progesterone to last between clinic visits will be provided to subject.
      Those women in the vaginal progesterone group will also be informed on how to obtain
      additional medication in case of missed clinic appointment. Treatment will be continued until
      36 weeks 6 days or as dictated by date of preterm delivery.
    

Intervention name(s): Intramuscular Progesterone; Vaginal Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P; Vaginal Progesterone: 100 mg vaginal suppository daily
Other intervention name(s): 17 alpha hydroxyprogesterone caproate
Intervention MeSH terms: Progesterone; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pre Term; Pre Term Birth; Premature Birth; Premature baby; High risk pregnancy; Progesterone; IM Progesterone; Vaginal Progesterone
This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years
Condition: Multiple Sclerosis, Relapsing Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg
      and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with
      treatment-naïve RRMS for ≤ 3 years.
    

Detailed description: 
      This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg
      and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with
      treatment-naïve RRMS for ≤ 3 years..

      Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug
      in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be
      switched to INT131 1 mg PO QD and followed for an additional 6 months.
    

Intervention name(s): INT131
Intervention type(s): Drug
Intervention description(s): INT- 131
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized double blind parallel group study with 3mg, 1mg or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer
Condition: Malignant Neoplasm of Colorectum
MeSH terms: Neoplasms; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal
      metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial
      is that radical colorectal resection plus HIPEC is superior to only radical colorectal
      resection in terms of overall survival.
    

Detailed description: 
      To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer,
      patients are randomized into HIPEC group and control group. In HIPEC group, the patients
      undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu.
      Patients in the control group just undergo radical colorectal resection with lymphadenectomy.
      Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are
      followed up for 5 years or until death.

      The trial is designed as a prospective, randomized, open, multicenter and parallel group
      study.
    

Intervention name(s): Hyperthermic intraperitoneal chemotherapy (HIPEC); Radical colorectal resection; Oxaliplatin , Capecitabine; Normal saline , Cisplatin , 5-Fu
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.; radical colorectal resection with lymphadenectomy; XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment