bioihbjkbjnl/mcl2 huggingface dataset:
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Condition: Myofascial Pain Syndromes; Low Back Pain; Lumbago
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Back Pain; Low Back Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in
      myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and
      imaging exams.
    

Detailed description: 
      BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal
      conditions, however no randomized controlled trial are available about its use for chronic
      low back pain with myofascial pain syndrome (MPS).

      HYPOTHESIS: Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and
      functional disability compared with placebo in patients with chronic low back pain due to
      MPS.

      STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized,
      double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to
      severe pain (VAS > 4) for more than 6 months, despite 6 weeks of conservative treatment with
      antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000
      impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo.
      The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index,
      Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the
      temperature of the treated area will be evaluated with Thermography. The assessments will be
      apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.
    

Intervention name(s): Swiss DolorClast® CLASSIC applicator; Swiss DolorClast® CLASSIC placebo applicator
Intervention type(s): Device; Device
Intervention description(s): Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure; Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial Pain Syndromes; Myofascial Trigger Point; Low Back Pain; Lumbago; Shock Waves, High-Energy; High-Energy Shock Waves; Interdisciplinary Health Team; Multidisciplinary Pain Centers
Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
Condition: Graft-versus-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX
      (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the
      prevention of Graft-versus-Host Disease (GvHD).
    

Detailed description: 
      Approximately 30% of HLA-identical related bone marrow graft recipients and up to 90% of
      patients receiving bone marrow from unrelated donors develop significant acute GvHD despite
      the use of prophylactic therapies such as cyclosporine and methotrexate. About half of these
      patients respond to initial treatment with steroids and require no further treatment. The
      remainder of these patients are either unresponsive to initial therapy or become
      steroid-resistant over time. The prognosis in these cases is poor and mortality for patients
      with steroid-resistant GvHD may be as high as 50%.

      ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable
      compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are
      reinfused into the patient, their function is altered, thereby activating mechanisms that
      allow for further regulation of specific lymphocyte populations. ECP has shown activity in
      several inflammatory and autoimmune diseases, including scleroderma, rheumatoid arthritis,
      transplantation rejection, acute and chronic GvHD.

      In a previous single-center, open label, single-arm study of 56 patients receiving ECP
      treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to
      bone marrow transplantation from matched or partially matched human donors, the incidence of
      grade II-IV acute GvHD was less than 10%. This is in contrast to an expected incidence of
      approximately 40%.

      The purpose of this study is to determine the role of ECP, administered pre-transplant, in
      preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen.
    

Intervention name(s): Methoxsalen; Extracorporeal Photopheresis
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Methoxsalen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Extracorporeal Photopheresis; Graft-versus-Host Disease
Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with
      the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
    


Intervention name(s): Budesonide/formoterol; Charcoal; Symbicort Turbuhaler
Intervention type(s): Drug; Other; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose
Other intervention name(s): Budesonide/formoterol 160/4.5microg; Symbicort Turbuhaler 160/4.5 microg
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-operative Dental Pain Study Comparing Analgesic Efficacy
Condition: Post-surgical Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

Summary: 
      GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol
      1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic
      efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The
      duration of the entire study will be approximately 16 weeks. Each subject will have to come
      to the clinic for three visits (Screening, Treatment and Follow up visits).
    


Intervention name(s): Paracetamol 1000 mg; Paracetamol 500 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Paracetamol 1000 mg; Paracetamol 500 mg; Placebo
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: paracetamol; dental pain; Post-surgical dental pain
Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Condition: Parastomal Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the
      many prevention and treatment techniques that have been described. Since the introduction of
      laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia
      remains a surgical problem of considerable importance, requiring significant consumption of
      public health and economic resources, and representing a major alteration of the quality of
      life of these patients.

      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in
      elective surgery for laparoscopic abdominoperineal resection.

      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.
      Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal
      resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic
      abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25).
      Sample size was calculated based on a proportion of parastomal hernia of 65% in the control
      group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are
      required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32
      patients. The efficacy will be evaluated clinically at six months and abdominal CT will be
      performed at 12 months along with another clinical evaluation.
    


Intervention name(s): laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Parastomal hernias; Tolerance of lightweight meshes; laparoscopic abdominoperineal resection
Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy
Condition: Radiculopathy; Herniated Disk
MeSH terms: Intervertebral Disc Displacement; Radiculopathy
Study type: Interventional

Summary: 
      Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by
      disc herniation.

      Among the various surgical techniques practiced the percutaneous discectomy occupies its
      space since the first description of the technique by Hijikata, 1975. Throughout, many
      techniques have been described. Studies indicate that the treatment was successful for pain
      and disability resulting from herniated disc associated with radiculopathy small.

      However, some methods remove very small amounts of tissue with little change in volume of the
      disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more
      macroscopic changes of the disc with a predictable amount of removal and significant disc
      material.

      The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which
      creates a suction effect in tissues adjacent to the exit point of the fluid and the opening
      point of the collector. However, no studies have examined the effect of the Percutaneous
      Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc
      degeneration by imaging methods or how these characteristics might correlate with clinical
      outcomes.

      Thus, the study will compare outcomes of patients with contained or extruded disc herniation,
      with complaints of radiculopathy, concordant with the imaging findings. With treatment by
      surgical technique or the traditional by SpineJet ®, in order to determine whether
      percutaneous discectomy with SpineJet ® will produce results comparable to open
      microdiskectomy.
    


Intervention name(s): Open microdiscectomy; Percutaneous Diskectomy SpineJet
Intervention type(s): Procedure; Procedure
Intervention description(s): The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.; Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spine surgery; low back pain; herniated disk
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is constituted of 2 parts:

      Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will
      participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion
      (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company).
      Each treatment period consists of 10 treatment days under free living conditions (e.g. home /
      workplace) and under standardised conditions at the clinic. Various assessments for
      pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are
      performed on selected days, including:

        -  Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the
           post-prandial glucose response for 6 hours after individualized standard meal (fixed
           nutrient ratio) ingestion and bolus administration via CSII.

        -  Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode
           (i.e. neither subjects nor the investigators are aware of the sensor glucose values).

        -  Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the
           Investigational Medicinal Products (IMP) during the outpatient periods.

      Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period
      cross-over study aiming at comparing the performance of BC Lispro and Humalog after a
      prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and
      Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump
      compatibility and safety will be analyzed.

      Each period will include a mixed meal tolerance test with a CSII device and a mixed meal
      tolerance test with the same dose of insulin administered with a syringe.
    


Intervention name(s): BioChaperone insulin lispro; Humalog®
Intervention type(s): Drug; Drug
Intervention description(s): BioChaperone insulin lispro bolus infusion followed by test meal intake; Humalog® bolus infusion followed by test meal intake
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks
Condition: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Interventional

Summary: 
      The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol
      ester either with or without added camelina oil on the serum cholesterol levels in moderately
      hypercholesterolemic subjects
    


Intervention name(s): 1.6 g plant stanols; 2 g plant stanols; 1.6 g plant stanols and camelina oil; 2 g plant stanols and camelina oil; Placebo
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols; Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols; Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil; Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil; Lipid-lowering effect of Placebo Yoghurt Drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cultivating Well-being in Severe Psychiatric Conditions
Condition: Wellbeing
MeSH terms: Disease
Study type: Interventional

Summary: 
      The multicomponet psychological intervention is called Feliz-Mente, with third generation
      therapy components that aims to improve wellbeing and self-enhancement. Without intervening
      directly on the symptoms, it is expected to increase positive experiences, the use of
      personal strengths and positive relationships, and aims to build a more meaningful
      self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group
      intervention of 12 sessions in which participants are expected to perform exercises during
      and between sessions to improve treatment adherence and daily practice. The design for the
      present study is a randomized controlled trial, which compares the post-intervention measures
      of the experimental group (group receiving the intervention) with the post-intervention
      measures of the control group (treatment as usual + waiting list).
    


Intervention name(s): FelizMente
Intervention type(s): Behavioral
Intervention description(s): The intervention aims to improve well-being, without denying the existence of symptoms or problems, focusing on generating positive emotions and actions congruent with the person's values through 11 weekly 90-minute group sessions. The multi-component intervention manual was composed of evidence-based exercises of Positive Psychoterapy Interventions, Acceptance and Commitment Therapy and Mindfulness and was theory driven according the broaden-and-build-theory (Fredrickson, 2001) and the self-serving model of paranoia (Murphy et al., 2018). It was also informed by previous pilot studies carried out on people with paranoid tendencies (see Valiente et al., 2020) and with Severe Psyquiatric Condition samples.
Other intervention name(s): Positive psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; severe psychiatric conditions; wellbeing; RCT; positive psychology; third-generation psychotherapy
Study of Tocotrienol Absorption and Distribution Under Different Fat Status
Condition: Absorption
Study type: Interventional

Summary: 
      Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans
      remains unclear especially with different fat diets.This study aimed at evaluating the
      absorption and distribution of tocotrienols in plasma and lipoproteins in associations with
      high and low fat diets. Different fat level will affect the absorption and distribution of
      tocotrienols
    

Detailed description: 
      There is a possibility that the absorption and distribution of tocotrienols may occur
      differently compared with tocopherols, especially under different fat status
    

Intervention name(s): Tocotrienol; Tocotrienol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg of tocotrienol will be administered after consumption of high fat diet; 500 mg of tocotrienol will be administered after consumption of low fat diet
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Vitamin E; Absorption
The Study of Bemnifosbuvir in Healthy Japanese Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in
      healthy adult Japanese subjects
    


Intervention name(s): Bemnifosbuvir (BEM)
Intervention type(s): Drug
Intervention description(s): BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)
Other intervention name(s): AT-527
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
Condition: Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
MeSH terms: Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence of the clinical tablet
      formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects
      under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the
      pharmacokinetics of bosutinib after administration of the proposed commercial tablet
      formulation (100 mg x 4) in healthy subjects (Cohort 2).
    


Intervention name(s): Bosutinib; Bosutinib
Intervention type(s): Drug; Drug
Intervention description(s): 5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition; 4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition
Other intervention name(s): SKI-606, PF-05208763; SKI-606, PF-05208763
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bosutinib; Bioequivalence and Food Effect Studies
CT 327 in the Treatment of Psoriasis Vulgaris
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at how safe and effective, a novel agent, CT 327 cream is in treating
      patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily
      for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed
      throughout the treatment period.
    


Intervention name(s): placebo; CT 327
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 g (w/w) placebo cream applied to both target lesions twice daily; 1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to moderate psoriasis vulgaris