bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
Condition: Carpal Tunnel Syndrome; Entrapment Neuropathy
MeSH terms: Carpal Tunnel Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Syndrome
Study type: Interventional

Summary: 
      Prospective controlled clinical trial in which a minimally invasive microsurgical approach
      was used following the keyhole principle in 55 patients and 65 hands under local anesthesia
      and ambulatory strategy. All patients included in the study had an average of 3 months
      disease course and were considered refractory to conservative treatment. Patients were
      evaluated with stringent inclusion criteria with the Levine severity and functional status
      scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are
      reported.
    

Detailed description: 
      Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with
      open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and
      in an ambulatory setting.
    

Intervention name(s): keyhole approach
Intervention type(s): Procedure
Intervention description(s): The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microsurgical treatment; pain; dexterity; Phalen sign; functional status
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional
      40 weeks in patients with PTSD who have participated in a double-blind lead-in study and
      completed an initial 12-week open-label extension study (TNX-CY-P303).
    

Detailed description: 
      This is an open-label, extension trial designed to evaluate safety over 40 additional weeks
      of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.

      The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which
      is anticipated to be the same visit as the last visit of the 12-week open-label extension
      study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label
      treatment.
    

Intervention name(s): TNX-102 SL 5.6 mg
Intervention type(s): Drug
Intervention description(s): cyclobenzaprine HCl sublingual tablets
Intervention model: Single Group Assignment
Intervention model description: Open-label Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TNX-102 SL; Bedtime; Sublingual; Safety; PTSD
Abuse Potential of Sativex
Condition: Evaluation of Abuse Potential of Sativex
Study type: Interventional
Phase: Phase 1

Summary: 
      This crossover study with six treatment sessions is to evaluate the abuse potential of three
      doses of Sativex as compared to Marinol and placebo, in subjects with a history of
      recreational marijuana use.
    

Detailed description: 
      Subjects attended a two-session, randomized, double-blind, crossover qualification in which
      they received the positive control drug (Marinol 30 mg) and matching placebo 48 hours apart
      in a randomized fashion. To qualify, subjects must have discriminated between Marinol and
      placebo.

      Eligible subjects then went on to the main study divided into six treatment sessions each
      separated by 7-21 days.

      Serial pharmacodynamic evaluations were taken at each treatment session as well as occasional
      pharmacokinetic blood samples to verify proof of exposure. In addition, safety monitoring
      included regular assessments of vital signs, telemetry, 12-lead ECG, clinical laboratory
      tests and adverse events (AEs).
    

Intervention name(s): Sativex; Sativex; Sativex; Placebo; Marinol; Marinol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules.; Sativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules; Sativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules; 16 placebo sprays and 4 placebo capsules; Marinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays; Marinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays
Intervention MeSH terms: Nabiximols; Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sativex; Cannabinoids; Abuse potential; Addiction
NAC Supplementation and Skeletal Muscle Performance
Condition: Skeletal Muscle Damage; Skeletal Muscle Performance; Intgracellular Signaling in Skeletal Muscle; Inflammatory Status
Study type: Interventional

Summary: 
      In this investigation the investigators utilized NAC administration to foster GSH
      availability during an 8-day period following eccentric exercise-induced muscle damage in
      order to test our hypotheses: i) antioxidant supplementation does not disturb performance and
      adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in
      skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.
    

Detailed description: 
      The major thiol-disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a
      key-regulator of major transcriptional pathways regulating aseptic inflammation and recovery
      of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper
      exercise-induced cellular adaptations.

      Our objective was to examine how thiol-based antioxidant supplementation affects skeletal
      muscle's performance and redox-sensitive signalling during the inflammatory and repair phases
      associated with exercise-induced micro-trauma.In a double-blind, counterbalanced design, 12
      men received placebo (PLA) or N-acetylcysteine (NAC, 20 mg/kg/day) following muscle-damaging
      exercise (300 eccentric contractions). In each trial, muscle performance was measured at
      baseline, post-exercise, 2h post-exercise and daily for 8 consecutive days. Muscle biopsies
      from vastus lateralis and blood samples were collected pre-exercise and 2h, 2d, and 8d
      post-exercise.
    

Intervention name(s): n-acetylcysteine supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): n-acetylcysteine administration: 20 mg//kg/day, orally, daily for eight days following exercise
placebo administration: 500 mL orally, daily for eight days following exercise
Other intervention name(s): Exercise-induced skeletal muscle damage
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: aseptic inflammation; skeletal muscle function; exercise
ASCT Versus Chemotherapy as First-Line Consolidation Therapy inT-Cell Lymphoma
Condition: T-cell Lymphoma Adults
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Observational

Summary: 
      To compare the effectiveness of autologous hematopoietic stem cell transplantation and
      chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic
      response in T-cell lymphoma through a multicenter retrospective real-world study in China.
    

Detailed description: 
      T-cell lymphoma is characterized by high molecular heterogeneity, high disease
      aggressiveness, and high chemotherapy resistance rate, and the prognosis is extremely poor.
      Autologous hematopoietic stem cell transplantation (ASCT) is an important consolidation
      therapy for patients with T-cell lymphoma who have achieved therapeutic response to
      chemotherapy, but it is still controversial whether the efficacy of ASCT is significantly
      better than that of chemotherapy consolidation in patients who have achieved a complete
      therapeutic response. In this study, the investigators compared the efficacy of ASCT with
      that of chemotherapy as a first-line consolidation therapy for T-cell lymphoma patients who
      had achieved a complete therapeutic response in a multicenter real-world study in China. This
      study included patients with primary T-cell lymphoma diagnosed during 2015-2021 at Shanghai
      Ruijin Hospital, Peking University People's Hospital, and Wuhan Tongji Hospital, and based on
      electronic case information, the investigators retrieved the diagnosis, staging, extranodal
      and bone marrow involvement, and induced and consolidated the efficacy of chemotherapy. The
      participants were divided into ASCT group and consolidation chemotherapy group according to
      the consolidation therapy adopted after obtaining complete therapeutic response, and the
      primary endpoint was adopted as progression-free survival, and the secondary endpoints
      included overall survival, non-recurrent death, and disease progression/recurrence, so as to
      explore the efficacy of ASCT and chemotherapy as a first-line consolidation therapy after
      obtaining a complete therapeutic response in T-cell lymphoma.
    

Intervention name(s): consolidation with ASCT
Intervention type(s): Drug
Intervention description(s): high dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion
Other intervention name(s): consoliation therapy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A preliminary count of approximately 80 patients who received ASCT autologous
        transplantation and 250 patients who received chemotherapy was conducted as a retrospective
        cohort study, and all eligible patients were proposed to be included in this study.
      
Keywords: NHL; T-cell lymphopma; adults
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Condition: Finger Injuries; Soft Tissue Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries; Finger Injuries
Study type: Interventional

Summary: 
      Multiple finger defects are common in hand trauma and result in functional disability. These
      injuries are often complex and severe, and thus reconstructive alternatives are limited. In
      this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the
      digital artery, for reconstruction of multiple finger defects. At the final follow-up, we
      would evaluate the efficacy of this technique.
    

Detailed description: 
      At final follow-up, sensation of the flap and the donor site would be assessed using static
      two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of
      the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger
      is measured by a goniometer. The cold intolerance of the injured finger is measured using the
      self-administered Cold Intolerance Severity Score questionnaire that is rated into mild,
      moderate, severe, and extreme. The pain of the injured finger and the donor site is given
      subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and
      groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).
    

Intervention name(s): Soft tissue coverage
Intervention type(s): Procedure
Intervention description(s): The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: surgical flap;; dorsal branch of the digital artery
Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone
Condition: Comparative Study
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix
      vs Soft tissue Graft after immediate implant placement
    

Detailed description: 
      It was conclude that SCTG is the gold standard for soft tissue augmentation up till now,
      However ADM can be alternative to autogenous soft tissue graft.
    

Intervention name(s): Acellular Dermal Matrix
Intervention type(s): Combination Product
Intervention description(s): Feasibility of soft tissue graft after immediate implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of different levels of counseling
      (intensive outpatient versus standard outpatient) on treatment outcomes for African American
      adult patients receiving buprenorphine in 2 formerly "drug-free" programs.
    

Detailed description: 
      This two-group randomized clinical trial will test the effectiveness of intensive outpatient
      (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults
      receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly
      assigned to one of the two treatment intensity conditions at intake and assessed at baseline,
      3-, and 6-months post-baseline to determine treatment retention, frequency and severity of
      heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV
      criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors
      potentially critical for treatment success (e.g., attitudes towards buprenorphine and average
      buprenorphine dose while in treatment) will be examined to determine their importance in
      influencing treatment outcomes. Moreover, both patient and staff attitudes and average
      buprenorphine dose will be evaluated to determine their respective relationships to treatment
      experiences and treatment retention.
    

Intervention name(s): Outpatient; Intensive Outpatient
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.; Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence; outpatient treatment; intensive outpatient treatment
Probiotic Effects on the Microbe-brain-gut Interaction and Brain Activity During Stress Tasks in Healthy Subjects
Condition: Probiotics; Gut Microbiota; Emotional Stress; Magnetic Resonance Imaging
Study type: Interventional

Summary: 
      The aim of this study is to determine if and how the "Probiotic Product" affects functional
      brain responses in healthy subjects during an emotional- and arithmetic stress task,
      respectively and in terms of microbe-brain-gut interactions.
    

Detailed description: 
      The aim of this study is to determine if and how the "Probiotic Product" affects functional
      brain responses in healthy subjects during an emotional- and arithmetic stress task,
      respectively and in terms of microbe-brain-gut interactions.

      In this randomized double-blind placebo-controlled study, n=22 healthy subjects will receive
      the following interventions in a crossover fashion, separated by a 4-week wash-out period: 1)
      Probiotic Formula, 2) placebo. After baseline assessments, study participants will start with
      a 4-week intervention with the study product or the placebo, followed by a 4-week wash-out
      period and a subsequent 4-week intervention period (placebo or study product, respectively).
      fMRI (functional magnetic resonance imaging) scanning during two validated stress tasks will
      be performed after each of the intervention periods (week 4 and week 12). At the same time
      points and in addition on the days before the 1st and 2nd intervention (baseline 1 and 2),
      saliva, blood and faecal samples will be collected. Questionnaire data will be collected and
      psychological tests and instruments will be performed. For one week at baseline and during
      the intervention periods (last week), subjects will wear actigraphs to record their physical
      activity and help assess sleep quality. At baseline, subjects will undergo a carbon dioxide
      (CO2) challenge test as well as a food diary to record dietary habits.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The Probiotic Formula is commercially available and contains a combination of 3 probiotic strains in addition to other nutrients. The total daily amount of probiotic strain in the product will be no less than 3 billion colony-forming units (CFU) per 3 g powder sachet.; Placebo intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral
      control after treatment with antiretroviral therapy will be enrolled to receive once a day
      Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune
      parameters will be monitored for 12 weeks in both arms.

      The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T
      cells immune parameters.
    

Detailed description: 
      In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral
      control after treatment with antiretroviral therapy will be enrolled to receive once a day
      Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion.

      The main objective is to investigate whether the continuous, once a day, 12-weeks use of
      Yakult product containing Lactobacillus casei Shirota could affect immunological parameters
      in HIV-infected patients on suppressive antiretroviral treatment with poor CD4+ T cell
      recovery. A total of 48 volunteers will be followed for 12 week after initiation of daily use
      of Lactobcillus casei Shirota or placebo, randomized in a 1:1 ratio.

      We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12
      weeks of continuous use will increase the level of CD4+ T-cells, at least, 50 cells/mm³.

      We also propose to investigate several markers of immune response, including T cellular
      activation and NK cells function, and changes in the intestinal microbiota.
    

Intervention name(s): Fermented Milk Drink Yakult 40; Fermented Milk Drink Yakult 40
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks.; Ingredients: Skimmed milk and/or Reconstituted Skimmed Milk, Sugar, Glucose, Live Lactic Bacteria (Lactobacillus casei Shirota) 40 billions per 80 g - concentration of 5 x 108 CFU/g), Flavour. Gluten Free.
Other intervention name(s): Yakult; Live Lactic Bacteria (Lactobacillus casei Shirota); Live Lactic Bacteria (Lactobacillus casei Shirota); Yakult
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: HIV; Lactobacillus casei Shirota; NK cell; CD4; Lymphocyte; Cell activation; Antiretroviral therapy; Immune discordants
OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to
      evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS)
      imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
    

Detailed description: 
      Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging
      modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for
      achieving optimal stent deployment.

      This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to
      evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary
      Intervention (PCI) strategy.

      We will enroll the first 100 patients who have enrolled in the main-study of OPINION
      trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned
      device in the main study at the time of post-PCI.

      We will then assess lesions by OFDI at a 8-month follo-up.
    

Intervention name(s): OFDI-guided PCI & IVUS; IVUS-guided PCI & OFDI
Intervention type(s): Device; Device
Intervention description(s): Assessment by IVUS at post-PCI
Assessment by OFDI at a 8-month follow-up; Assessment by OFDI at post-PCI
Assessment by OFDI at a 8-month follow-up
Other intervention name(s): OFDI; LUNAWAVE; Biolimus A9-eluting stent (Nobori stent); VISIWAVE; ViewIT; Biolimus A9-eluting stent (Nobori stent)
Intervention MeSH terms: Sirolimus; Umirolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Optical Frequency Domain Imaging; Intravascular Ultrasound