bioihbjkbjnl/mcl2 huggingface dataset:
Remission of Lumbar Disc Herniation by Physiotherapy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      This study was conducted with the aim of determining whether or not Non surgical spinal
      decompression therapy was effective in remission of herniation, decreasing pain and improving
      functional status.
    

Detailed description: 
      Both groups received combination of electrotherapy, deep friction massage and stabilization
      exercise for fifteen session.

      Combine group received non surgical spinal decompression therapy (NSDT) different from
      conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test,
      Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and
      herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at
      baseline and three months after therapy.
    

Intervention name(s): DRX 9000, Axiom Worldwide, Tampa, Florida; physiotherapy; spinal stabilization exercise
Intervention type(s): Device; Other; Other
Intervention description(s): non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).; electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.; spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non surgical spinal decompression therapy; deep friction massage; exercise
Continuation Protocol to Protocol BBCO-001
Condition: Muscular Dystrophy, Oculopharyngeal (OPMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent
      control, parallel group study. Patients completing protocol BBCO-001 will be offered the
      opportunity to enter into this 12-month randomized withdrawal protocol.
    

Detailed description: 
      This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent
      control, parallel group study. Patients completing protocol BBCO-001 will be offered the
      opportunity to enter into this 12-month randomized withdrawal protocol.

      Eligible patients will be randomized to one of the following treatment arms:

        -  Treatment Arm 1: active treatment; continuation of 30 g IV Cabaletta once a week over an
           additional 52 weeks.

        -  Treatment Arm 2: no-treatment concurrent control; discontinuation of IV Cabaletta and
           follow-up over 52 weeks.

      IV Cabaletta will be administered once a week to patients in Treatment Arm 1. All patients,
      regardless of treatment arm allocation, will undergo the same safety and efficacy assessments
      during the monthly site visits.
    

Intervention name(s): Tehalose 30gr
Intervention type(s): Drug
Intervention description(s): Trehalose 30 g for IV infusion administered every week over an additional 52 weeks
Other intervention name(s): Cabellta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the
      combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
    


Intervention name(s): Placebo; GSK233705/GW642444
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo; The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; long-acting beta agonist; Emphysema; Chronic Bronchitis; Chronic Obstructive Pulmonary Disease (COPD); bronchodilator; long acting muscarinic antagonist
Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise
Condition: G6PD Deficiency
MeSH terms: Glucosephosphate Dehydrogenase Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation
      on redox status, physiological and biochemical parameters in G6PD deficient individuals after
      acute exercise.
    

Detailed description: 
      In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of
      both sexes will be supplemented with either 600 mg of alpha-lipoic acid (experimental
      condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before
      intervention, all participants will be informed about the study protocol, fill a medical
      history questionnaire and sign an informed consent form. Moreover, measurements of
      anthropometric characteristics and physiological parameters, as well as a VO2max test will be
      performed.

      Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion)
      before and after each condition. Blood samples will be collected before, immediately after
      and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and
      physiological parameters will be performed before and after each condition. There will be a
      washout period of at 4 weeks between conditions.
    

Intervention name(s): Alpha-lipoic acid; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A trial of exercise before and after 4 weeks of alpha-lipoic acid supplementation.; A trial of exercise before and after 4 weeks of placebo administration.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption, the metabolic pathways, the route
      and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived
      radioactivity in healthy male adult participants after administration of a single oral dose
      of 14C-JNJ-56136379.
    


Intervention name(s): 14C-JNJ-56136379
Intervention type(s): Drug
Intervention description(s): 14C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert.
Intervention MeSH terms: JNJ-56136379
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This study wants to assess different intensive therapy sequences for the treatment of
      non-small-cell lung cancer.

      It claims less on the efficacy of different chemotherapy combinations, than more on the
      comparison of different strategies of sequential single-agent, sequential double-agent or
      sequential triple-agent therapy.
    


Intervention name(s): Gemcitabine; Navelbine; Carboplatin; Cisplatin; Mitomycin; Ifosfamide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Carboplatin; Gemcitabine; Ifosfamide; Mitomycins; Mitomycin; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Creatine Supplementation on Renal Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal
      function remain controversial. The aim of this study was to evaluate the effects of creatine
      supplementation on renal function and oxidative stress in healthy sedentary males (18-35
      years old) submitted to exercise training. Our hipothesis is that creatine supplementation
      does not affect renal function in this population.
    

Detailed description: 
      Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal
      function remain controversial. Purpose: The aim of this study was to evaluate the effects of
      creatine supplementation on renal function and oxidative stress in healthy sedentary males
      (18-35 years old) submitted to exercise training. Methods: Subjects (n = 18) were randomly
      divided in two groups and were allocated to receive treatment with either creatine (CR) (~10g
      • day-1 over three months) or placebo (PL) (dextrose). All subjects undertook moderate
      intensity aerobic training, in three 40-minute sessions per week, during 3 months. Serum
      creatinine, TBARS, serum and urinary sodium and potassium were determined at baseline and at
      the study endpoint. Furthermore, cystatin C was also assessed prior to training (PRE), after
      4 (POST 4) and 12 weeks (POST 12). Results: There were decreased in both oxidative stress
      (evaluated by TBARS - µM/24 h) (PRE CR: 8.2  4.4; PL: 6.4  0.8 vs. POST 12 CR: 2.5  1.8;
      PL: 2.1  1.6, p=0.0001) and cystatin C levels (mg/L) (PRE CR:0.82  0.09; PL: 0.88  0.07
      vs. POST 12 CR: 0.71  0.06; PL: 0.75  0.09, p=0.0001) over the time, suggesting an increase
      in glomerular filtration rate. There were no significant differences between groups in other
      renal parameters investigated. Conclusions: These data indicate that high-dose creatine
      supplementation throughout three months does not provoke renal dysfunction in sedentary
      healthy males urdergoing aerobic training. Moreover, our results suggest that moderate
      aerobic training per se could improve renal function.
    

Intervention name(s): creatine supplementation; aerobic exercise training
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study
      will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose
      ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple
      oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all
      subjects will receive multiple oral doses of the combination danoprevir with ritonavir and
      efavirenz for 14 days. Anticipated time on study treatment is 28 days.
    


Intervention name(s): danoprevir; efavirenz; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): multiple oral doses; multiple oral doses; multiple oral doses
Intervention MeSH terms: Ritonavir; Efavirenz
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes
Condition: ACL Injury; Rehabilitation After ACL Reconstruction; Accelerated Protocol
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The main goal of a rehabilitation program after an ACL reconstruction is to regain mobility
      and muscle function and ultimately to return to sports participation. Purpose of the study:
      to investigate the effect of the accelerated rehabilitation program on knee pain, and
      function in patients post ACLR surgery. Fifty adult amateur males athletes who underwent ACLR
      surgery participated in this study, their age ranged from 18 to 35years.They were randomly
      assigned into two equal groups. Group (A) received accelerated rehabilitation protocol and
      group (B) received conventional physical therapy program. Treatment sessions were conducted 5
      times per week for 22 weeks for both groups. All patients assessed pre and post treatment for
      pain intensity using visual analogue scale (VAS), and knee function using knee injury and
      osteoarthritis outcome score (KOOS), knee effusion, and LSI of Hop test.
    


Intervention name(s): rehabilitation protocol
Intervention type(s): Other
Intervention description(s): It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep Extension and Behavior of Young Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This pseudo-randomized intervention study examined change in inhibitory control following a
      sleep manipulation in which children with and without ADHD were instructed to advance their
      bedtime by 90 minutes for five days.
    

Detailed description: 
      Objective: To evaluate the efficacy of a sleep extension intervention in young children with
      ADHD and determine whether sleep extension improves inhibitory control, a primary deficit in
      ADHD.

      Design: Children with and without ADHD completed two 5-day assessments: a baseline condition
      in which children followed their normal bedtime routine and a sleep extension condition in
      which children were instructed to go to bed 90 minutes earlier than their habitual bedtime.
      Sleep was assessed with actigraphy and, on the final night, polysomnography. A Go/No-Go task
      was used to assess inhibitory control.

      Setting: Participants slept in their home on nights 1-4 and in the sleep laboratory on night
      5 of each condition.

      Main Outcomes and Measures: Of interest is actigraph measurement of total sleep time for the
      baseline compared to the sleep extension condition. Polysomnography will be used to compared
      changes in sleep physiology. The primary behavioral outcome is inhibitory control, indexed by
      accuracy on No-Go trials in the Go/No-Go task.
    

Intervention name(s): Sleep Extension
Intervention type(s): Behavioral
Intervention description(s): Child attempted to go to bed 90 mins in advance of their normal bedtime.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to the ADHD or Typically Developing group based on diagnosis history. Each then completes the intervention (EXTENSION) either preceded or followed by a week of baseline sleep (CONTROL). The order is pseudo-randomized.
Masking: None (Open Label)
Primary purpose: Treatment
LIME Study (LFB IVIg MMN Efficacy Study)
Condition: Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use
      liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of
      MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.
    

Detailed description: 
      Multifocal motor neuropathy (MMN) is a chronic acquired, probably autoimmune, demyelinating,
      motor neuropathy. It is a rare disease, variable in its clinical features. The disease course
      is usually steadily progressive.

      Intravenous immunoglobulin (IVIg) is the standard and the first line treatment for MMN. The
      Cochrane review of four randomized placebo-controlled studies showed a significant clinical
      improvement in muscle strength from IVIg in 78% of patients with MMN versus 4% with placebo
      but a non-significant improvement in disability (39% versus 11%) (van Schaik IN, 2005).
      However, IVIg treatment does not prevent a mild gradual decline in muscle strength which is
      probably due to ongoing axonal degeneration. In addition to its efficacy, IVIg is also a safe
      treatment with a positive benefit-risk ratio in MMN.

      Muscle strength measured with the Modified Medical Research Council (MMRC 10) sum score as
      described in the study of Cats (Cats EA, 2008) including 20 movements i.e. 10 muscle groups
      of the upper and lower limbs on each side was selected as the primary endpoint. Other
      parameters of muscle strength such as measurement of grip strength by dynamometer - and
      functional disability will also be evaluated to reinforce the robustness of the study and
      substantiate the efficacy of I10E in MMN patients.
    

Intervention name(s): Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL); Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunoglobulin G
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multifocal Motor Neuropathy
Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy
Condition: Neuromuscular Block, Residual
MeSH terms: Delayed Emergence from Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      Neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and
      also to facilitate the performance of surgeries involving mainly the abdominal cavity. The
      introduction of neuromuscular blockers in clinical practice optimized the execution of
      mechanical ventilation. Since the use of these drugs, increased intercurrences such as
      prolonged muscle paralysis and respiratory complications have been observed, resulting in
      unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the
      occurrence of these complications. The present study aims to evaluate the incidence of
      residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room
      in patients submitted to videolaparoscopic cholecystectomy.
    

Detailed description: 
      This is an observational and prospective study in which patients aged 18-50 years classified
      as ASA (American Society of Anesthesiologists) I and II, body mass index below 35 and who
      will undergo cholecystectomy will be included. Patients will be allocated to two groups based
      on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie
      in group C patients will participate in the administration of cisatracurium and the group R
      will consist of the patients in whom rocuronium was administered. General anesthesia and
      assessment of muscle function will be performed by measuring the four-stimulus sequence (SQE)
      / train of four (TOF) at pre-established times. A residual neuromuscular block is considered
      to be the patient presenting the value of the four-stimulus sequence of T4 / T1 of less than
      0.9.
    

Intervention name(s): Cisatracurium
Intervention type(s): Drug
Intervention description(s): Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist participating in the surgery. In group C, the patients in whom cisatracurium was given and the R group consisted of the patients in whom rocuronium was administered. It is emphasized that the choice of the neuromuscular blocker was made by the preference and experience of the anesthesiologist of the case and not by randomization or lottery of the patients.
Other intervention name(s): Rocuronium
Intervention MeSH terms: Rocuronium; Cisatracurium
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of both sexes and who underwent videolaparoscopic cholecystectomy under balanced
        general anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II,
        age group of 18 to 50 years, body mass index below 35.
To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)
Condition: Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of rifampicin on the way the
      body handles darexaban and its metabolites (drug degradation products). The secondary
      objective of the study is to evaluate the safety and tolerability of a single dose of
      darexaban alone and when administered together with rifampicin.
    

Detailed description: 
      This is an open-label, 1-sequence study in young healthy male subjects to evaluate the effect
      of multiple daily doses of rifampicin on the PK of darexaban and metabolites after a single
      dose of darexaban. In addition, safety and tolerability of darexaban administered alone and
      in combination with rifampicin is evaluated. Eligible subjects are admitted to the clinical
      unit in the morning of Day -1.

      Subjects receive a single dose of darexaban on Day 1. Subjects then receive rifampicin once
      daily (qd) on Days 4-14.On Day 11, the second single dose of darexaban is given in
      combination with rifampicin.
    

Intervention name(s): darexaban; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM150; Rifadin
Intervention MeSH terms: Rifampin; Darexaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; darexaban; YM150; rifampicin; Phase 1
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
Condition: Influenza Immunization
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the non-inferiority (NI) of the HAI immune
      response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and
      to describe the immunogenicity and safety profile of RIV4 in all participants.
    

Detailed description: 
      The participation duration will be approximately 6 months for each participant.
    

Intervention name(s): Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Intervention type(s): Biological
Intervention description(s): Pharmaceutical form: Solution for injection Route of administration: intramuscular
Other intervention name(s): Supemtek / Flublok Quadrivalent
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention