bioihbjkbjnl/mcl2 huggingface dataset:
Early Surgical Intervention Combined With Weight-supported Walking Training
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      To determine the efficacy of a novel combinatorial treatment involving early surgical
      intervention and long-term weight-bearing walking training in spinal cord injury (SCI)
      patients clinically diagnosed as complete or American Spinal Injury Association Impairment
      Scale Class A (AIS-A).
    

Detailed description: 
      In the present study, the investigators reported the efficacy of a novel combinatorial
      approach involving early surgical intervention and long-term weight-bearing walking training
      in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves
      the intradural decompression (via durotomy), and, in some cases, intraspinal decompression
      (via myelotomy). In addition, the investigators had developed a weight-bearing walking
      training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to
      walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months
      (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal
      decompression would release the intraspinal pressure and, therefore, spare surrounding
      tissues that would otherwise degenerate during the course of secondary injury. The
      investigators further reasoned that long-term weight-bearing walking training would "retrain"
      the residual spinal pathways facilitating recovery of locomotor function, and that a
      combination of the two would result in even greater functional recoveries.
    

Intervention name(s): Surgical intervention combined with weight-supported ambulation training
Intervention type(s): Procedure
Intervention description(s): Surgeries were performed between 12 hours to 30 days after trauma. Internal fixation was implemented once instability of the injured spinal column was confirmed by radiology and exploration during operation. At 15 days after surgery, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. The training program was named "Kunming Locomotor Training Program (KLTP)"formulated by actively walking for a duration of 6 hours per day, 6 days per week for a minimum of 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: surgical intervention; decompression; walking training; functional recovery; spinal cord injury
Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee
      Arthroplasty (TKA).
    


Intervention name(s): surgical blade; electrocautery
Intervention type(s): Procedure; Procedure
Intervention description(s): Using surgical blade all the time of surgery; Using electrocautery all the time except at skin incision
Other intervention name(s): hot knife; cold knife
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood loss; total knee arthroplasty; hot knife; cold knife; unipolar electrocautery; surgical blade
Paracetamol CSF Pharmacokinetics Study
Condition: Paracetamol
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite its use for decades all over the world, the exact mechanism of action of paracetamol
      is not fully understood and essentially involves a combination of hypotheses. It is known to
      have an effect via the central nervous system, and of the many mechanisms proposed, one
      hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its
      novel metabolite AM404.

      This study aims to elucidate cerebrospinal levels of paracetamol and to measure the
      concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful
      information on the mechanism of action of paracetamol.
    

Detailed description: 
      Patients undergoing spinal blockade for urological surgery were administered 1g paracetamol
      intravenously at varying intervals prior to spinal anaesthesia, at which time 5mls of
      cerebrospinal fluid and 10mls of blood were sampled, and analysed for concentrations of
      paracetamol, paracetamol glucuronide, paracetamol sulphate, and AM404, a known
      endocannabinoid reuptake inhibitor, and metabolite of paracetamol.

      Paracetamol readily penetrates into the cerebrospinal fluid in animal studies and in
      children. This could account for the rapid central analgesic and antipyretic action of
      intravenous paracetamol however this remains to be studied in adults. AM404 has never before
      been identified in humans, and its presence in CSF following paracetamol supports the
      hypothesis of a central mechanism of action of paracetamol via AM404.
    

Intervention name(s): Administration of paracetamol
Intervention type(s): Drug
Intervention description(s): Administration of 1g intravenous paracetamol
Other intervention name(s): Perfalgan
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: paracetamol; acetaminophen; AM404; CSF; pharmacokinetics
Efficacy of Moderate Sedation for Dental Treatment of Young Children
Condition: Dental Caries; Child Behavior; Conscious Sedation Failure During Procedure
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      There is lack of clinical trials on pediatric dental sedation. The purpose of this study is
      to test (using a randomized controlled trial design) the hypothesis that young children
      behavior during dental treatment improves with oral midazolam sedation. A further aim of this
      study was is explore whether behavior also changes over sessions needed to dental treatment
      completion.
    

Detailed description: 
      There is a lack of clinical trials on pediatric dental sedation in children 3 years old and
      under. We investigated whether young children's behavior improves during dental treatment
      with combined oral ketamine and midazolam compared to midazolam alone or no sedation. Healthy
      children under 36 months of age, presenting early childhood caries and referred to a
      pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5
      mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective
      stabilization without sedative (PS). One observer scored children's behavior using the Ohio
      State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no
      sedative) and treatment session. Data were analyzed using non-parametric bivariate tests.
    

Intervention name(s): Midazolam; Protective stabilization; Midazolam, ketamine
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Oral midazolam 1.0 mg/kg (maximum 20 mg); Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.; Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
Other intervention name(s): Dormire, Cristalia, Sao Paulo, Brazil; No drug administered; Dormire, Cristalia, Sao Paulo, Brazil; Ketamin S+, Cristalia, Sao Paulo, Brazil
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preschool children
Fermented Milk Drink on Human Intestinal Microflora
Condition: Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional
Phase: Phase 2

Summary: 
      Fermented milk is a popular drink. Recent studies revealed that some fermented milk
      containing some strains of lactic acid bacteria have health-promoting effects through
      improvement of the intestinal microflora and modulation of the immune system. Lactobacillus
      casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk
      products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced
      immune responses in allergic rhinitis, altering fermentation patterns in the small bowel,
      prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk
      containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate
      the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the
      human intestinal microflora.
    


Intervention name(s): Yakult®300; Lactobacillus casei strain Shirota
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Yakult®300 was given 100 ml once per day for four weeks.
Fermented or unfermented milk per 100 ml bottle per day for four week.; Lactobacillus casei strain Shirota
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotics; Lactobacillus; Intestine; Flora
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon
      Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C
      virus (HCV) ribonucleic acid (RNA) levels
    


Intervention name(s): Ribavirin; Pegylated Interferon Alfa 2a; Placebo; Telaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet; Solution for injection; tablet; tablet
Other intervention name(s): VX-950
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
Condition: Skin Neoplasms
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the effects of supplementary antioxidant therapy
      on the levels of biomarkers and inflamatory citocines in patients with a previous history of
      non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,
      placebo-controlled trial. Patients were randomized into two groups, one receiving placebo
      (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50
      mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from
      patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,
      thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as
      well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two
      different times: (1) one day before the start of supplementation or placebo administration
      and (2) at 60 days after intervention. Statistical analyses were performed with the SAS
      System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.
    


Intervention name(s): Vitamin C, E and Zinc
Intervention type(s): Dietary Supplement
Intervention description(s): Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics
      (understanding how a drug is absorbed and moves through the body) and pharmacodynamics
      (understanding the effects of a drug on certain target sites of activity in the body).
    


Intervention name(s): PF-04308515; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.; Placebo solution/suspension to match active drug QD at a single dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; pharmacokinetics/pharmacodynamics
The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose
      metabolism, physical and mental health and quality of life in polycystic ovary
      syndrome(PCOS).

      Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.
    

Detailed description: 
      We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose
      metabolism, physical and mental health and quality of life in polycystic ovary
      syndrome(PCOS).

      PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and
      increased stress hormones from the adrenals. Furthermore there are changes similar to those
      seen in diabetes.

      Cipralex is known to decrease stress hormones. But no investigations are on the effect of
      cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.

      We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo.
      Treatment duration is 12 weeks.
    

Intervention name(s): Cipralex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.; Placebo
Other intervention name(s): Escitalopram
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Quality of Life; Adrenal hyper activity; Glucose metabolism
Physiopathological Study of Autonomic Failure in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Pure Autonomic Failure
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical,
      electrophysiological and neuropathological examination.
    


Intervention name(s): Biopsies of peripheral autonomic nervous system; Autonomic dysfunction questionnaires; Electrophysiological tests
Intervention type(s): Other; Other; Other
Other intervention name(s): a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.; A battery of electrophysiological tests to assess neurological functions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
Oxygen Portable Concentrator During Exercises in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to compare differences in oxygen delivery between portable
      oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs
      are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized,
      single-blind clinical trial.
    

Detailed description: 
      Our primary objective is to compare at rest and during exercise the evolution of oxygen
      saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen
      supplementation either with portable concentrators or liquid oxygen in a random order.
    

Intervention name(s): Oxygen concentrators versus constant flow axygen; oxygen concentrator
Intervention type(s): Device; Device
Intervention description(s): Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.; comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
Other intervention name(s): portable oxygen concentrator; portable concentrator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD patients with respiratory failure
A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers
Condition: Gaucher's Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate dose proportionality and pharmacokinetics
      for three different dose levels of eliglustat after single and repeated administration.
    

Detailed description: 
      Duration of the study for each subject will be between 42 to 79 days, including a screening
      period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10
      days, and an end-of-study visit 8+/-2 days after the last administration.
    

Intervention name(s): Eliglustat
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Capsule-Route of administration:Oral
Other intervention name(s): GZ385660; Cerdelga
Intervention MeSH terms: Eliglustat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability
      of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at
      3, 5, 7 and 13 months of age, compared to either alone.
    


Intervention name(s): Meningococcal group B Vaccine, rMenB+OMV NZ; Meningococcal ACWY Conjugate Vaccine, MenACWY
Intervention type(s): Biological; Biological
Intervention description(s): 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.; 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Other intervention name(s): Bexsero®; Menveo®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Central Nervous System Diseases; Nervous System Diseases; Meningitis
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft
      gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
    

Detailed description: 
      Prior to initiation of study treatment all patients are screened and baseline lab values are
      taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new
      NRTI's. Assessments will be performed at specified intervals throughout the duration of
      treatment.
    

Intervention name(s): Saquinavir
Intervention type(s): Drug
Intervention MeSH terms: Saquinavir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; HIV Protease Inhibitors; Dosage Forms; Saquinavir; Reverse Transcriptase Inhibitors; Anti-HIV Agents
Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
Condition: Anesthesia, Intravenous; Anesthesia Recovery Period
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the
      rate of propofol elimination from the brain and the blood will be increased and the patient
      will awake more quickly. There has been no study about the effects of hypercapnia. The
      investigators will evaluate hypercapnia's effects on the recovery time from propofol
      anesthesia.
    


Intervention name(s): Rebreathing tube; No rebreathing tube (Nothing)
Intervention type(s): Procedure; Procedure
Intervention description(s): 750 ml rebreathing tube will be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 50 mmHg.; 750 ml rebreathing tube will not be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 30 mmHg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Emergence; Hypercapnia; Hypocapnia; Propofol