bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical
           scale according to Good Laboratory Practice using xenogenic free media instead of the
           previously used FCS.

        2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients
           who fail to respond to conventional treatment.

        3. Assessing the therapeutic benefits on the participants in the trial as per established
           methods.
    


Intervention name(s): Autologous Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone marrow derived Mesenchymal Stem Cells; Multiple Sclerosis; Oligodendrocytes; Neuroimmunology; Autoimmune disease
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
Condition: Obesity, Morbid; Intubation Complication
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Macintosh laryngoscope is still considered a standard for tracheal intubation, however,
      visualization of the glottis may be inadequate mainly in morbidly obese patients. The Vie
      Scope is a novel type of laryngoscope consisting of a straight, shielded, illuminated tube
      that offers intubation via a bougie using the paraglossal technique. In this prospective,
      non-randomized study, we tested the research hypothesis that the use of Vie Scope may improve
      visualization of the larynx in comparison with the Macintosh blade.
    

Detailed description: 
      Prior to tracheal intubation, all patients were placed in the head-elevated laryngoscopy
      position (HELP). All study subjects were anesthetized with the concordance to European
      Society for Peri-Operative Care of Obese Patient (www.espcop.eu) protocols: proper
      positioning, pre-oxygenation with CPAP, induction of anesthesia with propofol 2.0 mg kg-1 of
      corrected body weight; for muscle relaxation rocuronium 0.6 mg kg-1 of ideal body weight
      (IBW); ketamine 50 mg ; lidocaine 100 mg, and fentanyl 0.1 mg. After achieving 100%
      neuromuscular block confirmed by TOF-Watch monitoring, laryngoscopy was performed by the
      anesthesiologist familiar with the use of both Vie Scope and Macintosh blade laryngoscope,
      and also experienced in bariatric anesthesia. All anesthesiologists participating in the
      study underwent training with Vie Scope on the manikin model.

      The evaluation of glottis visualization in direct laryngoscopy using Cormack-Lehane scale
      (CL) in all patients was performed in sequence using two laryngoscopes: first Macintosh blade
      laryngoscope (MCL) and then Vie Scope laryngoscope (VS). Tracheal intubation was performed
      with the VS. The study subjects all received oxygen using nasal CPAP in order to maintain
      sufficient oxygenation
    

Intervention name(s): Laryngoscopy with Vie-Scope laryngoscope; Laryngoscopy with Macintosh blade laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications; Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: morbid obesity; endotracheal intubation
HIT in the Healthy Elderly Population
Condition: Interval Training; Pre Operative Exercise; Prehabilitation; Elderly
Study type: Interventional

Summary: 
      It is widely known that exercise improves general fitness and that fitter patients recover
      more easily from illness and surgery. Conversely, unfit patients have a significantly higher
      morbidity and mortality after surgery and a longer inpatient stay. This will become
      increasingly important in an aging population as baseline fitness generally declines with
      age.

      One method of improving cardiovascular fitness is by using low intensity endurance training
      programmes, a disadvantage of these it that they can take several months to show improvement.
      High intensity interval training (HIT) programmes that use short episodes of high intensity
      exercise have also been shown to improve fitness. These HIT programmes have also shown
      improvement in functional capacity and quality of life in patients with chronic disease. An
      advantage of HIT is that improvements in fitness may occur in a shorter time than traditional
      endurance training. It is also known that HIT can give superior gains over endurance
      training.

      The primary aim of this study is to determine whether an improvement in aerobic fitness, as
      judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT
      programme, in a group of healthy elderly volunteers.

      As a secondary aim we will assess whether this programme would be acceptable to the group
      studied, through determination of subject compliance and adherence to the training programme.
    


Intervention name(s): HIT
Intervention type(s): Behavioral
Intervention description(s): 12 sessions of HIT exercise in 31 days on a stationary cycle ergometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Epidermal Langerhans Cell Population in AIDS / ARC Patients by the Topical Application of a Potent Contact Allergen (1-Chloro-2,4-Dinitro-Chlorobenzene) (DNCB)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To evaluate the effect of application of Dinitrochlorobenzene (DNCB) on the number,
      morphology, and antigen expression of epidermal Langerhans cells in AIDS and AIDS related
      complex (ARC) patients.
    


Intervention name(s): Dinitrochlorobenzene
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Langerhans Cells; Dinitrochlorobenzene; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
Condition: Chronic Pain; Nociceptive Pain; Pain
MeSH terms: Chronic Pain; Nociceptive Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an
      open-label, 2-period crossover, food effect cohort.
    


Intervention name(s): CNTX-6016; Other: Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral Dose CNTX-6016; Oral Dose Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Pain; Nociceptive Pain; Mixed Pain; Cannabinoid; Cannabinoid-2 Receptor Agonist
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
Condition: Diabetes Mellitus, Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      To test the hypothesis that there is no difference in change in HbA1C among men with type
      2-diabetes after an exercise intervention with strength versus endurance training.
    

Detailed description: 
      Exercise training is well documented as part of effective treatment for type 2-diabetes
      patients. Endurance training has been suggested as the most suitable form of exercise. There
      are reasons to believe that strength training also has a positive effect. However,
      comparisons of endurance training and strength training regimes are limited.

      Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or
      a strength training group. Both groups exercised three sessions per week for three months.
      The training was supervised.
    

Intervention name(s): Endurance training; strength training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): supervised endurance training. Three sessions per week in three months.; Supervised strength training. Three sessions per week in three months.
Other intervention name(s): Aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2-diabetes; exercise therapy; RCT; Norway
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy
      Chinese and Japanese male subjects following the administration of single rising oral doses
      and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809
      after single dosing of product.
    


Intervention name(s): BI 425809; BI 425809; Placebo; BI 425809
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg
      ODT
    

Detailed description: 
      To Compare the single-dose bioavailability of Kali's Ondansetron 16 mg ODT with that of
      GlaxoSmithKine's Zofran 16 mg ODT under fasting conditions
    

Intervention name(s): Ondansetron; Zofran ODT
Intervention type(s): Drug; Drug
Intervention description(s): ODT, single-dose, fasting
Other intervention name(s): Zofran ODT; Ondansetron ODT
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ondansetron ODT; Fasting; To Determine Bioequivalence Under Fasting conditions
Parenting Intervention for Pediatric Obesity
Condition: Childhood Obesity; Parenting
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to see if educational videos about how to help children develop
      healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase
      caregiver confidence and improve child behaviors and weight. Caregivers of children between
      the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be
      invited to take part in the study. All families will receive the standard treatment provided
      in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few
      educational videos every month for 3 months in between clinic visits.
    


Intervention name(s): Parenting videos; Standard pediatric obesity treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.; Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Parenting intervention; Video intervention; Healthcare delivery
Westeinde Brachialgia Study
Condition: Radiculopathy, Cervical
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the
      effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with
      acute cervical radiculopathy.
    

Detailed description: 
      Cervical radiculopathy caused by spondylosis or disc protrusion is a common disorder with a
      usually benign natural course. Often, physiotherapy (exercise programs) and/or cervical
      collar are prescribed. However, there are no reliable data on the effects of these
      conservative therapies.

      In this study, patients with acute cervical radiculopathy, defined by clinical criteria, are
      randomized for cervical collar, physiotherapy or a wait-and-see policy.
    

Intervention name(s): cervical collar; physiotherapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical radiculopathy conservative treatment
Paclitaxel in Treating Patients With Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who
      have unresectable stage IIIB, stage IV or recurrent lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma
           (BAC).

        -  Assess the duration of response in patients presenting with an objective response.

        -  Characterize the acute side effects of paclitaxel in patients with BAC.

        -  Assess the role of some biological parameters in the natural history and the response to
           therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.

      OUTLINE: This is an open label, nonrandomized, multicenter study.

      Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or
      normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or
      complication occur.

      Disease is assessed every 6 weeks until documented progression; treatment side effects are
      assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles
      of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.

      PROJECTED ACCRUAL: 16 or 25 patients will be accrued.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung
The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients
      with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice.
      The hypothesis is that Pirfenidone will decrease cough and increase quality of life.
    

Detailed description: 
      Rationale: Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of
      unknown cause with a median survival of 3-5 years. No curative treatment exists, though in
      2011 Pirfenidone was approved for the treatment of IPF as it appeared to slow down the
      decline in lung function. In patients with IPF, the most common symptoms are cough and
      breathlessness. Cough is not only a major distressing and disabling symptom but also an
      independent predictor of disease progression and death in IPF. Recent preliminary data
      suggest a possible effect of Pirfenidone on cough.

      Objective: In this study we want to objectively measure the effect of Pirfenidone on cough in
      patients with IPF that are treated with Pirfenidone in daily practice .

      Study design: This is a prospective, observational, international multicenter study.

      Intervention: Objective 24-hour cough frequency will be recorded using the Leicester Cough
      Monitor (LCM), a validated ambulatory cough monitoring system, prior to starting with
      Pirfenidone treatment. The cough recording will be repeated at 4 weeks and at 12 weeks during
      treatment with Pirfenidone. At the days of cough recording, patients will be asked to fill in
      questionnaires related to cough and to quality of life. Patient will be treated according to
      normal clinical practice at their Physician's discretion.

      Main study parameters/endpoints: The primary endpoint is change in cough frequency measured
      by the Leicester cough monitor at week 12 compared to baseline. Secondary endpoints look at
      the relationships between cough, change in cough, quality of life and clinical parameters.
    

Intervention name(s): Cough monitor
Intervention type(s): Other
Intervention description(s): questionnaires about cough and quality of life
Other intervention name(s): cough monitoring; Leicester Cough Monitor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with IPF about to start on Pirfenidone according to regular practice in the
        participating University Hospitals
      
Keywords: idiopathic pulmonary fibrosis; cough; quality of life
Use of Smartphone Health Applications Among Patients Aged 18 to 69 Years Recruited in Primary Care in Grenoble Area
Condition: Mobile Applications; Mobile Health
Study type: Observational

Summary: 
      This study evaluates the frequency of use of smartphone health applications among people
      consulting in primary care in the Grenoble region, France.

      This is a descriptive study using a questionnaire completed by the patient and distributed by
      general practitioners. The study also collects the type of used application as well as the
      rhythm of usage, and compares the use of mobile health applications according to the
      sociodemographic, geographical and medical characteristics of the studied population.
    

Detailed description: 
      Smartphones are more and more present and change many aspects of people's life, especially in
      the field of health. The appearance of numerous mobile health applications over the past
      years explains this strong attractiveness.

      According to some studies, these could lead to savings in health care systems by promoting a
      preventive approach and refocusing cares on the patient who would be more independent.
      However, not much data on the use of smartphone health applications by patients are reported
      in the scientific literature.

      The main objective of this study is to evaluate the frequency of use of smartphone mobile
      health applications among primary care patients aged 18 to 69 in the Grenoble region, France.

      The secondary objectives are the collection of the kind of application used, the rhythm of
      usage of these health applications and the comparison of the frequency of use with the
      sociodemographic, geographical and medical characteristics of the studied population.

      To this end, the investigators use a questionnaire distributed by voluntary general
      practitioners and filled by patients. The number of subjects to be included is 385 and the
      number of distributed questionnaires is 1500.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Population recruited in 12 general practictioners and 1 primary care center in Grenoble
        area in France.
      
Keywords: Health mobile applications; Apps; mhealth; ehealth; France; msanté; applications mobiles
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine
      hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in
      patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48
      weeks.
    


Intervention name(s): terbinafine hydrogen chloride; amorolfine nail lacquer
Intervention type(s): Drug; Drug
Intervention description(s): 10 % terbinafine hydrogen chloride (HCL); 5 % amorolfine nail lacquer
Other intervention name(s): Lamisil
Intervention MeSH terms: Terbinafine; Amorolfine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses
Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene
Condition: Postprandial Glucose and Insulin Response
Study type: Interventional

Summary: 
      Individuals with low copy numbers of salivary amylase gene have lower salivary amylase levels
      and might therefore have decreased capacity to metabolize starch into glucose. We will in a
      randomized crossover meal study examine the postprandial response of high-starch meals in
      individuals with either low or high copy number of the salivary amylase gene.
    


Intervention name(s): 40 grams of starch; 80 grams of starch
Intervention type(s): Other; Other
Intervention description(s): 40 grams of starch in form of white bread to be consumed within 15 minutes; 80 grams of starch in form of white bread to be consumed within 15 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants with low and high copy numbers of AMY1 were randomized to either 40 or 80 grams of starch in a crossover design.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention