bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2
      clinical trial, which aims to evaluate the early bactericidal activity, safety and
      tolerability of WX-081 in patients with drug-naive&susceptible and drug-resistant
      tuberculosis. Also the efficacy of WX-081 will be explored in participants with
      drug-resistant tuberculosis.
    

Detailed description: 
      This is a Phase 2, multi-center, randomized, parallel, open-label, positive-controlled
      clinical trial. The objective of this trial is to evaluate the early bactericidal activity,
      safety and tolerability of WX-081 patients with drug-naive&susceptible and drug-resistant
      tuberculosis. and the efficacy in participants with drug-resistant tuberculosis.

      This trial will be divided into core research stage (stage 1) and extended research stage
      (stage 2). During stage 1, a panel of 59 participants with drug-naive&susceptible
      tuberculosis will be randomized to receive either WX-081(including 3 groups:150mg qd, 300mg
      qd, 450mg qd. n=12 per group) or standard treatment (n=8) for 2 weeks, and then followed by a
      follow-up period of 2 weeks. A panel of 40 participants with drug-resistant tuberculosis will
      be randomized to receive either WX-081 (400mg qd, n=20) or bedaquiline (400mg qd, n=20) for 2
      weeks. During stage 2, the 40 participants with drug-resistant tuberculosis will receive
      WX-081(150mg qd) + MBT treatment (ie. multi-drug background treatment) and bedaquiline (200mg
      tiw) +MBT treatment for 6 weeks respectively, and then followed by a follow-up period of 4
      weeks.
    

Intervention name(s): WX-081; Bedaquiline; Standard treatment; Multi-drug background treatment (MBT)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): WX-081 is not licensed yet. WX-081 will be used in arms A, B, C, WX-081+MBT.; This licensed drug will be used in arm F as positive comparator.; Standard treatment will be used in arm D as positive comparator, according to the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.; MBT will be used in arm E, F as background treatment. The drugs used in MBT are all licensed drugs, and the treatment complies with the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis
A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in
      subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24
      months and compared to a reference population of healthy controls.
    

Detailed description: 
      This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the
      evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients
      treated with GA and in healthy controls.
    

Intervention name(s): MRI
Intervention type(s): Other
Intervention description(s): All subjects will undergo a MRI.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of
        Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their
        disease modifying therapy.

        Healthy controls from the general population.
      
Keywords: multiple sclerosis; MRI; Copaxone; healthy controls; glatiramer acetate
Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to compare the effects of intrathecal levobupivacaine plus midazolam
      and levobupivacaine plus fentanyl in patients undergoing caesarean section to get a prolonged
      postoperative analgesic effect and less side effects
    


Intervention name(s): Midazolam; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position; 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position
Intervention MeSH terms: Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
ImPACT Intervention for Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This randomised-controlled trial will assess the effect of an early intervention on the
      social-communicative abilities and brain activity of preschoolers with autism spectrum
      disorder (ASD). The children´s social-communicative abilities and the related brain activity
      will be evaluated at three time points: before the start of the intervention
      (pre-intervention), immediately after its conclusion (post-intervention) and several weeks
      after its conclusion (follow-up).
    

Detailed description: 
      Previous research has shown that parent-implemented interventions are effective in improving
      the social skills of children with autism spectrum disorder (ASD). The aim of the present
      project is to investigate the brain activity changes that are at the basis of the changes
      observed in the children's behaviour. More specifically, the investigators will assess the
      effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques
      to stimulate the social-communicative abilities of their children.

      The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18
      sessions of maximum 2 hours each, one session per week, delivered by trained therapists of
      the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are
      suspected of ASD) between 1,5 and 4 years old and their parents will participate in the
      study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The
      investigators will assess the effect of the intervention on the children's
      social-communicative abilities, and on the neural and biological correlates of these
      abilities.

      The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at
      three time points: before the start of the intervention, immediately after the end of the
      intervention (which is expected to last 18 weeks) and 12 weeks after the end of the
      intervention.
    

Intervention name(s): ImPACT; TAU
Intervention type(s): Other; Other
Intervention description(s): Teaching parents to train social communicative skills as outlined in arm description.; TAU can include targeting eating and sleeping problems, adaptive skills, or other goals.
Other intervention name(s): Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 will receive the intervention specifically targeting social-communicative abilities (Project ImPACT).
Group 2 will receive a generic intervention, that will not focus on social-communicative skills.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Influence of Parental Behavior on the Course of the Pediatric Dentistry Session
Condition: Behavior, Child; Parents; Dental Anxiety
Study type: Observational

Summary: 
      The aim of the experiment is to analyze the impact of the behavior of the accompanying parent
      on the behavior of the child during a first dental session according to the age group.
    

Detailed description: 
      I will receive the children for consultation at the CHU Saint Pierre - César de Paepe site,
      to assess the impact of parents' behavior on the child.

      First, I will make a first contact with the child in the waiting room using the CORAH scale
      (self-assessment based on diagrams) which will allow him to assess his temperament in the
      face of dental care. . Then, I will have the parents / caregiver sign informed consent and
      authorization to film.

      Once the child enters the practice, the video recording will be initiated: the installation
      on the seat, the confidence building and the care provided will be filmed.

      These videos will then be analyzed by several practitioners from different categories
      (experts in pedodontics, general dentists, dental students, etc.) using the Venham
      hetero-assessment scale modified for the behavior of the child and of a scale of parental
      cooperation. These practitioners will be selected via the ADUB (association of dentists of
      Université Libre de Bruxelles) and some of them could be external to the hospital.

      Following this study, the results obtained will be described and statistically analyzed.
    

Intervention name(s): Parents
Intervention type(s): Behavioral
Intervention description(s): To observe the influence of the parents/caregivers behavior on their child during dental treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients presenting for the first time to the pediatric dentistry consultation at the
        CHU Saint-Pierre - César de Paepe site were selected for this study between. 3 groups of 20
        children, respectively aged 4 and under, 5 to 6 years old and over 7 years old, were
        formed.67 children participated in this study. They were divided into 3 groups according to
        their age (4 years and under, 5 to 6 years and 7 years and over). During the search, 7
        patients were excluded: due to the image rights not granted. The data were collected and
        analyzed by 2 observers. Then a randomization took place thus creating a sample of 15
        children divided into 3 same groups. The data were collected and analyzed by 20
        practitioner observers
Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the clinical effects of natalizumab versus
      placebo in acute ischemic stroke on clinical measures of functional independence and
      activities of daily living. The secondary objective of the study is to explore dose and
      exposure response and the clinical treatment effects of natalizumab versus placebo in acute
      ischemic stroke on the following: measures of independence, activities of daily living,
      neurologic function, quality of life, cognition, and safety and tolerability
    


Intervention name(s): natalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Matched placebo
Other intervention name(s): BG00002
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke
Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease
Condition: Diabetes Mellitus; Essential Hypertension; Renal Failure; Chronic Nephropathy
MeSH terms: Renal Insufficiency, Chronic; Kidney Failure, Chronic; Essential Hypertension
Study type: Observational

Summary: 
      Many patients with chronic renal disease show a loss of the nocturnal decline of blood
      pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate
      24-hour blood pressure in patients with chronic renal disease using an ambulatory blood
      pressure monitoring device (A & D TM2425). We also analyze the power spectrum of heart rate
      variability as an index of autonomic cardiovascular modulation using the same device.
    

Detailed description: 
      The ratio of lower frequency (LF) and higher frequency (HF) heart rate rhythmic oscillations
      is expressed as an index of sympathovagal balance. Patients with chronic renal disease
      participate in the study. Blood pressure and power spectrum of heart rate variability for 24
      hours are measured when they receive no medication for at least 1 week. The mean waking and
      sleeping time systolic and diastolic blood pressure are calculated. LF/HF ratios in the
      chronic renal disease are evaluated to calculate the waking/sleeping ratio for LF/HF.
    

Intervention name(s): Ambulatory blood pressure monitoring
Intervention type(s): Device
Observational model: Natural History
Time perspective: Prospective
The Effects of Sacroiliac Joint Dysfunction on Gait and Disability
Condition: Chronic Low-back Pain; Sacroiliac Joint Dysfunction; Gait, Unsteady; Disability Physical
MeSH terms: Joint Diseases; Gait Disorders, Neurologic; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      It has been reported that gait coordination changes in patients with chronic low back pain,
      walking slower, taking shorter steps and having asymmetrical stride lengths compared to their
      healthy peers. In addition to many factor cause gait dysfunction, sacroiliac joint
      dysfunction might be one of reason of these problems. A study examining the effects of
      sacroiliac joint dysfunction on gait and disability in individuals with chronic low back pain
      has not been found in the literature. Therefore, the aim of this study is to evaluate the
      gait parameters and disability of individuals with chronic low back pain and to reveal their
      relationship with sacroiliac joint dysfunction.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention in this study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants who directly presented to the Physical Therapy Department of Kutahya Health
        Sciences University Hospital during the study period with persistent low back pain, will be
        screened for eligibility by an independent physician (H.H.G.)
Young Smokers Have Impaired Airway Defense
Condition: Smoking
Study type: Observational

Summary: 
      Background: Smoking is a key factor for development and progression of chronic obstructive
      pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease,
      there are few studies that report physiological or inflammatory changes in the upper airways
      in young asymptomatic smokers. The investigators investigated physiologic and inflammatory
      changes in the nasal and lower airways of young smokers and if these changes were related to
      smoking history.

      Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers)
      participated in this study. The investigators measured nasal mucociliary clearance (MCC),
      nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in
      nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy nonsmokers and smokers aged between 18 and 35 y.o. that were recruited from the
        Faculdade de Medicina da Universidade de São Paulo
      
Keywords: smoking, nasal lavage, exhaled breath condensate, mucociliary transport
iTBS in Bipolar I Depression
Condition: Bipolar Depression; Bipolar I Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      A multisite, open label pilot study to investigate the efficacy and safety of a novel
      accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes
      in neuroimaging biomarkers associated with treatment response.
    


Intervention name(s): Magnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
Intervention type(s): Device
Intervention description(s): Novel intermittent theta burst stimulation protocol with individualized targets in the brain for stimulation using structural and functional MRI inputs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
Condition: Gastric Cancer; Adenocarcinoma; Effects of Chemotherapy; Surgery; Gastrointestinal Neoplasms
MeSH terms: Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with
      locally advanced gastric cancer and the identification of prognostic factors.
    

Detailed description: 
      Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially,
      patients are diagnosed by computerized tomography scan and endoscopic ultrasound.

      The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by
      concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently
      with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after
      the end of CRT. Pathological response is graded according to the Becker criteria. Statistical
      analysis is performed IBM SPSS v20.

      Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and
      long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size,
      neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
    

Intervention name(s): Induction chemotherapy; Radiotherapy with concurrent chemotherapy; Salvage surgery
Intervention type(s): Drug; Radiation; Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant
        protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)and salvage
        surgery. Patients must have a medically fit condition to complete the protocol.

        Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic
        ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and
        renal function.

        Radiological and endoscopic evaluations are performed at baseline and at the completion of
        ICT and CRT.

        Blood tests are acquired at baseline, before each chemotherapy course and concurrently with
        evaluations. Blood tests are also obtained during follow-up and at the time progression.
      
Biospecimen description: 
      Surgical specimen with potential for extraction of DNA.
    
Keywords: Radiotherapy; Neoadjuvant therapy; Induction chemotherapy; Concurrent chemoradiotherapy; Preoperative factors; Dynamic factors; Prognostic Factor
Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
Condition: Emphysema; Bronchoscopic Lung Volume Reduction; Hospital-based Pulmonary Rehabilitation; Home-based Pulmonary Rehabilitation
MeSH terms: Emphysema
Study type: Interventional

Summary: 
      The recent years, the use of bronchoscopic lung volume reduction in emphysema patients
      instead of surgical operations has become widespread. Before this procedure, the
      implementation of Pulmonary Rehabilitation became a necessity. The inadequacy of the number
      of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number
      of mentioned operations have increased the need for different exercise program applications.
      Prior to valve and coil applications in our study, changes in clinical conditions of patients
      will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.
    

Detailed description: 
      The records of emphysema patients referred to the Pulmonary Rehabilitation Unit for
      prophylactic pulmonary rehabilitation prior to bronchoscopic lung volume reduction will be
      recorded prospectively. Two parallel groups will be formed from patients with hospital-based
      pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation (Group
      2). The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program and will be
      reevaluated after 8 weeks. The differences in the parameters of initial and rehabilitation
      end-tracing and the differences between the groups will be examined.
    

Intervention name(s): Hospital-based pulmonary rehabilitation; Home-based pulmonary rehabilitation
Intervention type(s): Other; Other
Intervention description(s): The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, treadmill walking, cycle ergometer, arm ergometer training and strengthening trainning with free weights at hospital.; The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation(Group 2).
Masking: None (Open Label)
Primary purpose: Treatment
4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety,
      and tolerability of once daily oral administration of BI 10773 administered for 28 days in
      Japanese patients with T2DM.
    


Intervention name(s): Placebo (middle dose); Placebo; BI 10773; BI 10773; BI 10773; Placebo (high dose); BI 10773; Placebo (low dose)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablets once a day; Placebo tablets once a day; BI 10773 middle dose tablets once a day; BI 10773 high dose tablets once a day; BI 10773 middle dose tablets once a day; Placebo tablets once a day; BI 10773 low dose tablets once a day; Placebo tablets once a day
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment