bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2
      Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma
      Inadequately Controlled on Inhaled Corticosteroid.
    

Detailed description: 
      This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2
      study to designed evaluate the effect of a 300 mg dose of tralokinumab administered
      subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately
      controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately
      80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered
      via subcutaneous injection at the study site, over a 12 week treatment period.
    

Intervention name(s): Tralokinumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous Injection; Subcutaneous Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Tract Disease; Lung Diseases
Ultrasound for Guidewire Detection
Condition: Kidney Failure, Acute; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury
Study type: Observational

Summary: 
      The aim of the project is to check if there is a possibility for a nephrologist to visualise
      the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of
      catheter insertion will be expanded by ultrasound examination of right atrium and inferior
      vena cava border using substernal view. Such imaging seems to ameliorate the safety of
      catheter implementation and could be a good alternative for fluoroscopy, eliminating its
      adverse effects.
    


Intervention name(s): Ultrasound guidance
Intervention type(s): Diagnostic Test
Intervention description(s): Jugular vein is punctured with ultrasound guidance and guidewire is advanced. Right atrium and inferior vena cava junction is visualized by ultrasound using substernal view. Presence of guidewire in inferior vena cava or right atrium is confirmed. The procedure of catheter insertion is continued.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute kidney disease or end stage renal disease who need dialysis catheter
        insertion for hemodialysis performance
      
Keywords: hemodialysis; vascular access; dialysis catheter
Homeless Youth Study - Stepping Stone 2.0
Condition: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
MeSH terms: Substance-Related Disorders; Personality Disorders
Study type: Interventional

Summary: 
      Housing instability is both a cause and consequence of mental health problems. As such youth
      experiencing housing instability (e.g., homeless or marginally housed) have higher rates of
      mental health problems.Because of their circumstances, these youth also face significant
      barriers to mental health care and are therefore less likely to receive the treatment that
      they need. Mobile technology may offer a novel platform for increasing access to mental
      health care in this population. The primary goals of this pilot study are to (1) establish
      the feasibility and acceptability of delivering automated mental health interventions via
      smartphone technology, (2) examine the extent to which automated mental health interventions
      delivered via mobile technology improve mental health in homeless, marginally-housed, and
      exiting foster youth.
    


Intervention name(s): Mobile self-help intervention
Intervention type(s): Behavioral
Intervention description(s): Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy. Participants also receive the Pocket Helper app, which has been designed for this study. The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys. Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Foot Disorders in X-linked Hypophosphatemia
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to characterize foot pathologies using X-rays and clinical examination and
      assess related outcome scores in adolescents and adults with X-linked Hypophophatemia
    

Detailed description: 
      A single center, cross-sectional analysis of adolescent and adult patients with XLH with and
      without previous surgical intervention was performed at the Orthopaedic Hospital Speising,
      Vienna, Austria. Clinical examination, quality of life questionnaires and radiographic data
      of foot x-rays in standing position were collected. Radiographic evaluation was performed to
      analyze foot deformity as well as signs of osteoarthritis at the foot.
    

Intervention name(s): Foot X rays; Clinical examination + scores
Intervention type(s): Radiation; Diagnostic Test
Intervention description(s): Radiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint.; The American Orthopedic Foot and Ankle Society Score (AOFAS- midfoot section and 1st Forefoot ray, Forefoot ray 2-5) and the foot function index (FFI) were assessed
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with rare bone disease (XLH) with and without foot problems
      
Keywords: foot and ankle
Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
Condition: Uncontrolled Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm,
      Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and
      tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients
      with Uncontrolled Type-2 Diabetes Mellitus (T2DM).
    

Detailed description: 
      In this phase-III trial, after due consent and completing initial 2-weeks of placebo run-in
      period with diet, exercise and counseling, eligible patients with uncontrolled T2DM will be
      randomized in balance to receive either once daily oral CPL-2009-0031 140 mg or Sitagliptin
      100 mg.

      After completing 12 weeks of study post-randomization for regulatory submission, patients
      will be instructed for continuation of extension phase of treatment and follow up upto 36
      weeks.

      HbA1c will be measured at screening, baseline, 12 weeks, 24 weeks and 36 weeks of treatment.
      While, Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) measurement will be
      performed every 2 weeks.

      The enrolled patients will be monitored for safety (AE and SAE) throughout the study period.
    

Intervention name(s): CPL-2009-0031 140 mg; Sitagliptin 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.; Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of
      ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria
      (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses
      of H1 antihistamines (H1AH) following the guideline on treatment of CSU.
    

Detailed description: 
      This was a Phase IIb dose-finding, randomized, double-blind, parallel-group,
      placebo-controlled, multicenter study in adolescent patients. The study consisted of 3
      distinct study periods: Screening, Treatment and Follow-up period.

      After the screening period (up to 4 weeks), at Day 1 participants were randomized into one of
      the three treatment arms in 1:2:1 fashion to ligelizumab high dose (120 mg every four weeks
      (q4w)) versus ligelizumab low dose (24 mg q4w) versus placebo. During the 24 weeks of
      treatment period, doses were administered on Day 1 then on weeks 4, 8, 12, 16, and 20 weeks
      after randomization. Participants randomized to placebo received placebo on Day 1, Weeks 4
      and 8; thereafter they received 120 mg ligelizumab (high dose) on Weeks 12, 16 and 20 such
      that by the end of the study, the same number of participants received ligelizumab high dose
      as low dose. The treatment period was followed by a treatment-free follow-up period of 16
      weeks to a maximum of Week 40.
    

Intervention name(s): Ligelizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg or 24 mg, high and low doses respectively.; Placebo 0 mg per 1 ml liquid injection once every 4 weeks.
Other intervention name(s): QGE031
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a Phase 2b dose-finding, randomized, double-blind, parallel group, placebo controlled multicenter study in adolescent patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anti-IgE; Chronic spontaneous urticaria
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Condition: Healthy; Pregnant
Study type: Observational [Patient Registry]

Summary: 
      To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant
      woman
    

Detailed description: 
      Any local and systemic reaction after Td immunization in pregnant woman (as a routine
      immunization program)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 pregnant woman, 18-39 years old From provincial health primary center
      
Keywords: Td Vaccine; Safety; Pregnant; Pregnant Women
A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate safety and tolerability of BI 1356225
      in male and female patients with overweight and obesity following oral administration of
      multiple rising doses per day over 28 days. Secondary objectives are the exploration of
      pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative
      bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225
      will be evaluated
    


Intervention name(s): BI 1356225; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1356225; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Metabolic and Chronobiological Changes in Vestibular Rehabilitation
Condition: Vestibular Disorder; Metabolic Disease; Sleep Disorder
MeSH terms: Vestibular Diseases; Sleep Wake Disorders; Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the impact of vestibular rehabilitation on
      metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart
      watch device and actigraphy in a group of vestibular hypofunction patients previously studied
      by means of video head impulse test, posturography and clinical validated scales
    

Detailed description: 
      Recent advances in the field of vestibular-related disorders demonstrated that such
      conditions may interfere on different pathways underpinning metabolic behaviour, daily life
      activities and also chronotype behaviour. However, no studies evaluated how vestibular
      rehabilitation procedures - well established in literature - may interfere on these
      vestibular-related disorders. On the other side, recent advances in portable bioelectrical
      impedenzometry devices, smart watches devised to evaluate energy expenditure during daily
      life activities and actigraphy devices demonstrated to be useful in continuously monitoring
      different aspects of metabolic, activity and sleep behaviour.

      Thus, the aim of the present study is to evaluate the impact of vestibular rehabilitation on
      metabolic aspects when evaluated by means bioelectrical impedenzometry analysis, smart watch
      device and actigraphy in a group of vestibular hypofunction patients previously studied by
      means of video head impulse test, posturography and clinically validated scales
    

Intervention name(s): Vestibular Rehabilitation
Intervention type(s): Procedure
Intervention description(s): The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tailored Asthma Management for Urban Teens
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this project is to refine and further evaluate an online asthma management and
      education program for urban teenagers. This project is a continuation of Puff City I, a
      project piloting and evaluating a tailored, school-based, computerized asthma education
      program for urban teenagers. In this second phase of research, a new version of software
      (Puff City II) will be created that will target resistance to change and relapse, and using a
      tested, theory-based approach to student recruitment, conduct a randomized trial to test the
      efficacy of this new software.
    

Detailed description: 
      BACKGROUND:

      Teenagers are among an age group that has seen dramatic increases in deaths from asthma. In
      Detroit, asthma death rates for teenagers are high relative to younger ages, despite a higher
      prevalence in the latter age group. Early studies suggest that inadequate asthma management
      plays a significant role in these grim statistics.

      DESIGN NARRATIVE:

      The study hypothesis is that students randomized to the intervention group will have lower
      asthma-related morbidity as determined by fewer emergency department visits and
      hospitalizations at the time of the 12-month follow-up. Based on a second hypothesis of
      better functional status among students randomized to the intervention group, secondary
      outcomes include fewer symptom-days, symptom-nights, school days missed, and days of
      restricted activity at the time of the 12-month follow-up. In addition, it is hypothesized
      that students in the intervention group will have higher scores on the Juniper Pediatric
      Quality of Life scale at 12 months. Finally, it is hypothesized that intervention students
      would exhibit positive changes in adherence behavior, having a rescue inhaler nearby, and
      smoking at the 12-month follow-up.
    

Intervention name(s): Tailored Web-based Asthma Management; Generic web-based asthma education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Web-based asthma management; 4 computer sessions over a period of 180 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urban; adolescents; African American; web-based; computer tailoring; school based
Linguistic Predictors of Outcomes in Psychosis
Condition: Schizophrenia and Related Disorders
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Longitudinal observational study of the relationship between speech patterns and clinical
      symptoms in schizophrenia spectrum disorders.
    

Detailed description: 
      The accurate prediction and tracking of clinical and functional outcomes in young people with
      schizophrenia-spectrum disorders is critical for delivering appropriate interventions and for
      understanding the brain mechanisms behind psychosis. Language is an optimal avenue for
      tracking psychosis processes because language is readily produced and captured, has
      well-established disruptions in psychosis, and known relationship to brain circuits. Using
      computers to automate detection of language features has the further advantage of being
      objective, quantitative, and adaptable into an efficient and cost-effective tool. The
      investigators propose to use automated linguistic analyses in young people early in the
      course of schizophrenia spectrum disorders to measure language features including fluency
      (speech rate), complexity (proportion of unique words), prosody (changes in tone during
      speech), and semantic coherence (how sequencing of words conform to expected patterns).

      The investigators will test whether these features meaningfully reflect clinical symptoms,
      cognition, and functioning, and whether they help predict how psychosis symptoms change over
      time.
    

Intervention name(s): There is no intervention
Intervention type(s): Other
Intervention description(s): There is no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients will be recruited from Northwell Health. Patients whose treatment team believes
        they would be appropriate for a research study will be approached by research staff and the
        research project will be explained to them in detail. Potential participants will also be
        screened for by reviewing newly admitted patients to the inpatient units. Educational
        seminars regarding this study may be held to inform clinicians and staff of our goals and
        protocol. Potential participants will be made aware that declining participation will not
        affect their care.
      
Keywords: Schizophrenia; speech; language; language processing; digital health
Analysis of Immune Response In Bacterial Infection of Obese Subject
Condition: Obesity
MeSH terms: Bacterial Infections
Study type: Interventional

Summary: 
      Improve knowledge of the immune response to sepsis in obese patients. Define immunological
      and genetic prognostic factors of severe infections which can motivate a change in the
      therapeutic attitude
    


Intervention name(s): blood analysis
Intervention type(s): Biological
Intervention description(s): Pilot study, single center, interventional including 15 obese subjects with acute sepsis. Inflammatory and immunological tests during acute phase and one month later after a presumed return parameters at baseline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
Condition: Hepatitis; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0
      μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin
      in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.
    

Detailed description: 
      After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of
      rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV
      RNA level PCR data. In patients without virologic response after 12 weeks, AVT was
      discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a
      follow-up period. During the follow-up period, patients of the first and the second group
      will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients
      of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending
      on a genotype of the virus), afterwards they will be followed up without therapy for 24
      weeks.
    

Intervention name(s): Algeron; PegIntron; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously; 1.5 μg/kg/week subcutaneously in combination with ribavirin; 800-1400 mg/day orally
Other intervention name(s): cepeginterferon alfa-2b; Peginterferon alfa-2b
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cepeginterferon alfa; Peginterferon; Treatment