bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent
      for this duration of immunity study to provide up to two additional blood samples. SBA & IgG
      testing will be done on these samples taken at 6 & 12 months. The sites participating in this
      duration of immunity study are the same sites participating in the 6108A1-500 study.
    


Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): Blood draws at 6 and 12 months following end of 6108A1-500 trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation and carboplatin, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving more than one drug
      (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
      formulation given together with carboplatin works in treating patients with stage IIIB, stage
      IV, or recurrent non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the response rate, in terms of overall response rate (complete response and
           partial response), of paclitaxel albumin-stabilized nanoparticle formulation and
           carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who
           are ineligible for treatment with bevacizumab.

      Secondary

        -  To evaluate safety of this regimen in these patients.

        -  To describe the overall survival of these patients.

        -  To describe progression-free survival of these patients.

      Tertiary Objectives

        -  To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers
           including serum SPARC levels, methylation of SPARC in primary tumor samples and serum,
           Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression
           profiles.

      OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
      minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to
      6 courses in the absence of disease progression or unacceptable toxicity.

      Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for
      correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND
      SPARC by immunohistochemistry, and serum miRNA expression profiling.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): carboplatin; paclitaxel albumin-stabilized nanoparticle formulation; protein expression analysis; immunoenzyme technique; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Genetic; Other; Other; Other
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer
Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method
Condition: Pharmacokinetics; Bioequivalence
Study type: Interventional

Summary: 
      Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous
      administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for
      subcutaneous administration, 100 IU/ml (Lilly France, France) using the euglycemic
      hyperinsulinemic clamp.
    

Detailed description: 
      A double-blinded, randomized, comparative, crossover pharmacokinetics study of Rinsulin® NPH,
      suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin®
      NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using
      method of euglycemic hyperinsulinemic clamp on healthy volunteers
    

Intervention name(s): Rinsulin NPH; Humulin NPH
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection at a dose of 0.4 IU/kg; subcutaneous injection at a dose of 0.4 IU/kg
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment two-way crossover
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: human recombinant insulin; euglycemic hyperinsulinemic clamp
A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the use of home blood pressure monitors plus
      nurse telephone monitoring is more effective than the use of blood pressure monitors alone in
      improving control of high blood pressure in an urban medical clinic.
    

Detailed description: 
      Participants will all have home blood pressure monitors, education session on controlling
      their blood pressure and will be randomized to recieve 6 months of intensive telephonic on a
      set monitoring schedule or no telephonic follow up. Phone calls will be weekly for 4 weeks,
      then every 2 weeks for 8 weeks then monthly for 3 months.
    

Intervention name(s): Home monitoring; monitor & phone call
Intervention type(s): Device; Other
Intervention description(s): Participants will receive a home blood pressure monitor and be taught how to use it. They will have an education session to review treatment goals, medications, diet and exercise. They will be asked to see their primary care provider at least every 3 months and the research nurse at 3, 6 and 12 months.; Participants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; home blood pressure monitoring; nurse telephone follow up; medically underserved populations
D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA)
      receptor function in the brain and thereby increasing the capacity of the brain to both form
      new connections and strengthen existing connections, schizophrenic patients may derive both
      greater and sustained benefit from cognitive retraining.
    

Detailed description: 
      Patients with schizophrenia or schizoaffective disorder who are currently receiving
      antipsychotic medication will be randomly assigned in a double-blind manner to receive either
      D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive
      placebo for 12 weeks.
    

Intervention name(s): D-serine; Cognitive Retraining (CRT); Placebo; Cognitive Retraining Placebo
Intervention type(s): Drug; Behavioral; Drug; Behavioral
Intervention description(s): D-serine (30 mg/kg); Cognitive retraining therapy (CRT); Placebo D-serine Drug; Cognitive retraining therapy (CRT) control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the treatment effect of montelukast 10mg on the
      primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent
      asthma patients with or without allergic rhinitis.
    


Intervention name(s): MK0476, montelukast sodium / Duration of Treatment: 8 Weeks
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Voice Telerehabilitation
Condition: Vocal Fold Palsy
MeSH terms: Vocal Cord Paralysis
Study type: Observational

Summary: 
      The aim of the study was to determine functional results of telerehabilitation (TR) in
      subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19
      pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent
      voice teletherapy with a synchronous approach. A multidimensional assessment by means of
      videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was
      carried out before, at the end of teletherapy and six months later.
    


Intervention name(s): teletherapy
Intervention type(s): Other
Intervention description(s): speech therapy remotely delivered
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        15 subjects affected by permanent iatrogenic UVFP
Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome
Condition: Polio and Post-polio Syndrome; Fatigue; Polio
MeSH terms: Poliomyelitis; Postpoliomyelitis Syndrome; Syndrome; Fatigue
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to investigate the differences in the severity of fatigue, impact on
      quality of life, and mood between individuals with post-polio syndrome and healthy volunteer
      groups. Additionally, the interrelationships of these parameters within the post-polio
      syndrome patient group will be examined. The goal is to raise awareness during the follow-up
      process for individuals with post-polio syndrome by questioning fatigue and mood symptoms,
      and to facilitate the implementation of necessary precautions.
    

Detailed description: 
      Our research is designed as a case-control study. 20 patients diagnosed with post-polio
      syndrome who present to the Istanbul Physical Medicine and Rehabilitation Training and
      Research Hospital clinics and 20 healthy volunteers will be included in the study. The
      sociodemographic data of patients and volunteers, such as age, gender, height, weight, body
      mass index, education level, and occupation, will be recorded. The age at which polio was
      contracted, the time elapsed since polio, and any accompanying illnesses will be documented.
      Additionally, if patients experience new symptoms such as pain, weakness, or fatigue, the
      severity of these symptoms will be assessed using the Visual Analog Scale. The frequency of
      falls and the presence of fractures caused by falls, ambulation method, and devices used will
      be noted. Muscle weakness in the extremities will be identified by applying the Manual Muscle
      Test through physical examination. Subsequently, the patient's current symptoms related to
      depression and anxiety will be evaluated using the Hospital Anxiety and Depression Scale
      (HADS), fatigue level will be assessed using the Fatigue Severity Scale (FSS), and quality of
      life will be evaluated using the Short Form-36 (SF-36).
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Individuals aged between 18 and 60 with post-polio syndrome.

          -  Healthy volunteers aged between 18 and 60
      
Keywords: Poliomyelitis; Fatigue; Postpoliomyelitis Syndrome
Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand
Condition: PrEP Test and Treat
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM
      and TG at five health facilities in four provinces of Thailand. Each participant will be
      followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4
      counts, retention in care, and ART adherence at the study clinics, at the study clinics
      combined, and national data (if available) will be compared with rates after implementation
      of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence
      and incidence. This study will use similar objectives, indicators, and procedures as those
      used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three
      tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations
      Implementation Science (KPIS) funding through United States Agency for International
      Development (USAID), in community-based centers, allowing comparison of uptake and follow-up
      of MSM and TG using the Test and Treat strategy in a variety of settings.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Thai nationals not known to be HIV-infected aged ≥18 years old who are men or transgender
        women who report unprotected anal sex with a man in the past 6 months and are eligible for
        the study.
      
Keywords: MSM/TG who agree to start PrEP
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Condition: Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show the efficacy of promethazine in management of patients
      with moderate to severe migraine
    


Intervention name(s): Sumatriptan+Promethazine (SPr)
Intervention type(s): Drug
Intervention MeSH terms: Promethazine; Diphenhydramine; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PASCAL: Safety and Complications, Experience After 1301 Consecutive Cases
Condition: Bruch Rupture; Choroidal Detachment
MeSH terms: Choroidal Effusions; Rupture
Study type: Observational

Summary: 
      To report the safety and incidence of adverse effects, during and after a successful
      photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its
      modified settings
    


Intervention name(s): Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients which has been treated with the pattern scan laser system between november
        2007 to july 2008.
      
Keywords: Panretinal photocoagulation; Bruch rupture; Choroidal detachment; complication rates
Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Continuous cardiovascular monitoring as part of management of high-risk surgical patients is
      widely practiced, however its role in low-risk surgical patients is unclear. Detailed
      monitoring of cardiovascular parameters from pre-induction stage allows clinicians to
      individualise anaesthetic management in the perioperative period. The investigators' aim was
      to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing
      surgery following induction of anaesthesia with propofol using a continuous non-invasive
      blood pressure device (LiDCOrapid™).
    

Detailed description: 
      Recruitment Orthopaedic surgical teams, anaesthetists and theatre staff were made aware of
      the study that was being conducted at the investigators' institution. Prospective subjects
      that met the inclusion criteria were identified from the hospital operating theatre's
      database two weeks prior to surgery. A letter, which contained the study's objectives and
      methods, was sent out to all patients. Subsequently, a telephone call was made to patients
      one week before surgery to clarify any queries they had. Consent was obtained on the morning
      of surgery. All study participants provided written informed consent.

      Peri-operative monitoring LiDCO™ CNAP and BIS monitoring were attached prior to induction of
      anaesthesia in the anaesthetic room of the operating theatre. A standardised anaesthetic
      technique was used for every participant, consisting of propofol induction, sevoflurane
      maintenance to a target BIS (40-60) and opioid analgesia with fentanyl. Participants
      underwent positive pressure ventilation to a tidal volume of 8ml/kg.

      Measurements of the following variables were taken continuously from pre-induction to time of
      extubation: heart rate, mean arterial blood pressure, stroke volume, cardiac output, systemic
      vascular resistance and BIS. Data recorded up to 3 minutes following propofol injection was
      analysed to capture the post-induction period. Further measurements were taken in recovery
      room. The total quantity and type of fluids, drugs administered, time of tourniquet
      application and removal (if performed), and the duration of the operation were recorded.
    

Intervention name(s): LiDCO rapid™ CNAP monitoring
Intervention type(s): Device
Intervention description(s): LiDCO rapid™ CNAP monitoring allows through analysis of the arterial blood pressure trace to acquire information about CO, HR variability, SVR, SV and BIS during general anaesthesia.
Other intervention name(s): http://www.lidco-ir.co.uk
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on
      admission might be predictive for early neurological deterioration in acute ischemic stroke
      patients, specifically for the DWI lesion evolution within the first week after stroke onset.
    

Detailed description: 
      Early neurological deterioration (END ) is a major concern in stroke care, consistently
      associated with adverse clinical outcomes.END is a heterogeneous complex of
      pathophysiological and clinical entities. Despite some straight forward causes, DWI lesion
      growth is reportedly a primary underlying mechanism. Early recognition of END risk would
      allow for timely identification and proper intervention, improving stroke health care.

      Thromboelastography (TEG) measures the coagulation process from initial clotting cascade to
      clot strength, providing an integrated picture of two separate but simultaneously occuring
      components of coagulation, thrombosis and lysis. It has been reported to be associated with
      short and long-term outcome in patients with trauma, coronary artery diseases , pulmonary
      embolism and, most recently, stroke prevention.The purposes of this study is to evaluate how
      effective TEG is on predicting END, by producing a range of TEG values correlated with
      clinical and radiological assessment.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes consecutively admitted patients with acute ischemic stroke in
        Dongguan people's Hospital. Patients would take TEG study within 6 hours after admission,
        as well as other routine lab tests. Serial MRI studies would be taken on admission and
        followed up on 7th day afterward, except when patients experience END, in which case
        followup MRI should be preformed immediately.
      
Biospecimen description: 
      thrombelastography on admission
Niacin and Endothelial Function in Early CKD
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to obtain information on whether raising levels of
      HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney
      disease. This may help us understand the causes leading to high rates of heart disease in
      kidney disease and also ways to reduce this risk.
    


Intervention name(s): Niacin; Active Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg tablets once per day; 100 mg Niacin tablets once per day
Other intervention name(s): Niaspan
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; Niacin; HDL; Endothelial Function