bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome
Condition: SAPHO Syndrome
MeSH terms: Acquired Hyperostosis Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone
      marrow edema in patients with SAPHO syndrome.
    

Detailed description: 
      The study will evaluate the long term efficacy at 3 days, 3 and 6 months after pamidronate
      disodium administered. Patients will be administered pamidronate disodium 1 mg/kg, IV, QD,
      for 3 days, and every 3 months (up to month 6).
    

Intervention name(s): pamidronate disodium
Intervention type(s): Drug
Intervention description(s): the patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 month (up to month 6)
Intervention MeSH terms: Pamidronate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment; Bisphosphonates; Response rate
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Condition: Transposition of the Great Vessels; Hypoplastic Left Heart Syndrome; Oxygen Consumption Based Assessment of Hemodynamics
MeSH terms: Hypoplastic Left Heart Syndrome; Transposition of Great Vessels
Study type: Interventional

Summary: 
      The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn
      infants recovering from congenital heart surgery. Currently, we utilize important but
      unsophisticated measures, such as vital signs and lactate measurements, to monitor these
      patients. Although they are useful in categorizing patients as well or unwell, these signs
      currently lack the power quantify a patient's risk for cardiac arrest. More to the point,
      they are mostly indirect measures of what we really are assessing, which is tissue oxygen
      delivery.

      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a
      baby consumes every minute. Historically, these values are more commonly used in combination
      with other measures to assess nutritional and metabolism status. In critically ill patients,
      however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen
      their circulation delivers. This may represent a critical relationship, which has been
      previously described, but not exploited for the purpose of identifying patients with
      critically low oxygen delivery.

      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely
      and precisely measured continuously in newborns undergoing one of two common congenital heart
      surgeries, (2) to determine whether postoperative circulatory failure is associated with a
      precedent change in oxygen consumption, and (3) to determine whether the addition of the
      oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to
      standardly measured parameters will add power in predicting which patients will experience
      postoperative circulatory failure.

      If successful, this study may improve our capacity to non-invasively and continuously monitor
      patients following the highest risk congenital heart surgeries, and in the future,to create
      an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may permit
      providers to intervene on these patients earlier, improving the morbidity and mortality
      associated with congenital heart disease.
    


Intervention name(s): General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments; Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
Intervention type(s): Device; Device
Intervention description(s): Breath to breath VO2 measurements; Edwards continuous SVO2 measurement system
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hemodynamics; neonatal; cardiac disease; congenital heart disease; volumetric oxygen consumption
Efficacy of Phosphatidylcholine in NAFLD
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates efficacy of Phosphatidylcholine in addition to life style modification
      and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty
      Liver NAFLD. All participants with NAFLD will receive life style intervention and half of
      them will receive additionally Phosphatidylcholine.
    

Detailed description: 
      As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most
      common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic
      Syndrome (MetS) and its components which also increases the risk of more advanced disease
      both in adults and in children.

      Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and
      metabolic factors. New concepts are constantly appearing in the literature, promising new
      diagnostic and therapeutic tools. Further studies are needed to better characterize not only
      NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients
      at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological
      treatments aimed primarily at improving liver disease should generally be limited to those
      with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver ﬁbrosis. Not much
      therapeutic options for NAFLD are accepted until today besides correction of obesity with
      hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or
      oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential
      phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with
      significant positive effects as antioxidative, antifibrotic effects and high biocompatibility
      on NAFLD.
    

Intervention name(s): Phosphatidyl Choline; Lifestyle modification
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): 2.1 g Phosphatidylcholine daily in addition to lifestyle modification; Lifestyle modification and health education by Clinical Pharmacist
Other intervention name(s): Behavior therapy; Health education
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.
Masking: None (Open Label)
Primary purpose: Treatment
Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is
      a second-generation platinum compound that is more active against squamous cell carcinoma of
      the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.
    


Intervention name(s): Nedaplatin; Cisplatin; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Docetaxel; Nedaplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nedaplatin; lung squamous cell carcinoma
Stem Cell Fistula Plug in Perianal Crohn's Disease
Condition: Perianal Crohn's Disease
MeSH terms: Crohn Disease; Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
      using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of
      20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated
      perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard
      adjuvant therapy including drainage of infection and placement of a draining seton with
      continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining
      seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per
      current clinical practice. The subjects will be subsequently followed for fistula response
      and closure for 24 months. This is an autologous product derived from the patient and used
      only for the same patient.
    


Intervention name(s): MSC-AFP
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prognostic Potential of Prehospital Biomarkers in TBI Patients
Condition: Traumatic Brain INjury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated
      in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in
      patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as
      predictors of neurological outcome and mortality may underline the potential of a
      point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate
      monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the
      clinical decision-making regarding treatment and level of care offered to the patient.

      Hypotheses:

        1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome
           (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E)
           measures) in severe TBI patients.

        2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome
           (dichotomized DRS and GOSE measures) in severe TBI patients.

        3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome
           (dichotomized DRS and GOSE measures) in severe TBI patients.

        4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of
           unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI
           patients.

        5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI
           patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance
        dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark
        Region.
      
Biospecimen description: 
      Blood samples
    
Keywords: biomarkers; point-of-care analysis
Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label, multinational study designed to evaluate the "standard"
      regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm
      PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously
      once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week
      treatment duration for both arms. Additionally, the study examined the efficacy of reduced
      treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg
      for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .
    

Detailed description: 
      This is a randomized, open-label, multinational study designed to evaluate the "standard"
      regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm
      PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously
      once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week
      treatment duration for both arms. Additionally, the study examined the efficacy of reduced
      treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg
      for 16 weeks [Arm PEG2b 1.5/R (16 weeks)].
    

Intervention name(s): peginterferon alfa-2b (SCH 54031); peginterferon alfa-2b (SCH 54031); peginterferon alfa-2b (SCH 54031); ribavirin (SCH 18908); ribavirin (SCH 18908)
Intervention type(s): Biological; Biological; Biological; Drug; Drug
Intervention description(s): 1.5 mcg/kg QW SC for 24 weeks; 1.0 mcg/kg QW SC for 24 weeks; 1.5 mcg/kg QW SC for 16 weeks; 800-1200 mg daily for 24 weeks; 800-1200 mg daily for 16 weeks
Other intervention name(s): PegIntron (SCH 54031); PegIntron (SCH 54031); PegIntron (SCH 54031); REBETOL (SCH 18908); REBETOL (SCH 18908)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Genotype 2 and Genotype 3
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The
      purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a
      Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In
      Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and
      preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,
      ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of
      brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who
      consent to provide tumor biopsies while participating in the study.
    


Intervention name(s): PF-05212384 (also known as PKI-587)
Intervention type(s): Drug
Intervention description(s): Intravenous dosing once weekly infusion
Intervention MeSH terms: Gedatolisib
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Dose Finding; Solid Tumors; Tumors; PF-05212384
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate performance on the Attention Deficit Hyperactivity
      Disorder ( ADHD) Battery of the Cambridge Automated Neuropsychological Test Battery (CANTAB),
      including spatial working memory, inhibitory control, and attention while using either a
      noise cancelling headphone or sham headphone control in the presence of standardized auditory
      distractors in children and adolescents with ADHD.
    

Detailed description: 
      This will be a proof-of-concept, randomized, within-subject cross-over design with the
      administration of noise cancelling headphones or sham headphones on two separate study days.
      Following screening and a baseline assessment session with no headphones, participants will
      be assigned to complete each experimental session. During each session, they will undergo the
      CANTAB and Academic tasks. The order of sessions will be randomized and balanced across
      participants to be either noise-cancelling headphones first followed by sham headphones; or
      sham headphones first followed by noise-cancelling headphones. Eligible participants
      currently taking stimulant medications for ADHD will be asked to stop taking their medication
      on the day of the baseline visit and during the 2 experimental sessions.
    

Intervention name(s): Use of Noise Cancelling Headphones
Intervention type(s): Other
Intervention description(s): During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Proof-of-concept, randomized, within-subject cross-over design.
Masking: Single (Participant)
Primary purpose: Other
Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy
Condition: Hysteroscopy, Distension Medium, Pain
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for
      suspected uterine pathologies. Women will be randomized into two groups on the basis of
      distension medium : group A CO2; group B physiological solution. Pain discomfort will be
      evaluated after the examination.
    


Intervention name(s): diagnostic hysteroscopy; physiological solution; carbon dioxide
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Endoscopic procedure to visualize uterine cavity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Effects of Exercise on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome
Condition: Osa Syndrome
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      the investigators aim in this study is to investigate the effects of aerobic and
      oropharyngeal exercises on sleep quality in patients with Obstructive Sleep Apnea Syndrome
      (OSAS).
    

Detailed description: 
      The study will be conducted in a randomized controlled manner. Participants will be divided
      into groups of 3 equal numbers using the simple randomization method. The control group will
      not be given exercise. The first intervention group will be given 10-15 minutes of
      oropharyngeal exercises. In addition to oropharyngeal exercises, the second intervention
      group will be given 50 minutes of moderate-intensity aerobic exercise at least 3 days a week.
      Both intervention groups will apply the given exercise program for 8 weeks. All participants
      will be evaluated 3 times in total, at the beginning of the treatment, at the 4th week and at
      the 8th week. Epworth Sleepiness Scale, Pittsburgh Sleep Quality Questionnaire, Fatigue
      Severity Scale, Berlin Questionnaire, 6-minute walk test, Modified Medical Research Council
      (MMRC) Dyspnea Scale, Functional Results of Sleep Scale (FOSQ) tests will be applied to the
      participants. Pre- and post-intervention data were statistically analyzed and compared.
    

Intervention name(s): control; oro-granary exercises.; aerobic exercises
Intervention type(s): Other; Other; Other
Intervention description(s): No exercises will be given.; soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises; We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; It includes activities such as walking, cycling, jogging, aerobic dancing, swimming.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: oropharyngeal exercises and aerobic exercises
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: OSAS; quality of life; sleep
Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors
Condition: Suicidal Behaviors
Study type: Interventional

Summary: 
      Suicidal behaviors among adolescents represents a public health problem due to its high
      prevalence and its low predictability. It is also known that brain development continues
      during adolescence, therefore, a therapeutic intervention during this period might propitiate
      neural changes that might favor the emotional regulation involved in suicidal behaviors.
      Dialectical Behavioral Therapy has proved to be effective regarding this problem.

      For this reason, the investigators aimed to study the clinical, neuropsychological and neural
      effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.
    

Detailed description: 
      Suicidal behaviors represent a public health problem due to its high prevalence and its low
      predictability. At a neurological level, higher vulnerability for suicidal behavior has been
      related to a frontostriatal-cingulum tract dysfunction as well as attention, memory and
      executive deficits. It is also known that brain development continues during adolescence,
      therefore, a therapeutic intervention during this period might propitiate neural changes that
      could favor the emotional regulation involved in suicidal behaviors. Specifically,
      Dialectical Behavioral Therapy has proved to be effective regarding this problem.

      The investigators hypothesis is that DBT (Dialectical Behavioral Therapy) will improve
      clinical symptoms associated with suicidal behaviors, as well as the neural interconnections,
      which will result not only in structural and functional connectivity changes, but also in a
      better cognitive functioning. The investigators aimed to investigate the clinical,
      neuropsychological, and neural effects of Dialectical Behavioral Therapy in adolescents with
      suicidal behaviors.

      The investigators method is a randomized, controlled study that includes 30 patients with
      suicidal behaviors and 15 healthy controls between the ages of 12 and 18 years. Patients were
      assigned to one of two groups (randomized): DBT and Regular Support Therapy. Clinical and
      neuropsychological evaluations were performed before and after the treatment for both patient
      groups. Additionally, Structural MRI data sets, diffusion-tensor imaging (DTI) and Functional
      Connectivity (Resting State fmri) were acquired for all patients and controls at baseline and
      after treatment. Initial characteristics will be compared between the three groups, and the
      investigators will also compared clinical, neuropsychological and imaging measures before and
      after the treatment.
    

Intervention name(s): Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
Condition: Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and
      parallel group study in participants with Impaired Renal Function.
    


Intervention name(s): Aldafermin (NGM282)
Intervention type(s): Biological
Intervention description(s): Single 3 mg dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment