bioihbjkbjnl/mcl2 huggingface dataset:
Examining Cortisol and Alpha Amylase in a Healthy Sample of Youth and Adults
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how healthy youth and adults' cortisol levels and
      other hormone levels relate to anxiety levels while they participate in a behavioral task
      called the Trier Social Stress Task.

      Data from these healthy participants will also be compared to those of anxious youth and
      adults collected as part of the in the Principal Investigator's ongoing study titled,
      "Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687)."
    

Detailed description: 
      The aim of this study is to investigate the independent and interactive associations linking
      salivary cortisol (a marker of hypothalamic-pituitary-adrenal activity or HPA activity) and
      alpha amylase (a marker of autonomic nervous system activity or ANS activity) in a sample of
      healthy controls. Data from these healthy controls will be compared in the future to
      clinically anxious youth. In this study, participants are asked to complete a one-time
      assessment consisting of interviews, questionnaires, and a behavioral task (called the Trier
      Social Stress Task) involving a short public speaking task and an arithmetic task in front of
      study staff. Throughout the behavioral task, study staff will collect four, small saliva
      samples using a straw-like tube from each participant. The assessment will take approximately
      3 hours. Participants will be fully debriefed regarding the purposes of the stress procedure
      and assessed for any signs of residual distress. Since there is no treatment or
      randomization, blinding of study staff is not applicable. Participation in this study will
      not affect any current or future medical or psychiatric treatment.

      AIMS: To examine whether a) salivary cortisol and alpha amylase response and recovery to the
      Trier Social Stress Task is associated with anxiety in non-psychiatrically ill participants.
    

Intervention name(s): Trier Social Stress Test
Intervention type(s): Behavioral
Intervention description(s): The TSST is the gold standard social stress test and involves speaking in front of confederate judges and completing arithmetic tasks. The task takes 10-15 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
One Key Question: Pilot Study at NorthShore
Condition: Reproductive Health
Study type: Interventional

Summary: 
      This study is a pilot assessment of whether practices that implement the One Key Question®
      (OKQ) pregnancy intention screening tool will demonstrate differences in patient-reported
      receipt of preconception and/or contraceptive counseling, compared to practices that provide
      usual care. In Phase I, the study team surveyed patients at six practices within NorthShore
      University HealthSystem to establish baseline rates of counseling. Phase II assesses the
      effects of the OKQ tool on patient care, and half of participating sites are randomly chosen
      as intervention sites and exposed to the OKQ tool. After the intervention practices implement
      OKQ, patients will be surveyed at both intervention and control (usual care) practices to
      measure changes in preconception and contraceptive care.
    

Detailed description: 
      Effectively delivered preconception counseling leads to healthier pregnancy behaviors.
      However, many clinicians miss opportunities to provide this counseling due to a lack of
      processes in place to provide this counseling and access to evidence based care once the need
      is identified. The purpose of this study is to build upon baseline data collected on
      pregnancy intention and receipt of contraceptive and preconception counseling. Half of the
      study practices will be randomly selected to receive comprehensive One Key Question® Training
      through the nonprofit Power To Decide. These practices have already displayed interest in
      taking part in this intervention.The training will act as our intervention, and will be given
      to help improve the quality of preconception and contraceptive counseling in Primary Care and
      Obstetrics/Gynecology. All of the participating practices will then be surveyed again to
      determine changes in contraception and preconception counseling. After patient data
      collection is complete, a research assistant will return to each practice to collect surveys
      from clinicians and staff (this includes: physicians, nurses, medical assistants, patient
      support associates, or anyone that participated in the OKQ training) at the intervention
      practices to assess the experience of implementing OKQ and their perceptions of its utility
      for patients. Following the Phase II collection of surveys, the remaining control practices
      will be given the option to receive Power To Decide training.
    

Intervention name(s): OKQ Training Program
Intervention type(s): Behavioral
Intervention description(s): The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic
      properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects
      with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin degludec
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.; 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies
Condition: Gastric Cancer; Helicobacter Pylori Infection; Bismuth
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with
      rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium
      citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line
      eradication. It is hypothesized that different bismuth containing quadruple therapies have
      comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status
      will be randomized to one of the treatments described above. At week 2and 6 follow-up visits,
      a urea breath test(UBT) will be performed to confirm eradication.
    

Detailed description: 
      The study will include three phases: screening, treatment and follow-up.Screening: this phase
      will last a maximum of 28 days and subjects eligibility will be evaluated after informed
      consent signature. Endoscopy and Urea Breath test will be performed in addition to the
      baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will
      be treated for 14 days. A randomization visit will take place on Day 0 and an
      end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits.
      approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H.
      Pylori will be confirmed through urea breath test(UBT).
    

Intervention name(s): Bismuth potassium citrate containing quadruple therapy; Colloidal pectin bismuth capsules containing quadruple therapy; Colloidal pectin bismuth particles A quadruple therapy; Colloidal pectin bismuth particles B quadruple therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID; Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID; Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID; Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
Intervention MeSH terms: Potassium Citrate; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists
Condition: Prostatic Neoplasms; Cardiovascular Diseases
MeSH terms: Prostatic Neoplasms; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test whether Degarelix is associated with less endothelial
      dysfunction (an intermediate in the development of cardiac disease) and cardiovascular
      biomarkers compared to LHRH agonists.
    

Detailed description: 
      This is a national multicenter randomized open-label superiority study of the use of
      Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing
      cardiovascular disease. Patients will be stratified based on baseline endothelial function
      and presence prostate cancer metastasis.

      Study population: Subjects with pre-existing cardiovascular disease with locally advanced or
      metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT).
      Patients already on ADT will be excluded. subjects will receive either two initial loading
      doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or
      an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up
      visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac
      biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months
      EndoPAT2000 measurements will be taken.
    

Intervention name(s): Degarelix (LHRH antagonist); LHRH agonist; EndoPAT2000
Intervention type(s): Drug; Drug; Device
Intervention description(s): Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.; LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.; Peripheral arterial plethysmography using an EndoPAT2000 device
Other intervention name(s): Firmagon; Luteinizing hormone-releasing hormone agonist; Peripheral arterial plethysmography
Intervention MeSH terms: Hormones; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Prostate Cancer; Cardiovascular disease; Degarelix
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers
Condition: Lower Extremity Chronic Venous Ulcers
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability
      and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous
      ulcers patients.
    

Detailed description: 
      This is a phase I/II prospective, randomized, double blind, placebo controlled, dose
      escalating, three patient-group study, to evaluate the safety and efficacy of DermaStream™ -
      EnzyStream™ System in non-healing lower extremity chronic venous ulcers patients. The
      DermaStream™ - EnzyStream™ System will be evaluated during continues streaming of 3 different
      doses of EnzystreamTM (papain based) solution given in an escalating order (15,000, 30,000
      and 60,000 papain USP units/ml) up to 5 consecutive treatment days. Each treatment session
      lasts for 6 hours. This study is a Multi center trial. It is anticipated that three (3) sites
      will enroll subjects into this study. Overall, forty eight (48) patients will be recruited,
      and randomly allocated to placebo or EnzyStream™ treatment in each study dose group prior to
      EnzyStream™ administration. The ratio of drug to placebo treated patients will be 4;1, namely
      12 patients will be administered with EnzyStream™ solution and 4 patients will be placebo
      treated in each of the three respective EnzyStream™ dose groups. Treatment will start with
      the lowest dose (15,000 papain USP units/ml) administered over a 6 hour period followed with
      saline wash for an additional half an hour. The treatment dose will be increased to the next
      highest dose, for the next patients group only following safety analysis, and the procedure
      will be repeated.

      The treatment period will be followed by a 3 month follow up period. During the follow up
      period patients will be observed for every 2 weeks during the first month and once a month
      (every 20 days) during the 2 additional months (allowing a time window of ± 3 days).
    

Intervention name(s): Papain; Papain; Papain
Intervention type(s): Other; Other; Other
Intervention description(s): 15,000 USP U/ml; 30,000 USP U/ml; 60,000 USP U/ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streaming; DermaStream-EnzyStream
Safety and Tolerability of BI 409306 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 409306 in schizophrenic patients following oral administration of multiple low, medium,
      and high doses over 14 days.

      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI
      409306 in schizophrenic patients.
    


Intervention name(s): Placebo; BI 409306; BI 409306; BI 409306
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): matching placebo; low dose; medium dose; high dose
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label,
      controlled pilot trial designed to evaluate the effect of infliximab induction therapy on
      sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus
      ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV)
      infection and high serum tumor necrosis factor (TNF)-alpha values.
    


Intervention name(s): Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin; Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Powder for intravenous infusion (100 mg strength), intravenous, single dose of 5 mg/kg, at Day -7, prior to initiation of the following combination therapy:
powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks; Powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks
Other intervention name(s): (a) SCH 215596, Remicade; PEGETRON combination therapy; (b) SCH 54031, PEG-Intron, PegIntron; (c) SCH 18908, REBETOL; PEGETRON combination therapy; (a) SCH 54031, PEG-Intron; PegIntron; (b) SCH 18908, REBETOL
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegylated interferon alfa-2b; ribavirin; infliximab; chronic hepatitis C
Study of Human Sensory Perception
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      This study will help describe how the human brain works when a person sees something, hears
      something, learns something, or thinks about something by recording brain activity that
      occurs when the person does a series of computer tasks. This study will be offered to people
      who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain.
      The study will record brain activity that occurs when a patient does a memory task, for
      example.
    

Detailed description: 
      Patients who have elected to have invasive electrophysiological monitoring for epileptic
      activity are invited to participate in this study. While the electrodes are in place,
      patients are asked to view several scenarios on a laptop computer. During these scenarios,
      for example, patients are asked to click a mouse button if they see the same picture twice in
      a row or to remember a film clip of a scooter ride. Trigger points in the computer scenarios
      are recorded on a separate channel alongside the brain-wave activity to allow correlation
      between the brain activity and the task requested in the scenario. Using this technique,
      researchers can determine what areas of the brain were active during recognition or recall
      activities.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        People between 10 and 65 years old diagnosed with epilepsy who will have invasive
        eletrophysioloigcal monitoring as part of a clinical evaluation for epilepsy treatment.
      
Keywords: Epilepsy; Invasive monitoring; Human sensory perception
Comparison of Telemedical and Conventional Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the study is to compare antihypertensive treatment based on either
      conventional blood pressure measurements or telemedical home blood pressure measurements.

      Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood
      pressure, is more cost-effective and provides better quality of life.
    


Intervention name(s): Telemedical home blood pressure measurements; Conventional blood pressure monitoring
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Condition: Non-Cystic Fibrosis Bronchiectasis; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic
      lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable
      inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed
      to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in
      healthy male subjects.

      The study will comprise two parts:

      Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety,
      tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.

      Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety,
      tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333
    


Intervention name(s): CHF6333 (Part 1 - SAD); Placebo (Part 1 - SAD); CHF6333 (Part 2 - MAD); Placebo (Part 2 - MAD)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single doses of CHF6333 at each period; Single doses of placebo matching CHF6333 at each period; once daily multiple doses of CHF6333 for 14 days; once daily multiple doses of placebo matching CHF6333 for 14 days
Allocation: Randomized
Intervention model description: Part 1: alternating cross-over design
Part 2: parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment