bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Navigation for Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people
      with a history of opioid use disorder releasing to WA Department of Corrections (DOC)
      community corrections supervision in King County. Half of the subjects will receive treatment
      as usual (e.g. referral to treatment or outpatient drug counseling by DOC community
      corrections staff) and half will receive 6 months of intervention. The intervention involves
      treatment decision making, in which the study interventionists help subjects understand
      treatment choices, decide on the treatment that is best for them, get enrolled in treatment
      and remain in treatment. The study does not provide treatment, but works with treatment
      providers to facilitate access to care.

      The aims of this study are to determine: 1) whether study procedures can be implemented with
      as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which
      medications/treatment options subjects select and their experiences and satisfaction with the
      interventions, and 4) preliminary intervention effect size on outcomes of interest including
      recidivism, drug use, hospitalization, and treatment enrollment and retention.
    


Intervention name(s): Treatment Navigation (Intervention); Control
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone.; Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone.
Other intervention name(s): Treatment Navigation, Treatment Decision Making, Shared Decision Making
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Efficacy of a Diabetes Educational Program to Improve Flash Adherence in Type 1 Diabetes Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Prospective observational study to analyse the clinical effectiveness of a diabetes
      educational program to improve intermittently continuous glucose monitoring (iCGM) adherence
      in adult type 1 diabetes (T1D) patients
    

Detailed description: 
      Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational
      program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult
      type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from
      isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change
      after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software.
      Results are presented as mean ± SD values or percentages. A paired Student's t-test or a
      Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between
      proportions were analyzed using a chi-squared test. A P value < 0.05 was considered
      statistically significant. The protocol was approved by the reference Castilla-La Mancha
      Public Health Institute Ethic Committee (C-558).
    

Intervention name(s): Diabetes educational program
Intervention type(s): Other
Intervention description(s): 30-minute long diabetes educational program
Intervention model: Single Group Assignment
Intervention model description: 30 minutes diabetes educational program:
10-minute talk about Flash measurements and importance of diabetes control.
10-minute practic exercises with Flash values and tendencies.
10-minute talk about recomendations for increasing daily Flash scanning.
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Condition: Gestational Diabetes; Diabetes, Gestational; Pregnancy in Diabetes
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over
      400,000 pregnant women in the United States each year. Without adequate treatment, women with
      GDM and their infants are at risk for substantial morbidity. Because of this, experts
      recommend treatment focused on normalization of hyperglycemia to improve outcomes. However,
      providers have limited capacity to predict which treatment will achieve glycemic goals. This
      results in a choice based on provider and patient preference and a trial and error approach,
      which can create delays in glycemic control within the short (8-10 weeks) window between
      diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between
      glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM
      is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit
      (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of
      hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use
      of an individualized treatment approach. The overall goal of this project is to investigate
      an individualized treatment approach for GDM where treatment is based on each woman's GDM
      mechanism. The study will employ the same treatment in both arms, but choice of treatment
      will differ based on study arm (matched or unmatched to GDM mechanism).
    


Intervention name(s): Insulin; Glyburide; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin will be used for GDM treatment; Glyburide will be used for GDM treatment; Metformin will be used for GDM treatment
Intervention MeSH terms: Metformin; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gestational diabetes; Diabetes in pregnancy; Insulin resistance; Insulin secretion deficiency
Day-Case Closure of Loop Ileostomy in Rectal Cancer
Condition: Ileostomy Closure in Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to investigate if day-case closure of ileostomy is feasible and
      safe.
    

Detailed description: 
      For all patients that match the inclusion criteria a registration-protocol is completed. Then
      the patients are operated and a surgery-protocol is completed. The patients are observed for
      maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the
      investigators do a follow-up of complications.
    

Intervention name(s): ileostoma closure
Intervention type(s): Procedure
Intervention description(s): The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients earlier operated at the local hospital, who are now planned for closure of
        ileostomy
Relations Between Residual Renal Function and Oxidative and Carbonyl Stress in Peritoneal Dialysis Patients
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      Residual renal function is reported to contribute to the survival and cardiovascular disease
      of peritoneal dialysis patients. Oxidative and carbonyl stress are increased in peritoneal
      dialysis patients and are associated with cardiovascular risk. The aim of this study was to
      determine the relations between residual renal function and oxidative and carbonyl stress in
      peritoneal dialysis patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        single dialysis center
      
Keywords: residual renal function; oxidative stress; carbonyl stress; peritoneal dialysis
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic
      neuralgia (PHN) - nerve pain.
    


Intervention name(s): AGN-214868; Placebo to AGN-214868
Intervention type(s): Drug; Drug
Intervention description(s): AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.; Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK
      following single oral administration of TAK-536 pediatric formulation in Japanese healthy
      adult male participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-536. TAK-536 is being tested in Japanese
      healthy adult male participants. This study will look at the PK and effect of food on the PK
      following single oral administration of TAK-536 pediatric formulation.

      The study will enroll 12 healthy participants. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups and will receive a single
      oral dose of 10 mg of TAK-536 pediatric formulation with 200 mL of water according to the
      following treatments in each period during the study.

        -  Treatment Group A: single oral administration in the morning under fasted condition
           (Period 1), followed by single oral administration after breakfast (Period 2)

        -  Treatment Group B: single oral administration after breakfast (Period 1), followed by in
           the morning under fasted condition (Period 2)

      This single-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately one month. Participants will make five visits to the clinic and be
      hospitalized for eight days in total.
    

Intervention name(s): TAK-536
Intervention type(s): Drug
Intervention description(s): TAK-536 granule formulation
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Japanese Phase I of GSK1605786
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an double-blind, single dose, four-period, crossover study in Japanese healthy male
      volunteers to assess the pharmacokinetics and safety/tolerability of single doses of
      GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg
      GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose
      ascending crossover design. Serial pharmacokinetic samples will be collected following each
      dose and safety assessments will be performed. The pharmacokinetics and dose proportionality
      of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and
      1000 mg under fasted conditions will be assessed. In addition, a comparison will be made
      between the pharmacokinetics of GSK1605786 under fed and fasted conditions.
    


Intervention name(s): GSK1605786; GSK1605786 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Opaque Swedish orange body and cap.; Opaque Swedish orange body and cap.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
Condition: Pulmonary Fibrosis; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether iloprost inhalation solution is
      safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial
      pressure. The secondary purpose is to evaluate the effectiveness of this treatment in
      subjects with this disease.
    

Detailed description: 
      While there are no FDA approved therapies for the treatment of IPF, there are therapies that
      have been shown to be effective in ameliorating the effects of pulmonary hypertension in
      patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However,
      these therapies have not been used extensively in patients with IPF who have pulmonary
      hypertension as a complication. The potential benefits of treatment of pulmonary hypertension
      complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary
      artery pressure and pulmonary vascular resistance, and increase in cardiac output.
    

Intervention name(s): Iloprost Inhalation Solution (Ventavis)
Intervention type(s): Drug
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ACTIVE; iloprost; idiopathic pulmonary fibrosis; pulmonary arterial hypertension
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine.
      The vaccine schedule and dose will also be assessed.
    

Detailed description: 
      The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be
      evaluated using a randomized, parallel-group, active-controlled, double-blind design with
      three immunization schedules and two dose levels in healthy adult volunteers. Safety will be
      assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis),
      monitoring of adverse events, vital signs, and physical examinations. Reactogenicity
      (systemic and injection site reactions) will be assessed by the subjects using subject
      e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7
      and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will
      be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.
    

Intervention name(s): AV7909; BioThrax
Intervention type(s): Biological; Biological
Intervention description(s): Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
Other intervention name(s): AV7909 Anthrax Vaccine; NuThrax; Anthrax Vaccine Adsorbed (AVA)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post-exposure prophylaxis; toxin neutralization assay
Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      To investigate the relationship of tissue oxygenation of different organs and tissue beds
      (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus
      can be used as a surrogate of renal tissue oxygenation monitoring.
    

Detailed description: 
      In this study, we will monitor tissue oxygenation of four different tissue beds including
      cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm
      (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and
      the secondary end points are postoperative major non-renal complications (e.g. stroke,
      delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical
      ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between
      tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI
      and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation
      has a stronger association with the outcomes of interest. The strength of this study is to
      use the patient as self-control.
    

Intervention name(s): FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA
Intervention type(s): Device
Intervention description(s): Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are going to have double valves replacement surgery
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis; Allergic Rhinitis Due to Grass Pollen; Healthy Volunteers
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal
      allergic rhinitis.
    

Detailed description: 
      This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal
      allergic rhinitis. This will be a 2-part study. In Part 1, safety and tolerability will be
      evaluated during 14 days of study treatment twice-a-day followed by 4 weeks of follow-up in
      healthy volunteers. In Part 2, preliminary efficacy will be evaluated in subjects with a
      history of seasonal allergic rhinitis outside of the local pollen season.

      For Part 1 (safety and tolerability evaluation in healthy volunteers) we will enroll 24
      subjects. Safety and tolerability will be assessed by reporting of AEs, physical examination
      and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment
      and up to 28 days of follow-up.

      An internal safety committee meeting will review the 2 week Part 1 safety data and, if there
      are no safety concerns, the study will proceed to Part 2 to evaluate preliminary efficacy in
      subjects with a history of seasonal allergic rhinitis (SAR)

      For Part 2 (preliminary efficacy evaluation in subjects with a history of SAR to ragweed
      pollen) will enroll 42 subjects. Safety and tolerability will be assessed in subjects with
      allergic rhinitis by reporting of AEs, physical examination and vital signs (blood pressure,
      heart rate, respiratory rate) during 14 days of treatment.

      For Part 2, study will be paused for safety review using the same stopping criteria as in
      Part 1.

      Rescue medications will not be allowed during the study.
    

Intervention name(s): B244 suspension; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): B244 suspension in 30ml/bottle; Vehicle, 30ml/bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Condition: Sleep Troubles Associated With Anxiety
MeSH terms: Sleep Wake Disorders; Parasomnias; Anxiety Disorders
Study type: Interventional

Summary: 
      The objective of this double-blind randomized clinical trial is to compare the effects of a
      dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of
      supplementation, in subjects suffering from sleep troubles associated with anxiety.
    


Intervention name(s): Noctesia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 tablets every day at bedtime with a large glass of water; 3 tablets every day at bedtime with a large glass of water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment