bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis; Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the immune response in 18-40 year old IBD patients
      after receiving the hepatitis A vaccine.
    

Detailed description: 
      The spread of hepatitis A has prompted the need for vaccination against this virus. It is
      uncertain that IBD patients can achieve a truly protective response after vaccination. The
      efficacy and safety of hepatitis A vaccination have not been evaluated in this population of
      patients. We would like to estimate the efficacy and safety of vaccination against hepatitis
      A in patients with IBD.
    

Intervention name(s): Epaxal Berna (virosomal hepatitis A vaccine)
Intervention type(s): Biological
Intervention description(s): standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.
Other intervention name(s): Epaxal Berna
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Crohn's disease; Ulcerative colitis; Hepatitis A; vaccine
Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A prospective, single center, open randomized, six way crossover study comparing the dose
      response effect of four different doses of Technosphere Insulin after pulmonary function
      delivery in comparison to s.c. injection of two different doses of regular human insulin.
    


Intervention name(s): Technosphere Insulin; Technosphere insulin; Technosphere insulin; Regular human insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Patients
Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group,
      multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different
      doses of OMT-28 given once daily versus placebo in patients with persistent AF.
    

Detailed description: 
      This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group,
      multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different
      doses of OMT-28 given once daily versus placebo in patients with persistent AF. At
      randomization, the duration of the current episode of persistent AF must be shown to be
      greater than 7 days and not greater than 3 months, as confirmed by two ECGs (one ECG must be
      a 12-lead ECG) and further patient enquiry (including doctor visits, hospital admissions,
      symptom onset, etc.).

      A sample size re-evaluation will be performed to avoid an underpowered study because of
      imprecise estimates for the study population or overoptimistic parameter estimates.
      Therefore, an interim analysis will re-evaluate sample size assumptions after approximately
      15 patients per study arm (~50 % of planned sample) have completed the treatment phase (Visit
      8) of the study. Predefined rules will govern the decision for adjustment of sample size.

      Patients will be monitored for cardiac events throughout the study using an Implantable
      Cardiac Monitor (ICM). Safety will be monitored throughout the study. Blood samples will be
      collected in pre-specified windows for popPK analysis and at pre-specified timepoints for
      PK/PD analysis. Patients will be provided with a diary to record timing of drug
      administration and clinical symptoms while not on site. Diaries will be reviewed and checked
      for compliance at each non-resident visit to the clinical site.
    

Intervention name(s): OMT-28; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).; 1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Electrical Cardioversion; Dose-finding
A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and
      pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.
    

Detailed description: 
      This study represents the first administration of dipeptidyl peptidase 4 (DPP4) inhibitor
      DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and
      pharmacodynamic (PD) properties following single oral doses in healthy subjects.

      DPP4 is a validated drug target for the treatment of human type 2 diabetes. Objectives of the
      study will be to characterize the safety and tolerability of single doses of DBPR108; to
      characterize the single dose PK of DBPR108 in plasma and urine; to characterize the single
      dose PD of DBPR108 on glucose, glucagon, dipeptidyl peptidase 4 activity, and total and
      active forms of glucagon-like peptide-1 (GLP-1) in plasma levels and insulin and C-peptide in
      serum levels.
    

Intervention name(s): DBPR108; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.; Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DBPR108; DPP4; Diabetes; GLP-1; Incretins
Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi
Condition: Posttraumatic Stress Disorder; Aggressive Behavior
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional

Summary: 
      Children either living in the streets of Bujumbara or that are similarly affected by extreme
      poverty or violence are regularly exposed to traumatic events. Additionally, they often find
      themselves in situations where engaging in violent behavior appears to be useful or even
      necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to
      reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful
      experiences and potential positive emotions linked to violent behaviour in the past.
      Additionally, visions for the future are developed in order to enable reintegration into the
      family.

      The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and
      ongoing aggressive behavior which in change facilitates reintegration into society.
    


Intervention name(s): Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)
Intervention type(s): Behavioral
Intervention description(s): FORNET aims to reduce trauma-related symptoms and aggressive behavior via narrative exposure of traumatic and violent life events.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise for Low Back Pain in Children
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study aimed to determine the efficacy of an eight-week specific exercise programme in
      reducing self-reported episodes and intensity of LBP, as well as modifying some of the
      identified risk factors for LBP, in children.
    


Intervention name(s): exercise programme
Intervention type(s): Other
Intervention description(s): Specific low back pain exercise programme for children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Randomised controlled trial; low back pain; exercise; children; school-based; prevalence; intensity
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      After 24 weeks of treatment evaluate the efficacy and security.
    


Intervention name(s): sitagliptin phosphate
Intervention type(s): Drug
Intervention description(s): Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
Other intervention name(s): MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of
      methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.
    

Detailed description: 
      This study will allow investigation of potential drug-drug interaction mediated through drug
      transporter proteins. During each part, blood samples will be collected at prespecified times
      for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There
      will be approximately 16 subjects enrolled into each part.
    

Intervention name(s): Methotrexate; Leucovorin; BMS-986371; Sulfasalazine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): CC-99677
Intervention MeSH terms: Leucovorin; Sulfasalazine; Methotrexate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction
      phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower
      number of minority variant HIV-1 strains.
    

Detailed description: 
      This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study
      to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients
      meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral
      loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients
      will be block randomized (the size of each block will be two patients) into one of two
      treatment arms.

      All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and
      Tenofovir 300mg once a day. After randomization, one half of the patients will receive no
      additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the
      viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).
    

Intervention name(s): Enfuvirtide; Efavirenz, lamivudine, and tenofovir
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneously twice a day; Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
Other intervention name(s): Fuzeon (T-20); Atripla, Epivir and Viread
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz; Enfuvirtide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NK-1 Antagonism of SLV317 in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on
      substance P-induced venodilation in the hand vein of healthy male volunteers as compared to
      placebo.
    

Detailed description: 
      This will be a double-blind, placebo-controlled, oral single dose cross-over study. 18
      healthy male volunteers will receive 250 mg SLV 317 or placebo in randomised order with a
      minimum wash-out period of one week between the two administrations.

      Pharmacodynamic assessments will be performed up to 4.25 hours post-dose using the dorsal
      hand vein compliance technique. After obtaining venoconstriction via infusions of
      phenylephrine, substance P will be co-infused intermittently to induce venodilation.
      Substance P infusions will be separated by intervals of 45 minutes in order to prevent the
      well-known occurrence of tolerance.

      Venous blood sampling for pharmacokinetic evaluation will be performed up to 24 hours
      post-dose.

      Safety will be assessed by measuring ECG, pulse rate, blood pressure, haematology, blood
      chemistry, urinalysis, and by monitoring of adverse events.
    

Intervention name(s): SLV317
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      To date, all the electrophysiological methods for auditory testing rely on the measure on
      synchronous evoked auditory nerve activity. This measure only takes into account the response
      of the first action potential in every auditory fibber, but provides no information about the
      neural response during a sustained activity. This can explain why in experimental models, a
      loss of more of 80% of auditory nerve fibbers cannot be detected by usual
      electrophysiological measurements. In this study we aim at investigating the global
      spontaneous and sound evoked auditory nerve activity by recording directly the electrical
      field by an electrode placed directly on the auditory nerve of subjects during a skull base
      surgical procedure. We expected to demonstrated differences in the electrical activity
      between subjects with or without hearing loss.
    


Intervention name(s): Recording of auditory nerve activity
Intervention type(s): Procedure
Intervention description(s): near field recording of auditory nerve activity with contact electrode
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Evoked auditory nerve activity; Hearing Loss; Tinnitus
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
Condition: Renal Impairment; Healthy Volunteer
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate BMS-986165 in participants with different levels
      of kidney function.
    


Intervention name(s): BMS-986165
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention MeSH terms: Deucravacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Lifestyle Program on Healthy Weight in Postpartum Period
Condition: Weight Reduction
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to examine the impact of lifestyle intervention on postpartum weight
      loss. So the investigators will have two groups in this study. In Experimental group women
      will receive the Healthy Lifestyle Intervention. This intervention will have been delivered
      during 12 weeks. In Control group women will receive general information via pamphlet about
      postpartum period and tips for stress management.
    

Detailed description: 
      This study will be conducted in two phases. In the first phase , the investigators will
      conduct a cross-sectional study to assess factors related to the healthy lifestyle after
      childbirth based on the PRECEDE model. Regarding results of the study, the investigators will
      plan and implement a lifestyle promoting intervention and will evaluate the effect of the
      intervention on weight reduction among postpartum women.
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): The investigators will provide information on healthy eating and physical activity. They will give pedometers to the participants to monitor their daily steps in order to increase it till 10000 steps/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postpartum Period
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive
      transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
    


Intervention name(s): Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Intervention type(s): Device
Intervention description(s): The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; MDD; Transcranial Magnetic Stimulation; Depressive Disorder; TMS
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      456906 in healthy subjects following single rising doses.

      The secondary objective is the exploration of the pharmacokinetics including dose
      proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing
    


Intervention name(s): BI 456906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Patient and Physician Intervention to Increase Organ Donation
Condition: Tissue and Organ Donation; Communication
Study type: Interventional

Summary: 
      The number of persons on the national solid organ waiting list continues to increase while
      the number of donated organs has failed to keep pace. In some portions of northeastern Ohio
      the donation rate is as low as 32%. There is a positive association between discussing organ
      donation with a primary care physician and signing a donor card. However, such discussions
      are rare. The investigators propose a blinded randomized controlled trial to evaluate the
      effectiveness of two interventions: 1) showing a donation video to patients in primary care
      settings waiting to see their physician and 2) cueing of primary care providers to have
      donation discussions with their patients. The study will be conducted throughout Cuyahoga
      County in at least 10 ambulatory clinics associated with a single county medical system. Nine
      hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that
      patients exposed to the interventions will be 1) more likely to consent to donate organs, 2)
      more likely to have donation discussions with their primary care providers, and 3) equally
      satisfied with the time spent with their doctor compared to patients who are not exposed to
      the interventions.
    


Intervention name(s): Participant Video and Provider Cueing
Intervention type(s): Behavioral
Intervention description(s): Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients
      with Peripheral Artery Disease.
    

Detailed description: 
      A randomized, double-blind, parallel group, multicentre phase IIIb study to compare
      ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial
      infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID
      Examining Use of tiCagreLor In paD)
    

Intervention name(s): Ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets; Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Other intervention name(s): Brilinta/Brilique; Plavix
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Peripheral artery disease Atherothrombotic events Atherosclerosis