bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3337641 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  If there are any differences in the amount of LY3337641 in the blood/body when it is
           taken in different formulations. A total of 3 different formulations of LY3337641 are
           being tested.

        -  How a high-fat meal affects the amount of LY3337641 in the blood/body.

        -  How safe and well tolerated LY3337641 is.

      The study has four periods. Individuals will participate in all four periods. Each period
      will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

      This study is expected to last up to 8 weeks. This includes the initial screening period, the
      study or dosing period, and the follow up period.
    


Intervention name(s): Reference Formulation (R); LY3337641 (T1); LY3337641 (T2)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered PO; 20 mg PO; 20 mg PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gemfibrozil for Nicotine Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      This project will test whether gemfibrozil, a well-studied medication for high cholesterol,
      will help people stop smoking nicotine cigarette smoking. The study will also test whether
      gemfibrozil decrease cravings for cigarette and the desire to smoke.
    

Detailed description: 
      This is a pilot clinical trial examining the feasibility and efficacy of gemfibrozil
      treatment for smoking cessation. Adults with a desire to quit nicotine cigarette smoking will
      be recruited. Eligible participants will be randomly divided into two groups: those who
      receive gemfibrozil and waitlist controls. Screening will be conducted with a brief phone
      screen followed by a longer screening visit for those who qualify. During the screening
      visit, all study participants will provide demographic information and will be interviewed
      regarding smoking history. Procedures performed during the screening visit include a blood
      draw, urine pregnancy test, physical exam, clinical psychiatric interview, and measurement of
      exhaled carbon monoxide (CO). At baseline, participants will complete the Heavy Smoking Index
      (HSI) and the Brief Questionnaire of Smoking Urges (QSU-Brief). Participants will also
      complete the Quick Inventory of Depressive Symptoms-Self Rated (QIDS-SR) to assess symptoms
      of depression and changes in mood associated with smoking cessation will be assessed with the
      Concise Associated Symptoms Tracking (CAST) scale . Participants will work with the research
      clinician to set a target quit date within one week of the baseline session, and all
      participants will be provided written materials with guidance for smoking cessation as part
      of a smoking cessation counseling session. All participants will attend visits at the
      research clinic at 3 days and 4 weeks from target quit date to assess safety, adherence, and
      smoking status; participants will also receive additional smoking cessation counseling.
      Smoking status will be determined with exhaled breath CO and a single item questionnaire
      regarding the number of cigarettes smoked since target quit date and symptoms of depression
      and mood changes will again be measured. Medication side effects will be quantified using the
      Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The final study visit
      will occur at 8 weeks after target quit date for completion of the HSI, QIDS-SR, CAST,
      FIBSER, exhaled breath CO, QSU-Brief, and smoking self-report.
    

Intervention name(s): Gemfibrozil; smoking cessation counseling
Intervention type(s): Drug; Behavioral
Intervention description(s): FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use); smoking cessation counseling
Other intervention name(s): Lopid
Intervention MeSH terms: Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron Status and Lung Function in Pediatric Asthma
Condition: Pulmonary Function Tests
Study type: Observational

Summary: 
      Iron has a variable role regarding asthma and respiratory function. In addition, iron
      deficiency may affect spirometry results in asthmatic children. So, we aimed to assess the
      effect of ion status on lung function in childhood asthma
    

Detailed description: 
      This cross-sectional study included fifty asthmatic children in the age group of 6-16 years.
      Asthmatic patients were classified according to their complete blood count and iron profile
      into 2 groups: group 1; asthmatic children without iron deficiency anemia (IDA), group 2;
      asthmatic children with IDA. All patients underwent full history taking, clinical
      examination, laboratory investigations, asthma control test, and pulmonary function tests.

      Pulmonary function testing was performed using standardized spirometry. Lung function was
      measured by forced expiratory volume in one second (FEV1), forced vital capacity (FVC),
      FEV1/FVC, and maximal mid-expiratory flow (MMEF 25-75%) of FVC. both patients' groups are
      compared.
    

Intervention name(s): iron studies
Intervention type(s): Diagnostic Test
Intervention description(s): Pulmonary function testing was performed using standardized spirometry for asthmatic patients with iron deficiency anemia and those without iron deficiency anemia
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic children with and without iron deficiency anemia
      
Keywords: asthma, pediatric, iron deficiency anemia
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
Condition: Lumbosacral Radiculopathy
MeSH terms: Neuralgia; Radiculopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of two dose regimens of
      BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR).
      Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional
      neuropathic pain measures and assessments of low back pain, disability, and quality of life;
      To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize
      the pharmacokinetics (PK) of BIIB074 in this population.
    

Detailed description: 
      This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been
      acquired by Biogen.
    

Intervention name(s): BIIB074; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Matched placebo
Other intervention name(s): CNV1014802
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients
Condition: Leukemia; Precursor b-Cell Lymphoblastic Leukemia-Lymphoma; ACUTE LYMPHOBLASTIC LEUKEMIA
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is
      approved and a lower dose. The main purpose of this study is to evaluate whether a dose of
      inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient
      with relapsed or refractory ALL who may be at higher risk for severe liver problems after
      inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that
      can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be
      evaluated.
    


Intervention name(s): inotuzumab ozogamicin-dose level 2; Inotuzumab ozogamicin-dose level 1
Intervention type(s): Drug; Drug
Intervention description(s): Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle. This treatment arm evaluates a lower starting dose of 1.2mg/m2/cycle.; Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose of 1.8mg/m2/cycle is administered in this treatment arm.
Other intervention name(s): Besponsa; Besponsa
Intervention MeSH terms: Inotuzumab Ozogamicin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be conducted in 2 phases: a run in phase and a randomized phase.
Run in phase: a total of up to 22 patients will be enrolled to receive the starting dose of 1.2 mg/m2/cycle (dose level 2). A Simon Two Stage optimal design will be used. If acceptable efficacy (CR/CRi and MRD negativity) is observed in the run in phase, the study will enter the randomized phase.
Randomized phase: if acceptable efficacy is observed in the run in phase, the study will enter the randomized phase. A total of approximately 80 patients will be randomized (1:1) to 1 of 2 dose levels of inotuzumab ozogamicin (40 patients per dose level).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; ACUTE LYMPHOBLASTIC leukemia; inotuzumab ozogamicin; Besponsa; transplant
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
Condition: Incidence of Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to evaluate the effects of a follow on formula containing the
      human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old
      infants.
    


Intervention name(s): Lactobacillus fermentum; Follow on formula without probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Gastric pH and Anthocyanin Absorption
Condition: Anthocyanin Metabolism
Study type: Interventional

Summary: 
      Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and
      vegetables. The purpose of the study is to determine whether absorption of anthocyanins
      occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of
      an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from
      strawberries and blackberries.
    


Intervention name(s): omeprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): omeprazole 20.6 mg tablet with berries (blackberries + strawberries); Placebo with berries (blackberries + strawberries)
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: anthocyanin; omeprazole; Prilosec; gastric pH; proton pump inhibitor; PPI; nutrition
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study is designed to examine the impact of telephone-based colorectal cancer risk
      assessment on colorectal screening attitudes and behavior among previously unscreened adults
      ages 50 to 75.
    

Detailed description: 
      Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are
      preventable, but screening participation remains suboptimal. Several factors have been
      associated with screening compliance, such as perception of CRC risk. Here we study the
      impact of telephone-based administration of the National Cancer Institute Colorectal Cancer
      Risk Assessment Tool (CCRAT) compared to usual care.
    

Intervention name(s): Risk Assessment (CCRAT); Usual Care (UC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html); Patients receive standardized general information about colorectal cancer screening over the telephone.
Other intervention name(s): CCRAT; UC
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cancer screening beliefs; colorectal cancer screening
Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Prematurity birth lead to an early breaking link with the in utero environment. A special
      attention is brought in the neonatal intensive care units to reduce noise and lighting
      surrounding aiming to protect the newborn.

      During the uterine life fetus benefits previously of several auditory stimulations by the
      maternal voice, the mother's heartbeat. After birth the auditory environment is dramatically
      modified.

      Aim of this study is to submit to the newborn an audio recording of his mother's heart beat
      to analyze the comfort, stress and autonomic response. Heart rate variability (HRV) analysis
      is a non-invasive tool able to consider autonomic nervous system activity. Previous studies
      have shown that pleasant feelings are associated with an increase of high frequencies
      variations index (HFnu index) reflecting a prevalence of parasympathetic activity in the
      sympathetic-parasympathetic balance. This one can be simply assess by a monitor named NIPΣ
      and can provide a comfort index by quantifying the parasympathetic tone.
    

Detailed description: 
      The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care
      units of the University Hospital of Saint-Etienne (France).
    

Intervention name(s): electronic stethoscope; acoustic listening of mother's heartbeats; Recording of the newborn's heart rate
Intervention type(s): Device; Device; Device
Intervention description(s): Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.; Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.; Recording of the newborn's heart rate: one hour before the acoustic listening, during the acoustic listening and one hour after the acoustic listening .
The variations of the autonomic nervous system will be analyzed.
An coupled Heart rate variability recording (ECG signal obtained from a Philips® IntelliVue MX700 monitor) and NIPΣ index of comfort (MDMS® NIPΣ monitor) will be used.
Other intervention name(s): Littmann® Electronic 3200; Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.
      
Keywords: Premature; Maternal heart beat; Newborn; Heart rate Variability; Autonomous nervous system
Serum Markers as a Bioassay for Unipolar Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The goal of the study is to validate a biomarker assay for unipolar depression based on serum
      proteins involved in inflammation, metabolism, and stress response. The study will compare
      patients with a current major depressive episode to individuals with no history of
      depression. The hypothesis is that the assay can serve as a diagnostic tool that would be
      more objective than standard diagnostic questionnaires.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from the community by advertisement.
      
Biospecimen description: 
      serum, plasma
    
Keywords: biomarker; depression; blood test
The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The investigators aim to investigate whether exercise therapy during 12 weeks including a
      lesson on general healthy lifestyle in adult patients with a moderately active disease is
      more effective, compared to control patients only receiving a lesson on general healthy
      lifestyle recommendations. The three main categories of outcomes are 1) health-related
      quality of life, 2) general health status of the patients 3) explorative outcomes. The
      primary outcome is health-related quality of life, the secondary outcome is general health
      status measured by waist circumference, disease activity scores, blood pressure, and blood
      lipids, and the third outcome are explorative outcomes (none-disease specific quality of life
      scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including
      interleukins).
    

Detailed description: 
      The investigators will apply a superior trial design in this randomized clinical trial with
      two arms, intervention and comparison. In both the intervention and comparison arm, the
      patients will receive the proper and usual medical treatment decided by their responsible
      physician and changes in the medical treatment is allowed at all times.
    

Intervention name(s): Exercise intervention; Lifestyle - online lesson intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level. This includes two supervised exercise sessions of 60 minutes per week, combined with one weekly home training session. The type of exercise is planned by a physiotherapist to fit each patient during sessions. We monitor the intervention by training diaries including frequency, intensity, time, and type of exercise (FITT) and the verbal BORG 15-point scale and heart rate monitors. We will also monitor the overall seven days' physical activity level by accelerometry using the AX3 device from the company Axivity at weeks 0 and 12.; The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention, and comparison.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluate the pharmacokinetic drug interactions and safety after co-administration
      of ilaprazole and NSAID in healthy adults.
    


Intervention name(s): Ilaprazole; Naproxen; Aceclofenac; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ilaprazole 10mg; Naproxen 500mg; Aceclofenac 100mg; Celecoxib 200mg
Other intervention name(s): Noltec(the brand name); Naxen-F(the brand name); Airtal(the brand name); Celebrex(the brand name)
Intervention MeSH terms: Celecoxib; Naproxen; Aceclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomization, Open-label, Repeated administration, Crossover
Masking: None (Open Label)
Primary purpose: Treatment
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to investigate relative BA at steady state and to
      investigate dose proportionality of pharmacokinetic parameters

      Relative BA at steady state:

        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.

        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.

      Dose proportionality of pharmacokinetic parameters:

      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
    


Intervention name(s): Pramipexole ER tablet; Pramipexole IR tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Subcutaneous Doses of HIP2B in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.

      The purpose of this study is to investigate the safety and tolerability of repeat doses of
      HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet
      β-cell number and function will increase over time in response to repeat HIP2B injections.
    


Intervention name(s): HIP2B; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 Diabetes Mellitus; HIP2B; Placebo; islet β cell
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain
      alcohol) when they are given together.
    

Detailed description: 
      Patients are randomized to one of the following three regimens:

      Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3:
      1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for
      3 weeks.
    

Intervention name(s): Abacavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Abacavir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Interactions; Antiviral Agents; Ethanol; abacavir