bioihbjkbjnl/mcl2 huggingface dataset:
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics
      (PK) of single rising doses of BI 416970. A further objective is to assess the influence of
      CYP2C9 phenotype on the PK of BI 416970.
    


Intervention name(s): Placebo to BI 416970; BI 416970
Intervention type(s): Drug; Drug
Intervention description(s): single rising doses; single rising doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to
      standard therapy in the treatment of severe asthma attacks in children admitted to the
      Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and
      half will receive an inhaled placebo.
    

Detailed description: 
      Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a
      pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include
      corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a
      bronchodilator, but has a different mechanism of action than albuterol. The addition of
      Ipraropium to children in the Emergency Room with severe asthma exacerbations improves
      outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium.
      However, two studies of children hospitalized in the general wards of the hospital (not the
      PICU) show that the addition of Ipratropium to standard care does not effect clinical
      outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU
      patients (like it is in ER patients) or if it not helpful (like it is in general ward
      patients).
    

Intervention name(s): Ipratropium; 0.9% Sodium Chloride; Albuterol; corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"; systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
Other intervention name(s): Atrovent; Duoneb; Normal saline; methylprednisolone; prednisone; dexamethasone; prednisolone
Intervention MeSH terms: Dexamethasone; Prednisone; Methylprednisolone; Prednisolone; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety (primary objective) and immunogenicity
      (secondary objective) and fecal shedding of vaccine viruses (secondary objective) of two
      novel oral polio vaccines, nOPV1 and nOPV3, as compared to Sabin monovalent vaccine controls,
      in 150-230 healthy adults.
    

Detailed description: 
      This multicenter trial is the first-in-human assessment of two novel oral polio vaccines for
      poliovirus type 1 and type 3. It will be an 8-arm, randomized, observer-blind, controlled
      trial, with Sabin monovalent vaccines serving as the control for each type. One hundred and
      fifty to 230 healthy, adult participants will be recruited, 70-80 participants with an
      exclusive inactivated poliovirus vaccine (IPV) prior vaccination history and 120-150
      participants with an oral poliomyelitis vaccine (OPV)-containing prior vaccination history.
    

Intervention name(s): Novel Oral Polio Vaccine Type 1 (nOPV1); Novel Oral Polio Vaccine Type 3 (nOPV3); Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1); Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.; Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.; The Sabin mOPV1 control vaccine contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose.; the Sabin mOPV3 control vaccine contains ≥ 10^5.8 CCID50 per 0.1 mL (2 drops) dose.
Other intervention name(s): Sabin monovalent oral polio vaccine type 3
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It will be an 8-arm, randomized, observer-blind, controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine tolerability; Vaccine reactogenicity; Vaccine viral shedding; Vaccine immunogenicity
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of long term escitalopram
      treatment in participants with Major Depressive Disorder (MDD) with associated anxiety
      symptoms.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single arm,
      prospective (study following participants forward in time), post-marketing, multi-center
      (when more than one hospital or medical school team work on a medical research study) study
      to evaluate the efficacy and safety of escitalopram in participants with MDD with associated
      anxiety symptoms. The duration of the study will be 24 weeks at a starting dose of
      escitalopram 10 milligram per day (mg/day). The dose will be flexibly adjusted (maximum 20
      mg/day) after 2 weeks of treatment depending on Investigator's discretion. The study will
      consist of 9 visits: Baseline, Week 1, 2, 4, 8, 12, 16, 20 and 24. Assessments of efficacy
      and safety will be performed at each visit. The primary efficacy evaluation will be done by
      Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale(HAM-A).
      Participant's safety will also be monitored throughout the study.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram tablets will be administered orally at 10 milligram per day (mg/day). The dose may be increased to maximum of 20 mg/day depending on Investigators discretion for 24 weeks
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Escitalopram; Lexapro
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy
Condition: Arthritis, Rheumatoid; Healthy
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of multiple doses of BI 655064 administered
      subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To
      explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI
      655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical
      effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after
      12 weeks of treatment
    


Intervention name(s): BI 655064 medium dose; BI 655064 high dose; BI 655064 high dose; Placebo; BI 655064 low dose; Placebo; BI 655064 medium dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Medium dose; High dose; High dose; Placebo; Low dose; Placebo; Medium dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment in adult Japanese participants with moderately to severely active ulcerative
      colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will
      continue with the same blinded treatment assigned in Study APD334-302 for a total treatment
      duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
    


Intervention name(s): Etrasimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
Other intervention name(s): APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Etrasimod; APD334; UC
Nucleophilic Defense Against PM Toxicity (NEAT Trial)
Condition: Air Pollution Toxicity
Study type: Interventional

Summary: 
      Carnosine is a naturally occurring peptide found in high levels in skeletal muscle and the
      brain and is also available commercially as a dietary supplement. Since carnosine has
      anti-oxidant properties and air pollution exposure induces a state of oxidative stress, the
      purpose of this study is to see if those taking carnosine as a dietary supplement are
      protected from air pollution-induced oxidative stress and adverse cardiovascular outcomes.
    

Detailed description: 
      This is a placebo controlled, randomized, double-blind, interventional trial investigating
      the efficacy of carnosine in reducing the effects of particulate matter air pollution
      (PM2.5). A total of 240 participants from the Louisville metropolitan and neighboring areas
      will be randomized into two dietary supplement study groups - carnosine (n=120) versus
      placebo (n=120). Intervention of study dietary supplements will occur from May through
      September, when the levels of PM2.5.are highest in the Louisville, KY area. Study
      participants will be given a daily oral dose of total of 2 grams of carnosine (or placebo)
      for a total of 12 consecutive weeks (during May through September).

      Urinary levels of carnosine will be used to screen and identify potential candidates with low
      carnosine levels. Those with levels less than the median levels of the population, will be
      invited to participate in the study. The following measurements will be performed - blood and
      urine sample collection, physical examination, arterial stiffness, physical function, and
      self-reported surveys on environmental exposure, sleep, diet, and exercise. Supplement
      intervention (carnosine or placebo) will be initiated at the time of Baseline Assessment and
      will continue for 12 weeks from that date. Two follow up visits will occur at 6 weeks and 12
      weeks respectively after initiating supplementation.

      This innovative clinical investigation will provide an insight into the pre and post
      intervention effects of a cheap, safe, and over-the-counter available dietary supplement in
      countering the effects of air pollution.
    

Intervention name(s): L-carnosine; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): a naturally occurring di-peptide; an identically appearing supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo controlled, randomized, double-blind
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: air pollution; oxidative stress; intervention
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic
      (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy
      administered to pediatric participants 2 to 8 years of age with single ventricle physiology
      who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to
      evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched
      to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid
      (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for
      thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle
      physiology who have completed the Fontan procedure within 4 months prior to enrollment.
    

Detailed description: 
      Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period.
      Participants in Part A will not participate in Part B. Randomization in Part B of this study
      will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in
      Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the
      study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety
      Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone
      contact. Part B: Participants will be randomly assigned to two treatment groups and
      randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There
      will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a
      30-day Follow-Up phone contact.
    

Intervention name(s): Rivaroxaban; Acetylsalicylic Acid
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.; Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
Intervention MeSH terms: Aspirin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Thromboembolism; Fontan Procedure; Children
Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery
Condition: Foot Surgery; Ankle Surgery
Study type: Interventional

Summary: 
      Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and
      motor blockade obtained with stimulating popliteal catheters versus those placed without
      nerve stimulation.
    


Intervention name(s): Placement of nerve block catheter; Placement of nerve block catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): Placement of nerve block catheter with nerve stimulator and ultrasound; Placement of nerve block catheter with ultrasound only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: foot surgery; ankle surgery; Patients scheduled for foot and ankle surgery
Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine (Second Sub-Project)
Condition: Itch
Study type: Interventional

Summary: 
      The aim of our 2nd sub-project is to clarify if the capsaicin receptor TRPV1 is implicated in
      the mechanism of morphine-induced mast cell degranulation. Moreover, we also aim to clarify
      if the mechanism of opioid-induced itch relay on the histaminergic pathway by using the
      antihistamine (diphenhydramine) to suppress the release of histamine from peripheral mast
      cells.
    


Intervention name(s): Capsaicin; Diphenhydramine; Morphine Chloride; Isotonic saline; Histamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A capsaicin patch will be applied on a 3x3 cm squared area on the volar forearm. The patch will be left in place for 24h after which it will be removed.; Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.; Morphine solution (0.1mg/ml, Morphine Hydrochloride) 50 μl will be applied intradermally to the center of a predetermined area on the volar forearm by a 1 ml syringe.; injections of isotonic saline (0.05 ml, 0.9%) as vehicle will be performed.; A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
Other intervention name(s): Antihistamine
Intervention MeSH terms: Diphenhydramine; Promethazine; Morphine; Capsaicin; Histamine; Histamine Antagonists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Quadriceps Concentric vs Eccentric
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to compare the effects of concentric and eccentric exercises on
      muscle strength, muscle thickness and balance in healthy Individuals. Participants will
      randomly be divided into 2 groups: Concentric exercise (CE) group, eccentric exercise (EE)
      group. Concentric exercise group will be doing 2 concentric exercises and eccentric exercise
      group will be doing 2 eccentric exercise for 8 weeks. The evaluations will be repeated after
      8 weeks of training to reveal the effects of concentric and eccentric exercises.
    


Intervention name(s): Concentric exercises; Eccentric exercises
Intervention type(s): Other; Other
Intervention description(s): Resistance concentric straight leg raise and knee extension will be done.; Resistance eccentric straight leg raise and knee extension will be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle thickness; muscle strength; hop Test; Balance; performance
A Multiple Ascending Dose Study of COR388
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to
      assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy
      male and female subjects and a cohort of Alzheimer's disease subjects.
    

Detailed description: 
      The study will enroll 3 cohorts of 8 healthy subjects ≥55 and ≤80 years of age at the
      Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects ≥55 and ≤80 years of age.
      Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while
      confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28
      days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.
    

Intervention name(s): COR388; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): COR388 administered for 10 or 28 days.; Placebo administered for 10 or 28 days.
Other intervention name(s): COR388 HCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Unilateral Lymphoedema of the Leg
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the
      leg using the same principles for arms.
    

Detailed description: 
      When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of
      the tissues. This results in an overall increase in the total amount of extracellular fluid
      (ECF) in the limb, causing swelling. This can be documented by measuring the impedance
      (opposition) to a low frequency current that has been passed into the limb. Low frequency
      current travels predominantly through the ECF, where the Lymphoedema manifests. As the fluid
      builds up in the limb, the impedance to the current decreases and it is in this way that low
      frequency bioimpedance is able to assess Lymphoedema.

      Multi-frequency bio-impedance analysis otherwise known as Bioimpedance Spectroscopy (BIS) has
      been reported to be effective for the measurement of ECF and sub clinical changes in ECF to
      predict the onset of Lymphoedema in the arms in studies conducted by Cornish et al. It has
      been reported by Warren et al that BIS can be used as a reliable and accurate tool for
      documenting presence of lymphoedema in patients with wither upper- or lower-extremity
      swelling.

      The L-Dex U400 device uses an "impedance ratio" methodology to assess unilateral Lymphoedema
      of the arm. By this method the unaffected arm acts as an internal and subject specific
      control. The strategy of this study is to show that the L-Dex U400 can use this methodology
      to assess unilateral leg Lymphoedema.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group 1 - Test group - will be recruited through advertisements placed at Qld Lymphoedema
        and Breast Oncology Physiotherapy, Lymphoedema Association of QLD, Gynecological Cancer
        Support Group and notification to other private therapists to inform them of the study.

        Group 2 - Control group - will be through advertisements placed at Qld Lymphoedema and
        Breast Oncology Physiotherapy.
      
Keywords: Lymphedema; Bioimpedance