bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose Study of Lu AF76432 in Healthy Young Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the
      drug Lu AF76432 given as single oral ascending doses to healthy young men
    


Intervention name(s): Placebo; Lu AF76432
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to Lu AF76432 oral solution; Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
Condition: Onchocerciasis
MeSH terms: Onchocerciasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11
      years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in
      people 12 years and over. The secondary purpose is to evaluate the safety and
      pharmacokinetics of a single dose of moxidectin in children and adolescents aged 4 to 17
      years.
    


Intervention name(s): Moxidectin
Intervention type(s): Drug
Intervention description(s): 2 mg tablets
Intervention MeSH terms: Moxidectin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2.
If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled.
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675,
      a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus
      placebo in patients with bilateral treated moderate dry eye syndrome
    

Detailed description: 
      The aim of the present study is to evaluate the efficacy of a 6-month (± 14 days) dietary
      supplementation period with T1675 versus placebo in patients with bilateral moderate dry eye
      syndrome already treated with tear substitutes, and to point out, through several parameters,
      the best efficacy parameter that could be used for a future clinical phase III study.
    

Intervention name(s): Food supplement (T1675)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Randomized Trial to Assess PO Versus IV Antibiotics
Condition: Wound Infection
MeSH terms: Infections; Wound Infection
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effect of treatment of post-op wound infection in
      long bones after fracture fixation or joint fusion and either: (Group 1) operative
      debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and
      IV antibiotics for 6 weeks.

      Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in
      Group 1 will be non-inferior to the rate in Group 2.

      Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be
      non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that
      require surgery >2 weeks after initial debridement, infection recurrence, infection with a
      new pathogen, joint erosion, implant failure, medical problems related to the treatment
      administration which necessitates a switch from one arm to the other.

      Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection,
      non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2.

      Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment
      costs at 1 year will be lower in Group 1 than in Group 2.

      Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2.

      Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior
      to adherence in Group 2.

      Specific Aim 2: To build and validate a risk prediction model for failure of treatment of
      early post-op wound infections after fixation of fractures and joint fusions.
    


Intervention name(s): PO versus IV antibiotics Route of administration evaluation
Intervention type(s): Other
Intervention description(s): This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
Other intervention name(s): based on local practices and bacterial susceptibilities
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Antibiotic; Intravenous Antibiotic; Wound infection; Randomized Controlled Trial
Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
Condition: HIV Infections; Pregnancy; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4
      counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and
      the passive acquisition of vaccine-specific antibody in their infants.

      Evidence suggests that an advanced stage of disease with high plasma viremia is associated
      with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,
      reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody
      are potentially attainable goals through active immunization of the mother during pregnancy.
    

Detailed description: 
      Evidence suggests that an advanced stage of disease with high plasma viremia is associated
      with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,
      reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody
      are potentially attainable goals through active immunization of the mother during pregnancy.

      Pregnant women are randomized to receive an initial injection of VaxSyn or alum placebo
      between week 16 and week 24 of gestation, followed by monthly booster injections concluding
      at the end of pregnancy, for a total of five injections. Patients may have optional booster
      immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and
      infants are followed through 18 months after delivery.
    

Intervention name(s): gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; Pregnancy; Pregnancy Complications, Infectious; HIV Envelope Protein gp160; AIDS Vaccines; HIV Preventive Vaccine; HIV Therapeutic Vaccine
A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of 3 different dose
      levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy
      participants, using conventional Salk IPV (cIPV) as an active control.
    


Intervention name(s): sIPV; cIPV
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.; Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Other intervention name(s): JNJ-64152348
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Internal Jugular Ultrasound Measures During Respiration in Children
Condition: Ultrasound Measurements; Normative Values
Study type: Observational

Summary: 
      Project Aims: The purpose of this study is to determine the size of the right internal
      jugular vein (RIJV) in children with normal respiratory physiology during the respiratory
      cycle and evaluate the reliability of those measurements.

      Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be
      reliably measured in the respiratory cycle.

      Intervention: We will ensure that the patient is not having any respiratory symptoms or signs
      of dehydration. A clinical asthma score will be assigned using the Modified Woods pulmonary
      index scoring system. The Gorelick Dehydration Scale with also be calculated.

      Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement
      will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees
      with the subject's head in the neutral position and then turned 45 degrees leftward.
      Measurements of the internal jugular vein at maximal inhalation and exhalation will be
      recorded. Reliability calculations will be assessed.
    


Intervention name(s): Sonosite Titan Ultrasound Machine
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric emergency department
      
Keywords: measurements; jugular; ultrasound; pediatric; respiratory; diameter
By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgical revascularization has proven its efficacy in term of morbidity and mortality in
      patients with multivessel coronary disease and poor left ventricular function. Nevertheless,
      if left ventricle is severely dilated, the improvement of global contractility and reduction
      of volumes is frequently absent after CABG even if substantial amount of myocardial viability
      is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for
      the absence of recovery after revascularization.

      Recently, a reduction of cardiac volumes and improvement of regional and global contractility
      has been demonstrated in patients with advanced ischemic heart disease, severe dilation of
      left ventricle and poor candidates for revascularization after injection of stem cells in
      territories with residual viability.
    

Detailed description: 
      The screening of patients will be performed after contrast coronar ventriculography realized
      for diagnostic or prognostic purpose.

      Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification
      of inclusion criteria.

      Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical
      revascularization alone or surgical revascularization associated with autologous bone marrow
      derived stem cells injection in viable territories.

      During the follow up evolution of left ventricular volumes and contractility will be analyzed
      by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed
      by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.
    

Intervention name(s): Autologous bone marrow derived stem cells myocardial transplantation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Chronic ischemic cardiomyopathy with residual viability; surgical coronary revascularization; stem cell therapy; Chronic ischemic heart disease; severe impairment of global contractility left ventricular dilation; residual viability
Nutraceuticals and Vascular Remodelling
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Vascular Remodeling
Study type: Observational

Summary: 
      Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on
      lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular
      prevention in a setting of controlled dietary habits. The nutraceutical combination used in
      this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of
      Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
    


Intervention name(s): Liposcudil Plus
Intervention type(s): Dietary Supplement
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile
      
Keywords: Atherosclerosis; Carotid; Lipid profile
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic; Diabetes Complications
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Complications; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical research study of an experimental topical drug for the treatment of
      chronic, neuropathic, diabetic foot ulcers.

      Patients participating in the study may receive an active drug (MRE0094), inactive drug
      (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the
      United States. What treatment a patient will receive is determined by chance (like drawing a
      number from a hat). All patients will receive additional care for diabetic foot ulcers during
      the study.

      Participation in the study can be up to 4½ months.
    


Intervention name(s): MRE0094
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: toe ulcer; heel ulcer; foot ulcer; diabetic feet; diabetic foot; complications of diabetes
Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone
Condition: Healthy; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone
      and to demonstrate evidence of hemodynamic effect

      Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort)
      - to demonstrate evidence of haemodynamic benefit

      Study Design: Open label
    


Intervention name(s): Milrinone 6mg; milrinone 10mg ER; milrinone 14mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements; Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements; Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
Other intervention name(s): Milirone; Milirone
Intervention MeSH terms: Milrinone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)
Condition: Congenital Muscular Dystrophy
MeSH terms: Muscular Dystrophies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to establish the pharmacokinetic profile of omigapil in
      paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of
      omigapil.

      Funding source - FDA OOPD
    


Intervention name(s): Omigapil
Intervention type(s): Drug
Intervention description(s): Cohort 1 0.02 mg/kg/day Cohort 2 0.08 mg/kg/day Cohort 3a 0.04 mg/kg/day Cohort 3b 0.06 mg/kg/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder
Condition: Opioid Abuse; Opioid Dependence; Opioid-Related Disorders; Opioid Use
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this project is to develop initial human data on effects of novel
      compounds on safety (interactions with oxycodone) and efficacy (subjective response to
      oxycodone) in non-treatment seeking opioid use disorder subjects. The compound to be studied
      will be the 5-HT2CR agonist lorcaserin. There are no known or reported adverse interactions
      between lorcaserin and oxycodone or other opioids.
    

Detailed description: 
      Lorcaserin is a serotonin (5-HT) 2C receptor agonist (Trade Name Belviq) approved for
      treatment of obesity. The study teams's preclinical research collaborators and others have
      shown that lorcaserin and other 5-HT2CR agonists have been shown to reduce drugs of abuse
      self-administration and cue reactivity in rodents including cocaine and nicotine. Recently,
      this data has been expanded to opioids. Rats trained to self-administer oxycodone showed a
      significant reduction in self-administration and oxycodone cue induced lever presses after
      lorcaserin administration.

      This is a single center, double-blind, placebo-controlled, randomized, 1b/2a study. 18
      subjects are planned. The following treatment regimens will be used:

      Lorcaserin will be administered at a dose of 10mg twice daily. Placebo or Comparator -
      identical placebo capsules administered at the same time as lorcaserin.
    

Intervention name(s): Lorcaserin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days; Placebo will be administered twice daily for for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxycodone; lorcaserin; Belviq
Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of
      autologous bone marrow-derived MSCs. Following informed consent, patients who meet the
      criteria will be screened and enrolled. Up to 100 mls of bone marrow will be harvested from
      the participant from which MSCs will be culture expanded. In this dose escalation study, 3
      participants on each cohort will be treated with a targeted dose of either 20 million hMSC;
      40 million hMSC; or 80 million hMSC. The cells will be administered to the ischemic leg by 20
      intramuscular injections of approximately 0.5ml per injection . Treatment groups will be
      completed sequentially, beginning with the lowest dose group.
    

Detailed description: 
      This is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study to examine
      the safety of intramuscular autologous transplantation of escalating doses of mesenchymal
      stem cells to patients with no option critical limb ischemia.

      Trial Aims and Objectives: To examine the safety of intramuscular transplantation of
      escalating doses of autologous bone marrow derived mesenchymal stem cells to patients with no
      option critical limb ischemia.

      Patient Population: Patients with critical limb ischemia who are not candidates for
      revascularization.

      Trial Setting:HRB Clinical Research Facility Galway and Galway University Hospitals.

      Trial Intervention:Intramuscular delivery of autologous bone marrow-derived mesenchymal stem
      cells to patients with no option critical limb ischemia.

      Study Design: Open label, uncontrolled, non-randomized, dose escalation study. Sample Size: 9
      Method of Participant Assignment:Sequential administration of 3 escalating doses of
      autologous bone marrow-derived mesenchymal stem cells.

      Examination Points: Day 0, 7, 30, 90, 180, 365 and 730 Primary Outcome: Serious adverse
      events that are attributable to intervention. Secondary Outcomes :Amputation free survival,
      median time to amputation, TcPo2, ABI, pain scale, ulcer healing, quality of life
      assessments, collateral vessel formation detected by MRI at 12 months.
    

Intervention name(s): 20 million hMSCs; 40 million hMSCs; 80 million hMSCs
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): 20 million hMSCs intramuscularly; 40 million hMSCs intramuscularly; 80 million hMSCs intramuscularly
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Advanced Therapeutic Medicinal Product ( ATMP) Bone Marrow Derived Mesenchymal Stem Cells
Masking: None (Open Label)
Primary purpose: Treatment