bioihbjkbjnl/mcl2 huggingface dataset:
A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and
      elderly subjects.
    


Intervention name(s): SHR-1707; Placebo; SHR-1707; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.; A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.; A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects.; A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR-1707 compared with placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule
Condition: Chronic Stable Angina
MeSH terms: Angina, Stable
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg,
      64mg, 128mg in healthy male volunteers.
    


Intervention name(s): Dilatrend SR capsule
Intervention type(s): Drug
Intervention description(s): single oral administration in period 1 or 2, 3 for each sequential group.
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Cannabidiol on Marijuana-seeking in Humans
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      The purpose of the proposed study is to investigate the effectiveness of cannabidiol for
      reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid
      (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of
      marijuana.

      Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and
      increase price-elasticity of marijuana demand.
    

Detailed description: 
      Participants will be asked to participate in a total of three choice sessions over two weeks
      with each session day separated by at least two days. Each session day will last
      approximately 8 hours.

      During each study session participants will be asked to smoke a cigarette. Participants will
      be asked to smoke from a marijuana cigarette. These cigarettes may contain cannabidiol or
      they may not (placebo).

      Participants will be asked to answer questions about how the drugs make them feel. Vitals
      signs (blood pressure, heart rate, and oxygen saturation) will be measured using a
      non-invasive (external) vitals monitor.

      Six samples will be taken in each of the three sessions. Blood samples will be obtained via
      butterfly catheter placed in a vein.

      Participants will be asked to remain in the laboratory until all marijuana-related subjective
      and physiological effects have returned to the original levels recorded this morning before
      they smoked the first marijuana cigarette.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Marijuana Dependent Participants
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
Condition: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy
      subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in
      blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will
      be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days.
      The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the
      5 days of the study.
    


Intervention name(s): BAY85-3934; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of 20 mg BAY85-3934 as tablet; Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: BAY85-3934; pharmacokinetics; age; gender
A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      BC106 is a molecule that when injected with insulin lispro may change the speed of absorption
      of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin
      lispro and any side effects that might be associated with it, blood levels of insulin lispro
      after injection under the skin and how BC106 insulin lispro affects blood sugar after
      injection under the skin. There is a minimum 7 day washout between single doses.
    


Intervention name(s): Insulin Lispro; BC106 insulin lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Humalog; LY275585; BioChaperone insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Background:

      Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.

      More recnetly it is regularly use in the treatment of pericarditis. It couls exert
      antiiflammatory effects targeting the adverse inflammation occuring incase of acute
      myocardial infarction, which is involved in poor outcomes or longer stay at hospital.

      Endpoints:

        -  Main endpoint: AUC CRP during the initial hospital stay

        -  Secondary endpoints:

             -  Clinical: oucomes

             -  Imaging: ETT, MRI

             -  Biological: various biomarkers

      Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal
      optimal treatment versus conventionnal optimal treatment + colchicine
    


Intervention name(s): Colchimax®; Conventional treatment
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Inflammation; CRP; Colchicine
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
Condition: Asthma; Atopic Dermatitis; Healthy
MeSH terms: Asthma; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single ascending dose
      of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose
      administered IV in participants with asthma and atopic dermatitis.
    

Detailed description: 
      This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study
      consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for
      asthmatic participants and atopic dermatitis participants) and outpatient period (105 days
      for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The
      total duration of participation for each participant will be approximately 21 weeks for
      healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis
      participants. All eligible participants will be randomly assigned to receive active agent or
      placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO
      7160 or placebo will be administered to sequential cohorts of healthy participants as an IV
      infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as
      IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood
      samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters
      in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part
      2. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Part 1: CNTO 7160; Part 2 (Asthma): CNTO 7160; Part 2 (Atopic Dermatitis): CNTO 7160; Part 1 and Part 2: Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).; Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).; Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).; Participants will receive single IV infusion of placebo matched to CNTO 7160.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Efficacy; CNTO 7160; Healthy; Asthma; Atopic Dermatitis
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70
      or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl
      Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.
    

Detailed description: 
      This study tests the safety and effectiveness of the experimental drug, tipifarnib in older
      patients who have acute myeloid leukemia (AML). The purpose of this study is to test if
      tipifarnib can make patients with leukemia live longer. In this study, half the patients will
      receive tipifarnib and half of the patients will receive the standard treatment. The standard
      treatment will help to control the symptoms of AML and may include hydroxyurea to lower
      levels of circulating leukemia cells. Tipifarnib or the standard treatment will be given
      until the patient's leukemia gets better, or until they experience unacceptable side effects,
      or until the patient or study doctor decide to stop the study medication. Patients assigned
      to tipifarnib will be given tipifarnib tablets. Patients should take 6 tablets with food in
      the morning and 6 tablets with food in the evening, for 21 days in a row. Patients will not
      take tipifarnib for the next 7 days. This 28 day period is called a cycle. The rest period
      may be extended beyond 7 days depending on how well the patients tolerate the treatment.
      Patients will return to the study clinic every week and to visit their study doctor at least
      every two weeks. A blood draw for routine tests will be done every week. Depending on how
      your disease is doing, a bone marrow aspiration may be done at the end of every cycle. When
      patients finish treatment with the study medication, or if they leave the study early, they
      will be asked to see your doctor for one last visit. Routine laboratory tests will be done.
      After this visit the study doctor will continue to check with patients to see how they are
      doing and if they have started a new treatment for leukemia. This check will be made every 30
      days and may be made by phone to the patient or to their health care provider. Tipifarnib;
      six 100 mg in a film coated, compressed tablets are given orally twice a day at for 21
      consecutive days on a 28-day cycle schedule.
    

Intervention name(s): Tipifarnib;Zarnestra; R115777
Intervention type(s): Drug
Intervention MeSH terms: Tipifarnib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloid leukemia acute disease; Tipifarnib; Bone marrow aspirate
Branched Chain Amino Acid Plus Glucose Supplement Reduces Exercise-Induced Delayed Onset Muscle Soreness in College Females
Condition: Exercise-induced Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a dietary supplement containing branched chain
      amino acids will reduce the muscle soreness that sometimes occurs in the days following
      exercise.
    

Detailed description: 
      Supplementation with branched chain amino acids (BCAAs) has been used to stimulate muscle
      protein synthesis following exercise. The purpose of this study was to determine if
      supplementation with BCAAs in combination with glucose would reduce exercise-induced delayed
      onset muscle soreness (DOMS). Using a double-blind crossover design, 20 subjects (11 females,
      9 males) were randomly assigned to either BCAA (n=10) or placebo (n=10) groups. Subjects
      performed a squatting exercise to elicit DOMS and rated their muscle soreness every 24 hours
      for four days following exercise while continuing to consume the BCAA or placebo. Following a
      three-week recovery period, subjects returned and received the alternate BCAA or placebo
      treatment, repeating the same exercise and DOMS rating protocol for the next four days. BCAA
      supplementation in female subjects resulted in a significant decrease in DOMS versus placebo
      at 24 hours following exercise (p = 0.018). No significant effect of BCAA supplementation
      versus placebo was noted in male subjects, nor when male and female results were analyzed
      together. This gender difference may be related to dose per body weight differences between
      male and female subjects.
    

Intervention name(s): Branched Chain Amino Acid drink supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: branched chain amino acids, exercise, delayed onset muscle soreness
The Effect of Omalizumab on Responses to Cat Allergen Challenge
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      This research is being done to study the effects of the drug omalizumab (Xolair) in people
      with cat allergies. The investigators will use omalizumab to study changes in the cells in
      the nose, skin and blood that cause allergies. The investigators predict that cells in the
      blood will be effected before cells in the nose or skin.
    

Detailed description: 
      Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is
      FDA-approved for use in allergic asthma, though its clinical role is not precisely defined.
      It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and
      therefore, blocks the interaction between IgE and mast cells or basophils. It, therefore, may
      be used as a mechanistic tool in the study of IgE. As IgE levels are reduced with omalizumab,
      FcεRI expression on human basophils is reduced. This reduction of basophil receptors and
      allergen induced activation is pronounced within 7 days of the initial administration and is
      reversible once omalizumab administration is discontinued. The omalizumab-induced reductions
      in mast cell FcεRI expression and function is unchanged at day 7 and significantly reduced by
      day 70. These changes were based upon intravenously administered omalizumab at a dose of 0.03
      mg/kg/IU IgE/mL in a total of three subjects. We propose to exploit the kinetics of faster
      omalizumab effects on circulating basophils relative to tissue mast cells to elucidate the
      role of the basophil versus mast cell activation in nasal airway allergen challenge, which
      has not been studied to date.
    

Intervention name(s): omalizumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosing is based on IgE level and weight given every 2 or 4 weeks; Dosing is based on IgE level and weight given every 2 or 4 weeks
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Basophils; Mast Cells; IgE; IgE receptors; omalizumab
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a range of doses of
      SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin
      alone.
    


Intervention name(s): SK-0403; Placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SK-0403; Placebo; Sitagliptin
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Condition: Hepatitis A Virus Infection
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the
      vaccine in Chinese children between 12 and 23 months of age.
    


Intervention name(s): Hepatitis A Vaccine, Purified Inactivated (VAQTA™)
Intervention type(s): Biological
Intervention description(s): Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.
Other intervention name(s): VAQTA™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared
      to the present commercial formulation
    


Intervention name(s): Asasantin ER, new formulation I; Asasantin ER, new formulation II; Asasantin ER, present commercial formulation
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent
      diseases associated with bone loss. Following bacterial colonization, the gingiva becomes
      inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has
      two distinct but interconnected etiologic components, periodontopathic bacteria and
      host-mediated connective tissue-destructive responses to the causative bacteria and their
      metabolic products.

      A few studies have revealed that probiotic Lactobacillus strains were useful in reducing
      gingival inflammation and the number of black-pigmented rods, including Porphyromonas
      gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions,
      its shown that application of beneficial bacteria, as an adjunct to scaling and root planing
      (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on
      probing.

      The aim of the present study is to evaluate the improvement of periodontal health with
      probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].
    


Intervention name(s): Probiotic (Inersan); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2; Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment