bioihbjkbjnl/mcl2 huggingface dataset:
Temperature Control in Central Fever in the Neuro-ICU
Condition: Fever; Brain Hemorrhage
MeSH terms: Intracranial Hemorrhages; Hemorrhage; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      There are few treatments for central fever (fever that is due to the central nervous system,
      as opposed to an infectious source). We hypothesize that an externally applied cooling
      blanket will reduce temperature in neurologically ill patients with central fever.
    


Intervention name(s): Gaymar Rapr-Round (external cooling blanket)
Intervention type(s): Device
Intervention description(s): Application of the device per its approved labeling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: subarachnoid hemorrhage; intracerebral hemorrhage; fever
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Condition: Breast Cancer; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To assess the excretion balance after oral and IV administration of [14C]-SAR439859

        -  To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV
           administration of [14C]-SAR439859 and, PK of radioactivity, SAR439859 and M7 after oral
           administration of SAR439859 alone or with [14C]-SAR439859

        -  To assess IV clearance and absolute bioavailability of SAR439859 using microdose of
           [14C]-SAR439859 tracer on top of a single tablet oral dose.

        -  To assess relative bioavailability of SAR439859 given as tablet or solution

      Secondary objectives:

        -  To collect samples in order to assess metabolic profile in plasma and excreta of
           SAR439859 after oral administration of [14C]-SAR439859 as solution, contribution in
           plasma of SAR439859 and metabolite relative to total radioactivity and identify
           metabolites (samples will be analyzed according to metabolic analysis plan and results
           will be documented in a separate report).

        -  To assess safety and tolerance of SAR439859
    

Detailed description: 
      Total study duration is 3 to 10 weeks, including a screening period of up to 27 days,
      treatment period of up to 16 days and a follow-up and end of study of up to 4 weeks.
    

Intervention name(s): amcenestrant; [14C]-SAR439859 microtracer; [14C]-SAR439859
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet Oral; Solution for infusion Intravenous; Powder for oral solution Oral
Other intervention name(s): SAR439859
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers
    

Detailed description: 
      An Open-label, Randomized, Single-dose, Crossover Study
    

Intervention name(s): IN-C004 with water; IN-C004 without water; K-CAB tab. with water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One time dose of IN-C004 taken with water; One time dose of IN-C004 taken without water; One time dose of K-CAB tab. taken with water
Other intervention name(s): IN-C004; IN-C004; K-CAB tab.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum
Condition: Contraception
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being offered to all participants of the ACY-5 study as an optional addition to
      the male contraceptive study in which they participated. Participation is voluntary.

      The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount
      of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.
    

Detailed description: 
      The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all
      individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that
      some individuals have persistent sperm in their semen despite treatment. We hope to be able
      to determine whether differences in intratesticular hormone levels account for persistent
      sperm production in men who do not reach counts of zero as compared to those who do in the
      male contraceptive study. This study will measure testosterone levels in the testes of men
      who are participating in male contraceptive studies. Testosterone will be measured in a small
      amount of testicular fluid at the end of the study treatment phase after sperm counts have
      been reduced to zero or very low levels.
    

Intervention name(s): Acyline; Testosterone Gel; Depo-Medroxyprogesterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks; Testosterone (T) gel 10 g daily for 6 months; 300 mg IM every 3 months
Other intervention name(s): Testim; DMPA
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Testosterone; Acyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male contraception; Testosterone
Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label, non-comparative, multi-centre, phase II prospective trial to assess the
      efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors
      (SSRIs) in SSRI-resistant major depressive disorder.
    


Intervention name(s): Quetiapine fumarate (Seroquel)
Intervention type(s): Drug
Intervention description(s): 300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: considered; entry; into; the study; SSRI; Seroquel; Quetiapine; fumarate; antipsychotic
The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the long-term immunogenicity and safety of the
      inactivated split-virion vaccine after one immunization.
    


Intervention name(s): split-virion, non-adjuvanted H1N1 vaccine of 15 μg; split-virion, non-adjuvanted H1N1 vaccine of 30 μg; split-virion, non-adjuvanted H1N1 vaccine of 45 μg; Placebo control
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.; 120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.; 120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.; 120 adults were assigned to receive 1 dose of placebo.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H1N1; Vaccine; Immunogenicity; Safety
A Drug Interaction Study of Montelukast and Levocetirizine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium
      and levocetirizine dihydrochloride in healthy male volunteers.
    


Intervention name(s): Levocetirizine; montelukast sodium; Montelukast & levocetirizine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levocetirizine dihydrochloride 5mg. PO. Single dose.; Montelukast sodium 10mg. PO. Single dose.; Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.
Intervention MeSH terms: Cetirizine; Montelukast; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: montelukast; levocetirizine; interaction
Peripheral Vision Training Study
Condition: Visual Impairment; Cognitive Change
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      This study will train participants (young people and older adults) to do a visual task, and
      will assess whether this results in changes in behavioral assessments. In some participants,
      we will be also testing whether MRI measures (cortical thickness, functional connectivity)
      change with training.
    


Intervention name(s): computerized training
Intervention type(s): Other
Intervention description(s): Computerized training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
Condition: Alcohol Drinking
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Study type: Interventional

Summary: 
      This study aims to develop a phone app to assess gait differences at different levels of
      alcohol intoxication.
    

Detailed description: 
      250 adult volunteers who will each participate in a single laboratory-based visit. At the
      orientation, each participant will provide informed consent, be weighed, and undergo a
      medical history to confirm eligibility. A urine drug quick-screen will be given. Female
      participants will take a urine pregnancy test. Baseline questionnaires will be administered.
      After giving participants the phone on which the AlcoGait 2.0 app is installed, baseline
      assessment of gait will be performed with the participant walking a distance of 50 yards ten
      times.

      Drinking will then commence. The total amount will be consumed over 30 minutes. Participants
      will have their BrAC assessed multiple times during and after drinking has commenced and
      finished. At BrAC levels of .02, .04, .06 and .08 g%, will perform the gait task. After the
      last gait task, participant data will be transmitted to a secure server. Participants will
      receive a meal, and will be escorted to a sitting area with a DVR and videos, and allowed to
      use their own electronic devices. Their BrAC will be periodically tested until it reaches .02
      g% or below, then a taxi will be called to take them home.
    

Intervention name(s): All Participants
Intervention type(s): Other
Intervention description(s): all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cognitive Multi-Tasking Training in Healthy Older Adults
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluated the feasibility of a remote web-based ecological cognitive training
      protocol to healthy older adults. The training protocol involves 5 training sessions.
    

Detailed description: 
      Previous research demonstrated the relevance in training cognitive abilities that typically
      decline with age, such as those associated with executive control (e.g., abstract thinking,
      selective and divided attention, planning, task-switching and inhibitory control). The aim of
      the present study is to investigate the feasibility of a web-based cognitive training focused
      on executive control to cognitively healthy older adults. The participants will undergo the
      web-training in a daily type situation of meal preparation (i.e., Breakfast Game). The
      training protocol combines the tasks of table setting and cooking in a multi-tasking fashion.
      In some sessions Emphasis Change approach will be apply to the training, in order to assess
      it feasibility and potential effects in optimizing the performance. In addition, participants
      will undergo a brief web-based cognitive evaluation before and after training. If feasible,
      the investigators protocol will allow training older adults in critical cognitive skills for
      daily life situations. The web-based training is an advancement since it can be delivered
      at-home, remotely supervised, and is easily scalable. Recently, remote interventions have
      been particularly relevant to older adults due to the COVID-19 pandemic, which may limit
      in-person research participation.
    

Intervention name(s): Multi-tasking Training
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo training protocol where they will have, concomitantly, to cook different meals and set the table under different instructions, rules and difficulty level.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Web-based Cognitive Training; Executive Functions; Attention; Multi-tasking; Aging; Healthy Adults
Time Course of Postprandial Protein Metabolism
Condition: Muscle Protein Synthesis; Protein Metabolism
Study type: Interventional

Summary: 
      The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein
      synthesis has been established to be short-lived in healthy young adults. Our aim was assess
      the time course of anabolic signaling events and stimulation of muscle protein synthesis
      rates (MPS) after ingestion of a food source that represents a more typical meal-induced
      pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.
    


Intervention name(s): Milk Protein Concentrate
Intervention type(s): Dietary Supplement
Intervention description(s): The macronutrient composition and energy of the milk protein beverage provided to participants is 38 g protein (3.46 g leucine), 4.17 g carbohydrate, and 1.4 g fat. The milk protein met all chemical and bacteriologic specifications for human consumption. The L-[1-13C]phenylalanine and L-[1-13C]leucine enrichments in the milk protein concentrate averaged 38.3 and 10.8 mole percent excess (MPE), respectively.
Intervention MeSH terms: Caseins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Protein; Amino Acids; Anabolic Signaling; Muscle Mass
A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
Condition: Chronic Hepatitis C Infection; Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ascending
      doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study
      is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The
      exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy
      in combination with RBV.
    


Intervention name(s): recombinant variant of interferon-alpha 2b; Peginterferon alfa-2a
Intervention type(s): Drug; Drug
Intervention description(s): SC, Weekly; SC Weekly
Other intervention name(s): Hanferon; Pegasys
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Interferon; Hanferon
Tolerance and Development of Healthy, Term Infants
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the tolerance and early bone status of healthy, term infants fed formulas during
      the first three months of life.
    


Intervention name(s): Alternate protein infant formula; Standard infant formula
Intervention type(s): Other; Other
Intervention description(s): Feed as per HCP directions; Feed as per HCP directions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy infants
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
Condition: Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion
MeSH terms: Arterial Occlusive Diseases; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the
      interventional treatment of de novo and non-stented restenotic lesions in the superficial
      femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with
      standard percutaneous transluminal angioplasty (PTA).
    


Intervention name(s): MDT-2113 Drug-Eluting Balloon; Standard angioplasty balloon
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm; Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Drug-Eluting Angioplasty Balloon; Drug Coated Angioplasty Balloon; Peripheral Artery Disease; Experimental; Percutaneous Transluminal Angioplasty (PTA)
To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin,
      placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of
      cenerimod on the duration of the QT interval in healthy male and female participants.

      Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg,
      cenerimod 4 mg or moxifloxacin.
    

Detailed description: 
      Participants randomized in one of the cenerimod or placebo groups will receive combined oral
      contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on
      Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2).

      Half of the participants randomized in one of the cenerimod or placebo groups will be
      enrolled in an accelerated elimination procedure part (Period 3).
    

Intervention name(s): Combined oral contraceptives (COC); Moxifloxacin 400mg; Cenerimod 0.5 mg; Cenerimod 4 mg; Charcoal, activated; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other; Drug
Intervention description(s): A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.; A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.; This will be administered orally as a film-coated tablet in the morning.; This will be administered orally as a film-coated tablet in the morning.; Granules for oral suspension will be used and administered open-label.; Cenerimod matching placebo tablets will be administered once daily orally in the morning.
Other intervention name(s): Levonorgestrel/Ethinylestradiol; ACT-334441; ACT-334441; Carbomix 50g
Intervention MeSH terms: Moxifloxacin; Levonorgestrel; Ethinyl Estradiol; Contraceptives, Oral, Combined; Contraceptive Agents; Contraceptives, Oral; Charcoal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Period 1: Pharmacokinetic study, Period 2: Thorough-QT and Drug-drug-interaction study. Period 3: Accelerated elimination study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline
Condition: Parkinson´s Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      There is convincing evidence from numerous studies using both psychophysical and
      electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease
      (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49%
      in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work
      of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life,
      safety, and interpersonal relations, as well as food behavior/nutritional intake are severely
      altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed
      in patients with Parkinson's disease. If it was possible to improve olfactory function this
      would appear as a significant effect in patients with Parkinson's disease. Provided the study
      would reveal an improvement of olfactory function following therapy with rasagiline, this
      would have tremendous worldwide impact on the use of this drug. Considering the frequency of
      PD a very large number of patients would benefit from these findings, especially in terms of
      quality of life.
    


Intervention name(s): Azilect 1mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg daily orally for 120 days; 1 mg daily orally for 120 days
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Parkinson´s disease; olfaction; rasagiline; smell testing
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
Condition: Schizophrenia; Mania
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of
      aripiprazole tablets following oral administration to children and adolescents.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics,; Aripiprazole; acute mania in pediatric populations