bioihbjkbjnl/mcl2 huggingface dataset:
Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study
      of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100
      microcuries[µCi]) oral solution to 8 healthy males and females, following at least a 10 hour
      fast from food to assess the pharmacokinetics (PK), metabolism, and routes and extent of
      elimination of a single oral dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in
      healthy males and females.
    


Intervention name(s): [14C]-lasmiditan
Intervention type(s): Drug
Intervention description(s): [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

Summary: 
      The aim of the study was to evaluate the clinical control program in patients with
      hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by
      monitoring the patients every 4. week during pregnancy to keep the thyroid function
      parameters within the recommended range?

      A retrospective study of consecutive pregnant women with hypothyroidism followed at the
      outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients
      selected through electronic medical system. Blood tests for the The hormone levels drawn from
      the laboratory of Clinical Biochemical Department, Herlev Hospital
    


Intervention name(s): biomedical outcomes
Intervention type(s): Other
Intervention description(s): Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A retrospective study of consecutive pregnant women with L-T4 treated hypothyroidism
        followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark
        during 2012
      
Keywords: hypothyroidism; pregnancy
Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study
Condition: Alcohol Relapse Prevention; Alcoholism; Alcohol Drinking; Alcohol Consumption; Alcohol Abuse
MeSH terms: Recurrence; Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Due to Quetiapine's particulars and the promising receptor profile, we want to examine the
      efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or
      affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive
      symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind
      pilot study.

      We further want to compare the course of the above mentioned craving and affective symptoms
      under medication with quetiapine / matching placebo.
    

Detailed description: 
      Naltrexone and Acamprosate are the best evaluated and established therapy options in relapse
      prevention of alcoholics at present (Litten et al. 1996, Mann et al. 2004). Studies on cue
      exposure showed that Naltrexone (Monti et al. 1999) and Haloperidol (Modell et al. 1993)
      block stimuli triggered craving. In addition, they indicate that both may also stop the
      craving for further alcohol consumption that is induced by a priming dose of alcohol (Modell
      et al. 1993). However, the clinical relevance of Haloperidol is rather limited due to the
      risk of extrapyramidal side effects. New atypical dopamine antagonists are reported to have
      this profile as well, but without the risk of developing extrapyramidal side effects. In a
      placebo-controlled clinical trial, the atypical antipsychotic Olanzapine has proved to reduce
      craving for alcohol both after alcohol exposure and a priming dose of alcohol in
      non-dependent heavy social drinkers (Hutchison et al. 2001). However, Amisulpride in a dose
      of 50 mg per day failed to prevent alcohol relapse in a double-blind, placebo-controlled
      study in 71 patients over 6 months (Marra et al. 2002).
    

Intervention name(s): Seroquel®
Intervention type(s): Drug
Intervention description(s): dosage form: oral, adjusted in the range of 25 to max. 300 mg /day
Other intervention name(s): Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: novel antipsychotic; quetiapine; depression; psychopathology
Autologous Stem Cell Rescue for Primary Amyloidosis
Condition: Amyloidosis; Blood and Marrow Transplant (BMT)
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for
      amyloidosis.
    

Detailed description: 
      To learn about the use of high dose chemotherapy followed by transplantation using peripheral
      blood stem cells.
    

Intervention name(s): high dose chemo then auto hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Ketone Metabolism in Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to examine the value of infusing BHB in type 1 diabetic subjects
      during experimentally induced hypoglycemic episode in conjunction with testing of cognitive
      function. This will lay the basis for subsequent trials exploring the novel use of
      therapeutic doses of oral ketone formulations that are currently under commercial
      development, which could serve as adjunct therapies to protect the brain from hypoglycemia in
      type 1 diabetic subjects experiencing recurrent hypoglycemia.
    

Detailed description: 
      Healthy controls as well as type 1 diabetic subjects will undergo a
      hyperinsulinemic-hypoglycemic clamp with concomitant BHB or saline (control) infusion in
      random order. During each experimental condition the participants will complete a battery of
      validated cognitive tests that are sensitive to the cognitive impairment typically caused by
      hypoglycemia. An additional healthy control arm was added to the study design after the
      initial registration as a 2 arm study, to provide imaging results of normal healthy responses
      to hypoglycemia.
    

Intervention name(s): Beta-hydroxybutyrate; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Both healthy subjects and type 1 diabetic subjects will receive a bolus-continuous infusion of 40umol/min/kg of BHB for 5 min, followed by a 12µmol/min/kg of BHB or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study.; Both healthy subjects and type 1 diabetic subjects will receive a bolus-continuous infusion of 40umol/min/kg of BHB for 5 min, followed by a 12µmol/min/kg of BHB or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study.
Other intervention name(s): BHB; NaCl 0.9%
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The added 3rd arm does not apply to the crossover design.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: brain metabolism; cognitive function
Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemophilia
Condition: Severe Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will be a single-arm, open-label, non-randomized, non-controlled
      investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      PF-06741086 in Chinese adult participants with severe hemophilia.
    


Intervention name(s): PF-06741086
Intervention type(s): Biological
Intervention description(s): single dose SC injection of 300 mg PF-06741086
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Condition: Healthy; Chronic Stable Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of co-formulated
      subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab

      The secondary objectives of the study are to:

        -  Explore variability in the drug concentration profiles of casirivimab and imdevimab
           after co-formulated subcutaneous (SC) or intravenous (IV) administration

        -  Characterize the immunogenicity of casirivimab and imdevimab in serum over time
    


Intervention name(s): Casirivimab+Imdevimab
Intervention type(s): Drug
Intervention description(s): Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
Other intervention name(s): REGN-COV2; Casirivimab; Imdevimab; REGEN-COV™; Ronapreve™
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
Leipzig Exercise Intervention in Chronic Heart Failure and Aging
Condition: Heart Failure; Ageing
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig
      Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate
      how aerobic short-term training interventions affect exercise capacity, left ventricular
      systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and
      endothelial function in chronis heart failure patients (CHF-patients) and healthy subjects
      (HS) in two different age strata: Above 65 years and below 55 years.

      Aim of the trial is therefore to compare the effects of aerobic exercise training in young
      and old healthy subjects as well as in young and old heart failure patients. To our knowledge
      this study is the first to prospectively investigate age differences of training responses in
      both CHF patients and age-matched healthy controls.

      Because of the extensive clinical and molecular assessment the results of this trial will be
      made public in predefined substudies:

        -  LEICA-Echo

        -  LEICA-Biomarkers

        -  LEICA-Endothelium

        -  LEICA-Cardiopulmonary Exercise Function

        -  LEICA-Muscle
    

Detailed description: 
      A total of 60 healthy subjects and 60 heart failure patients (in each group 30 <55 years, 30
      >65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or
      control group.

      Before and after the intervention period maximal exercise tolerance is determined by
      ergospirometry, endothelial function is measured by high-resolution A-mode ultrasound, left
      ventricular function by echocardiography including tissue Doppler imaging, and thigh muscle
      mass is assessed by CT. Skeletal muscle biopsies are obtained at both time-points and are
      analysed for inflammatory cytokines and markers of catabolism/anabolism.
    

Intervention name(s): Aerobic endurance exercise training (ergometer)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: heart failure; ageing
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and
      immunogenicity of two formulations of SB5 in healthy male subjects.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): SB5 (adalimumab), 40 mg, single-dose
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to evaluate the absolute bioavailability, metabolism and elimination
      pathways of AQX-1125 in healthy male and female subjects.
    

Detailed description: 
      This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy
      male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4
      male and 4 female) who will participate in Part 1 and Part 2 of the study.

      In Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV
      microtracer dose of carbon-14-AQX-1125 ([14C]-AQX-1125). In Part 2, each subject will receive
      a single oral dose of [14C]-AQX-1125.
    

Intervention name(s): AQX-1125 Oral Tablet; [14C]-AQX-1125 IV; [14C]-AQX-1125 Oral Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.; Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.; Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.
Other intervention name(s): Radiolabelled AQX-1125 IV; Radiolabelled AQX-1125 Oral Solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
      with recurrent glioblastoma multiforme or other malignant glioma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival rate at 6 months in patients with recurrent
           glioblastoma multiforme or other malignant glioma treated with temozolomide.

      Secondary

        -  Determine the overall survival of patients treated with this drug.

      OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression
      or unacceptable toxicity.

      Blood samples are collected at baseline and every 2 months for 2 years for evaluation of
      markers of neo-angiogenesis. Samples are analyzed by protein expression,
      reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected
      and tested as of 1/12/09)
    

Intervention name(s): temozolomide; protein expression analysis; reverse transcriptase-polymerase chain reaction; diagnostic laboratory biomarker analysis; immunoenzyme technique
Intervention type(s): Drug; Genetic; Genetic; Other; Other
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult subependymal giant cell astrocytoma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic oligodendroglioma; adult oligodendroglioma; adult brain stem glioma; adult mixed glioma; adult pineal gland astrocytoma
Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)
Condition: Insulin
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to investigate brain insulin's relationship with food
      intake in African Americans. Facilitating insulin's entrance into the brain through a nasal
      spray is currently being studied as a way to prevent or treat Alzheimer's disease. However,
      brain insulin may also have an impact on food intake. This study is designed to help
      researchers understand how different factors related to Alzheimer's disease (i.e. APOE
      genotype and cognitive functioning) influence brain insulin's relationship with food intake.
    

Detailed description: 
      The investigators will utilize a double-blind, placebo-controlled, randomized crossover
      design comparing a single acute dose of intranasal insulin to a single acute dose of a saline
      placebo.

      The primary aim will consist of exploring the differences in ingestive behaviors constructs
      (i.e. hunger, satiety, and fullness) and ad libitum lunch caloric intake between acute
      administration of either a dose of intranasal insulin or saline placebo. The hypothesis is
      that acute intranasal insulin will result in the consumption of fewer calories, greater
      feelings of satiety and fullness, and less hunger compared to acute saline. A secondary aim
      of this investigation will be to analyzing differences in food intake by APOE genotype,
      adiposity, and AD family history.
    

Intervention name(s): Insulin, Regular, Human; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The spray will last a few seconds and then the participant will be asked to sniff to aid the drug into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.; The spray will last a few seconds and then the participant will be asked to sniff to aid the saline into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.
Other intervention name(s): Novolin R; Saline
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Intranasal Insulin; Food Intake; APOE; Cognition; African American
Media, Morphokinetics, and Mosaicism
Condition: Embryonic Mosaicism; Embryo Culture Media; Embryo Morphokinetics; Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and
      miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has
      been advocated as a strategy for increasing live birth rates with a single embryo transfer.
      Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS.
      Several commercially-available single-step embryonic culture media with varying composition
      have been established for use in the IVF laboratory. Early reports have suggested differences
      in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media
      currently in standard use. However, there have been no clinical trials demonstrating the
      superiority of any one commercially-available culture media formulation. As a result, clinics
      use media with varying composition based upon familiarity and cost.
    


Intervention name(s): EmbryoScope Plus; GLOBAL MEDIA; SAGE MEDIA
Intervention type(s): Device; Other; Other
Intervention description(s): All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data; Embryos will be cultured in GLOBAL media; Embryos will be cultured in SAGE media
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: sibling embryo study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment