bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
Condition: Birch Pollen-Related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of successive single rising doses of SLIT in
      subjects with allergic rhinitis and to investigate the safety and tolerability of multi high
      dose regimens of SLIT in subjects with allergic rhinitis.
    


Intervention name(s): Placebo; rBet v 1
Intervention type(s): Biological; Biological
Intervention description(s): Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.; Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.
Other intervention name(s): rBet v 1.0101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rBet v 1; Birch pollen allergy; Sublingual Immunotherapy
A Study of IBI351 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction,
      food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of
      two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated
      the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2:
      This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy
      subjects.
    


Intervention name(s): IBI351; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): IBI351 is administered orally; Esomeprazole is administered orally
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period
      cross-over study using a standardised solid meal test in subjects with type 2 diabetes to
      investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25
      and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate
      dosing visits.
    

Detailed description: 
      This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period
      cross-over study using a standardised solid meal test in subjects with type 2 diabetes to
      investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25
      and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate
      dosing visits.

      Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three
      different study treatments.

      During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days
      (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid
      meal test.
    

Intervention name(s): BioChaperone® Combo; Humalog® Mix25; Humalog®; Lantus®; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Injection of BioChaperone® Combo; Injection of Humalog® Mix25; Injection of Humalog®; Injection of Lantus®; Injection of 0.9% NaCl
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY3314814 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it
      is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The
      study will last at least two weeks for each participant, not including screening.
    


Intervention name(s): LY3314814; [13C415N3] LY3314814
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered as an IV infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response
Condition: Improving Ovarian Stimulation; Suboptimal Responders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to investigate the difference in the number of oocytes obtained by performing
      ovarian stimulation in follicular phase vs. luteal phase in a population of patients with
      previous suboptimal response.

      This is a controlled randomized clinical study.

      We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian
      stimulation in order to vitrify and accumulate oocytes.

      The main variable for evaluating the efficacy in this exploratory study will be the number of
      oocyte cumulus complexes obtained.
    


Intervention name(s): time of administration of Corifollitropin Alfa
Intervention type(s): Drug
Intervention description(s): The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study
      conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50
      milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged
      50 to 85 years.
    


Intervention name(s): E2609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Participants; E2609; Pharmacokinetics; Japan
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene
      cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary
      pharmacokinetics
    


Intervention name(s): BIBB 1464 MS low dose; Placebo; Pravastatin; BIBB 1464 MS medium dose; BIBB 1464 MS high dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa
Condition: Anorexia
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This prospective pilot study will compare adolescents with restrictive anorexia nervosa who
      participated for 3 months at olfactory workshops, patients who did not, and healthy
      patients.The groups will be evaluated before the workshops and after three months, with the
      wanting score after olfactory stimuli and with serum oxytocin level.
    

Detailed description: 
      The restrictive anorexia nervosa (AN) in adolescents is an eating disorder with decreased
      desire to eat (wanting) following olfactory stimulation. Oxytocin is an hormone involved in
      the neuromodulation of eating behavior, but also involved in olfactory perception in
      schizophrenia patients, and in social cognition in patients with autism. Its plasma level was
      found low in anorexic patients compared to control subjects.

      Because of the similarity in disorders of social cognition between these three diseases, we
      assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin
      levels.

      With a prospective pilot study we will compare patients with AN who participated for 3 months
      at olfactory workshops, AN patients who did not, and healthy patients.

      The groups will be evaluated before the workshops and after three months, with the wanting
      score after olfactory stimuli and with serum oxytocin level.

      One application of this study will be the use of ocytocyne nasal spray to increase the eating
      desire and to allow weight regain
    

Intervention name(s): olfactory workshop; other workshop; No intervention
Intervention type(s): Other; Other; Other
Intervention description(s): olfactory workshop; other workshop: discussion group, dance and body Expression; control group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Condition: Migraine Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Phase 4

Summary: 
      investigators hypothesize that T2 * vein abnormalities are frequent and are specific to the
      migraine aura.
    

Detailed description: 
      The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of
      the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to
      this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a
      stroke, so a diagnosis can be poorly established, resulting in poor patient care. The
      possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2
      *, would be an important advance for the management of these patients
    

Intervention name(s): MRI; MRI control; telephone consultation
Intervention type(s): Combination Product; Diagnostic Test; Other
Intervention description(s): Routine MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion).; MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion); telephone consultation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: migraine aura
Joint Attention Intervention and Young Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the effectiveness of an intervention aimed to
      increase joint attention in 2-4 year old children with autism. The study will be conducted in
      mainstream preschools in Norway. The intervention will be implemented by preschool teachers
      and paraprofessionals supervised by trained counselors.
    

Detailed description: 
      Young children with autism experience severe deficit in joint attention skills (e.g. pointing
      to objects, showing, following another person's gaze, responding to invitations to social
      interaction). Ability to initiate and respond to joint attention is linked to children's
      later language abilities. As a mean to improve language outcome in children with autism, it
      is important to target joint attention in early intervention programs.

      This study investigates the effectiveness of a joint attention intervention. Sixty 2-4 year
      old children with autism will be randomized to an intervention group or a control group.
      Children in both groups will continue their ordinary preschool program. However, the children
      in the intervention group will also participate in 80 joint attention intervention sessions.
      The sessions (20 minutes each) will be conducted twice a day for 8 weeks by preschool
      teachers or paraprofessionals working in the preschools. Before starting the intervention
      preschool teachers and paraprofessionals will be taught how to teach joint attention skills
      and how to initiate and maintain episodes of joint engagement. During the course of
      intervention they will be supervised by trained counselors.

      Outcome measures will include joint attention skills, language skills and joint engagement.
      Children will be assessed at baseline, after 10 weeks and at follow up 6 months and 1 year
      after the end of the intervention. The measures are based on direct testing of the children,
      video observations and questionnaires to parent and professionals.
    

Intervention name(s): Joint attention intervention
Intervention type(s): Behavioral
Intervention description(s): Eight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; joint attention; intervention; joint engagement; language
The Effect of Relaxation Response Training on Declarative Memory and Salivary Cortisol in Older Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate whether a 5-week relaxation response intervention influences the learning, memory
      or attention of healthy older adults.
    


Intervention name(s): Relaxation Response
Intervention type(s): Behavioral
Intervention description(s): Relaxation training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Influence of "Espresso" on Adsorption of Myo-inositol
Condition: Neural Tube Defects
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Observational

Summary: 
      Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise
      from failure of embryonic neural tube closure. Several studies have demonstrated that
      periconceptional administration of folic acid can prevent approximately 70% of all NTDs
      cases. The finding of several NTDs cases in a single family, despite prophylactic therapy
      with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no
      preventive therapy for folate-resistant NTDs is available. Studies performed on
      folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs
      occurrence. Preliminary results in patients with at least two previous pregnancies affected
      by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with
      500 mg/day of inositol (three months before conception and two months after) is able to
      prevent NTDs recurrence in humans.

      Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of
      NTDs, especially for subgroups of people that carry genetic variants for enzymes involved in
      caffeine metabolism.

      The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest to
      pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether
      pre-conception caffeine intake interferes with prophylactic therapy for NTDs.

      In the proposed study, we aim to evaluate the effect of "espresso" consumption (corresponding
      to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (MI), in
      order to highlight any possible negative effects of caffeine on MI adsorption and excretion
      before conception.

      The study will consist of two phases and will be carried on twelve healthy volunteers. During
      phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this
      period, 20 g of MI will be administrated in a single dose. Basal levels of serum and urinary
      concentration will be evaluated before MI administration (t0); subsequently, sampling will be
      performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist of 15 additional
      days of inositol-poor diet: basal levels of MI will be again measured before MI
      administration. In phase 2, MI administration will be concomitant to caffeine exposure
      through single"espresso" consumption. Samples will be collected at the same time points as in
      phase 1.
    


Intervention name(s): Inositol
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Inositol
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Volunteers
      
Keywords: inositol; caffeine; NTDs
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The purpose of this study is to verify the intra-individual difference of the SDLP values in
      driving simulator.
    


Intervention name(s): Road-tracking test; Car-following test; Harsh-braking test
Intervention type(s): Other; Other; Other
Intervention description(s): Driving with simulator program for SDLP measurement; Driving with simulator program for DCV measurement; Driving with simulator program for BRT measurement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Comparison Study of the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare relative oral bioavailability of a capsule
      formulation of LGD-6972 to a solution formulation of LGD-6972.
    

Detailed description: 
      This is a single center, randomized, open-label, single dose study conducted in a 2-way
      crossover design.

      A total of 8 subjects will be enrolled in the study. The duration of participation for each
      subject will be approximately 36 days, not including a Screening Period of up to 30 days.

      Each treatment period, subjects will be admitted to the study site on Day -1 and observed
      through the morning of Day 3 (48-hour post-dose assessment). Over 2 treatment periods,
      subjects will receive each of the following treatments as a single dose orally, under fasting
      conditions, per the randomization (4 subjects per treatment in each treatment period:

      Treatment A - 15 mg of LGD-6972 as capsules

      Treatment B - 15 mg LGD-6972 as solution

      Serial blood samples will be collected through 48 hours following each dose to determine the
      concentration of LGD 6972 in plasma. Safety assessments will also occur during this time.
      Subjects will be discharged from the study site after the 48 hour assessments and return to
      the study site on Days 4, 7, and 14 for follow up procedures. Subjects will return to the
      study site for the second treatment period after an additional 7 days. Subjects will be
      discharged from the study after returning to the study site on Day 14 of the second treatment
      period.
    

Intervention name(s): LGD-6972 Solution; LGD-6972 Capsules
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg of LGD-6972; 15 mg LGD-6972
Other intervention name(s): LGD-6972 Sodium Salt in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF); LGD-6972 Sodium Salt Capsules
Intervention MeSH terms: Betadex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Family-Centered Diabetes Project - Sharing Wisdom
Condition: Prediabetes; Metabolic Syndrome; Overweight; Obesity
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      This is a randomized trial of an educational intervention to reduce the risk of diabetes
      among urban American Indian women
    

Detailed description: 
      Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest
      city to participate in a type 2 diabetes prevention intervention. Half of the women were
      randomized to participated in the educational intervention and half were assigned to a
      delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.
    

Intervention name(s): A lifestyle educational program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes; Prevention; American Indian
A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ASP0892 after
      intradermal or intramuscular injection in adults with peanut allergy.
    


Intervention name(s): ASP0892 Intradermal; ASP0892 Intramuscular; Placebo Intradermal; Placebo Intramuscular
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intradermal injection; Intramuscular injection; Intradermal injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Peanut Allergy; ASP0892