bioihbjkbjnl/mcl2 huggingface dataset:
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the
      duration of action of insulin lispro due to facilitation of the absorption of the insulin
      after subcutaneous injection.

      The aim of the trial is to investigate the dose-response and the dose-exposure relationships
      of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and
      glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and
      to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.

      This is a double-blinded, randomised, four-period crossover phase 2 trial using automated
      12-hour euglycemic clamps in subject with type 1 diabetes mellitus.

      Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three
      single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of
      Humalog® (0.2 U/Kg) on 4 separate dosing visits.
    


Intervention name(s): BioChaperone insulin lispro 0.2U/Kg; BioChaperone insulin lispro 0.1U/Kg; BioChaperone insulin lispro 0.4U/Kg; Humalog®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 0.2U/Kg body weight injected subcutaneously; Single dose of 0.1U/Kg body weight injected subcutaneously; Single dose of 0.4U/Kg body weight injected subcutaneously; Single dose of 0.2U/Kg body weight injected subcutaneously
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
Condition: Cerebral Hypoxia
MeSH terms: Hypoxia, Brain; Hypoxia
Study type: Interventional

Summary: 
      The investigators will investigate the effect of hypobaria and hypoxia on physiological
      responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation,
      brain's activity and concentration performance.
    

Detailed description: 
      The main goal of this project is to investigate how hypoxia affects cognitive functions. The
      KLT-R test asses the concentration level of a person. Subjects will do this test at different
      simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators'
      first hypothesis is that concentration level will be altered by hypoxia. The higher altitude
      the subjects are, the more the concentration would be altered. KLT-R performance would be
      impaired by hypoxia compare to sea level performance.

      The primary endpoint of this project is to investigate how KLT-R performance is affected by
      the different hypoxic conditions. KLT-R test will be passed nine times in total during the
      test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH,
      5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before
      each condition) and a post-test at the end of the protocol. To avoid influence of fatigue,
      all conditions will be randomized.

      The second endpoint of this study is how the brain electrical activity is modulated by
      hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and
      5500m HH).
    

Intervention name(s): Hypoxia
Intervention type(s): Other
Intervention description(s): No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.
Intervention model: Single Group Assignment
Intervention model description: Single-Blind study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoxia; Brain; Cerebral vaso-reactivity; EEG; Concentration performance; Cerebral oxygenation; Cerebral blood-flow; Heart rate variability
Acute Effects of Fats on Satiety and Energy Needs
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to assess the acute effect of dietary fat on satiety and energy
      metabolism.
    

Detailed description: 
      The influences of specific dietary fat sources on satiety, appetite and energy utilization
      remains unclear; evidence is lacking on whether responses vary according to acute intake. The
      researchers will use a controlled setting to determine whether the source of dietary fat is
      related to perceived satiety, satiety hormone responses, and energy expenditure by conducting
      experiments to evaluate short term (acute) effects.
    

Intervention name(s): SFA; MUFA; PUFA-LA; ALA; LCn3
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): High saturated fatty acid/SFA oil source; High monounsaturated fatty acid/MUFA oil source; High polyunsaturated fatty acid (linoleic)/PUFA-LA oil source; High polyunsaturated fatty acid (alpha-linolenic)/ALA oil source; High polyunsaturated fatty acid (omega-3)/LCn3 oil source
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Energy Expenditure; Appetite; Satiety
Lactation Cookie Study
Condition: Breastfeeding
Study type: Interventional

Summary: 
      Lactation cookies contain ingredients thought to increase breast milk production. Although
      these cookies are widely purchased and consumed with the intention to increase breast milk
      supply, no scientific investigation has explored the effects of lactation cookies on human
      breast milk production.

      This study will evaluate the effects of a lactation cookie in breast milk production,
      relative to cookies without ingredients thought to increase breast milk production in
      exclusively breastfeeding mothers of healthy, term babies.
    

Detailed description: 
      Caring for an infant is demanding, and breastfeeding can become a stressful experience,
      particularly if mothers are concerned about their breast milk supply or whether their milk is
      nutritious enough to meet their infant's nutritional needs.

      In the US, research suggests that about 60% of women perceive their breast milk as
      insufficient to meet their infant's nutritional needs. As a consequence, about one-fourth of
      women that perceive insufficient milk production wean their infants prematurely.

      Lactation cookies contain ingredients thought to increase breast milk production and are
      widely consumed for this purpose. However, there is no research that has explored the effects
      of lactation cookies on breast milk supply. To answer this, the investigators plan a
      randomized controlled trial involving 176 exclusively breastfeeding mothers of 2-month-old
      infants. Participants will be randomized into "lactation cookies" or "control cookies"
      (cookies without ingredients thought to increase breast milk production" and will be asked to
      eat a bag (2 OZ) of cookies per day for 1 month.
    

Intervention name(s): Lactation cookies; Control cookies
Intervention type(s): Other; Other
Intervention description(s): 1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.; 1 serving of 2 OZ of cookies per day for 30 consecutive days.
The cookies will not contain ingredients thought to increase breast milk production.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Breastfeeding, lactation cookies, breast milk production
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose is to establish the equivalence of Triferic iron administered via dialysate
      into the arterial blood line and into the venous blood line
    

Detailed description: 
      An open-label, four period, randomized, crossover study of Triferic iron administered via
      hemodialysis compared to Triferic administered intravenously pre- and post- hemodialyzer.
    

Intervention name(s): Triferic
Intervention type(s): Drug
Intervention description(s): ferric pyrophosphate citrate
Other intervention name(s): ferric pyrophosphate citrate; FPC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Equivalence
Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions
Condition: Effect of Irrigation Activation on Periapical Healing
Study type: Interventional

Summary: 
      The aim of this study was to highlight the healing rates of large periapical lesions after
      different irrigation activation treatments as manual dynamic activation (MDA), passive
      ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS)
      using CBCT scans based on volumetric change analysis during 1-year follow-up.
    

Detailed description: 
      The aim of this study was to highlight the healing rates of large periapical lesions after
      different irrigation activation treatments as manual dynamic activation (MDA), passive
      ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS)
      using CBCT scans based on volumetric change analysis during 1-year follow-up.

      A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth
      with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment
      lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups
      (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were
      taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D
      evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values
      were statistically analyzed with the Wilcoxon test.
    

Intervention name(s): Manual dynamic activation; Passive ultrasonic activation; Laser activation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.; A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.; A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irrigation activation; periapical healing
Treatment of Suicidal Women With Borderline Personality Disorder
Condition: Borderline Personality Disorder; Suicide
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a component analysis of dialectical behavior therapy (DBT) to determine the
      importance of DBT skills training and DBT individual therapy in treating suicidal women with
      borderline personality disorder.
    

Detailed description: 
      People with borderline personality disorder have limited behavioral skills and react
      abnormally to emotional stimulation. Standard dialectical behavior therapy (SDBT) has been
      shown to be an effective treatment for borderline personality disorder. This treatment
      combines weekly group sessions, at which patients learn new ways of dealing with their
      emotions, with weekly individual sessions with a therapist to discuss their emotions. The
      study compares SDBT to both individual DBT with no skills training and DBT skills training
      with no individual therapy. The study will determine whether efficacy of standard DBT is
      reduced when either DBT skills training or individual DBT therapy is removed.

      Participants are randomly assigned to receive 1 year of SDBT, DBT with group sessions but no
      individual sessions, and DBT with individual sessions with no group sessions. Participants
      are monitored for 1 year after completing their assigned therapy. Throughout the 1-year study
      and during the 1-year follow-up period, self-report scales and questionnaires are used to
      assess participants every 4 months. These scales and questionnaires measure participants'
      suicidal thoughts and attempts, treatment compliance, emotional coping skills, social
      functioning, and overall well-being.
    

Intervention name(s): Standard dialectical behavior therapy (SDBT); Individual DBT with no DBT group sessions (DBT-I); Group Skills DBT with no DBT individual sessions (DBT-S)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Standard DBT includes: 1) individual DBT therapy (1 hour per week), 2) DBT group skills training (2.5 hours per week), 3) telephone consultation (as needed), and 4) therapist consultation team (1 hour per week).; Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.; DBT group skills training is 2.5 hours per week and includes individual case management.
Other intervention name(s): DBT, SDBT; DBT, DBT-I; DBT, DBT-S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Suicide; Women; Emotions; Psychotherapy, Group
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to assess stool consistency, in combination with additional
      health-related parameters including gastrointestinal tolerance and health-related quality of
      life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and
      reasons for changes in the choice of formula or method of feeding among infants in this
      sample, as well as incidence of common infant illness and associated healthcare usage.
      Anthropometric measures and the frequency and duration of physician- and parent-reported
      gastrointestinal and other adverse events will be evaluated.
    

Detailed description: 
      Parents / legally acceptable representatives of eligible infants will be invited to
      volunteer.
    

Intervention name(s): Study formula feeding; Human milk feeding; Mixed feeding
Intervention type(s): Other; Other; Other
Intervention description(s): Infants who are exclusively fed the new study formula at time of enrollment; Infants who are exclusively fed human milk at time of enrollment; Infants who are exclusively fed human milk and the new study formula at time of enrollment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy term infants aged approximately 42 days (range 35 - 49 days) who are brought to the
        health clinic for their first normally-scheduled well-baby visit (i.e. typically age 42
        days in China).
      
Keywords: infant; term birth; human milk; infant formula; breast feeding; bottle feeding; gastrointestinal tract; quality of life; infant development
Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a
      marketed comparator.
    


Intervention name(s): Yasmin 20; Mercilon
Intervention type(s): Drug; Drug
Intervention description(s): Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral); Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination; Dacuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception,; Cycle control,; Bleeding pattern
Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This trial includes patients with chronic lymphocytic leukemia, the most common kind of
      malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation antigen
      20 have improved treatment results in different forms of lymphomas; however in chronic
      lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been
      suggested that this is depending on a lower expression of the cluster of differentiation
      antigen 20 protein on the chronic lymphocytic leukemia cells.

      Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation
      antigen 20 expression, and the rationale in this study is that an increasement of cluster of
      differentiation antigen 20 would make treatment with monoclonal antibodies in patients with
      chronic lymphocytic leukemia more effective.
    


Intervention name(s): Valproate
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Lymphocytic Leukemia; Valproate; Cluster of differentiation antigen 20; Lymphomas; B-cell lymphomas; Translational research; Monoclonal antibodies
Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome
Condition: Obstructed Defecation Syndrome (ODS)
Study type: Observational

Summary: 
      To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal
      Rectal Resection (STARR)
    


Observational model: Cohort
Time perspective: Prospective
Study population: 
        Patients with ODS and diagnosis of rectal redundancy (intussusception/rectoceles) in MR
        defecography
Intracerebral Gene Therapy for Sanfilippo Type A Syndrome
Condition: Mucopolysaccharidosis Type III A; Sanfilippo Disease Type A
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis III
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical
      study evaluating the tolerance and the safety of intracerebral administration of
      adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the
      treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of
      the investigational medicinal product SAF-301 to both sides of the brain through 6
      image-guided tracks, with 2 deposits per track, in a single neurosurgical session.

      The primary objective is to assess the tolerance and the safety associated to the proposed
      treatment through a one-year follow up.

      The secondary objective is to collect data to define exploratory tests that could become
      evaluation criteria for further clinical phase III efficacy studies.

      Four patients will be included in the clinical trial and will be followed during one year.

      The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The
      Neurosurgery will be performed at Necker-Enfants Malades Hospital.

      Safety will be evaluating on clinical, radiological and biological parameters.
    


Intervention name(s): SAF-301
Intervention type(s): Genetic
Intervention description(s): The treatment plan consists on a direct injection of the investigational medicinal product SAF-301 to both sides of the brain through 6 image-guided tracks, with 2 deposits per track, in a single neurosurgical session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurodegenerative Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Metabolic Diseases; Gene Therapy; Adenovirus Associated Vector
Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to
      quantify the possible deleterious effect on the cardiac autonomic nervous system control of
      two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one
      beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.
    

Detailed description: 
      This is a cross-over study with randomization in terms of 4 treatments: two long-acting
      muscarinic antagonists (tiotropium and glycopyrronium), one long-acting beta-adrenoceptor
      agonist(indacaterol) and placebo.

      Each subject will pass 4 experimental random sessions, separated by at least 48 hours given
      the pharmacokinetic properties of the drugs tested. During each of the 4 sessions, blood
      pressure will be measured. Drugs inhaled by the patient will be prepared and administered by
      the nurse according to the randomization schedule. Patients and investigators will be blinded
      regarding the administered drug/placebo (anonymized inhaler). After 15 minutes (at rest, at
      neutral temperature), patients will have continuous measurement of blood pressure and heart
      rate (by a sphygmomanometer) (1) in supine position and (2) after a passive tilt test on a
      tilt test table.

      A flow-volume loop (BDV) will be performed after the tilt table test (measurement of Forced
      expiratory volume in 1 second (FEV1) and FVC).
    

Intervention name(s): Indacaterol; Glycopyrronium; Tiotropium; Placebo; photoplethysmography
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention description(s): inhalation; inhalation; inhalation; inhalation
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; bronchodilatators; autonomic nervous system; cardiovascular system