bioihbjkbjnl/mcl2 huggingface dataset:
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the within-subject
      variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in
      children and adolescents with type 1 diabetes.
    


Intervention name(s): insulin detemir; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin); On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Lapaquistat Acetate Coadministered With Atorvastatin in Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily
      (QD), coadministered with a statin to lower lipid levels in Subjects with
      Hypercholesterolemia.
    

Detailed description: 
      Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances
      (dyslipidemias) are major risk factors for coronary heart disease. Normally, the balance
      among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy
      cholesterol plasma levels. However, in patients with hypercholesterolemia, elevation in
      low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the
      arterial walls. Consequently, it has been established that lowering the low-density
      lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity and
      mortality. As a result of this finding, the National Cholesterol Education Program Adult
      Treatment Panel III identifies control of low-density lipoprotein cholesterol as essential in
      the prevention and management of coronary heart disease. Additional lipid risk factors
      designated by Adult Treatment Panel III include elevated triglycerides, elevated non-high
      density lipoprotein cholesterol, and low levels of high-density lipoprotein cholesterol.
      Lipoproteins rich in triglycerides, such as very low-density lipoprotein cholesterol, appear
      to contribute to atherosclerosis, whereas the apparent protective effect of high-density
      lipoprotein cholesterol may be limited at low density lipoprotein concentrations.

      TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at
      Takeda for the treatment of dyslipidemia.
    

Intervention name(s): Lapaquistat acetate and atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Lapaquistat acetate 100 mg, tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.; Lapaquistat acetate placebo-matching tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
Other intervention name(s): Lapaquistat acetate; Lipitor; TAK-475; Lipitor; TAK-475
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia; Drug Therapy; Dyslipidemia
Safe, Healthy, Adolescent Relationships and Peers
Condition: Juvenile Delinquency Unspecified; Risk Behavior; Adolescent Behavior; Sexual Behavior; Drug Use
Study type: Interventional

Summary: 
      The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the
      factors that contribute to the behaviors and health of teen girls, such as girl's
      friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about
      how to make healthy choices. This study will inform us on ways to help teen girls engage in
      safe and healthy relationships and adjustment.
    

Detailed description: 
      Initiation of drug use and participation in sexual-risk behaviors such as having multiple
      sexual partners, unprotected sexual intercourse, and intercourse with drug users are all too
      common among girls with at-risk histories, such as those who have experienced poverty, abuse,
      neglect, or been in the juvenile justice system. Studies consistently find that these girls
      have disproportionately high rates of these problems that, in addition to increasing risk for
      negative outcomes, have other costly sequelae such as drug addiction, early pregnancy,
      sexually-transmitted infections (STIs) and HIV contraction, delinquency, and early mortality
      (e.g., Santelli et al., 2001; Stueve et al., 2005). In our prior work, the investigators
      showed that the investigators could prevent early onset sexual intercourse and tobacco and
      marijuana initiation in pre-teen girls in foster care. Although this intervention, delivered
      to girls who were 11-years old and had not yet entered middle school, demonstrated efficacy,
      the investigators know very little about how to prevent the more serious and costly
      sexual-risk and illicit drug use behaviors in at-risk girls during the high school years, a
      period of risk for engagement in such behaviors. This study builds from this prior work to
      develop a new intervention for teenage girls with early adversity.
    

Intervention name(s): Parent Ed. and Youth Skills Coaching; Services as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills.; Services as usual as provided by community service organizations from which the sample was drawn.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
Condition: Patients With Borderline Resectable Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      FOLFIRINOX regimen was recently presented at an international oncology meeting and represents
      a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of
      the high response rate treatment regimen , the investigators considered as a promising
      treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4
      neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX
      group compared with gemcitabine group. Therefore, it was decided to consider the balance of
      safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen
      by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from
      FOLFIRINOX regimen
    

Detailed description: 
      FOLFIRINOX regimen was recently presented at an international oncology meeting and represents
      a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of
      the high response rate treatment regimen , the investigators considered as a promising
      treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4
      neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX
      group compared with gemcitabine group. Therefore, it was decided to consider the balance of
      safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen
      by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from
      FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX
      therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0
      resection rate, and resection rate for borderline resectable pancreatic cancer.
    

Intervention name(s): FIRINOX
Intervention type(s): Drug
Intervention description(s): FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.
Other intervention name(s): Oxaliplatin, Irinotecan, 5-FU.
Intervention MeSH terms: Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Borderline resectable pancreatic cancer; R0 resection; Resection rate; Optimal schedule
Evaluation of Glycemic Variability (GLAIVE)
Condition: Critical Illness; Anesthesia
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      This study compared two methods of insulin infusion by syringe pumps to assess the impact of
      medical devices on the glycaemic variability in patients under IIT in ICU. The main objective
      of the study was to show the superiority of the infusion system which permitted to dedicate a
      line for the insulin administration on the "standard" installation in terms of control of
      glycaemic variability.
    


Intervention name(s): Edelvaiss Multiline-8; Standard infusion line
Intervention type(s): Device; Device
Intervention description(s): Optimised infusion line
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Glycemic lability index; Continuous glucose monitoring system; intensive care; Insulin
Breastfeeding Education Support Tool for Baby
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This study will compare data associated with breastfeeding experiences and
      outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months
      of an infant's life, and breastfeeding duration--among 120 subjects recruited late in
      pregnancy and provided peer counseling and education services incorporating mobile health
      (mHealth) tools during a period of at least 6 months post-delivery with the data collected
      from a control group of approximately 120 mothers that did not receive the study
      intervention.
    

Detailed description: 
      Approximately 24 women that are experienced in breastfeeding will be recruited to serve in
      the role of breastfeeding peer counselors. These women will assess usability and
      acceptability of mobile health (mHealth) education tools designed following a series of focus
      groups for the project, Breastfeeding Education Support Tool for Baby. The mHealth tools will
      be used during the training and education of the peer counselor subjects. Following
      appropriate modification, some of the mHealth tools will be used with a total of
      approximately 120 women recruited late in pregnancy for initial breastfeeding counseling
      before delivery and the subsequent provision, for at least 6 months post-delivery, of home
      visits for peer counseling and education that integrates use of mHealth tools. Peer
      counselors and research staff will gather data from mothers receiving the intervention about
      breastfeeding experiences and outcomes, including breastfeeding continuation after
      initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration. This
      data will be compared to data obtained through surveys administered to a control group of
      approximately 120 maternal subjects that received standard pre- and post-delivery care but
      not the study intervention of peer counseling and education using mHealth tools.
    

Intervention name(s): Breastfeeding counseling and education services
Intervention type(s): Other
Intervention description(s): Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group having peer counseling and education and a comparative (control) group having standard of care
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Initiation, Exclusivity, Duration
Visual Dependence and Multisensory Balance Rehabilitation After Stroke
Condition: Stroke; Balance; Distorted; Gait, Unsteady
MeSH terms: Stroke; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      This cross-sectional study aims to investigate the prevalence of post-stroke visual
      dependence, and the effects of visual dependence on balance and gait. It also determines
      whether visual dependence could differentiate stroke patients with a history of falls from
      without.
    

Detailed description: 
      Stroke participants will be recruited to measure the level of visual dependence, muscle
      strength, neurological recovery, balance ability, vertigo symptom, gait pattern and
      activities of daily living. This will calculate the prevalence of post-stroke visual
      dependence, and investigate the negative impact of visual dependence on balance and walking
      functions. This also determines whether the value of visual dependence could differentiate
      stroke patients with a history of falls from without a history of falls.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chronic stroke patients with the first stroke will be recruited from the 3 departments of
        physical and rehabilitation medicine, regional hospitals.
Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo
Condition: Soft Tissue Mobilisation; Vestibular Exercises; Physiotherapy; Vertigo, Paroxysmal; Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Vertigo; Dizziness
Study type: Interventional

Summary: 
      The purpose of this study was to investigated effectiveness of temporamandibular joint and
      soft tissue mobilization on patients with Benign Paroxysmal Positional Vertigo (BPPV).
    

Detailed description: 
      Aim: In this study was aimed to investigated effectiveness of temporamandibular joint and
      soft tissue mobilization on patients with Benign Paroxysmal Positional Vertigo (BPPV).
      Material and Methods; Dix Hallpike maneuver was administered to all patients to confirm the
      diagnosis at the initial evaluation. If the Dix Hallpike test was positive, Epley maneuver
      was applied The patients were randomly divided into 2 groups as study group (n=) and control
      groups (n= ). Temporomandibular joint ve soft tissue techniques were applied 30 minutes once
      a week for 4 weeks by physiotherapist. Routin medication therapy was applied to control
      group. Both groups were asked to do the home exercise program twice a day consisting of
      vestibular exercise videos sent over whatss app. It was questioned with a phone call once a
      week whether the exercises were done or not. Patients were evaluated by Dizziness Disability
      Inventory (DHI) , Dizziness Assessment- Visual Analogue Scale (VAS), Vertigo Symptom
      Scale-Short Form (VSS) , Beck Anxiety Inventory (BAI) , Vertigo Dizziness Imbalance
      Questionnaire (VDI) , Tinnitus Disability Scale (TDS), Romberg Posture Test , Tandem Posture
      Test, Semitandem Tandem Balance Test, Fonseca's Anamnestic Index (FAI) and amount of mouth
      opening was measured with goniometer before and after treatment.
    

Intervention name(s): Study Group; Control Group
Intervention type(s): Behavioral; Other
Intervention description(s): Study Group (n= 20) was recieved Temporomandibular joint ve soft tissue techniques. The techniques were applied 30 minutes once a week for 4 weeks by physiotherapist to the study group.; Routin medication therapy was applied to the control group. Both groups were asked to do the home exercise program twice a day consisting of vestibular exercise videos sent over whatss app. It was questioned with a phone call once a week whether the exercises were done or not.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bening Paroxymal Positional Vertigo; Temporomandibular Joint Mobilization; Soft Tissue Mobilisation; Vestibular Exrecises; Physiotherapy; Otorhynology
99Tc-MDP for Thyroid-Associated Ophthalmopathy
Condition: Thyroid-Associated Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to
      Methylprednisolone, in the treatment of participants suffering from active moderate to severe
      TAO.
    


Intervention name(s): Methylprednisolone; 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
Intervention type(s): Drug; Drug
Intervention description(s): 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.; 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Other intervention name(s): Yunke
Intervention MeSH terms: Methylene diphosphonate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Technetium Tc 99m Medronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 99Tc-MDP; TAO; efficacy; safety
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride
      Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.
    

Detailed description: 
      A randomized, open label, two treatment, two period, two sequence, single dose, crossover
      bioequivalence study of Fluoxetine Hydrochloride Delayed-Release capsules 90 mg of Dr.
      Reddy's laboratories limited, Generics, India and Prozac®weekly 90 mg delayed release
      capsules of Eli Lilly and company, USA in healthy adult human subjects under fed conditions.
    

Intervention name(s): Fluoxetine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Other intervention name(s): Prozac ® weekly 90 mg Delayed Release Capsules
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Fluoxetine Hydrochloride
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Condition: Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in
      the management of patients with rhinitis and the first line of treatment in patients with
      urticaria. Currently, the use of antihistamines has become popular due to its excellent
      safety profile and clinical efficacy, however to the investigators knowledge, there are no
      studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of
      tropical Latin America. The investigators main interest is to evaluate if skin test
      inhibition correlates with the clinical effect of five anti-histamines.
    

Detailed description: 
      This was a randomized, double-blind, study that was conducted in six health care centers from
      Medellín and Bogotá (Colombia). This study was conducted in compliance with the ethical
      principles of the Declaration of Helsinki and with Good Clinical Practice guidelines. Written
      informed consent was obtained from all subjects or they parents in patients under 18 years.
      Ethical committee of University of Antioquia (Medellín, Colombia) approved the protocol.
      Considering the large number of articles that demonstrate the efficacy of antihistamines as
      first-line treatment in patients with urticaria, the ethics committee request that all
      participants would receive an antihistamine during the two months of the study because a
      placebo group would provide little information for the principal objective and the high risk
      of airway angioedema. Thirty heath subjects were used as a control group to evaluated the
      characteristics of the wheal in the prick test with histamine.
    

Intervention name(s): Cetirizine; Desloratadine; Fexofenadine; Ebastine; Bilastine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug administration; Drug Administration; Drug administration; Drug administration; Drug administration
Other intervention name(s): Alercet; Aerius; Allegra; Pinaval; Bilaxten
Intervention MeSH terms: Cetirizine; Fexofenadine; Desloratadine; Ebastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: urticaria; bilastine; fexofenadine; cetirizine; ebastine; desloratadine
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units
      and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
      angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

      Secondary Objectives - To assess the safety and tolerability, characterize the
      pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
      levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
    


Intervention name(s): CINRYZE 500; CINRYZE 1000
Intervention type(s): Biological; Biological
Intervention description(s): 500 Units of CINRYZE administered by IV injection; 1000 Units of CINRYZE administered by IV injection
Intervention MeSH terms: Complement C1 Inhibitor Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pediatric; C1 inhibitor; HAE; Cinryze; C1 INH; Prevention