bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics
      of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with
      faldaprevir in healthy male and female subjects.
    


Intervention name(s): BI 207127 + faldaprevir
Intervention type(s): Drug
Intervention description(s): fixed dose combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Working Memory Training in Young ADHD Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether working memory training improves
      behavioral symptoms, neurocognitive performance, and neural functioning in young children
      with ADHD.
    


Intervention name(s): Cogmed Working memory training; Control version of Cogmed working memory training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 minutes of working memory training, 5 days a week for a period of 5 weeks; 15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention deficit disorder with hyperactivity; Working memory training; Placebo; Behavioral symptoms; Neuropsychology; Electropsychophysiology
Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation
Condition: Healthy
Study type: Interventional

Summary: 
      The left ventricular torsion during systole and diastole is a normal dynamic mechanism which
      participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic
      modifications are major and probably affect this mechanism. The aim of this study is to
      compare the left ventricular twist in healthy newborns, between their first days of life and
      their third month of life, using the 2D-speckle tracking echocardiography.
    

Detailed description: 
      The left ventricular torsion during systole and diastole is a normal dynamic mechanism which
      participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic
      modifications are major and probably affect this mechanism.

      The main objective is to compare the left ventricular twist mechanism in healthy newborns, at
      birth and at their third month of life, using the peak LV twist as primary endpoint.
      Secondarily, we compare other LV rotation and deformation parameters during the same period:
      peak LV torsion, peak LV twist rate, peak LV untwist rate, circumferential strain and radial
      strain. Finally, we compare the endo- and epicardial LV deformation, using the inner and
      outer circumferential strain as endpoints.

      This is a longitudinal, prospective and monocentric study in the Grenoble-Alpes University
      Hospital between April 2018 and September 2018.

      The number of required subjects is 30 with a statistical power of 80% and a p-value of 0,05
    

Intervention name(s): Echocardiography
Intervention type(s): Other
Intervention description(s): Two echocardiographies will be performed in healthy newborns: The first between day 2 and day 5 of life, the second between day 60 and day 90 of life
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Left ventricular Twist; 2D-speckle-tracking; Postnatal adaptation
Behavioral Therapy for Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional

Summary: 
      Tourette Syndrome (TS) is a common neuropsychiatric disorder in childhood and adolescence,
      and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the
      first choices, but may associate with adverse effects. Behavioral intervention for TS has
      been shown to be an effective treatment for children and adolescents, yet have not been
      performed and evaluated using control trails in Taiwan.
    

Detailed description: 
      TS is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid
      with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but
      may associate with adverse effects. Behavioral intervention for TS has been shown to be an
      effective treatment for children and adolescents, yet have not been performed and evaluated
      using control trails in Taiwan. This study therefore was to evaluate the efficacy of a
      comprehensive behavioral intervention therapy on improving tics and tic-related impairment
      for children and adolescents with Tourette syndrome.
    

Intervention name(s): habit reversal training (HRT)
Intervention type(s): Behavioral
Intervention description(s): The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment.
Pyridoxine(50mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A collection of behavioral skills named as Comprehensive Behavioral Intervention (CBIT) for Tics had been found to be effective (Piacentini et al., 2010).The major components of CBIT includes psychoeducation of tics, habit reversal training (HRT), function-based interventions, and relaxation training (Piacentini et al., 2010).The HRT consists of several therapeutic activities, including awareness training (i.e., observing the premonitory urge or other signs preceding the occurrence of a tic), competing response training (i.e., engaging in a voluntary behavior that is physically incompatible with the tic to manage the premonitory urge), self-monitoring of tics and relaxation training (Himle et al., 2006).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tourette syndrome; behavior therapy; children and adolescents
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
Condition: Healthy
MeSH terms: Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1,
      multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding
      of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory
      syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center
      study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in
      healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening.
      MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to
      three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine
      (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal
      spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1
      (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be
      stratified by site. This study will enroll during the RSV off season at multiple sites in the
      United States and Chile.
    

Intervention name(s): MEDI-534; MEDI-534; MEDI-534
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 10:4 TCID50 of MEDI-534 intranasal spray Study Day 0; 10:5 TCID50 of MEDI-534 intranasal spray Study Day 0; 10:6 TCID50 of MEDI-534; intranasal spray
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lower respiratory tract illness; RSV and PIV3 infection
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will examine whether the effects of computerized brain training are enhanced when
      training is combined with mild brain stimulation in patients with mild cognitive impairment.
      We hypothesize that this combination will produce greater improvements in cognitive
      functioning than computerized brain training alone.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      MT-3921 in subjects with spinal cord injury.
    

Detailed description: 
      This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal
      cord injury.
    

Intervention name(s): MT-3921 Low dose
Intervention type(s): Biological
Intervention description(s): MT-3921 Low dose, intravenous, single dosing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to assess the bioequivalence of Olanzapine tablets of two different
      manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two
      different manufacturers.
    

Detailed description: 
      A comparative, open-label, randomized, two-period, two-treatment, two-sequence, two-way
      crossover clinical trial to evaluate the bioequivalence of single doses of test product
      Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) and reference product Zyprexa®
      coated tablets 5 mg (Eli Lilly, Nederland B V) in healthy, adult male and female subjects
      under fasted conditions.

      During each period 22 blood samples were taken in each Study Period: prior to dosing (-1.0)
      and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 14.0,
      16.0, 24.0, 48.0 and 72.0 hours after IMP administration.
    

Intervention name(s): Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine); Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
Intervention type(s): Drug; Drug
Intervention description(s): After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .; After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .
Other intervention name(s): Adagio film-coated tablets 5 mg (JSC Farmak, Ukraine); Olanzapine
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Olanzapine
Vitamin D Status and Immune Function
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to examine the relationship between Vitamin D status and
      immunity.
    

Detailed description: 
      Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D
      levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is
      associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo
      immunity is limited. This observational study aims to investigate the relationship between
      Vitamin D status and the in vivo immunity.
    

Intervention name(s): In vivo immunity model
Intervention type(s): Other
Intervention description(s): A measure of in vivo immune function.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adults who are starting basic training in the army.
      
Biospecimen description: 
      Blood serum collected at Week 1 (start of training) and Week 13 (end of training).
Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Condition: Coronary Stenosis
MeSH terms: Coronary Stenosis
Study type: Observational

Summary: 
      Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the
      accepted management of choice for significant blockage of the carotid artery. Previous
      studies showed improved perioperative outcomes and prevention of recurrent blockage by the
      use of the patch to close the surgical incision in the artery. The ideal patch reduces
      bleeding and prevents recurrent blockage.This is looking at long-term results toward
      improvement with the use Accuseal patch than Bovine Patch.
    

Detailed description: 
      This study will be a prospective, randomized, evaluation comparing the outcomes resulting
      from the use of two different patches (Accuseal vs Bovine Pericardial) used for CEA.Our
      proposed study will evaluate the perioperative (within 30 days of operation) and long-term (6
      month, 1 year, 2 year, 3 year) complications associated with the Accuseal and Bovine
      Pericardial patches. This will include thrombosis of the carotid artery, and the degree of
      recurrent plaque formation of the patched artery as determined by duplex ultrasound
      evaluation in the perioperative and long-term periods.Patients will be blinded to the type of
      patch they received.Survival analysis (Kaplan-Meier) (used in this case for time to the event
      analysis) will be used for time to restenosis, time to stroke, and time to late death.
    

Intervention name(s): Comparing Accuseal Vs. Bovine Pericardial in CEA
Intervention type(s): Procedure
Intervention description(s): Accuseal patch - The Goretex Company has since designed a new patch, "the Accuseal," which is marketed as decreasing the intra-operative time (i.e, having a short hemostasis time) without affecting the perioperative stroke rate.
Bovine Pericardial patch - The Bovine Pericardial patch has been used for nearly two decades, since the late 1990s. However, studies based on retrospective review of data in which patients received the Bovine Pericardial patch, reported the clinical outcomes post-operative stroke, death, time to hemostasis and recurrent restenosis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population includes Carotid Endarterectomy (CEA), surgical removal of the blockage in
        the neck artery patients.
      
Keywords: Patch for Carotid Endarterectomy
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the use of resources during titration of Duodopa at
      home.
    

Detailed description: 
      Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa
      infusion at home. The study evaluated the use of resources, measured as the number of
      contacts and time spent by health care professionals (Duodopa nurse specialists and the study
      Investigators) and the TM technician, during Duodopa infusion at home. Data was collected
      from four (4) clinical centers in Sweden. Data collection period for each participant started
      at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa
      titration period was complete. Post-titration, the participants and caregiver were
      interviewed and the investigators and nurses answered a web based questionnaire on their
      experiences.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with advanced Parkinson's disease admitted to movement disorder specialty
        clinics
      
Keywords: LCIG; Parkinson's disease; levodopa carbidopa intestinal gel; Telemedicine
In Utero Capacity Formation and Socio-economic Outcomes
Condition: Folic Acid Deficiency
MeSH terms: Folic Acid Deficiency
Study type: Observational

Summary: 
      Because of the high returns of schooling in developing countries, policymakers pay a lot of
      attention to increasing school access. But if the mother is deficient in key micronutrients,
      brain development can biologically constrain children's demand for education. To execute this
      strategy, the investigators collect cohort observational data on a previous randomized
      controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar
      es Salaam, Tanzania, between 2001 to 2003.
    

Detailed description: 
      This is a cohort study which collected follow-up observational data on households which were
      offered micronutrient supplements. The followup study outcomes include various socio-economic
      household characteristics and parental post-natal behaviors.
    

Intervention name(s): observational follow-up
Intervention type(s): Other
Intervention description(s): observational follow-up
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals from a larger study and this study is an observational follow-up.
Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      In a prospective case-control study, 140 medical students (,novices') and 10 Senior
      gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone
      (LLETZ) on a Training model afte having undergone a Video Training session. Their
      LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical
      Skills (OSATS) protocol designed for judging the surgical proficiency when performing a
      LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training
      model to distinguish between experts and novices will be assessed. Secondary endpoints are
      differences in OSATS scores within the group of novices based on gender and handyness, as
      well as satisfaction of the novices with the learning experience.
    

Detailed description: 
      In a prospective case-control study, 140 medical students (,novices') and 10 Senior
      gynecologists (,experts') will be included. All participants undergo a video training with
      demonstration of the LLETZ procedure on a training model using a sausage as previously
      described (Hefler et al. 2014). After the Video Training, the LLETZ procedure will be
      performed by the study probands and their performance will be assessed using an Objective
      Structured Assessment of Technical Skills (OSATS) protocol with 23 consecutive items. The
      exact time Frame for the assessment of the Primary outcome is within 1 hour after the Video
      Training. Using metrical and non-metrical items, the construct validity of the LLETZ training
      model to distinguish between experts and novices will be assessed. The study hypothesis is
      that the LLETZ Training model as used in this study has construct validity and is therefore a
      valid Instrument to discriminate between experts and novices. Secondary endpoints are
      differences in OSATS scores within the group of novices based on gender and handyness, as
      well as satisfaction of the novices with the learning experience.
    

Intervention name(s): LLETZ on a training model
Intervention type(s): Procedure
Intervention description(s): LLETZ is performed on a sausage-based training model using all surgical devices used in the original procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Profermin® in Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study the investigators aim was to investigate the safety and possible efficacy of
      Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the
      usefulness of a new online daily symptom registration system.
    


Intervention name(s): Profermin
Intervention type(s): Other
Intervention description(s): Medical Food (food for special medical purposes)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hyaluronic Acid Gel in Ridge Preservation
Condition: Hyaluronic Acid Gel for Preservation the Extraction Socket
Study type: Interventional
Phase: Phase 4

Summary: 
      hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve
      the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and
      new bone formation.
    

Detailed description: 
      twenty-four patients with one hopeless tooth at least, first CBCt before extraction to
      evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the
      bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid
      gel inside the socket and applied collagen membrane to secure the socket. After 4 months of
      extraction, CBCt was done to evaluate the dimension of the socket and the effect of
      hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of
      implant placement for evaluate the histological appearance of the bone to evaluate the
      secondary outcome. then after three months the crown was delivered as a prosthetic part.
    

Intervention name(s): Hyaluronic acid; empty socket
Intervention type(s): Drug; Other
Intervention description(s): Alveolar ridge preservation by atraumatic tooth extraction and socket curettage then application hyaluronic acid gel after extraction and covering the socket by collagen membrane.; Alveolar ridge preservation by atraumatic tooth socket without application any drug but just covering the socket by collagen membrane.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hopeless anterior tooth; atraumatic extraction; hyaluronic acid gel