bioihbjkbjnl/mcl2 huggingface dataset:
Schizophrenia TreAtment With electRic Transcranial Stimulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct
      current stimulation) for treatment of negative symptoms in patients with schizophrenia. The
      proposed design is a clinical trial, randomized, double-blind, placebo-controlled study.
      Participants will receive ten sessions of active or sham stimulation in five consecutive
      days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be
      assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators
      expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and
      Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for
      Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests.
      Another goal is to see improvement in biological markers related to schizophrenia, plasma and
      DNA will be stored.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): The device will produce a direct current of 2 mA from one electrode to the other. In active stimulation, the device will be turned on for 20 min and in sham stimulation the device will be turned in 2 mA for one minute and will be automatically turned off the remaining 19 minutes. The sham or active mode is chosen by a numeric code.
Other intervention name(s): Transcranial eletric stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; transcranial stimulation
The Effect of Anodal tDCS on Motor Learning in Multiple Sclerosis
Condition: Anodal tDCS; Recruitment Curves
Study type: Interventional

Summary: 
      The current study investigates the effects of tDCS in patients with multiple sclerosis (MS).
      The investigators hypothesize that anodal tDCS will increase motor performance in patients
      with MS.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)
Intervention type(s): Device
Intervention description(s): The anode will be fixed over the primary motor cortex. The cathode will be fixed over the contralateral supraorbital region.
Other intervention name(s): Neuroconn DC-stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients
Condition: Heparin-induced Thrombocytopenia; Liver Transplantation
MeSH terms: Thrombocytopenia
Study type: Observational

Summary: 
      In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT)
      Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological
      findings in thrombocytes and anti-body patterns is going to be investigated.
    

Detailed description: 
      The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and
      their functional activity (HIPA) in 38 whole organ deceased donor liver transplant
      recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and
      laboratory findings (ALAT, ASAT, cholinesterase) were investigated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive livertransplant recipients of our transplant center, organ allocation via
        Eurotransplant Foundation, Leiden, The Netherlands; Laboratory investigations performed at
        the Abteilung für Transfusionsmedizin am Institut für Immunologie und Transfusionsmedizin
        der Universitätsmedizin Greifswald, Greifswald, Germany
      
Keywords: liver transplantation; thrombocytes; heparin-induced thrombocytopenia; multivariate analysis of associated factors of HIT 2 after OLT; laboratory investigations of HIT-antibodies
Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after
      single rising doses (SRD) in healthy Asian male volunteers
    


Intervention name(s): matching placebo; Test drug; matching placebo; Test drug; Test drug; Test drug; Test drug; matching placebo; matching placebo; matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): matching placebo in each dose level; BI 1021958; matching placebo in each dose level; BI 1021958; BI 1021958; BI 1021958; BI 1021958; matching placebo in each dose level; matching placebo in each dose level; matching placebo in each dose level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities
Condition: The Focus of the Study Was to Estimate Energy Expenditure Thanks to Accelerometry Data Collected by a Smartphone.
Study type: Interventional

Summary: 
      The aim of this study was to find functions for estimating energy expenditure in free-living
      conditions. This method was based on accelerometry data acquired from a smartphone worn in a
      trouser pocket. The developed functions have been compared to the estimations provided by two
      research devices named Armband and Actiheart.
    

Detailed description: 
      There is a growing interest in evaluating physical activity and energy expenditure (EE) to
      provide feedback to the user. The use of mass-market sensors such as accelerometers offers a
      promising solution for the general public due to the growing smartphone market over the last
      decade.

      Thus, the proposed EE estimation function has been created using accelerometry data collected
      from 10 volunteers equipped with a smartphone and two research sensors (Armband and
      Actiheart) used to estimate EE during several controlled activities. The research sensors'
      data serves as reference during the creation and evaluation of the proposed function.

      It has been evaluated with data of 6 other volunteers in free-living conditions. This new EE
      function using the smartphone technology is dedicated to light- and moderate-intensity
      activities, and we believe it can be a new way to help people controlling their daily
      physical activity level.
    

Intervention name(s): Energy expenditure estimation in controlled conditions; Energy expenditure estimation in free-living conditions
Intervention type(s): Device; Device
Intervention description(s): Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 3h30 They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.; Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Probiotic for Oral Health (PRO Health) Study
Condition: Oral Microbiome
Study type: Interventional

Summary: 
      The PRO Health Study is a single-center, prospective, double-blind, randomized,
      placebo-controlled trial of streptococcus-containing supplementation in healthy adults.
    

Detailed description: 
      Upon enrollment, healthy adults will enter a 1-week lead-in period which serves as an
      opportunity to collect baseline saliva samples and complete daily logs. Subjects that meet
      eligibility criteria on Day 7 will be randomized into 1 of 2 groups, receiving either a
      placebo-control or a streptococcus-containing probiotic supplement. Supplementation will
      begin on Day 8 and will continue for a total of 14 consecutive days. Participants will be
      observed for an additional 2 weeks following cessation of supplementation. The total duration
      of the study will be approximately 5 weeks. Saliva samples will be collected on 7 occasions
      and participants will be asked to complete questionnaires and daily diet and health logs
      throughout the course of the study.
    

Intervention name(s): Placebo-Control Supplement; Streptococcus-Containing Probiotic Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.; A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be enrolled and randomized, receiving either a streptococcus-containing probiotic supplement or a placebo-control supplement.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
Condition: HIV; AIDS; Lopinavir; Treatment Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine efficacy of ritonavir-boosted lopinavir
      monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed
      Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received
      salvage protease-inhibitor (PI) based regimens.
    


Intervention name(s): Ritonavir-boosted lopinavir; optimized background regimens (OBRs)
Intervention type(s): Drug; Drug
Intervention description(s): Lopinavir/ritonavir 200/50 mg every 12 hours; Optimized background regimens such as NRTIs, etravirine or raltegravir
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV or AIDS; Lopinavir; Ritonavir; Anti-Retroviral Agents; treatment failure; treatment experienced; NNRTI failure; monotherapy
A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
Condition: Alpha₁-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study
      to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI
      compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin
      Deficiency (AATD).
    


Intervention name(s): Liquid Alpha₁-PI; Prolastin-C
Intervention type(s): Biological; Biological
Intervention description(s): Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions; Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
Intervention MeSH terms: Alpha 1-Antitrypsin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a
      single dose to lactating women
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and
        lactating
      
Biospecimen description: 
      1. To obtain blood, urine, and breastmilk samples for pharmacokinetics calculations using a
      scheduled collection and analysis strategy. 2. To calculate distribution ratios for
      hydroxyurea across compartments, especially plasma to milk; and 3. To create population PK
      profiles for hydroxyurea to help calculate potential infant drug exposure
    
Keywords: Hydroxyurea
DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Physical activity is considered essential for optimal health, development, socialization and
      well-being of children. However patients with end-stage renal disease (ESRD) are often
      restricted from participation in exercise activities. This is especially true for children on
      hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most
      impressively after HD. In a nationwide randomized, multi-center design this study aims to
      proof the influence of an individualised endurance training program by bicycle ergometer
      performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary
      goals are to enhance physical performance, physical and mental well-being, and to improve
      measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A
      positive impact of physical activity was observed in adults on HD, although most studies did
      not address this issue in a randomised protocol. Despite this beneficial evidence in adults,
      sport is still not integrated as part of standard care in patients on maintenance HD. The
      study protocol, developed in close collaboration with the German Sport University Cologne,
      differs substantially from previously published reports as it uses bicycle ergometer training
      in an upright position outside the dialysis couch and adapts the intensity of intervention to
      the patient's capabilities. Based on the expected results the investigators will develop an
      individualised training program to be integrated in the standard care of (pediatric) patients
      on maintenance HD.
    


Intervention name(s): Bicycle-Ergometer Training
Intervention type(s): Other
Intervention description(s): Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).
In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hemodialysis; dialysis efficacy; cardiorespiratory capacity; exercise capacity; children and adolescents
Health of Children Born From ICSI With AOA (AOA-BABIES)
Condition: Infertility; Intracytoplasmic Sperm Injection
MeSH terms: Infertility
Study type: Observational

Summary: 
      The investigators follow up on the development of children born from ICSI-AOA using the
      Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires to give strong
      evidence about the safety of AOA in assisted reproductive technology.
    

Detailed description: 
      Intracytoplasmic sperm injection (ICSI) is the most widely utilized assisted reproductive
      technique (ART) worldwide. Fertilization rates obtained after ICSI treatment are reported
      between 70 and 80%, representing the most efficient ART; however, complete post-ICSI
      fertilization failure still occurs in 3-5% of cases.

      The leading cause of failed fertilization is failure to achieve oocyte activation, a crucial
      stage in the initiation of embryo development during fertilization. Assisted oocyte
      activation (AOA) using a calcium ionophore has been used for over a decade following ICSI
      fertilization failure. AOA is not considered a routine practice of ART yet, which is only
      suitable for patients with proper indications, including (i) total fertilization failure or
      low fertilization rate (<30%) in the previous IVF; (ii) severe male factor infertility; (iii)
      patients with a history of embryo arrest or poor embryo quality in previous IVF cycle.

      Regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the
      physiologically sperm-induced calcium oscillations. Little is known yet about the possible
      adverse effects of ionophores on post-implantation embryo development. Numerous studies have
      been conducted to compare the development of children born from ICSI - AOA versus non-AOA.
      Thus, the investigators performed this study to investigate the physical, mental, and motor
      development of children born following ICSI - AOA using the Developmental Red Flags and Ages
      & Stages Third Edition (ASQ-3) Questionnaires.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the ICSI+AOA group, indications of AOA are:

          -  Previous failed IVF treatment with no fertilization or poor fertilization rate
             (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of
             embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)

          -  Using sperm after retrieval technique, cryptozoospermia

        In the Control group, the indications of AOA for the next IVF cycle (if patients continue
        the next IVF cycle) are:

          -  Currently failed IVF treatment with no fertilization or poor fertilization rate
             (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of
             embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
      
Keywords: ICSI; Total fertilization failure; AOA; ASQ-3; Health of children
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor
      activity in subjects that are chronically constipated.
    


Intervention name(s): prucalopride; PEG 3350
Intervention type(s): Drug; Drug
Intervention description(s): One 2 mg tablet orally administered on Day 1; 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).
Other intervention name(s): Resolor (Marketed name in Europe); Movicol
Intervention MeSH terms: Prucalopride; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
Condition: Histamine Responsive Allergy Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the
      measurement of the wheal and flare from histamine skin prick testing. This is an open label,
      two-week, post-marketing study conducted on histamine responsive patients.
    


Intervention name(s): Bepreve; Refresh Tears
Intervention type(s): Drug; Drug
Intervention description(s): Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily; Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment
Other intervention name(s): bepotastine besilate
Intervention MeSH terms: Bepotastine besilate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: allergic conjunctivitis; histamine skin testing
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The aim of this study is to establish and validate High resolution manometry (HRM) criteria
      for the definition of transient lower esophageal sphincter relaxations (tLESRs) in
      gastroesophageal reflux disease (GERD) patients.
    

Detailed description: 
      tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient
      lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant
      therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors.
      HRM is the gold standard for detecting and characterizing tLESR, and could be considered as
      part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the
      objective definition of tLESRs in GERD patients have to be established, as it has been done
      in healthy patients Subjects will undergo impedance / manometry recording with solid-state
      catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
    

Intervention name(s): High resolution manometry
Intervention type(s): Procedure
Intervention description(s): Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GERD; tLESR; impedance; manometry