bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      It is of interest how ezetimibe alone or in combination with statin may influence atherogenic
      dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary
      objective of this study will be whether there is a change of the concentrations of
      Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.
    

Detailed description: 
      The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of
      cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with
      statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2
      diabetes mellitus.

      The primary objective of this study will be whether there is a change of the concentrations
      of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The
      comparison between treatment groups is exploratory due to insufficient power to detect any
      change between treatments.
    

Intervention name(s): ezetimibe; simvastatin; Ezetimibe 10/Simvastatin 20
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe 10 mg per day for six weeks; Simvastatin 20 mg per day for six weeks; Ezetimibe 10mg/Simvastatin 20mg per day for six weeks
Other intervention name(s): Ezetrol 10 mg; Zocor MSD; Inegy 10/20
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atherogenic lipoprotein; cardiovascular disease; coronary artery disease; type 2 diabetes; small, dense LDL
Effects of Probiotic VSL#3 on Expression of Small Intestinal Renin-angiotensin System
Condition: the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Probiotics have become very popular and are by WHO defined as "Live microorganisms which when
      administered in adequate amounts confer a health benefit on the host". For example,
      probiotics have been shown to contribute to improvements of abdominal discomfort and
      intestinal inflammation. The main hypothesis behind the present study is that probiotics
      influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II
      locally in the intestinal mucosa.
    


Intervention name(s): VSL#3; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The probiotic product VSL#3® comes in a powder (sachet) that is to be dissolved in half a glass of cold water before ingestion. Two sachets are ingested once daily over 2 weeks.
Each dose (sachet) contains 450 billion live (lyophilized) lactic acid bacteria (in defined ratios of the following strains: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus) and are delivered in a base of maltose and silicon dioxide.; Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: renin; angiotensin; probiotic; glucose absorption; intestinal
The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels
Condition: Nursing Caries; Anxiety; Fear
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Objective: The study was carried out in a randomized controlled manner to determine the
      effect of the watching cartoons on the fear and anxiety levels of children during treatment.

      Method: The population of the study consisted of children aged 5-10 years who were brought to
      a state hospital in a southeastern province for blood collection. A total of 92 children, 43
      of whom were in the cartoon group and 49 of which were in the control group, were included in
      the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child
      Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the
      treatment. Anxiety and fear levels before and during the blood collection were evaluated in
      the cartoon and control groups. The anxiety level of the children was evaluated according to
      their own expressions, and the level of fear was evaluated independently according to both
      the children's own statements and the observers' statements.
    


Intervention name(s): cartoon group
Intervention type(s): Other
Intervention description(s): The children in the groups were distracted by watching cartoon 2 minutes before treatment, until the process was over
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anxiety; fear; nursing
Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

      To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and
      faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of
      total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in
      plasma
    

Detailed description: 
      Monocentre, open, non-placebo-controlled, single-group, single-dose study. Safety
      measurements (12-lead ECG, vital signs, blood chemistry and haematology) were conducted
      before and after the study, adverse events were monitored throughout the study.

      Each subject was to receive a single oral dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg).
      This was the intended radiolabelled dose without any losses; the actual administered dose was
      of 2.29 MBq [14C]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the
      administration until 264 hours thereafter.

      Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for
      total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its
      metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4,
      6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose.

      Urine was sampled before the drug administration (pre-dose), then it was collected from 0-4,
      4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.

      Aliquots of each sample were taken for liquid scintillation counting by the investigator.

      Aliquots were separated for determination of parent drug and metabolite patterns.

      A baseline faeces sample was obtained during the screening or baseline period. Following
      dose, each faeces sample was collected in a separate container during the 264 hours post-dose
      period.

      Vomitus (if produced) was collected.
    

Intervention name(s): BIA 3-202 (200 mg)
Intervention type(s): Drug
Intervention description(s): 200 mg powder for oral use of unlabelled BIA 3-202
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nebicapone, Parkinson's disease
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive
      placebo in the treatment of schizophrenia
    


Intervention name(s): Pimavanserin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth; Placebo, taken as two tablets, once daily by mouth
Intervention MeSH terms: Pimavanserin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and
      procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway
      inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly
      Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is
      used as a bronchodilator in the management of reversible airways obstructive pulmonary
      disease. Budesonide and Procaterol therefore have complementary effects, treating two
      different components of asthma.
    

Detailed description: 
      Test drug: SYN006 HFA MDI Batch No: BPP-033-088 Dosage Form: HFA Metered Dose Inhaler Active
      Substance: Budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose Dosage regimen:
      Multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen
      consecutive doses
    

Intervention name(s): Budesonide/Procaterol 180/10 X 4 puffs
Intervention type(s): Drug
Intervention description(s): Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose
Other intervention name(s): SYN006 HFA MDI
Intervention MeSH terms: Budesonide; Procaterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis
Condition: Periodontal Intrabony Defect
Study type: Interventional

Summary: 
      clinical trial was conducted to evaluate regenerative potentials of cultured gingival
      fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony
      periodontal defects in human by clinical and radiographic parameters
    

Detailed description: 
      In the present study, twenty posterior two or three osseous intrabony periodontal defects
      were involved . They were grouped in to two groups. Group I included ten intrabony posterior
      defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten
      posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(GF)
      and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a
      resorbable collagen membrane. CBCT was used preoperatively and after 6 months for hard tissue
      evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.
    

Intervention name(s): GF+GMSCs carried on β TCP; β TCP bone substitute only
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Gersey, USA).
Ibuprofen; surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
Condition: Precapillary Pulmonary Hypertension; Interstitial Lung Disease
MeSH terms: Lung Diseases; Hypertension, Pulmonary; Lung Diseases, Interstitial; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of travelling to moderate altitude and
      of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of
      patients with pulmonary hypertension or with interstitial lung disease.
    

Detailed description: 
      Patients with pulmonary hypertension or with interstitial lung disease living below 800 m
      will be invited to participate in a randomized, cross-over field trial evaluating the
      hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced
      in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate
      altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen)
      administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich,
      490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St.
      Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low
      altitude (<800 m). The order of stays at the different altitudes and of the treatments will
      be randomized.
    

Intervention name(s): Moderate altitude sojourn; Low altitude sojourn; Oxygen; Sham oxygen (room air)
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention description(s): Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days; Low altitude baseline evaluations will be performed during a stay at Zurich (490); Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m; Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Other intervention name(s): Moderate altitude sojourn at 2048 m for 2 days; Low altitude sojourn at 490 m (Zurich) for 1.5 days; Nocturnal nasal oxygen administration during stay at 2048 m; Nocturnal nasal room air administration
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary hypertension; Interstitial lung disease; Pulmonary fibrosis
Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk
      for type 2 diabetes. The function of the endothelium has played a key role in the
      understanding of vascular complications in people with diabetes. Endothelial function and
      vascular reactivity are impaired not only in white adults with type 2 diabetes but also in
      those at risk for the disease by virtue of having impaired glucose tolerance or parental
      history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The
      investigators plan to assess the endothelial function and vascular reactivity in young
      Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging
      to a minority population.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Young Latino adults with and without family history of type 2 diabetes
The Efficacy of Symbiotic on Cytokines
Condition: Necrotising Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this prospective double blinded randomised study is to investigate the efficacy of
      symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum,
      Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama
      acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory
      pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing
      enterocolitis pathogenesis in very low birth weight neonates.
    

Detailed description: 
      Inclusion criteria:

        1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights

        2. Neonates who tolerated minimal enteral feeding within postnatal first week

      Exclusion criteria:

        1. PROM> 24 hours and/or chorioamnionitis

        2. Mechanic ventilation supply more than 7 days

        3. Culture proven sepsis

        4. Major congenital anomaly

        5. Patients undergoing surgery

      Intervention:

      The allocations will contain in opaque, sequentially numbered sealed envelopes. The study
      group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily);
      whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily)
      which will be added to breast milk or formula starting with the first feed.0.5 cc blood
      sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This
      samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will
      be analysed by ELISA multiplex method.
    

Intervention name(s): distilled water; symbiotic
Intervention type(s): Other; Drug
Intervention description(s): 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days; Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Other intervention name(s): Probiotic ATP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Symbiotic,cytokines, necrotising enterocolitis
Human Neutral Body Posture in Weightlessness
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The scientific goal of this experiment is to evaluate the performances of our
      three-dimensional digital model by comparing its prediction computed from underwater data to
      posture observed during real weightlessness during parabolic flight.
    

Detailed description: 
      Investigations description Throughout the experiment test subject will be safely attached to
      a fixation mechanism at its center of gravity (hip). This mechanism comprises a climbing
      harness connected to two lateral vertical guides by two magnetic connection plates at the
      level of the hips. The test subject will lie down on the floor on a plate equipped with foam
      pads to create a comfortable lying surface. This mechanism allows free postural movement in
      microgravity phase and also supports the test subject´s lying position during 1,8g- phase. At
      any stage of the experiment the test subject will be able to exit the fixation alone, by
      using one hand only.

      The harness can be moved vertically by a linear sliding system and springs in the vertical
      guides. Springs will remain compressed during the 1g/2g-phase and lift the subject with the
      reduction to microgravity.

      At the beginning of the weightlessness phase of each parabola, the sliding system will push
      participant's body up to about 30cm above the floor. After he has reached the free floating
      position, he will be asked to perform a short effort (crouching or stretching) and then to
      relax and stay still.

      Once free floating, three video cameras with wide angle lenses will record body movements
      from front, side and top view. By electronically synchronizing the cameras the produced
      images can be used for three-dimensional analysis. Additionally three-dimensional force
      sensors at the hip fixation will be used to evaluate the quality of microgravity provided
      during the parabolic flight.

      Experimental protocol Before flight subjects will be familiarized with the setup and the
      protocol. For each flight day, 3 subjects will be studied. The procedure will be the same for
      the 3 subjects and on all 3 days.

      The subject rests calm at the bottom until microgravity phase starts. As described above a
      spring forced linear sliding system will push his body mass up to about 300mm. After the test
      subject has reached its free floating position without any contact to the surrounding area
      (bottom), he will perform a short effort (crouching or stretching). From now on the subject
      should relax and is not allowed to move his muscles intentionally. At the end of microgravity
      phase, the sliding system will allow a soft landing on the foam pads.
    

Intervention name(s): body angles measurements during weightlessness
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and
      immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy
      population. After randomization, the trial for each participant will last for approximately
      13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two
      doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM)
      separated by 21 days.
    


Intervention name(s): BNT162b2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronavirus Disease 2019; Coronavirus infection; Vaccine; Protection against COVID-19; Covid19; SARS (Severe Acute Respiratory Syndrome)
PPARγ Agonist Treatment for Cocaine Dependence
Condition: Cocaine Use Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to determine whether a medication called pioglitazone
      (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain
      structural changes associated with cocaine use and reduce cocaine craving and drug use in
      cocaine dependent patients.
    


Intervention name(s): Pioglitazone; Placebo; Therapy; Contingency Management
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.; Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.; Cognitive-behavioral therapy 1 hour per week; Prize-based contingency management for attendance
Other intervention name(s): Actos; corn starch
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment