bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
Condition: Atrial Fibrillation; Cardioembolic Events; Oral Anticoagulation
MeSH terms: Atrial Fibrillation; Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of
      atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC
      in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm
      JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in
      these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the
      ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent
      cerebral embolic events in patients with a high risk for embolic events, free from AF after
      successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration
      of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation
      of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score
      ≥2 after the first pulmonary vein ablation for paroxysmal AF.
    


Intervention name(s): Dabigatran
Intervention type(s): Drug
Intervention description(s): Antral pulmonary vein ablation for patients with AF
left atrial fibrosis/electrical scar assessment by electroanatomical mapping
followed by 6 months OAC (3 months blanking period + 3 months observation period)
in case of AF-recurrence in month 4-6: re- pulmonary vein ablation
followed again by 6 months OAC (3 months blanking period + 3 months observation period)
AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms:
Experimental arm (group A): OAC with dabigatran for 12 months
Control arm (group B): No OAC (no placebo medication) for 12 months - Cerebral MRI at randomisation and 12 months later
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of
      treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon
      (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from
      PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
    


Intervention name(s): BI 201335; PegIFN/RBV
Intervention type(s): Drug; Drug
Intervention description(s): BI 201335 for 24 weeks; PegIFN/RBV for 48 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
Condition: Quality of Life; Daily Activity; Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional
      substances administration on work productivity, daily activity, and fatigue in subjects with
      chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.
    


Intervention name(s): Acetyl-L-carnitine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acetyl-L-carnitine; Interferons; Ribavirin; Hepatitis C; Fatigue
Organic Pollutants in Pelvic Endometriosis
Condition: Endometriosis; Infertility Unexplained
MeSH terms: Infertility; Endometriosis
Study type: Interventional

Summary: 
      The health toxicity of polycyclic aromatic hydrocarbons (PAHs), present in air and food,
      generated during energy production and waste incineration, is well known. PAHs can activate
      the aryl hydrocarbon receptor, which may interact with classic estrogen receptors and modify
      estrogen-dependent inflammation in endometriosis. There is no data on the hypothetical role
      of PAHs in the etiopathogenesis of endometriosis. The aim was to compare PAHs concentrations
      in visceral fat in women with endometriosis and idiopathic infertility.
    

Detailed description: 
      A prospective cohort tertiary-center study includes women undergoing laparoscopy due to
      pelvic endometriosis (arm 1) or/and idiopathic infertility (arm 2). A sample of 1 ml of the
      greater omentum is collected intraoperatively for detection of 16 PAHs, i.e. acenaphthene,
      acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene,
      benz[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene,
      benzo[a]pyrene, chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene, by gas
      chromatography-isotope dilution mass spectrometry method. The concentration of selected PAHs
      in visceral fat in both populations will be compared. The correlation of concentrations of
      selected PAHs with the occurrence of infertility, pelvic pain syndrome, intensity of pain,
      peritoneal adhesions and the degree of endometriosis will be checked.
    

Intervention name(s): Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry
Intervention type(s): Diagnostic Test
Intervention description(s): 1 ml sample of visceral fat collected during elective laparoscopy for detection of PAHS by gas chromatography-isotope dilution mass spectrometry
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective cohort tertiary-center study among women undergoing elective laparoscopy due to pelvic endometriosis (arm 1) or idiopathic infertility (arm 2).
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on
      24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with
      T2DM inadequately controlled on metformin alone.
    


Intervention name(s): Saxagliptin; Metformin XR; Placebo matching Metformin XR; Metformin XR; Placebo matching Saxagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, once daily, 4 weeks; Tablets, Oral, 1500 mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks; Tablets, Oral, 500 mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks
Other intervention name(s): BMS-477118; Onglyza; Glucophage XR®; Glucophage XR®
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Safety and Immunogenicity of NasoVAX Extension
Condition: Influenza
Study type: Observational

Summary: 
      This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind,
      placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy
      adults 18 to 49 years of age.
    

Detailed description: 
      This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX
      administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to
      15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be
      screened, and a serum sample will be collected from each eligible subject for evaluation of
      influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the
      one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be
      performed.
    

Intervention name(s): Subjects were administered NasoVAX high dose
Intervention type(s): Drug
Intervention description(s): NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All subjects who were previously randomized to the 1×10(11th) vp NasoVAX group in Study
        ALT-103-201
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the
      treatment of children and adolescents aged 6-17 with ADHD.
    


Intervention name(s): SPD503 (1 mg); SPD503 (2 mg); SPD503 (3 mg); SPD503 (4 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Guanfacine hydrochloride
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to characterize the change of respiratory admittance induced by salbutamol
      inhalation in children and young adults. A variation threshold will be fixed to distinguish
      asthmatic and healthy subjects.

      This project could allow a better identification of asthmatic individuals needing a
      treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments
      administered in individuals with respiratory but not asthmatic symptoms, a better
      comprehension of bronchial hyperreactivity and its role in asthmatic disease.
    


Intervention name(s): Salbutamol; Forced oscillation technique; Plethysmography
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber; before and after bronchodilation
Other intervention name(s): Ventoline
Intervention MeSH terms: Albuterol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three-way, three-sequence, two treatment, partial
      replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir &
      Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg
      Film Coated Tablets (Pfizer Europe, Belgium)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose); Nirmatrelvir 150 mg + Ritonavir 100 mg (test); Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg; 2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg; 2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Other intervention name(s): Paxlovid; Copaxid; Paxlovid
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Nirmatrelvir and ritonavir drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia
Condition: Anxiety State; Child Behavior; Postoperative Delirium
MeSH terms: Delirium; Emergence Delirium; Anxiety Disorders
Study type: Observational

Summary: 
      Induction of anesthesia can be distressing both for children and their parents.
      Nonpharmacological behavioral interventions can reduce the anxiety of children without
      significant adverse effects as seen with sedative drugs.

      The aim of this study will be to evaluate whether the children's or parental preference with
      attending parent affects on the postoperative delirium of the children or not. The delirium
      of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)
    

Detailed description: 
      Anesthetic induction can be one of the most stressful experiences for the child during the
      perioperative period, with almost 50% of the children showing significant anxiety. . To
      minimize the effect of anxiety, several methods have been adopted, such as the introduction
      of day-case surgery, parental presence at the induction of anesthesia, distractions and the
      use of pharmacological agents like midazolam to reduce anxiety. Although the effect of
      parental presence on the anxiety of children and parents was studied in various studies.
      Whether the children's choice of parental selection affects anxiety and postoperative
      delirium not studied yet. In this study, we will evaluate the anxiety of children by using
      mYPAS and postoperative delirium by using PAED.
    

Intervention name(s): Selection of parent(mother or father) according to children preference; Parent (mother or father) selection according to parents' preference
Intervention type(s): Procedure; Procedure
Intervention description(s): The parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference; Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included 80 children of both genders, aged 5-12 years, who underwent day-case
        surgeries in the Ear Nose and Throat Clinic with ASA physical Status I-II will be enrolled
      
Keywords: day- case surgery, anxiety children; Postoperative Delirium
Sun Protection Factor Assay (339/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987516; SPF Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code: Z43-090); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-6950
      across ascending single doses in healthy adult male and female subjects. The secondary
      objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950
      by measuring plasma concentrations of ONO-6950, pulmonary function, and potential
      cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a
      meal upon the pharmacokinetic profile of ONO-6950.
    


Intervention name(s): ONO-6950; ONO-6950
Intervention type(s): Drug; Drug
Intervention description(s): 1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study; 1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-6950; Healthy Adult Subjects
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions
Condition: Herpes
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets
      under fasting conditions.
    


Intervention name(s): famciclovir
Intervention type(s): Drug
Intervention description(s): 500 mg tablet
Other intervention name(s): FAMVIR
Intervention MeSH terms: Famciclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Bile Acid Pathway in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      It is unknown whether the bile acid pathway is altered in obesity. This study is designed to
      compare obesity and health to determine if the bile acid pathway differs depending on health
      state.
    

Detailed description: 
      This is a single center study involving diet intervention, including healthy obese and
      healthy normal weight participants. Participants will maintain their normal diet for 1 week,
      eat a high fat and high calorie diet for 1 week, return to their normal diet for 1 week, and
      eat a low fat and low calorie diet for 1 week, to study the effect of diet on the bile acid
      pathway in normal weight and obesity. During their first normal diet week, the high calorie
      week, and the low calorie week, blood samples will be collected at defined times to measure
      cholesterol, glycemia, Fibroblast Growth Factor 19 (FGF-19), Bile Acid (BA), C4, and
      incretins (GLP-1 (glucagon-like peptide-1), peptide tyrosine tyrosine (PYY 3-36)) fasting
      levels and responses to the meal. Stool samples will be collected for 48 hour BA excretion.
    

Intervention name(s): Normal Diet; High Fat Diet; Low Fat Diet
Intervention type(s): Other; Other; Other
Intervention description(s): The normal diet will consist of the participants' normal eating habits, and will be tracked by a food log. The participants will be on their normal diet during week 1 and week 3.; The high fat diet will consist of 2700 kcal, 100g total fat (33%), 300mg cholesterol, 350g carbohydrates (52%), and 100g protein (15%). The participants will be on this diet during week 2.; The low fat diet will consist of 1200 kcal, 26g fat (20%), 78mg cholesterol, 150g carbohydrates (50%), and 100g protein (30%). The participants will be on this diet during week 4.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
Condition: Energy; Focus; Caffeine Withdrawal
Study type: Interventional

Summary: 
      Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can
      enhance various markers of focus, including memory, reaction time, and attention in healthy
      adults. To assess these effects, this placebo-controlled crossover trial will compare the
      effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine
      for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants
      will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day
      3 of ingestion. Participants will have a 3-day washout period before trialing the next test
      product/placebo.
    

Detailed description: 
      Following enrollment to the study, participants will abstain from any products containing
      caffeine, for 3 days.

      On the night of the 3rd day of caffeine abstinence, participants will fast overnight (~10
      hours) The morning after the fast, participants will complete the Day 1 baseline
      questionnaire.

      Participants will then consume Test Product A and complete questionnaires 30, 60, 90, and 120
      minutes after ingestion. Test Products should be consumed in a fasted state, and 1-hour
      post-ingestion participants will consume a standardized meal (See Section 6.3).

      On Day 2, participants will consume Test Product A again but will not complete any
      questionnaires. The product should be consumed in a fasted state and participants will
      consume the standardized meal 60 minutes post-ingestion.

      On Day 3, participants will consume Test Product A in a fasted state and will again consume
      the standardized meal 1-hour following ingestion of the product. Participants will complete
      questionnaires 30, 60, 90, and 120 minutes after ingestion. Participants will then have a
      3-day washout period with no products consumed or questionnaires completed.

      Following the washout period, the intervention cycle will be repeated with Test Product B
      and, subsequently, Test Product C.

      The questionnaires will consist of study-specific surveys and a cognitive assessment battery.
    

Intervention name(s): Paraxanthine 200 mg; Paraxanthine 300 mg; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.; For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.; The placebo will contain resistant dextrin. For the three-day test cycle, participants will take one capsule per day amounting to 300mg of resistant dextrin.
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other