bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the
      pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.

      This is an open-label, fixed sequence two period study with healthy participants that will
      receive a single dose of PF-06651600 alone and co-administered with multiple doses of
      itraconazole at a single center.

      Participants will be screened within 28 days of the first dose of the investigational
      products and if entry criteria are met, the participant will report to the clinic on the day
      before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of
      PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will
      receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive
      30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after
      the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The
      participant will be followed up by phone contact.
    


Intervention name(s): PF-06651600 10 mg tablets; Itraconazole Solution 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.
On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.; Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.
On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.
Other intervention name(s): Sporanox Oral Solution
Intervention MeSH terms: Itraconazole; Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06651600; Itraconazole; CYP3A4; Drug-Drug Interaction
Treatment of Atrial Fibrillation by Minimal Invasive Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the feasability of a new epicardial and minimal
      invasive ablation technique of the left atrium isolating the pulmonary veins for prevention
      of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone
      atrial fibrillation.
    

Detailed description: 
      Atrial fibrillation is a major health problem.Despite adequate treatment of underlying heart
      disease, rhythm control is unsuccessful in almost half of patients, also in patients with
      lone atrial fibrillation.If patients remain highly symptomatic, a non-pharmacological
      approach may be considered including pulmonary vein isolation and Cox maze III surgery. Maze
      III surgery has high succes rates, however it includes major cardiac surgery with substantial
      risk of complications. New surgical strategies for symptomatic lone atrial fibrillation focus
      on minimal invasive off-pump procedures omitting cardiopulmonary bypass (and thus lowering
      the complication rate), while taking advantage of an easier approach to the ablation site and
      a shorter procedure time. Epicardial surgical ablation isolating pulmonary veins by high
      intensity focused ultrasound performed off-pump by Video Assisted Thoracic Surgery (VATS)may
      be a promising treatment option. In this pilot study, we aim to study the feasibility of this
      new surgical ablation approach in patients with lone atrial fibrillation.
    

Intervention name(s): ablation of pulmonary veins by video assisted thoracic surgery
Intervention type(s): Procedure
Intervention description(s): epicardial ablation using HIFU
Other intervention name(s): Epicor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; epicardial ablation pulmonary veins; video assisted thoracic surgery
Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the
      visual function of patients with glaucoma after oral administration for 3 months of
      citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs
      vitamin C.
    


Intervention name(s): Citicoline; Docosahexaenoic Acid (DHA); Citicoline and Docosahexaenoic Acid (DHA); Vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.; Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.; Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.; Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
Other intervention name(s): Cebrolux 800; Brudypio 1.5g; L-ascorbic acid
Intervention MeSH terms: Ascorbic Acid; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: glaucoma; nutraceuticals; dha (docosahexaenoic acid); citicoline
Evaluation of a Decision Assisting Tool for Prenatal Testing
Condition: Pregnancy
Study type: Interventional

Summary: 
      This is a randomized study of an interactive, computerized descision-assisting tool for
      prenatal testing decision making (PT Tool) versus standard educational booklets distributed
      to all pregnant women by the State of California (control). We hypothesize that, compared to
      controls, women randomized to view PT Tool will have greater knowledge about prenatal testing
      and its potential outcomes and better risk comprehension, and that they will be more
      satisfied with the intervention and have lower decisional conflict.
    

Detailed description: 
      We will evaluate the tool in a randomized controlled trial among 500 patients receiving
      prenatal care at one of the obstetrics clinics and practices affiliated with the University
      of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San
      Francisco, or California Pacific Medical Center (CPMC). After completing a baseline
      questionnaire, participants will be randomized to view either a control or intervention
      group. Patients assigned to the control group will view the computerized version of the
      age-appropriate educational pamphlet concerning prenatal testing developed by the State of
      California. Patients assigned to the intervention group will use the computerized decision
      support tool/educational module which provides important background information about
      chromosomal abnormalities, and patient-tailored information about the advantages and
      limitations of diagnostic testing.
    

Intervention name(s): Control - computerized age-appropriate prenatal testing educational brochure; PT Tool - interactive, computerized, prenatal testing decision tool
Intervention type(s): Other; Other
Intervention description(s): Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.; An interactive, computerized prenatal testing decision-assisting tool (PT Tool).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Prenatal testing; Amniocentesis; Decision making; Down syndrome
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

      The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in
      Haemophilia A patients.

      The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and
      NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600
      (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September
      2011) and NN7008-4015 (start: August 2012, stop: March 2013).
    


Intervention name(s): turoctocog alfa; turoctocog alfa
Intervention type(s): Drug; Drug
Intervention description(s): The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.; Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects
Condition: Healthy Elderly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the
      pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly
      subjects.
    


Intervention name(s): HSK3486; HSK3486; HSK3486; HSK3486
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.; Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.; Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.; Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
Other intervention name(s): HSK3486 0.2 mg/kg; HSK3486 0.3 mg/kg; HSK3486 0.4 mg/kg; HSK3486 0.4 mg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Elderly Subjects
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Condition: Whole Cell Pertussis; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this observer-blind study is to generate immunogenicity data with one
      formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and
      to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK
      Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response.
      Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib
      vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      Sep 2007.
    


Intervention name(s): Zilbrix-Hib; Tritanrix™-HepB/ Hiberix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 1 dose; Intramuscular injection, 1 dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B; Tetanus; Diphtheria; Pertussis; Haemophilus influenzae type b Vaccines
Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring
      delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:

        1. follicular function and inhibition of ovulation

        2. the endometrium

        3. bleeding patterns; and also to assess safety including effects on the endometrium
    


Intervention name(s): CDB-2914
Intervention type(s): Drug
Intervention description(s): Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CDB-2914; Contraceptive Vaginal Rings; ovulation; endometrial changes; bleeding patterns; normal cycling women; Inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study
      to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in
      healthy postmenopausal women.
    


Intervention name(s): ACE-011 or placebo
Intervention type(s): Biological
Intervention description(s): multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mini Theta Burst TMS in MDD Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This is not a treatment study.

      In this study, the researchers are primarily interested in examining whether functional MRI
      (fMRI)-guided transcranial magnetic stimulation (TMS) may be more effective than traditional
      TMS methods at temporarily influencing neural circuit communication. The investigators test
      this by combining TMS and fMRI technologies to probe and modulate brain activity.

      If the novel fMRI-guided TMS stimulation used in this study is more effective than
      traditional methods, future studies may utilize similar personalized TMS targeting methods to
      yield even better clinical outcomes.
    

Detailed description: 
      Non-invasive transcranial magnetic stimulation (TMS) is now FDA-approved for the treatment of
      major depressive disorder (MDD). However, there is growing evidence that the targeting
      strategy for delivering TMS treatment may yield superior clinical outcomes if it is tailored
      to individual neuroanatomy. In this observational study, the investigators plan to examine
      this theory by using individualized TMS targets created from participants' own fMRI scans.

      This is not a treatment study, and stimulation is not designed to provide treatment in this
      study. Instead, the TMS delivery is meant to temporarily modify brain circuit communication
      between the lateral prefrontal cortex and subcortical structures. The research team
      administers TMS inside of the MRI scanner to prove that this pathway can be influenced
      non-invasively with TMS.

      These subcortical structures are important to affective disorder, and may contribute to the
      symptoms that patients suffering from depression are experiencing. The researchers hope that
      this innovative TMS research will confirm neural networks important to affective disorders,
      and guide future treatment options.
    

Intervention name(s): TMS/ fMRI Stimulation
Intervention type(s): Combination Product
Intervention description(s): The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.
Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.
Intervention model: Single Group Assignment
Intervention model description: All subjects receive active TMS to the novel fMRI-guided targeting site. Participants will first receive TMS in the MRI scanner, then over the course of three consecutive "mini TMS" days, and lastly in a final MRI scan.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: depression; TMS; fMRI
Efficacy and Safety of Oltipraz in the Patients With Liver Fibrosis and Cirrhosis
Condition: Liver Fibrosis; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigated the effectiveness and safety of oltipraz therapy in treating patients
      with cirrhosis induced by chronic hepatitis type B or C.
    

Detailed description: 
      Oltipraz [5-(2-pyrazinyl)-4-methyl-1,2-dithiol-3-thione] has been extensively studied as a
      cancer chemopreventive agent. Comprehensive mechanistic and phase IIa studies supported the
      notion that oltipraz exerts chemopreventive effects, as supported by Phase IIa human clinical
      studies of oltipraz on cancer chemoprevention, conducted in Qidong, China. Hepatic stellate
      cells cause synthesis of large quantities of extracellular matrix. Transforming growth factor
      beta1 (TGF-beta1), as a key fibrogenic mediator for fibrogenesis after injuries through
      deposition of extracellular matrix and inhibition of collagenase activity in the liver, is
      associated with the regulation of cell growth and differentiation and causes synthesis of
      extracellular matrix proteins and cellular receptors for matrix proteins. Previously, we
      reported the effectiveness of oltipraz in regeneration of cirrhotic liver, which includes
      reduction of the intensities of liver fibrotic and cirrhotic nodules, elimination of
      accumulated extracellular matrix, and regeneration of cirrhotic liver in animal models.
      Oltipraz completely resolves fibrosis in the cirrhotic liver, thereby improving viability.
      TGF-beta1 signaling plays an important role in liver fibrogenesis and cirrhosis as evidenced
      by receptor knockout experiments. No therapeutic agent that is active in interrupting
      TGF-beta1 signaling is available, proposing that C/EBP serve as a molecular target for the
      treatment of liver cirrhosis.
    

Intervention name(s): oltipraz; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60mg bid 90mg qd
Intervention MeSH terms: Oltipraz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression
Condition: Major Depressive Disorder; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Depression involves the tendency to recall overgeneral personal memories, a phenomenon which
      has been linked to numerous adverse psychological outcomes. The purpose of this study is to
      investigate whether a group-based Memory Specificity Training (MEST) programme improves
      outcomes in depression, and how this compares to an education and support control group. The
      primary aim is to examine whether MEST, which involves repeated practice retrieving specific
      autobiographical memories reduces depressive symptoms immediately post-treatment, and whether
      this is maintained 3 months after treatment. The secondary objective of this trial is to
      examine the role of hypothesised cognitive processes (ie., rumination, executive control,
      cognitive avoidance) which may underlie improvements in depression and memory.
    


Intervention name(s): Memory Specificity Training; Education and Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is a manualised, structured treatment delivered over 5 x 60 minute sessions to groups of 5-8 individuals. This treatment involves repeated practice of retrieving specific autobiographical memories in response to positive, negative and neutral cue words. There is a single psychoeducation component in the first session about memory difficulties common in depression which provides the rationale for this treatment. The training is supplemented by weekly homework practice.; The education-and-support comparison condition is matched with the experimental arm for length and format (ie., 5 x 60 minute weekly sessions in groups of 5-8 individuals). Groups receive a single psychoeducation component where information about depression is provided. This is followed by non-directive support where participants are encouraged to raise different kinds of events that occur each week for discussion in the group. The sessions are supplemented by a homework diary where participants will be invited to note down an event that occurs each day, which may be positive, negative, or benign and non-emotional in nature. This material will provide the basis for discussion in the weekly group meetings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Memory specificity training; Autobiographical memory; Major depressive disorder
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Condition: Human Endotoxaemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40
      year. The design is based on 6 days:

        -  day 1: On day time administration of LPS.

        -  day 2: On night time administration of LPS.

        -  day 3: On day time administration of LPS + Placebo.

        -  day 4: On day time administration of LPS + melatonin.

        -  day 5: On night time administration of LPS + placebo.

        -  day 6: On night time administration og LPS + melatonin.

      Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin
      compared to placebo on the endotoxaemia.
    


Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention