bioihbjkbjnl/mcl2 huggingface dataset:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment
      for the induction of multifollicular growth in women undergoing controlled ovarian
      stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection
      (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy
      variable, live birth rate, was evaluated.
    

Detailed description: 
      This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal
      outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh
      embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific
      assessments are required, but information as obtained in standard practice will be used.
    

Intervention name(s): Corifollitropin alfa; GnRH antagonist; (rec)hCG; FSH; Progesterone
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.; SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.; SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.; SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.; Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Other intervention name(s): Org 36286; SCH 900962; MK-8962
Intervention MeSH terms: Progesterone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after fresh embryo transfer in base study
        P05714 (NCT00696878) were enrolled in this trial.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up
High Intensity Interval Training and Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The overall objective is to determine whether High Intensity Interval Training (HIIT) has
      potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By
      reducing inflammation and modifying immune function HIIT may offer a substantial paradigm
      shift in RA care, especially in older persons with RA who experience aging
      related-immunesenescence, increased systemic inflammation and greater physical inactivity
      than young persons. Prior to embarking on a large scale trial of HIIT-induced disease
      modification, this pilot study aims to demonstrate that HIIT can produce measurable responses
      in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment
      for RA.
    


Intervention name(s): HIIT
Intervention type(s): Behavioral
Intervention description(s): All participants will undergo high intensity interval training 3x/week for 10-12 weeks. Intense exercise will be interspersed with appropriate rest periods of low intensity exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Intensity Interval Training
Mindfulness-based Intervention for Teenagers With Cancer
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a mindfulness-based meditation
      intervention on quality of life, sleep and mood in adolescents with cancer compared to a
      control group.
    


Intervention name(s): Mindfulness Intervention
Intervention type(s): Behavioral
Intervention description(s): Mindfulness-based intervention adapted for teenagers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: mindfulness-based meditation; pediatric cancer; adolescence; quality of life; sleep; affect; health psychology
Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?
Condition: Diabete Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with
      empagliflozin in type 2 diabetic Egyptian patients.
    


Intervention name(s): Sitagliptin 50 mg; Empagliflozin 12.5 MG; Sitagliptin 50 mg + Empagliflozin 12.5 MG; Empagliflozin 12.5 MG + Sitagliptin 50 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.; Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.; Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%); Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)
Other intervention name(s): DPP4 inhibitor; SGLT2 inhibitor; DPP4 inhibitor + SGLT2 inhibitor; SGLT2 inhibitor + DPP4 inhibitor
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Image Quality and Radiation Dose in Angiography
Condition: Arteriovenous Malformations; Aneurysm; Stenosis; Dural Arteriovenous Malformations
MeSH terms: Hemangioma; Aneurysm; Arteriovenous Malformations; Congenital Abnormalities
Study type: Interventional

Summary: 
      ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise
      reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose
      significantly. This is realized by anatomy-specific optimization of the full acquisition
      chain (grid switch, beam filtering, pulse width, spot size, detector and image processing
      engine) for every clinical task individually. Furthermore, smaller focal spot sizes and
      shorter pulses are used, which are known to positively influence image quality . The final
      effect on the clinical image quality is investigated in this study.
    

Detailed description: 
      The advent of interventional neuroradiology (INR) has changed the treatment of neurovascular
      diseases by reducing the procedural invasiveness and the recovery time needed by patients,
      thus improving clinical outcome. However, INR procedures often require many high-quality
      digital substraction angiography (DSA) runs and long total fluoroscopy times, which can
      result in patients being exposed to considerable radiation doses levels.

      In order to introduce a dose reduction technology the most important aspect is to validate
      the diagnostic image information. Philips has developed a real-time noise reduction algorithm
      for DSA in neuroradiology that is capable to reduce the patient entrance dose by 75% without
      loss of image quality.
    

Intervention name(s): Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.; Normal dose DSA with conventional X-ray technology
Intervention type(s): Radiation; Radiation
Intervention description(s): Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.; Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
Other intervention name(s): ClarityIQ; AlluraXper
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: X-ray; Image processing; Neuro angiography; Radiation exposure
A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics
      (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone
      acetate in healthy adult male participants.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known) single-dose drug-drug
      interaction study to assess the effect of abiraterone on pioglitazone. Approximately 16
      healthy adult male participants will be enrolled in this study. The study consists of a
      screening phase, an open-label treatment phase consisting of 2 single-dose treatment periods,
      end-of-study or withdrawal assessments done upon completion of the 72-hour pharmacokinetic
      sampling on Day 11 of Period 2 or upon withdrawal, and a follow-up visit 5 to 7 days after
      the last study procedure. The total study length is 32 days. Participants will receive
      pioglitazone alone on Day 1 (Period 1) of the study. On Day 8 (Period 2), participants will
      receive a single dose of abiraterone acetate followed by a single dose of pioglitazone one
      hour later. Successive pioglitazone administrations will be separated by a washout period of
      7 days. Participants will be confined to the study center from Day -1 to Day 4 of Period 1
      and from Day 7 to Day 11 of Period 2, at least 10 hours before each study drug administration
      until completion of the 72-hour blood sample collection for each period. A pharmacogenomic
      blood sample will be collected from all participants on Day -1. Safety will be monitored
      throughout the study.
    

Intervention name(s): Pioglitazone HCl; Abiraterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration; 1000 mg tablets administered by mouth on Day 8
Intervention MeSH terms: Pioglitazone; Abiraterone Acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Drug-drug Interaction; Pharmacokinetics; Abiraterone; JNJ-589485; Abiraterone acetate; JNJ-212082; Pioglitazone HCl
Abuse Liability of Controlled-Release Oxycodone Formulations
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to examine the abuse liability of a single 40mg dose of 2
      controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent
      recreational opioid users by assessing the self-reported acute effects of the drugs and
      taking blood samples to measure drug concentrations. The investigators think there may be
      differences in how well these drugs are liked when swallowed whole due to differences in how
      the products are formulated.
    

Detailed description: 
      This is a single-center, single-dose, double-blind, placebo-controlled, randomized,
      crossover, abuse liability study conducted in healthy subjects who are non-dependent
      recreational opioid users. The study consists of 3 study days during which each subject will
      take one tablet of either 40mg OxyNEO®, 40mg Apo-Oxycodone CR®, or placebo. The participants
      will be assessed for both pharmacokinetic and pharmacodynamic outcomes.
    

Intervention name(s): Apo-Oxycodone CR®; OxyNEO®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®; a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®; a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
Other intervention name(s): Oxycodone; Oxycodone
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Substance-Related Disorders; Prescription Drug Misuse; Analgesics, Opioid; Oxycodone; Randomized Controlled Trial; Cross-Over Studies; Placebo; Healthy Volunteers
FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
Condition: Hemophilia A or B With Inhibitors
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to:

        -  1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight
           Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min

        -  2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased
           rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the
           regular volume
    

Detailed description: 
      15 JUN 2020: The temporary enrollment stop of new patients into this study due to the
      COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again
      enrolling new patients. However, some countries/sites may still have paused the enrollment of
      new patients due to the pandemic.

      23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19
      situation. The duration of this pause is dependent on the leveling and control of the
      COVID-19 pandemic.
    

Intervention name(s): FEIBA
Intervention type(s): Biological
Intervention description(s): Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Other intervention name(s): FEIBA NF.; AICC; anti-inhibitor coagulant complex; Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]); APCC; Activated prothrombin complex concentrate
Intervention MeSH terms: Thrombin; Anti-inhibitor coagulant complex; Coagulants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Synaptic Plasticity and Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      To explore: (a) if physical exercise (sports) combined with cognitive training leads to
      (superior) improvement of cognition in schizophrenia compared to sports or cognitive training
      alone (b) if a sports program alone or in combination with cognitive training has influence
      on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo
      condition.
    


Intervention name(s): Exercise; TableSoccer
Intervention type(s): Other; Other
Intervention description(s): Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.; Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; negative symptoms; cognitive deficits; synaptic plasticity
The Effects of Cervical Spine Manipulation On Postural Control
Condition: Posture
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of high velocity low amplitude (HVLA)
      chiropractic cervical manipulation on the patient's postural control as measured by a force
      plate.
    


Intervention name(s): HVLA chiropractic manipulation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: To determine the effects of cervical spine manipulation on postural control.
Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel to Acanya® Gel and Both to a Vehicle Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the safety and efficacy profiles of Taro
      Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya®
      (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior
      efficacy of the two active formulations over that of the vehicle in the treatment of acne
      vulgaris.
    


Intervention name(s): Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%; Acanya® Gel, 1.2%/2.5%; Vehicle of test product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).; Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC)applied at approximately the same time once daily for 84 days (12 weeks).; Vehicle of test product (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Clindamycin Phosphate and Benzoyl Peroxide Gel; Acanya® Gel
PECs for Implantable Cardiac Electronic Device Insertion
Condition: Cardiac Implantable Electronic Device; Nerve Block; Anesthesia; Analgesia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for
      CIED insertion.
    

Detailed description: 
      Implantable Cardiac Electronic Device (CIED) insertion can be performed under local
      anesthesia, regional anesthesia, or general anesthesia. Novel regional blocks may improve
      pain management for such patients and can shorten their length of stay in the hospital. At
      the study, the investigators aimd to evaluate the efficacy and feasibility of the PECS block
      for CIED insertion procedure.
    

Intervention name(s): Pectoral Nerve (PECs) block
Intervention type(s): Other
Intervention description(s): Pectoral Nerve (PECS) blocks were performed on the side of surgery, using the ultrasound-guided technique 30 min before the implantable cardiac electronic device (pacemaker, implantable cardioverter defibrillator) insertion procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
Condition: Intrusive Memories
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether oxytocin and oxytocin receptor gene
      polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.
    


Intervention name(s): Oxytocin nasal spray; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Placebo nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have
      been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels
      of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be
      measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose
      (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be
      investigated one month after administration.
    


Intervention name(s): IPV-Al
Intervention type(s): Biological
Intervention description(s): adjuvanted reduced dose inactivated polio vaccine
Other intervention name(s): Picovax®; IPV-Al AJV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of
      JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with
      low HDL
    


Intervention name(s): JTT-705 600 mg and simvastatin 40 mg; Placebo and simvastatin 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments; Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments
Intervention MeSH terms: Simvastatin; Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment