bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally
      disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's "Viagra®
      (sildenafil)" Film Coated Tablet (FCT) formulation (reference formulation) in healthy
      volunteers.
    

Detailed description: 
      -  Background: An orally disintegrating film (ODF) formulation of sildenafil was recently
           developed in Korea. This formulation is expected to enhance the dosing convenience and
           increase patient compliance while yielding pharmacokinetic profiles comparable to the
           conventional film coated tablet (FCT) formulation.

        -  Objective: The goal of present study is to compare the pharmacokinetic (PK) profiles of
           a newly developed ODF formulation with a FCT formulation of sildenafil in healthy Korean
           male volunteers.

        -  Methods: This is a randomized, open-label, 2-period cross-over, single-dose study
           conducted in 2 parts. Eligible subjects were healthy male volunteers between the ages of
           20 and 50 years and within 20% of their ideal body weight, and are equally divided into
           parts 1 and 2. Each subject will be received a single -dose of ODF and FCT formulations
           of sildenafil orally in a fasted state (part 1, 50mg; part 2, 100mg), with a 7-day
           washout period between the formulations. Blood samples are collected up to 24 hours.
           Pharmacokinetic parameters are determined for sildenafil and its active metabolite
           (N-desmethyl sildenafil). Adverse events will be also evaluated based on subject
           interviews and physical examinations.
    

Intervention name(s): SPO1101; SPO1101D
Intervention type(s): Drug; Drug
Intervention description(s): A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 50mg), with a 7-day washout period between the formulations.; A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 100mg), with a 7-day washout period between the formulations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orally disintegrating Film; Film Coated Tablet; Sildenafil; Pharmacokinetics
Intrathecal Morphine for Inguinal Hernia Repair.
Condition: Inguinal Hernia; Nausea; Vomiting; Pruritus; Postoperative Pain
MeSH terms: Pruritus; Hernia; Vomiting; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the effects of two different doses of intrathecal
      morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block
      regression times, postoperative analgesia and the severity of side effects, for inguinal
      hernia repairs.
    

Detailed description: 
      The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine
      combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia
      onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation,
      first voiding) time were compared. Also the postoperative pain management and side effects
      (nausea, vomiting and pruritus) were assessed.
    

Intervention name(s): intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg; intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg; standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; intravenous cannulation and premedication
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure; 18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spinal anaesthesia; morphine; postoperative analgesia; vomiting
Effect of Aerobic Exercise on Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The development of Polycystic Ovary Syndrome has been linked to chronic low-grade
      inflammation (PCOS). In this context, the current study looked into the effects of aerobic
      exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. This was a randomized
      clinical trial including 40 females diagnosed with PCOS who were between the ages of 25 and
      35. The participants were divided into two groups, each with an equal number of individuals:
      aerobic exercise (AEM) and Metformin (M). At baseline and after 12 weeks of intervention,
      participants' levels of IL6, TNF, and CRP were measured.
    


Intervention name(s): Aerobic exercise in addition to Metformin treatment
Intervention type(s): Other
Intervention description(s): The aerobic exercises were walking on the treadmill for 30 minutes at a 0% slope, including three phases: the warming-up phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of Maximum Heart Rate, MHR), the actual phase, which consisted of walking on the treadmill for 20 min at moderate intensity (60 -70% of MHR) and the cooling phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of MHR). The MHR was calculated according to the equation (210- age in years). Both the AEM and M groups received metformin 1,500 mg daily for a further 12 weeks.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants were divided into two groups equal in number: the aerobic exercise group (AEM), and the Metformin group (M). The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. The M group received Metformin only
Masking: Single (Investigator)
Primary purpose: Treatment
The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies
Condition: Sterility; Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective comparative randomized controlled trial investigating the effect of two
      GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women
      undergoing assisted reproductive technology.
    

Detailed description: 
      Follicle maturation triggering is the final differentiation process of an immature egg before
      fertilization, either in normal or stimulated ovarian cycles in assisted reproductive
      techniques. This step has traditionally been accomplished by the administration of human
      chorionic gonadotropin (hCG) trigger which mimics LH activity. However, hCG is a primary
      cause of severe ovarian hyperstimulation syndrome (OHSS) in women and appears to initiate the
      complex cascade that leads to the development of serious medical complications. Numerous
      strategies have been suggested to prevent OHSS; one of these is the administration of a
      gonadotropin releasing hormone (GnRH) agonist trigger instead of hCG. Despite a high safety
      profile, the GnRH agonist trigger of follicle maturation was found to be associated with a
      decreased probability of clinical and ongoing pregnancy rates and very high miscarriage
      rates. A profoundly deficient luteal phase is believed to be the cause of compromised
      reproductive outcome. Our personal clinical practice at the AUBMC Fertility Center seems to
      indicate that a novel GnRH agonist administration protocol is associated with a comparable
      reproductive performance to standard hCG trigger. In this study, we aim to validate the above
      clinical impression and assess associated parameters of success. Therefore, a prospective
      comparative randomized controlled trial will be performed in order to investigate the effect
      of three repeated doses of GnRH agonist trigger "Triptorelin" accompanied by intensive Luteal
      Support on the ongoing pregnancy outcome in women who are hyper-responders to ovarian
      stimulation when undergoing assisted reproductive technology.
    

Intervention name(s): Triptorelin
Intervention type(s): Drug
Intervention description(s): Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart
Other intervention name(s): Gonapeptyl
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH agonist; In Vitro fertilization; Assisted Reproductive Technology; Follicule Maturation; Pregnancy
To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus
      Valsartan (ARB) in the Diabetic Nephropathy (DN).
    

Detailed description: 
      Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal
      disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and
      slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some
      patients still have heavy proteinuria,and then loss their renal function rapidly. So, to
      reduce the proteinuria of DN is a very important therapy target.

      Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic
      glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess
      the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.
    

Intervention name(s): TW
Intervention type(s): Drug
Intervention description(s): TW,120 mg/d
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TW; Valsartan; treatment; diabetic nephropathy; Proteinuria
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort
      of its safety, efficacy and delivery system in treating CAD.
    

Detailed description: 
      The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation.
      The secondary endpoint is in-stent percent diameter stenosis.This study is based on
      non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical
      significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3
      chosen hospitals.
    

Intervention name(s): Firehawk; Xience V
Intervention type(s): Device; Device
Intervention description(s): Implantation of Firehawk drug eluting stent; Implantation of Xience V drug eluting stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Influence of Collective Schemas on Individual Memory
Condition: Episodic Memory
Study type: Interventional

Summary: 
      Schemas describe mental structures storing recurrent and organized pattern of information.
      Schemas may have a strong influence on the process of storing and retrieving new information
      into memory. Previous approaches in the cognitive neuroscience of memory have entirely
      focused on the individual dimension of preexisting schemas. In the real world though, much of
      our experiences and knowledge are collective or shared. Such social-cultural frameworks
      stored in collective memory may also reshape and reconfigure the construction of individual
      memories. Attempting to ascertain the influence of collective schema on the neural substrates
      of individual memories using cutting-edge brain imaging methods represents the challenge that
      MULTIBRAIN seeks to tackle. To achieve this goal, we will record brain activity in a group of
      24 participants while there are remembering pictures from a tour at the World War II Memorial
      of Caen. This study will seek to identify brain areas of the prefrontal cortex encoding the
      organization of knowledge in collective memory using multivariate analyses of brain patterns
      of activation, and then to understand how such regions might modulate the recruitment of the
      hippocampus during episodic memory retrieval using analyses of effective connectivity. The
      organization of knowledge in collective memory is measured in parallel through 1) the
      analysis of French social memory of World War II using a corpus of 100 000 television and
      radio shows from the National Institute of Audiovisual, and 2) an internet task measuring the
      organization of individual knowledge in a large group of individuals that will allow to
      separate shared from non-shared memories of the World War II. Once collected, these data will
      help us to understand how collective schemas may reconfigure the organization of individual
      memories.
    


Intervention name(s): Episodic memory task; fMRI
Intervention type(s): Behavioral; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Physiologic Effects of Sleep Restriction
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The
      investigators wish to determine whether 9 nights of modest sleep restriction results in
      activation of cardiovascular disease mechanisms, thus potentially increasing the risk of
      cardiovascular disease. The investigators hypothesize that sleep restriction will result in
      elevated blood pressure, inflammation, and neurocognitive deficits.
    

Detailed description: 
      Evidence suggests a relationship between sleep deprivation and cardiovascular disease.
      Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6
      or fewer hours of sleep per night, and those who do are 24% more likely to have
      cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may
      conceivably be one of the most common, and most preventable, cardiovascular risk factors. The
      investigators wish to determine whether 9 nights of modest sleep restriction results in
      activation of cardiovascular disease mechanisms, thus potentially increasing the risk of
      cardiovascular disease. The investigators will combine our cardiovascular studies with
      state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the
      physiologic effects of sleep restriction. Together, the investigators findings will help
      explain whether the reduced sleep duration in the general population may be contributing to
      the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.
    

Intervention name(s): sleep restriction
Intervention type(s): Behavioral
Intervention description(s): restricted sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sleep deprivation; sleep restriction
Fluoride Concentration in Inter-proximal Fluid From Dental Sealants
Condition: Caries
Study type: Interventional

Summary: 
      The hypothesis of this study is that the concentration of fluoride in oral interproximal
      fluids would increase more after using high-viscosity GIC as pit and fissure sealant,
      compared to Resin-Based sealants containing fluoride and RB sealants without fluoride
      content. To validate this hypothesis a randomized clinical trial was designed and performed
      in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after
      the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing
      fluoride and RB sealants without fluoride content.
    


Intervention name(s): Sealant application; sealant application; sealant application
Intervention type(s): Other; Other; Other
Intervention description(s): A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.; A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.; A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: caries; sealant; fluoride; prevention; community dentistry
Antibiotic Prophylaxis for Elective Cesarean Section
Condition: Infection of Cesarian Section Wound Following Delivery
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in
      elective cesarean section 30-60 min before skin incision versus after cord clamping.
    

Detailed description: 
      comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60
      min before skin incision versus after cord clamping.on post-cesarean section infection(wound
      infection as a primary outcome)
    

Intervention name(s): ceftriaxone 1gm for intravenous infusion
Intervention type(s): Drug
Intervention description(s): Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
Other intervention name(s): cefaxon
Intervention MeSH terms: Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Elective Cesarean Section; Antibiotic prophylaxis; Timing of Antibiotic prophylaxis; post cesarean section infection
Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on
      unaffected forehead skin
    


Intervention name(s): pimecrolimus 1% cream; hydrocortison 1% cream
Intervention type(s): Drug; Drug
Intervention description(s): twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks; twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
Other intervention name(s): Elidel 1% cream; Hydrogalen cream
Intervention MeSH terms: Hydrocortisone; Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; pimecrolimus; hydrocortison; Optical Coherence Tomography