bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Test for Risperdal 2mg of Janssen Korea
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to conduct the bioequivalence (biological equivalence of two
      preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea
      as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.
    

Detailed description: 
      This was a randomized (the study drug is assigned by chance) and open labeled (all people
      know the identity of the intervention) study. All participants were hospitalized in research
      rooms and were subsequently restricted in exercise, eating, drinking, smoking and
      xanthine-beverages until the end of blood collection. Water was allowed to be taken until one
      hour before drug administration. Participants were randomly assigned into two groups, one
      group receiving Risperdal OD (investigational drug), and one group receiving Risperdal
      Quicklet (control drug). On the day of testing, blood was collected from all participants to
      provide baseline measurements. Subsequently, the study drug was orally administered to the
      participants, followed by blood collection of a total of 13 time points, up to 24 hours.
      After the blood collection was finished, participants were discharged after receiving proper
      guidance and being examined by a psychologist. Following a wash-out period (period when
      receiving no intervention) of one week, participants were hospitalized once more and crossed
      over to receive the study drugs following the same procedure above described. The approximate
      study duration (including the drug administration days and wash-out period) was approximately
      10 days.
    

Intervention name(s): Risperdal OD Tab. 2mg; Risperdal Quicklet Tab. 2mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet Risperdal OD 2 mg administered orally.; 1 tablet Risperdal Quicklet Tab. 2mg administered orally.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Risperdal OD; Risperdal Quicklet; Korea
Safety and Efficacy of Cariprazine in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Other intervention name(s): RGH-188
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents
The Effect of Infant Feeding on Stool Characteristics
Condition: Healthy
Study type: Interventional

Summary: 
      Infants will be fed infant formula and stool characteristics assessed.
    


Intervention name(s): fecal bacteria analysis
Intervention type(s): Procedure
Intervention description(s): ad lib feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy infants
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Condition: Hemodialysis; Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Clopidogrel administration is essential in patients undergoing percutaneous coronary
      intervention, in patients with previous stroke, in patients under chronic hemodialysis via
      fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a
      viable option. Patients with chronic renal failure present lower clopidogrel response
      compared to those with normal renal function. Additionally, hemodialysis via the dialysis
      filter causes a decrease in glycoprotein platelet receptors, potentially associated with
      thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow
      P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel
      150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be
      carried out, without an interventing washout period. All patients will undergo platelet
      reactivity assessment, documentation of major adverse cardiac events and documentation of any
      serious adverse events(stroke, bleeding)at day 15 and day 30.
    


Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10 mg/day for 15 days; Clopidogrel 150 mg/day for 15 days
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clopidogrel Resistance; prasugrel; Hemodialysis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and
      Tiotropium Bromide when given as fixed dose combination
    


Intervention name(s): Single rising doses of BI 1744 CL, solution for oral inhalation; Tiotropium, fixed dose, solution for oral inhalation; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions; Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block
      vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic
      cholecystectomy.
    

Detailed description: 
      To study the difference between the effects of ultrasound-guided bilateral retrolaminar block
      and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic
      cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic
      cholecystectomy at Zagazig university hospitals.
    

Intervention name(s): Bilateral retrolaminar block; Thoracic epidural analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): in lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT7 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed parasagittal plane 1 cm lateral to the midline. The needle (18 gauge) is inserted in the plane view of the ultrasound probe to target the T7 and needle is advanced from downward to upward until the needle tip contacted the lamina. After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side.; In the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T7-8) will be identified by counting from the C7 to prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T7-8 intervertebral space . the needle 18 gauage will be inserted in plane to target T7-8 intervertebral space ., after needle tip reached target space, loss of resistance technique then 20 ml bupivacaine 0.25% plus 5ug/ml adrenaline (1:200000) was injected after aspiration
Other intervention name(s): Ultrasound guided retrolaminar block; Ultrasound guided thoracic epidural
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound; Bilateral retrolaminar; Thoracic epidural; post operative analgesia; Laparoscopic cholecystectomy
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Condition: Prehypertension; Stage-1 Hypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      Elevated systolic blood pressure is by far the largest single contributor to cardiovascular
      risks in middle-aged and older adults. Lifestyle modifications, including dietary
      modifications, are the first line approach for treating and preventing hypertension. The
      general aim of the proposed study is to address the efficacy of conventional dairy products
      as part of the normal routine diet for lowing arterial blood pressure in middle-aged and
      older adults with elevated blood pressure. The investigators hypothesize that the dietary
      intervention including dairy products will induce significant decreases in arterial blood
      pressure in this population. A secondary aim will be to test the hypothesis that these
      reductions in systolic blood pressure will be associated with increases in arterial
      stiffness/compliance and endothelial vasodilatory function.
    


Intervention name(s): Non-fat dairy; Add 4 servings fruit
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Add 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks; Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
Condition: Mydriasis; Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are:

        -  To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to
           expedite the reversal of pharmacologic mydriasis

        -  To evaluate the safety of Nyxol

        -  To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness)
           potentially associated with administration of Nyxol
    

Detailed description: 
      Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy
      subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced
      mydriasis.

      At the first visit subjects will be screened for study eligibility.

      After screening, eligible subjects will be randomized 1:1 to one of the two treatment
      sequences:

      Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).

      Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).

      Randomization will be stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide).
      Approximately one half of the randomized subjects will receive 2.5% phenylephrine and one
      half will receive 1% tropicamide. Subjects will receive their mydriatic agent 1 hour before
      treatment. Each subject will receive the same mydriatic agent throughout the study.

      At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and
      redness in each eye will be measured before (-1 hour/baseline) and 1 hour after (maximum/0
      minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment
      is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment
      dosing.

      As needed, two hours post treatment, subjects may request the administration of Lumify® in
      the non-study eye.
    

Intervention name(s): Phentolamine Mesylate Ophthalmic Solution 1%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention type(s): Drug; Other
Intervention description(s): 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Topical Sterile Ophthalmic Solution
Other intervention name(s): Nyxol®; Nyxol
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nyxol; Pharmacologically Induced Mydriasis; Dilation
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein
      and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea.
      Since light entering the eye passes through the MP before reaching the photo receptors it
      absorbs a significant portion of short-wavelength light. There is evidence that this
      absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen
      species are protective for the retina.

      Age-related macular degeneration is the leading cause of blindness among developed countries.
      The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit
      and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD).
      Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD.
      The present study investigates whether 6 months lutein supplementation increases MP optical
      density (OD), influences visual acuity, depth and dimension of central scotoma and alters
      symptoms in patients with AMD.
    


Intervention name(s): lutamax (leutein); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): leutein 20 mg for 3 months, then lutein 10 mg; Placebo capsules identical in taste and appearance
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lutein; nonexudative AMD; MPOD; Supplementary Concepts
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
Condition: Type II Hyperlipidaemia
MeSH terms: Hyperlipoproteinemia Type II; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C
      and on the inhibition of CETP activity versus placebo, in patients presenting with mild
      dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
    


Intervention name(s): Placebo; JTT-705 300mg; JTT-705 600mg; JTT-705 900mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablet, 3 tablets, oral, once daily after breakfast; JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.; JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast; JTT-705 tablet, 3 tablets, oral, once daily, after breakfast
Intervention MeSH terms: Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CETP Inhibitor; HDL-C; LDL-C; Apolipoprotein
Alliance With Therapeutic Entourage in Support of Young Suicidal
Condition: Suicide
MeSH terms: Suicide
Study type: Interventional

Summary: 
      Regardless of age, the quality of hospital care, the confidence that the young can have in
      the health care team, joining parents are pivotal elements and influence followed. Family
      support is all the more important as 14% of young people realize a new suicidal act within
      three months of hospitalization for attempted suicide, and that the essential predictors
      appear to be the young age and quality of intra-family relationships.

      The main objective of this study is to determine, through the construction of an instrument
      to quantify the therapeutic alliance, defined by the characteristics of the mobilization of
      the entourage and the mutual commitments in the care of nursing teams and the entourage, the
      role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether
      primosuicidants or repeat offenders, on short and medium term recurrences and early
      mortality.
    


Intervention name(s): Therapeutic alliance
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
Condition: Circulating Tumor Cells
MeSH terms: Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in
      cancer patients before and after undergoing treatment regimens where the primary treatment
      modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs
      pre- and post- XRT, both in absolute and relative terms.
    

Detailed description: 
      CTCs measurements will be taken pre- and post-RT treatment. CTCs measurements will also be
      taken during treatment. The CTCs measurements from this study will provide essential
      information for the power and sample size considerations for future translational studies,
      particularly for those looking to identify biomarkers possibly associated with CTCs and tumor
      response activity after XRT, and to adequately power more formal statistical comparisons of
      important associations between CTCs and patient characteristics and outcomes.
    

Intervention name(s): Blood draw
Intervention type(s): Other
Intervention description(s): Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC
        Hospitals for one of eight cancer types: head and neck, cervical, rectal, lung, prostate,
        endometrial, metastatic breast, and oligometastatic cancer with any solid tumor histology.
        Additionally, patients undergoing immunotherapy at Lineberger Comprehensive Cancer Center
        at UNC Hosptials, or undergoing induction chemotherapy for treatment of head and neck
        cancers.
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Approximately 60 patients suffering from moderate to severe ulcerative colitis will be
           evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or
           matching placebo once daily for 12 weeks in addition to their stable background
           treatment.

        -  During the course of the study, patients will also be examined for any side effects that
           may occur (safety and tolerability), and the amount of GLPG1205 present in the blood
           (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of
           action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will
           be determined.
    


Intervention name(s): GLPG1205; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG1205 daily dosing in the morning for 12 weeks; placebo daily dosing in the morning daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate to severe ulcerative colitis; GLPG1205
Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability
Condition: Intact Skin
Study type: Interventional

Summary: 
      It is the first clinical study aimed at assessing the safety and tolerability of
      HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The
      HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot
      ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent
      decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is
      a hydrogel for wound bed preparation to support the healing of the skin due to cleansing,
      moistening and subsequent decolonization and the coating of the wound.

      The study will be conducted in outpatient manner, adult patients who are healthy and has an
      intact skin.

      This is an prospective, open label, monocentric study. No comparative control group is
      planned as no other preventing infection solution is commercially available at this time.
    

Detailed description: 
      The objective of this study is to assess the local tolerability and safety of HM242-Solution
      and HM242-Gel after their application under occlusion on intact skin.
    

Intervention name(s): HM242
Intervention type(s): Device
Intervention description(s): HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Physical rinsing; Cleansing solution; Wound bed preparation