bioihbjkbjnl/mcl2 huggingface dataset:
Physiological Study of the Human CYP3A Activity (PiSA)
Condition: Cytochrome P450 CYP3A Enzyme Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigator-initiated physiological study to characterize the function of a major drug
      metabolizing enzyme using a microdosed phenotyping probe to avoid unwanted,
      concentration-dependent effects.
    

Detailed description: 
      Disposition of a drug depends on absorption, distribution, metabolism, and elimination
      (ADME). Quantifying the ADME capacity of a patient may help to individualize target exposure
      by choosing the corresponding dose required for this individual. The large group of drugs
      eliminated by members of the CYP3A isozyme subfamily accounts for about 50% of all marketed
      drugs. Co-medication can modulate CYP3A activity 400-fold either by inducing isozyme
      expression or inhibiting expressed enzyme. Therefore, due to the variability of CYP3A
      activity, dose requirements of CYP3A substrates vary considerably between individual patients
      and may even rapidly vary within a patient. There is clinical interest in using CYP3A
      activity as a biomarker to predict optimal CYP3A drug dosing, improve therapeutic efficacy,
      and minimize adverse drug effects.

      Determination of CYP3A activity is usually done with oral midazolam doses of 2-7.5 mg
      (phenotyping). Because therapeutic doses have pharmacological effects and can cause sedation,
      especially if CYP3A is inhibited, a microdosing approach for CYP phenotyping was developed to
      avoid any pharmacological activity. Oral midazolam pharmacokinetics are linear over a
      30,000-fold range and 300 ng doses can reliably predict drug interactions with strong CYP3A
      inhibitors like ketoconazole.

      The primary objective of this trial is to determine CYP3A activity using microdosed midazolam
      delivered from an oral disintegrating formulation in comparison to an oral midazolam
      solution. The oral disintegrating formulation is an innovative application form that would
      facilitate administration of the phenotyping probe in special patient populations.
    

Intervention name(s): AB (Midazolam OD formulation/Dormicum); BA (Dormicum/Midazolam OD formulation)
Intervention type(s): Drug; Drug
Intervention description(s): Oral disintegrating formulation (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd; Oral disintegrating film (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd
Other intervention name(s): oral disintegrating (OD) formulation containing midazolam; oral disintegrating (OD) formulation containing midazolam
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, randomised, single-dose crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Condition: Burns; Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether the use of a bioelectric wound dressing is
      effective in the healing of skin graft donor site wounds.
    


Intervention name(s): Procellera (Bioelectric Wound Dressing); Opsite (Transparent Adhesive Dressing)
Intervention type(s): Device; Device
Intervention description(s): Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed; Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.
Other intervention name(s): Procellera; PROSIT; Procellera Wound Dressing; Procellera Device; Opsite Dressing
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burns; Wounds and Injuries; Skin Grafts, Bioelectric; Grafting, skin
The Pathophysiology of Orthostatic Hypotension
Condition: Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance
MeSH terms: Nervous System Diseases; Hypotension, Orthostatic; Orthostatic Intolerance; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the cause of low blood pressure in selective
      patients who have problems with their involuntary (autonomic) nervous system. These patients
      frequently have had symptoms throughout their life, and their disorder might have a genetic
      basis. The biochemical, physiological and pharmacological procedures in this study should
      help us define the problem and perhaps lead to more effective treatment.
    


Intervention name(s): Standing or upright tilt; Microneurography; QSweat; neck cuff stimulation; phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine; clonidine,yohimbine,metoclopramide,alpha-methyldopa; BodPod; Eye exam; Sleep study; Pain response testing; Metabolic chamber; Brain function studies; Bicycle Exercise Test
Intervention type(s): Procedure; Procedure; Procedure; Device; Drug; Drug; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): stand upright or tilt table test; Recording from sympathetic nerve; quantitative sweat testing; Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.; IV Pharmacological Testing
phenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect; Oral Pharmacological Testing
clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo; Determination of body composition; Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:
0.5% proparacaine (Alcaine, Allergan, Inc)
Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)
0.5%, 1% tropicamide (Mydriacyl, Alcon)
Over-the-counter preservative-free artificial tears
0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)
1% cyclopentolate hydrochloride (Alcon); Recording of sleep pattern overnight; Subjects will rate the quality and intensity of 2 pain tasks.; Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter; Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.; Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.
Intervention MeSH terms: Propranolol; Atropine; Clonidine; Nitroprusside; Methyldopa; Phenylephrine; Isoproterenol; Metoclopramide; Yohimbine; Tyramine; Edrophonium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: autonomic nervous system diseases; blood pressure; congenital; orthostasis; catecholamines
Bowen's Technique In Postural Neck Pain Among Dentist
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      No previous randomized control trial has investigated the effectiveness of Bowen's technique
      on health status in dentists suffering from postural neck Neck pain. Moreover, there is
      limited evidence and low agreement regarding the effect of Bowen's therapy on Neck pain.
      Thus, this study aims to answer the question: bowmen's technique is effective for improving
      Neck pain dentists' function by reducing pain, and disability, and improving posture, and
      health status, without need for ergonomic alternation?"
    

Detailed description: 
      Bowen technique may be used for relaxation of tightening muscles in poor posture. The
      findings suggest that Bowen Therapy has inconsistent immediate effects on postural control
      and pain threshold in healthy subjects. Further studies are needed using symptomatic
      participants. No previous randomized control trial, to our knowledge, has investigated the
      effectiveness of Bowen's technique on health status in dentists suffering from postural neck
      pain. Moreover, there is limited evidence and low agreement regarding the effect of Bowen's
      therapy on neck pain. Thus, this study aims to answer the question: Bowen's technique is
      effective for improving neck pain dentists' function by reducing pain, and disability, and
      improving posture, and health status, without need for ergonomic alternation?"
    

Intervention name(s): Bowen's Technique; Convention Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): The thumb of the therapist was placed on the top of the targeted muscle (upper trapezius, levator scapulae, tight pectoralis and sternocleidomastoid, longissimus capitis, splenius capitis cervical multifidus). The skin was carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb was flattened in the medial direction, when this happened the muscle would plop or 15 respond in some way. Heating pad + TENS will be given The session lasted for 20 minutes 3sessions/week for 6th week; Myofascial Release + Active Range of Motion Deep transverse friction was given for 10 minutes followed by myofascial stretching of muscle for 3 times, each holding for 90 seconds. Then myofascial release was given using ulnar border of both palms of the therapist.
Active range of motion exercises will be given 10 reps with 5 seconds hold. Heating pad + Transcutaneous Electrical Nerve Stimulator (TENS) will be given The session lasted for 20 minutes 3sessions/week for 6th week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Dentist; Neck; Bowen technique
Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the bioequivalence of two different
      specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100
      mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different
      specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd.

      The secondary objective of the study is to evaluate the safety of test preparations and
      reference preparation fluzoparib capsules of different specifications in healthy subjects.
    


Intervention name(s): Fluzoparib; Fluzoparib
Intervention type(s): Drug; Drug
Intervention description(s): the first period: test preparation; the second period: reference preparation; the first period: reference preparation the second period: test preparation
Intervention MeSH terms: Fluzoparib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single dose of oral administration of fluzoparib capsules
Masking: None (Open Label)
Primary purpose: Basic Science
Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers
Condition: Pharmacokinetics; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1
      clinical trial to determine the safety and tolerability of BTA-C585 administered orally to
      healthy subjects.
    


Intervention name(s): BTA-C585 oral capsules; BTA-C585 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): BTA-C585; Single ascending doses from 50 mg to 800 mg; Single ascending doses to match 50 to 800 mg BTA-C585 capsules
Other intervention name(s): BTA585; BTA585
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Viral Diseases; Antiviral; Paramyxoviridae Infections; RSV; Respiratory Syncytial Virus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee
Condition: Osteoarthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and preliminary efficacy of autologous
      adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary
      osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed
      to subjects at a weekly interval.
    


Intervention name(s): Adipose-Derived Mesenchymal Stem Cells
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ILM Peeling in PDR Patients Undergoing PPV for VH
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower
      rates of DME to control subjects
    

Detailed description: 
      Proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME) frequently occur
      together in patients with diabetic retinopathy In the landmark study Protocol S, about 30% of
      PDR subjects had DME at baseline and 53% of subjects receiving panretinal photocoagulation
      (PRP) underwent treatment for DME during the 2-year study interval. Vitreous hemorrhaging is
      one of the most common indications for pars plana vitrectomy (PPV) in patients with PDR. PDR
      patients undergoing PPV for the treatment of vitreous hemorrhaging often have coexisting DME,
      although it is often difficult to identify preoperatively because of the media opacification
      from the vitreous hemorrhage. Following successful PPV and vitreous hemorrhage resolution,
      PDR patients may then require prolonged DME treatment with repetitive intravitreal injections
      and/or focal lasers.

      PPV with internal limiting membrane (ILM) peeling has been reported to reduce retinal edema
      and improve visual acuity in patients with DME. Although numerous studies report favorable
      outcomes in patients undergoing PPV with ILM peeling for the surgical indication of DME,
      there are presently not any studies evaluating ILM peeling in PDR patients undergoing PPV for
      the primary indication of vitreous hemorrhaging. Performing ILM peeling in conjunction with
      the usual techniques for addressing a vitreous hemorrhage (i.e. endolaser PRP, endodiathermy,
      etc.) during PPV may offer the benefits of better postoperative visual acuity and/or fewer
      postoperative treatments required to manage DME. In this randomized controlled trial, the
      authors evaluate the merits of ILM peeling in PDR patients undergoing PPV for the primary
      indication of vitreous hemorrhaging.
    

Intervention name(s): PPV/MP; PPV without MP
Intervention type(s): Procedure; Procedure
Intervention description(s): Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging; No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the steady-state pharmacokinetic profile of
      paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market
      tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the
      dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.
    

Detailed description: 
      This study is an open, randomized, repeat dose, two-period crossover design in Japanese
      healthy male volunteers. This clinical trial is designed primarily to compare the
      steady-state pharmacokinetic profile of paroxetine CR at the dosage of 25mg /day (25mg once
      daily for 14 days) using the proposed final market tablet of CR 25mg in Japan with that of
      paroxetine IR at the dosage of 20mg/day (20mg once daily for 14 days) using the currently
      marketed IR 20mg tablet in Japan, by the crossover oral repeat dosing manner.
    

Intervention name(s): Paroxetine CR and Paroxetine IR
Intervention type(s): Drug
Intervention description(s): Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: controlled-release tablet; repeat dose; immediate-release tablet; paroxetine; safety; crossover; pharmacokinetics; steady-state; Japanese healthy male volunteers; tolerance
The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is examining the effect of hypertonic saline compared to placebo on the Lung
      Clearance Index in Cystic Fibrosis patients.
    

Detailed description: 
      The life expectancy of patients with Cystic Fibrosis (CF) has greatly increased over time due
      to improved clinical care. While this is certainly beneficial to CF patients, the overall
      stability in lung function has made it more difficult to assess the effect of therapeutic
      interventions. Currently, FEV1 (forced expiratory volume in 1 second) remains the primary
      outcome measure for most clinical trials, but many CF patients have normal pulmonary function
      and the annual rate of decline is now less than 2% in large specialized centres. Therefore,
      additional parameters are needed that are more sensitive parameters to define abnormalities
      in CF patients and be used in therapeutic trials.

      One such promising parameter is the Lung Clearance Index (LCI). The LCI is a test to quantify
      ventilation inhomogeneity by assessing the washout of an inhaled inert gas. Abnormalities in
      gas clearance from the lung are largely due to retention of inhaled gases due to mucous
      obstruction in the lower airways.

      Interventions that improve mucus accumulation are expected to improve the LCI. Hypertonic
      saline has been shown to increase airway surface liquid (ASL), mucociliary clearance and
      pulmonary function. Therefore, this study will examine the effect of hypertonic saline
      compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.
    

Intervention name(s): hypertonic saline (7 %) and isotonic saline (0.9%); hypertonic saline (7 %) and isotonic saline (0.9%)
Intervention type(s): Drug; Drug
Intervention description(s): Patients in study arm 1 will receive hypertonic saline (7 %) during the first phase of the study and will crossover to placebo (0.9% isotonic saline) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.; Patients in study arm 2 will receive placebo (0.9% isotonic saline) during the first phase of the study and will crossover to hypertonic saline (7 %) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Lung Clearance Index; Hypertonic Saline; Pediatrics
Evaluating the Safety and Immune Response to a Dengue Virus Vaccine in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this
      study is to evaluate the safety and immune response to a dengue virus vaccine.
    

Detailed description: 
      Dengue viruses can cause dengue fever and the more severe disease, dengue hemorrhagic
      fever/shock syndrome (DHF/DSS). Infection with dengue viruses is the leading cause of
      hospitalization and death in children in at least 8 tropical Asian countries. There are 4
      types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause dengue
      illness ranging from a mild illness to life-threatening disease. This study will evaluate the
      experimental rDEN2Δ30-7169 vaccine for the prevention of illness due to DENV-2. The purpose
      of this study is to evaluate the safety and immunogenicity of this vaccine in healthy adults
      with no history of previous flavivirus infection.

      At study entry, participants will be randomly assigned to receive either the dengue virus
      vaccine or placebo. They will remain in the clinic for 30 minutes after receiving the
      injection for monitoring. Study visits will occur at Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28,
      56, and 180. All study visits will include a blood collection, and most study visits will
      include a physical examination. Female participants will have a pregnancy test at select
      visits. Participants will record their temperature at least 3 times a day for the first 16
      days; study researchers will review these readings during the study visits.
    

Intervention name(s): rDEN2Δ30-7169 vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered at a dose of 10^3 plaque-forming units (PFU); delivered by subcutaneous injection in the deltoid region of the upper arm; Delivered by subcutaneous injection in the deltoid region of the upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention