bioihbjkbjnl/mcl2 huggingface dataset:
fMRI Study Examining Effects of D-cycloserine in Specific Phobia
Condition: Phobias
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The research team hopes to use brain imaging and mental testing to learn more about specific
      phobias and the treatment of phobia. When given directly prior to therapy sessions,
      D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify
      reasons why D-cycloserine has this effect by measuring brain activity.
    

Detailed description: 
      Exposure and Response Prevention (ERP) therapy has become the treatment of choice for
      specific phobias. ERP involves systematic and repeated exposure to a feared or
      anxiety-provoking stimulus, leading to habituation and extinction of the fear response.
      Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS)
      prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in
      human subjects with height phobia (a specific phobia) has also demonstrated that DCS
      facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear
      extinction by enhancing the learning process and increasing consolidation of memories, but
      the neural mechanisms underlying this process are not understood. The proposed research aims
      to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom
      provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation
      and verbal recognition one week post-medication. This research will also examine the effects
      of DCS on cognitive functioning using neuropsychological testing both two house and one week
      post-medication.
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): D-cycloserine; Placebo
Other intervention name(s): Cycloserine; Sugar pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Patients with stroke in the brain, due to central nervous system damage, lack of correct
      action patterns, limited joint movement of upper limbs, affecting the patient's performance.
      The Kinesio taping effect is to facilitate the muscle activity of upper limb. This program is
      intended to provide a treatment for patients with chronic stroke, and to observe their upper
      limb movements before and after using the Kinesio taping.
    

Detailed description: 
      Motor impairment is the main cause of disability after stroke, leading to major health
      problems. Research has shown that the most common consequence of stroke is the paresis of
      limbs.The ability to live independently after a stroke depends on the recovery of motor
      functions,particularly those of the upper limb.The core concept of the Kinesio taping is to
      influence the brain through the sensory input, stimulate the nervous system, and improve the
      motor performance of the stroke patient.
    

Intervention name(s): Kinesio taping
Intervention type(s): Other
Intervention description(s): In KT group, KT was applied using the insertion-origin muscle and space-correction technique of affected upper limb with stroke patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
Condition: Hyperandrogenism,; Polycystic Ovary Syndrome,; Metabolic Syndrome,; Insulin Resistance,; Cardiovascular Disease.
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Cardiovascular Diseases; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Observational

Summary: 
      STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone
      [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate
      [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more
      insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with
      excess free androgen index tend to be obese and face the highest metabolic syndrome risk,
      adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT
      group presents with a marginal IR risk, while the excess A4 group has the highest
      antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S
      group have a favorable association with IR.
    

Detailed description: 
      STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165
      women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic
      women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent
      abnormally elevated androgen measures each above its cut-off value, and the groups were
      compared with each other and with controls.

      PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive
      Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic,
      endocrine, and IR components as well as lipid accumulation product (LAP) index were compared
      between the groups. IR was assessed with the following markers: fasting glucose and insulin
      levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model
      assessment of IR index (HOMA-IR).
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A retrospective review of the medical records of women who visited the Reproductive
        Endocrinology Clinic was carried out at the Wan Fang Medical Center at Taipei Medical
        University from 2009 and up to 2012. A total of 160 Taiwanese women with hyperandrogenism
        (HA) and 165 women without hyperandrogenism (non-HA) were included in the study.
      
Keywords: Hyperandrogenism/; FAI/; Metabolic syndrome/; Adipocytokines/; Insulin resistance.
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,
      India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest
      Laboratories Inc, USA] . Dosing periods were separated by a washout period during fasted
      study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Escitalopram Oxalate Tablets
Intervention type(s): Drug
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Condition: Primary Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of pitavastatin with that of
      atorvastatin.
    

Detailed description: 
      Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or
      Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing
      cholesterol levels.
    

Intervention name(s): Pitavastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hypercholesterolemia; dyslipidemia; kowa; KRE; pitavastatin; NK-104
Heel Warming Before Capillary Blood Sampling
Condition: Blood Specimen Collection
Study type: Interventional

Summary: 
      Capillary blood sampling from the heel is often used in the treatment of infants admitted to
      neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a
      disposable glove with warm water are the methods most often used.

      The purpose of this randomized controlled study is to investigate which of the mentioned
      heating methods ensures the best quality of the blood sample and provides the most gentle
      blood sampling for the infant.
    

Detailed description: 
      Some infants experience a difficult and painful blood sampling which can lead to bruised or
      swollen heels and a blood sample of poor quality. To minimize the risk of that, the infant's
      heel is heated before the procedure as described in standard GP42-A6 from The Clinical and
      Laboratory Standards Institute. However, no consensus exists on which heating method to use.
      The aim of this study is to compare three different heating methods in terms of which method
      can help reduce pain experienced by infants as well as increase the quality of the blood
      samples.

      Infants (postmenstrual age ≥ 28 + 0) admitted to the NICU, Kolding Hospital and having a
      blood sample taken by a Biomedical Laboratory Scientist are invited to participate. A
      parental informed concent must be signed by both parents before participation.

      Infants are randomized to one of the three heating methods: glove, blanket or gel pad.

      The following blood sampling procedure is closely monitored to register data corresponding to
      the five outcome measures.

      Furthermore the infants personal data, location of the infant during the procedure, surface
      temperature of the heel before and after heating, volume of sampled blood, sign of bruises
      and swelling as well as hematocrit are registered.

      Data registration, web-based block randomization, data storage and statistical analysis are
      supported by OPEN (Open Patient data Explorative Network, University of Southern Denmark).

      The study is registered as public research at the Region of Southern Denmark (journal no.
      20/1316) and is approved by The Regional Committees on Health Research Ethics for Southern
      Denmark (ID S-20200082).
    

Intervention name(s): Heating with a disposable glove containing water; Heating with a blanket; Heating with a gel pack
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Heating of the infants heel with a glove before blood sampling.; Heating of the infants heel with a blanket before blood sampling.; Heating of the infants heel with a gel pack before blood sampling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood Specimen Collection; Phlebotomy; Infant, Newborn; Heating; Heel; Pain
Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Condition: QT/QTc Interval in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study
      to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
    


Intervention name(s): WCK 5222; IV placebo matched to WCK 5222 / Moxifloxacin IV solution; Moxifloxacin 400-mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion); Placebo (IV placebo matched to FEP-ZID IV solution) and
1 placebo capsule matched to moxifloxacin overencapsulated tablet; Moxifloxacin 400-mg positive control (overencapsulated tablet)
Other intervention name(s): Placebo capsule matched to moxifloxacin
Intervention MeSH terms: Moxifloxacin; Cefepime-zidebactam; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial.
      The study is designed to evaluate the safety and local tolerability of DA-6034 upon single
      and repeated-dose topical application to the both eyes in healthy volunteers.
    


Intervention name(s): DA-6034; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eye drop, Dry eye
Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection
Condition: Intravitreal Injection; Pain; Subconjunctival Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Intravitreal injections (IVI) are the mainstay of treatment modality in many ophthalmologic
      diseases including neovascular age-related macular degeneration (AMD), diabetic retinopathy
      and retinal vascular occlusions. Patients endure monthly IVI for several years. Although
      standardized topical anesthesia protocols are being carried out, many still suffer from pain
      during and after the procedure. Previous studies at the investigators clinic have
      demonstrated that alpha-agonist eye drops and cool eye compresses can be successfully used in
      order to reduce pain levels when administered prior to IVI. In the current research, the
      investigators wish to study whether cooled anesthetic eye drops and antiseptics can be
      utilized as well to reduce the pain and subconjunctival hemorrhage caused by bevacizumab IVI.
    


Intervention name(s): Cooled eye drops and povidone-iodine
Intervention type(s): Procedure
Intervention description(s): Cooled oxybuprocaine HCl 0.4% and lidocaine HCl 2% eye drops and cooled povidone-iodine (cul-de-sac 5% povidone-iodine and 10% povidone-iodine).
Intervention MeSH terms: Povidone-Iodine; Povidone; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Intravitreal injection; Pain; Subconjunctival Hemorrhage; Bevacizumab; Eye drops
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD
      f\profile.
    

Detailed description: 
      The primary objective of this study is to investigate the safety and tolerability following
      administration of single ascending doses of GCC4401C in healthy male subjects; and the
      secondary objective of this study is to characterize the single-dose PK profile after oral
      administration of GCC-4401C, and to determine an appropriate dose range and dosing regimen of
      oral GCC-4401C for subsequent clinical trials.
    

Intervention name(s): GCC-4401; GCC-4401C
Intervention type(s): Drug; Drug
Intervention description(s): Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use
single dose
dosage
Cohort 1: 2.5-mg GCC-4401C
Cohort 2: 5.0-mg GCC-4401C
Cohort 3: 10-mg GCC-4401C
Cohort 4: 20-mg GCC-4401C
Cohort 5: 40-mg GCC-4401C
Cohort 6: 80-mg GCC-4401C; Capsule, identical in appearance to GCC-4401C, for oral use
single dose
dosage
Cohort 1: 2.5-mg matching placebo
Cohort 2: 5.0-mg matching placebo
Cohort 3: 10-mg matching placebo
Cohort 4: 20-mg matching placebo
Cohort 5: 40-mg matching placebo
Cohort 6: 80-mg matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of the Intravenous Tissue Plasminogen Activator Treatment Algorithm of Nursing Intern Students
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Intravenous (IV) tissue plasminogen activator (tPA) is one of the key elements of acute
      ischemic stroke. In this study, acute stroke patients maximum benefit from the treatment,
      intravenous tissue plasminogen activator (IV tPA) minimizing the errors related to the
      treatment of acute ischemic stroke patients of nursing students from clinical practice guides
      published on the treatment of It is aimed to be informed and to standardize nursing
      interventions.
    

Detailed description: 
      Time management in acute stroke patients is possible with a multidisciplinary approach and
      team members who have received specific training for acute stroke patients. Studies have
      shown that the maximum result of treatment for acute stroke patients depends on nurses'
      ability to identify disease symptoms, plan and apply symptom-specific nursing care. There is
      evidence that the multidisciplinary presence of stroke teams in stroke units and the delivery
      of coordinated care during the acute phase improve patient outcomes . Coordinated care by the
      stroke team improves patient outcomes, reduces hospital costs, reduces patient readmission,
      and improves patient care quality.
    

Intervention name(s): theory training; theory and simulation training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): theory training; theory and simulation training
Other intervention name(s): tPA treatment knowledge of nursing students will increase; tPA treatment knowledge of nursing students will increase
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intern nurses will be numbered from 1 to 75 and will be randomly divided into study and control groups from the random numbers table.
After the groups are determined by the randomization method, each intern nurse in the study and control groups will be interviewed face to face and their written informed consent will be obtained. Then, all nursing intern students participating in the research will be asked to fill in the IV tPA Treatment Knowledge Level Evaluation Form, Self-Efficacy Competence Scale. Intern nurses in both groups will be given 1-hour theoretical training on IV tPA treatment before, during and after the procedure. In addition, simulation-based training will be applied to the intern nurses in the study group regarding IV tPA treatment before, during and after the procedure.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tissue plasminogen activator; acute stroke; intravenous tissue plasminogen activator; nursing care; neurology nursing; acute stroke treatment
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Condition: Nicotine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether topiramate is effective as an aid to
      smoking cessation for recovering alcohol dependent men.
    

Detailed description: 
      This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of
      topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent
      men. Another aim of the study is to explore whether or not topiramate reduces relapse to
      alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will
      receive a standardized psychosocial intervention in combination with the medication (or
      placebo). Following completion of the treatment phase of the study, participants will enter a
      24-week follow-up period during which the longer-term outcome of the intervention will be
      assessed.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).; Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco use disorders; alcoholism
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male
      volunteers.
    


Intervention name(s): Samidorphan IV; [14c]-Samidorphan sublingual; [14c]-Samidorphan oral
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single IV administration; Single sublingual administration containing radiolabel; Single oral administration containing radiolabel
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; Samidorphan; ALKS 33; Healthy Volunteer; Pharmacokinetics
Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline
      compared to placebo in the treatment of moderate to severe facial acne vulgaris
    


Intervention name(s): Sarecycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg/kg/day taken orally at the same time each day,; Placebo-matching sarecycline tablets taken orally at the same time each day.
Intervention MeSH terms: Sarecycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne
A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of
      single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.
    

Detailed description: 
      The purpose of this study is to evaluate the food effect on the pharmacokinetics and safety
      of a single oral dose of TAK-536TCH under fasted and fed conditions in the morning in healthy
      adult male participants.
    

Intervention name(s): TAK-536TCH
Intervention type(s): Drug
Intervention description(s): TAK-536TCH tablets
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacological therapy