bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of two fixed doses of vortioxetine (Lu
      AA21004; 10 or 20 mg/day) after 8 weeks of treatment in patients with major depressive
      disorder (MDD) in Japan.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, phase III study to
      assess the efficacy and safety of 8-week treatment of two fixed doses of Vortioxetine (Lu
      AA21004; 10 or 20 mg/day) in Japanese participants with major depressive disorder (MDD).
    

Intervention name(s): Placebo; Vortioxetine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets; Vortioxetine tablets
Other intervention name(s): Lu AA21004
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers
Condition: Refractive Error - Myopia Bilateral
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The study will compare the short-term clinical performance and wearer and practitioner
      acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens
      to a currently marketed spherical DD hydrogel soft contact lens.
    

Detailed description: 
      This randomized clinical trial will compare the short-term clinical performance, and wearer
      acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against
      marketed DD lenses in a short cross-over clinical trial.

      The primary outcome variable for this study is overall subjective comfort.
    

Intervention name(s): Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
Intervention type(s): Device
Intervention description(s): Daily disposable contact lens wear for 1 week
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over with 1 week of lens wear with each contact lens type.
Masking: Single (Investigator)
Primary purpose: Treatment
Dry Needling and Electromyographic Changes in Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      There is evidence suggesting that patients with mechanical neck pain exhibit higher activity
      of the superficial neck flexor muscles during the execution of the cranio-cervical flexion
      test. In addition, some studies have reported the presence of active trigger points in the
      neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can
      affect motor control behaviour, it is possible that management of these trigger points with
      dry needling could be effective for improving muscle activity during low-load activities,
      such as the cranio-cervical flexion test. Therefore, the aim of this study will be to
      investigate the effects on electromyographical activity, pressure pain thresholds and
      cervical range of motion after the application of dry needling over active TrPs in the upper
      trapezius muscle in patients with mechanical neck pain.
    


Intervention name(s): Dry Needling; Manual Therapy
Intervention type(s): Other; Other
Intervention description(s): Patients will receive dry needling over active trigger points in the upper trapezius muscle; Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Trigger points; Dry needling; Cranio-cervical flexion test
Laparoscopic Versus Open Appendectomy
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      Comparison of open and laparoscopic appendectomy
    

Detailed description: 
      Adult patients with presumptive diagnosis of acute appendicitis were were operated by
      laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007
      and 2009).
    

Intervention name(s): laparoscopic appendectomy; open appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.; The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
Other intervention name(s): harmonic scalpel (UltraCision Ethicon ®); fusion device (Covidien LigaSure™); stapling device (Covidien Endo GIA™)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis
      
Keywords: open appendectomy; laparoscopic appendectomy; appendicitis
Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability
Condition: Stroke Patients
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study; To determine the immediate effect on fall risk and postural stability
      of vibration applied to the plantar region in stroke patients.
    

Detailed description: 
      Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA
      clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the
      inclusion criteria and who are excluded from the exclusion criteria will be randomized
      according to the order of arrival and will be divided into two groups as the vibration group
      and the placebo group.Patients will be taken to the placebo and vibration group respectively
      in order of arrival. If the next patient falls outside the inclusion criteria of the study,
      randomization will be applied to the next patient. The vibration group, one session in supine
      position will be applied to both sides of the soles of the feet under the soles of the feet
      for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group,
      both sides will be held in the supine position under the soles of the foot for 5 minutes each
      so that the device is in contact with the foot without vibration.
    

Intervention name(s): vibration group; placebo group
Intervention type(s): Other; Other
Intervention description(s): plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.; the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 stroke patients will be included in this study. The patients who meet the inclusion criteria will be divided randomly into 2 groups as vibration (n=15) and placebo (n=15).The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke vibration fall risk postural stability; immediate effect; fall risk; postural stability
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Characterize the relative abuse liability of a short versus a long acting opioid in chronic
      pain patients.
    

Detailed description: 
      A placebo-controlled, double-blind, crossover trial will be conducted providing study
      subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or
      placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45
      mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone
      (30 mg) selected. Subjects will participate in the three sessions at the UC Davis/Mather
      Medical Center General Clinical Research Center (GCRC) at intervals of 7-10 days. Sessions
      will be approximately 360 min in duration. Subjects will receive either
      hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior
      to the experimental session. At each experimental session, an assessment of abuse liability
      will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240
      minutes after the ingestion of the study medication.
    

Intervention name(s): Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; ER Morphine; hydrocodone plus acetaminophen; placebo
Intervention type(s): Behavioral; Drug; Drug; Drug
Intervention description(s): The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.
Other intervention name(s): Craving for drugs on 5 visual analog scales; Addiction Research Center; Morphine-Benzedrine Group (euphoria); Phenobarbital-Chorpromazine-Alcohol (sedation); Lysergic Acid Diethylmide (dysphoria, agitation); Benzedrine (an empiric amphetamine scale); Amphetamine (activation); Cue reactivity testing; Neurocognitive testing; extended release morphine
Intervention MeSH terms: Acetaminophen; Morphine; Hydrocodone; Phenobarbital; Amphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Pain; Opioids
Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP
Condition: Quality of Life
Study type: Observational

Summary: 
      A multicenter longitudinal study with data collection at 4 and 8 months after hospital
      discharge.
    

Detailed description: 
      The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19
      wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center),
      the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria
      Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months
      after hospital discharge in the patient's home environment, quality of life, residual
      disability, anxiety and insomnia.

      Enrollment took place only after the approval of the Ethics Committee of each participating
      center.
    

Intervention name(s): administration of questionnaires
Intervention type(s): Behavioral
Intervention description(s): administration of questionnaires
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19
        wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting
        center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio
        Sanitaria Territoriale in Lecco, from November 2020 to June 2021
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)
Condition: Overweight/Obesity; Insulin Resistance
MeSH terms: Obesity; Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in
      hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on
      overweight/obese subjects with hyperglycemia.
    

Detailed description: 
      In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a
      nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a
      combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was
      followed by a 4-week wash-out.

      Blood, urine and fecal samples were obtained at the beginning and end of each intervention
      stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight,
      anthropometry, bioimpedance) were measured at each control visit. Physical activity was
      controlled by accelerometry (1 week during each intervention stage). Energy expenditure was
      measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was
      determined by subjective (VAS) and objective (weighting consumed food) records after
      consuming the nutraceutical during each intervention stage.

      In a subset of volunteers (9), a pharmacokinetic study was performed to assess
      bioavailability and metabolism of polyphenols at the beginning and end of each intervention
      (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h;
      urine samples were also collected at different intervals during 24 h, and feces were obtained
      at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted
      metabolomic analysis was carried out in these samples. In these volunteers, incretins and
      hormones were also determined in blood samples.
    

Intervention name(s): Green coffee extract; Beta glucan; Green coffee + beta-glucan
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 150 mg polyphenols from green coffee, twice daily; 2.5 g BG twice daily; 150 mg polyphenols from green coffee + 2.5 g BG, twice daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obesity; Non-communicable diseases; Polyphenols; Soluble dietary fiber; Nutraceutical
Emergence Agitation in Adult Patients After Intracranial Surgery
Condition: Intensive Care, Surgical; Postoperative Care; Neurosurgery
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Observational

Summary: 
      Emergence agitation is a frequent complication that can have serious consequences during
      recovery from general anesthesia. However, agitation has been poorly investigated in patients
      after craniotomy. In this prospective multicenter cohort study, adult patients will be
      enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk
      factors and outcome will be investigated.
    


Intervention name(s): Anesthesia recovery after intracranial surgery
Intervention type(s): Procedure
Intervention description(s): Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients after craniotomy
      
Keywords: emergence agitation; intracranial surgery; general anesthesia; incidence; risk factor
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
Condition: Sexual Dysfunction; Sexual Arousal Disorder; Sexual Dysfunction, Physiological; Breast Cancer; Nipple Disorder; Neuropathy; Cancer of Breast
MeSH terms: Breast Neoplasms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study is to investigate the possibility that a topical drug
      could restore nipple sensitivity and improve sexual quality of life in breast cancer
      survivors.
    

Detailed description: 
      Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced
      reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life.
      Currently, there are no treatments for restoring nipple sensitivity and the associatedto
      improve lower sexual quality of life this condition. It would thus be of great clinical
      benefit to post breast surgery patients if a provide a new safe and , effective , topical ,
      on-demand, treatment for this condition can be developed.
    

Intervention name(s): AB-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Apply approximately 1 hour prior to sexual activity; Apply approximately 1 hour prior to sexual activity
Other intervention name(s): Phenylephrine; Vehicle Solution
Intervention MeSH terms: Phenylephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nipple Neuropathy, Cancer Survivor
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Condition: Cognitive Impairment Associated With Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of BIIB104 in participants
      with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).

      The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104
      in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS
      on measures of cognition, functioning, and psychiatric symptomology.
    


Intervention name(s): BIIB104; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Other intervention name(s): PF-04958242
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple
      doses of KW-6356 in healthy volunteers
    

Detailed description: 
      The study will have 3 parts:

        -  In Part A and Part B, a placebo-controlled double-blind study will be conducted to
           investigate safety, tolerability and pharmacokinetics of a single dose and 14 days
           multiple doses of KW-6356 in Japanese healthy men, respectively

        -  In Part C, an open-label study will be conducted to investigate safety, tolerability and
           pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy
           men
    

Intervention name(s): KW-6356 Low Dose; KW-6356 Middle Dose; KW-6356 High Dose; KW-6356 X Dose; KW-6356 Y Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): KW-6356 will be administered as single doses.; KW-6356 will be administered as single doses.; KW-6356 will be administered as single doses.; KW-6356 will be administered as multiple doses.; KW-6356 will be administered for Japanese healthy men as multiple doses.; All study cohorts (except Part C) are placebo controlled.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Ketone Ester Supplementation on Hypoxic Tolerance
Condition: Ketosis; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the
      development and severity of AMS symptoms, blood and tissue oxygenation status, as well as
      sleep quality during an episode of acute exposure to severe hypoxia.
    

Detailed description: 
      Acute altitude exposure impairs exercise tolerance and performance, decreases the rate of
      maximal oxygen uptake (V̇O2max), cognitive function and sleep quality, and often also induces
      symptoms of acute mountain sickness (AMS). Previous studies have clearly indicated that
      ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as
      improve hypoxic tolerance in rodents. In support of these earlier observations, recent pilot
      experiments in young volunteers in our laboratory provide proof of concept that IEK can
      attenuate oxygen desaturation during exercise in hypoxia. Therefore, given that impaired
      exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in
      active tissues (brain and muscle), we hypothesize that IEK can increase blood and tissue
      (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic
      tolerance, as well as improve exercise tolerance and endurance exercise performance.
    

Intervention name(s): Ketone ester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A total of 240g ketone ester supplementation will be provided in one of the 28h experimental sessions in order to establish intermittent exogenous ketosis. Sucralose (5% w/w) is added to the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate; Water, 5% sucralose (w/w), octaacetate (1 mM)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 1 session with ketone ester supplementation and 1 session with taste and viscosity matched placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Acute Mountain Sickness; Sleep; Cognitive Decline
Stroke COunseling for Risk REduction
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction
      (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle
      behavior change to reduce stroke risk in young adult African Americans.
    


Intervention name(s): SCORRE; Attention-Control Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 components based on the Health Belief Model; sexual health education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled two-group pre-post test design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Primary Stroke Prevention, Risk Factors for Stroke