bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Condition: Pain, Acute; Anxiety Acute
MeSH terms: Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This study was carried out to determine the effect of listening to music and acupressure
      application in reducing pain and anxiety during gynecological examination.
    


Intervention name(s): acupressure
Intervention type(s): Other
Intervention description(s): Data collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room
Other intervention name(s): music
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: randomized
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: acupressure,; nursing; music; gynecological examination
Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).
Condition: Alcohol Dependence; Stress Disorders, Post-Traumatic
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the
      treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and
      alcohol dependence.

      The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in
      reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and
      PTSD.
    

Detailed description: 
      Background:

      There is a high rate of comorbidity with alcohol dependence (AD) and post traumatic stress
      disorder (PTSD). The rates of PTSD among individuals with AD are at least twice as high as
      those in the general population. In addition, alcohol dependence is the most common comorbid
      condition in men with PTSD. Despite this, little is known about how to best treat individuals
      with comorbid AD and PTSD. The use of an alpha-1 adrenergic receptor antagonist represents a
      novel approach to treatment that may target symptoms of both AD and PTSD. There is evidence
      of common neurobiological mechanisms that underlie both AD and PTSD. Prazosin is an alpha-1
      adrenergic receptor antagonist that has been used successfully in the treatment of trauma
      nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence.

      Objective:

      The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in
      reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and
      PTSD. Methods: Thirty participants with a current diagnosis of AD and PTSD will be enrolled
      in a 13-week trial. They will be assigned, in a double-blind fashion, to either prazosin or
      placebo. Significance: This project will be the first to compare prazosin to placebo as
      effective treatments for reducing alcohol consumption and PTSD symptoms in patients with both
      AD and PTSD.
    

Intervention name(s): Prazosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): prazosin (16mg/day) 2 times a day; Placebo
Other intervention name(s): Minipress
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: alcohol dependence; post traumatic stress disorder; treatment; prazosin
Lubiprostone in Children With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to determine if children (6-17 years old) with functional constipation will respond to
      being treated with lubiprostone for 12 weeks.
    

Detailed description: 
      Dose administration details:

        -  Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for
           12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was
           increased to 24 mcg BID.

        -  Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for
           12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.
    

Intervention name(s): Lubiprostone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1; 0 mcg soft capsules of placebo for oral administration
Other intervention name(s): Amitiza; Matching Placebo
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
Condition: Biliary Tract Neoplasms
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to investigate the effect of second-line irinotecan and capecitabine
      versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract
      cancer patients.
    


Intervention name(s): Irinotecan; Capecitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the
      safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of
      ASLAN003 in healthy subjects
    

Detailed description: 
      This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and
      MAD of ASLAN003 in healthy subjects.

      The study is divided into two parts:

        -  Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.

        -  Part B: MAD cohorts with one cohort being of healthy elderly subjects.

      There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be
      dosed first and then the same dose will be given to the rest of the subjects in the
      respective cohorts.

      In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions
    

Intervention name(s): ASLAN003 ACTIVE
Intervention type(s): Drug
Intervention description(s): This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.
Other intervention name(s): ASLAN 003 , LAS186323
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Genotype Influence on Recovery After Traumatic Brain Injury
Condition: Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      Genetic differences in response to brain injury may reasonably be expected to play a role in
      the initial consequences of traumatic brain injury and in the rate of recovery from such
      injury.
    

Detailed description: 
      Polymorphisms in the Apolipoprotein E gene encode functional variants which differentially
      determine the rate at which neuronal repair can occur, and are associated with differences in
      expression of neurodegenerative processes, including traumatic brain injury. It is proposed
      that the accuracy of prediction of outcome after head injury will be significantly increased
      by inclusion of APOE genotype alone, or in combination with other variables such as severity
      of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment
      strategies.
    

Keywords: Traumatic Brain Injury
Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in
           treatment of obese patients.

        -  To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks
           of therapy in reducing body weight in obese patients.

        -  To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times
           daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.
    

Detailed description: 
      In general, patients will be observed during 24 weeks of trial.
    

Intervention name(s): Dietressa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of different dosages (frequency) of drug; Placebo either (2 tablets 3 times daily) or
(1 tablet 6 times daily)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally
      effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances,
      objective vigilance, and it is cost-effective compared to conventional fixed continuous
      positive airway pressure.
    

Detailed description: 
      1. To investigate whether computer controlled continuous positive airway pressure
           (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and
           nocturnal respiration to a similar degree as conventional fixed continuous positive
           airway pressure in the initial phase of treatment and over the subsequent 2 years during
           home therapy

        2. To investigate the cost of autoCPAP compared to fixed CPAP therapy
    

Intervention name(s): constant CPAP devices; automatic CPAP devices
Intervention type(s): Device; Device
Intervention description(s): different CPAP mode; different CPAP mode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; controlled; double blind; effectiveness; auto CPAP; treatment; sleep apnea
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
    


Intervention name(s): NKTR-118; NKTR-118; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Oral tablet intake once daily
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation.
Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of
      various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy
      male subjects
    

Detailed description: 
      Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul
      National University Hospital on the day before dosing, and they will be overnight-fasted from
      9P of Day -1. Urine collection is scheduled from 12 hours before sildenafil administration to
      12 hours after administration. Subjects will be administered sildenafil (oral) around at 9A
      of Day 1. Subjects will perform scheduled procedures including clinical laboratory tests,
      electrocardiograms and blood samplings for pharmacokinetic, pharmacometabolomic and mRNA
      assessment.

      Subjects will be administered either erythromycin or itraconazole (oral) around at 9A on Day
      3 and 9A/9P on Day 4. Urine collection is scheduled from 0 hour to 12 hours after Day 3
      erythromycin or itraconazole administration. Subjects will perform scheduled procedures
      including clinical laboratory tests, electrocardiograms and blood samplings for
      pharmacokinetic, pharmacometabolomic and mRNA assessment.

      On Day 5, sildenafil will be administered with erythromycin or itraconazole around at 9A.
      Urine collection is scheduled from 12 hours before Day 5 drug administration to 12 hours
      after administration. Subjects will perform scheduled procedures. After subjects perform
      scheduled procedure, the study will be discharged (around 9A of Day 6).

      Study participation was terminated on post-study visit (Day 12-14).
    

Intervention name(s): Sildenafil; Clarithromycin; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sildenafil 25 mg PO; clarithromycin 250 mg PO; itraconazole 100 mg PO
Other intervention name(s): VIAGRA TAB, Pfizer Pharmaceuticals Korea Limited, Korea; CLARI TAB, Hanmi Pharm.Co.,Ltd., Korea; ITRA TAB, Hanmi Pharm.Co.,Ltd., Korea
Intervention MeSH terms: Clarithromycin; Itraconazole; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Multicenter Study to Evaluate the Efficacy and Safety of of Four Doses of SR147778 in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect of SR147778 on weight loss over a period of
      24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective
      is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on
      several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks
      when prescribed with a hypocaloric diet in obese patients.
    


Intervention name(s): SR147778
Intervention type(s): Drug
Intervention MeSH terms: Surinabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity
Testosterone Gel Applied to Women With Pituitary Gland Problems
Condition: Panhypopituitarism
Study type: Interventional
Phase: Phase 4

Summary: 
      The principal aim of this study is to evaluate if application of testosterone gel leads to
      improvement in measures of sexual function, thinking ability and quality of life in women
      with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of
      testosterone replacement on body composition and muscle function and strength.
    

Detailed description: 
      Testosterone is the principal male sex hormone but is also present in smaller amounts in
      women and may be important for their health. Among its likely actions in women are the
      building of bone and muscle mass, increase in interest in sex (libido) and effects on the
      mood. Testosterone is commercially available as a hormone replacement therapy for males with
      an absence or lack of testosterone production. Testosterone for males is mainly given in the
      form of shots or skin patches which have certain disadvantages such as pain from shots and
      skin rashes from patches. It is anticipated that this experimental gel application will
      produce levels of the drug in the normal range in women.
    

Intervention name(s): Transdermal Testosterone gel
Intervention type(s): Drug
Intervention description(s): 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Testosterone and Placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is the first clinical trial proposed with PF-06865571. It is designed to
      evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of
      single doses of PF-06865571 to healthy adult subjects.
    


Intervention name(s): PF-06865571; PF-06865571; PF-06865571; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 5 mg, 50 mg, 500 mg, TBD (to be determined)/2000 mg.; Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 15 mg, 150 mg, 1000 mg, TBD/2000 mg.; Single repeated (TBD mg) dose as extemporaneously prepared solution/suspension of PF-06865571.; Matching Placebo for PF-06865571 for each cohort.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free
      (calcineurin inhibitor) regimen in renal transplant recipients.
    


Intervention name(s): cyclosporine (reduced exposure) / everolimus; AEB071 300 mg b.i.d. / everolimus; AEB071 200 mg b.i.d. / everolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily; twice daily; twice daily
Intervention MeSH terms: Cyclosporine; Everolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplant; AEB071
Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study will be conducted in order to compare the bioavailability of 40 mg
      Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca,
      France) under single dose fasted and fed conditions.

      The study will be conducted as a combined single dose study under fasted and fed conditions
      in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days
      between administrations.
    

Detailed description: 
      -  The primary objective of the single dose fasted part of the study is to compare the rate
           and extent of absorption of esomeprazole from 40 mg Esomeprazole Mepha capsules (Test)
           with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose
           administration under fasted conditions, determined by use of AUC0-tlast and Cmax
           obtained from esomeprazole plasma concentrations.

        -  The primary objective of the single dose fed in combination with the fasted part of the
           study is to compare the maximum concentration of esomeprazole determined after 40 mg
           Esomeprazole Mepha capsules (Test) single dose administration under fed conditions in
           comparison with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose
           administration under fasted and fed conditions.
    

Intervention name(s): 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland); INexium 40 mg MUPS tablets (AstraZeneca, France)
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg esomeprazole, single dose administration under fasted and fed condition; 40 mg esomeprazole, oral single dose administration under fasted and fed condition
Other intervention name(s): Test; Reference
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Bioavailability; Bioequivalence; Esomeprazole; Bioavailability, Therapeutical Indication Not Studied
Intra Articular Botox Injection in Treatment of Osteoarthritis
Condition: Osteoarthritis Knees Both
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Compared the short and long term effects sonography guided of intra articular Botox injection
      to relief pain and improve patients activity of daily living and disability to genicular
      nerves pulsed radio frequency fluoroscopy guided
    

Detailed description: 
      Compared the short and long term effects of sonography guided intra articular Botox injection
      to relief pain and improve patients activity of daily living and disability to genicular
      nerves pulsed radio frequency fluoroscopy guided
    

Intervention name(s): Botox Injectable Product; Radiofrequancy
Intervention type(s): Drug; Device
Intervention description(s): Intra articular Botox injection; Genicular nerves radiofrequancy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment