bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study to will compare the blood levels of sildenafil following administration of an
      experimental tablet vs. the conventional oral tablet.
    


Intervention name(s): Sildenafil; Sildenafil; Sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Dose of 50 mg Sildenafil Oral Tablet With Water; Single Dose of 50 mg Sildenafil Experimental Tablet With Water; Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL
Condition: Corneal and Endothelial Cell Measurements
Study type: Observational

Summary: 
      The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.
    

Detailed description: 
      The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium
      by capturing an image of corneal endothelium tissues. without making contact, analyzing the
      captured image, and calculating data such as cell density.
    

Intervention name(s): Tomey EM-4000 Specular Microscope; Konan CellChek XL Specular Microscope
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age
        at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the
        exclusion criteria.
A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination
Condition: Pain; Vaccination Adverse Event
Study type: Interventional

Summary: 
      The aim of this study was to assess the acceptability and usability of a newly developed
      intradermal device in healthy adults
    


Intervention name(s): Intradermal injection in the forearm (0,1cc NaCl 0,9%); Intradermal injection in the upper arm (0,1cc NaCl 0,9%); Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)
Intervention type(s): Device; Device; Drug
Intervention description(s): This injection is conducted by the newly developed device.; This injection is conducted by the newly developed device in the upper arm (deltoid region).; This injection is conducted by needle and syringe in the upper arm (deltoid region).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, multi-center clinical trial to evaluate the safety and
      efficacy in peripheral neuropathies patients treated with Mecobalamin Injection
    


Intervention name(s): Mecobalamin IV Injection; Mecobalamin IM injection; Mecobalamin IV or IM injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks; Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks; Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mecobalamin; peripheral neuropathy; diabetic neuropathy
Efficacy and Safety of Finalgon® Cream Multiple Doses in Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in
      patients with acute low back pain. To investigate the safety and tolerability of repeated use
      of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).
    


Intervention name(s): nonivamide + nicoboxil (Finalgon cream); placebo matching nonivamide + nicoboxil (Finalgon cream)
Intervention type(s): Drug; Drug
Intervention description(s): 2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period; 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
Intervention MeSH terms: Nicotinic Acids; Capsaicin; Nonivamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Self-administered Acupressure for Insomnia Disorder
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The study is to evaluate the clinical effects of self-administered acupressure for treating
      insomnia disorder delivered by a training course. Subjects will be offered either
      self-administered acupressure training or sleep hygiene education. Their insomnia severity
      will be compared after 8 weeks.
    

Detailed description: 
      Objectives: To evaluate the clinical effects of self-administered acupressure for treating
      insomnia disorder delivered by a training course.

      Hypothesis: Subjects in the self-administered acupressure group will have greater improvement
      in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE)
      group at 4 weeks and 8 weeks.

      Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder
      recruited from the community will be randomized to self-administered acupressure or SHE
      groups in a 1: 1 ratio.

      Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and
      daytime impairment.

      Interventions: Subjects in the self-administered acupressure group will attend two training
      lessons (2-hour each) to learn self-administered acupressure and practice it every night for
      4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and
      duration that are same to the self-administered acupressure group.

      Main outcome measures: The primary outcome measure is the ISI score. Other measures include
      sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and
      Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of
      self-administered acupressure will be evaluated.

      Data Analysis: Differences in the questionnaire scores, subjective and objective sleep
      parameters will be examined using a mixed-effects model.
    

Intervention name(s): Self-administered acupressure group; Sleep hygiene education (SHE) group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.; Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      Objective: This novel study aimed to interrogate from a biopsychosocial perspective the
      health conditions during the Covid-19 infection and long-Covid periods of 5 patients with
      rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise
      before the pandemic.

      Method: This case study included five patients suffering from Covid-19 infection among
      patients with rheumatic disease who had acquired the habit of regular exercise before the
      Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial
      perspective to see the short and long-term effects of Covid-19 during and after quarantine.
      Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a
      biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status,
      and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression.

      Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of
      all patients during Covid-19. After six months, although the results from these three scales
      improved, some of the patients could not return to their pre-covid state.

      Conclusions: The patients participating in the telerehabilitation were able to return to
      everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This
      study is important in guiding the exercise approach for patients with rheumatic diseases in
      pandemics such as Covid-19.
    


Intervention name(s): Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)
Intervention type(s): Other
Intervention description(s): Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation.
Intervention model: Single Group Assignment
Intervention model description: case series
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Exercise Therapy Approach; biopsychosocial exercise; rheumatology rehabilitation; qualitative research; case report
Longitudinal Study of Empathy Levels in Physiotherapy Students
Condition: Longitudinal Study of Empathy Levels in Physiotherapy Students
Study type: Observational

Summary: 
      'Empathy' is a core term of occupations related to health sciences like physiotherapy. In
      physiotherapy education programs, empathy is necessary to have a successful cooperation with
      the clients. This study was planned to follow the changes of empathy levels in physiotherapy
      students of a four-year bachelor program and therefore enhance the curriculum related to the
      results. To the best of our knowledge, this research is the first longitudinal study about
      empathy levels of students in Turkey. Hypotheses: Empathy levels of the students increase
      year by year (1). Female students are more empathetic than male ones (2).
    

Detailed description: 
      Totally 120 physiotherapy students at a non-governmental university in Istanbul participated
      in this study. The Turkish reworded student version of the Jefferson scale of physician
      empathy was used. Empathy scores were compared related to study years and gender. Empathy
      scores relevant to gender were compared using Mann-Whitney U test. The Kruskal-Wallis one-way
      analysis of variance was used for differences among the four study years.
    

Intervention name(s): survey
Intervention type(s): Behavioral
Intervention description(s): The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        physiotherapy students
      
Keywords: empathy; longitudinal studies; students
A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on
      sleepiness, concentration and brain activity.
    


Intervention name(s): AZD6280; AZD6280; Lorazepam; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10mg Capsule, oral, single-dose; 40mg Capsule, oral, single-dose; 2mg tablet, oral single-dose
Other intervention name(s): Ativan
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I
The Effects of Nutritional Supplementation on Occupational Performance in Firefighters
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study was to assess the usefulness of protein and carbohydrate
      supplementation, with and without creatine, on occupational performance in firefighters.
      Research has examined the effects of adding creatine to whey protein and carbohydrates on
      training adaptations in resistance-trained individuals with mixed finding.

      Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or
      without creatine, in firefighters is largely unknown. Therefore, the primary aim of the
      current study was to examine the effects of protein and carbohydrate supplementation, with or
      without creatine, on occupational performance in firefighters.
    


Intervention name(s): Creatine Monohydrate; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants were assigned to ingest a single serving daily of either A) a 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb); or B) a 25-gram dose of Whey Protein Isolate + 25-gram dose of carbohydrate powder + 5-gram dose of creatine monohydrate (Creatine) for a 17-21-day period.; A 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Creatine
Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome
Condition: Raynaud Syndrome
MeSH terms: Raynaud Disease; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether vardenafil is effective in improving
      clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud
      phenomenon.
    


Intervention name(s): vardenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg p.o. bid for 6 weeks; Placebo p.o. 6 weeks bid
Other intervention name(s): Levitra
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: double-blind placebo controlled cross-over study
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of
      baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer
      participants.
    

Detailed description: 
      Main Objectives were:

        -  To assess the safety and tolerability of single and multiple oral doses of baxdrostat in
           healthy Japanese subjects.

        -  To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple
           oral doses of baxdrostat in healthy Japanese subjects.

        -  To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat
           in healthy Japanese subjects.

        -  To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral
           doses of baxdrostat between Japanese and Caucasian subjects.

      Participants will take baxdrostat and have their safety and blood levels of baxdrostat
      measured over several days following single and multiple dose administration of 3 different
      dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain
      hormones that regulate blood pressure will be compared between the dose groups and between
      the healthy Japanese and Caucasian volunteer participants.
    

Intervention name(s): baxdrostat
Intervention type(s): Drug
Intervention description(s): Baxdrostat is an aldosterone synthase inhibitor
Other intervention name(s): CIN-107
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a single and multiple oral dose study of the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy Japanese subjects compared with a cohort of healthy Caucasian subjects. total of 41 subjects were enrolled in this study: 31 Japanese subjects and 10 Caucasian subjects. The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo). The Japanese cohorts (Cohorts 1, 2, and 4) were performed in parallel. The Caucasian cohort (Cohort 3) was performed after Cohort 2 was complete so that the Caucasian subjects could be matched by certain demographic factors.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; Japanese; PK; baxdrostat
Study to Examine the Effects of ATP Supplementation on Muscle Excitability and Reaction Time During and Following a Repeated Sprint Bout
Condition: Muscle Fatigue Caused by Repetitive Muscle Exercise
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance
      motor unit recruitment while simultaneously blunting the decline in power and reaction time
      that is typically seen during repetitive sprints. This will give researchers a better
      understanding of the mechanism by which ATP supplementation can augment power, especially
      under high fatiguing conditions.
    

Detailed description: 
      Healthy participants of similar training status as previously tested will be enrolled into
      the study. The participants will be randomly assigned to either placebo supplementation or to
      400 mg ATP per day for 14 days. The supplements will be taken in the morning and the last
      dose will be taken 30 min prior to testing on the last day. Testing will be performed at
      baseline and after the 14 days of supplementation. Ten successive sprints will be conducted
      on the Wingate apparatus as this has been previously demonstrated to decrease muscle
      excitability. After the sprints, muscle excitability, reaction time, and vertical jump power
      will be measured. In addition a blood sample will be obtained before and after
      supplementation and complete blood hematology and chemistry analyses will be performed. It is
      expected that ATP supplementation may help maintain muscle excitability and power after the
      successive sprint sessions.
    

Intervention name(s): Placebo; ATP
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg of ATP
Other intervention name(s): Placebo Comparator; Peak ATP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic
      Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of
      standard antidepressant treatment.
    

Detailed description: 
      Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate
      trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine,
      venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for
      12-weeks.
    

Intervention name(s): Adjunctive asenapine
Intervention type(s): Drug
Intervention description(s): participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.
Other intervention name(s): asenapine; Saphris
Intervention MeSH terms: Asenapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Posttraumatic Stress Disorder; Asenapine; Adjunctive; antidepressant; neuroleptic
Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended
      by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to
      potential increase of bleeding. Compared bolus injection followed by continuous infusion of
      Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding
      complication while maintaining decrease ischemic events. It was also reported that direct
      intracoronary injection of abciximab might be superior to intravenous injection regarding
      myocardial perfusion.

      Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of acute
      ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that
      combination of intracoronary abciximab bolus injection and aspiration thrombectomy might
      enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial
      infarction. We will determine whether combination of intracoronary abciximab injection and
      aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion
      through index of microcirculatory resistance and cardiac magnetic resonance imaging.
    


Intervention name(s): Gp 2b 3a inhibitor; aspiration thrombectomy; Both use
Intervention type(s): Drug; Device; Other
Intervention description(s): bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg; Aspiration thrombectomy via aspiration catheter; Both use of intracoronary abciximab and aspiration thrombectomy
Other intervention name(s): clotinab; Thrombuster II; Clotinab + Thrombuster II
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myocardial Infarction