bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Atomoxetine Treatment in Humans
Condition: Stress
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A total of 18 healthy volunteers will participate in this four-week, within-groups,
      double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day
      washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or
      placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After
      receiving medication or placebo for three days, subjects will have a 6-hour laboratory
      session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg
      maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and
      subjective outcome measures will be obtained during the experimental sessions. Subjects will
      then have a 4-15 day washout period and will be crossed over to the alternative treatment for
      Phase II.
    

Detailed description: 
      Objective: This pilot study will examine the effects of a norepinephrine reuptake blocker,
      atomoxetine, on physiological and subjective responses to physical and psychological models
      of stress and oral amphetamine in healthy volunteers. The physical stress model will be the
      cold pressor test (CPT) and the psychological stress will be the paced auditory serial
      addition task (PASAT).

      Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the
      physiological and subjective responses to stress and d-amphetamine.

      2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.

      3. Methodology: A total of 18 healthy volunteers will participate in this four-week,
      within-groups, double-blind, placebo-controlled study. The study has two phases separated by
      a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg
      atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for
      4 days. After receiving medication or placebo for three days, subjects will have a 6-hour
      laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20
      mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and
      subjective outcome measures will be obtained during the experimental sessions. Subjects will
      then have a 4-15 day washout period and will be crossed over to the alternative treatment for
      Phase II.

      4. Findings: A total of 10 subjects have completed this study. This study has been published.
    

Intervention name(s): Placebo; Atomoxetine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; 20mg maximum of d-amphetamine
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atomoxetine; Stress; d-amphetamine
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points
Condition: Trigger Point Pain, Myofascial; Neck Pain
MeSH terms: Myofascial Pain Syndromes; Neck Pain
Study type: Interventional

Summary: 
      Aim of this study is to investigate effectiveness of myofascial releasing on neck pain
      related to trigger points located on upper cervical region.
    

Detailed description: 
      Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is
      27.2% female and 17.4% in male population. Approximately 1/3 of acute onset neck aches become
      chronic. It causes increasing the cost of treatment and also the loss of labor.

      Myofascial pain is usually considered caused by myofascial trigger points. The trigger points
      in the neck muscles have been associated with a possible source of referred facial and
      cranial pain. Mechanical neck pain is a non-radicular pain caused by local musculoskeletal
      structures and is characterized by a spasm of the cervical muscles. Posture, emotional
      stress, cold and fatigue are etiologic causes, and pain is also reflected to the cervical,
      occipital and scapular regions depending on the severity of muscle spasm and the presence of
      trigger point in myofascial pain syndrome.

      Myofascial releasing is a specific type of passive soft tissue mobilization. Triggers points
      often considered as a pathology that occurs after excessive load or trauma on soft tissue
      which disturbs blood circulation. Fascial restriction can be found with triggers points and
      taut band.

      In this study effects of myofascial release on triggers points will be investigated.
    

Intervention name(s): Myofascial Group; Sham Group
Intervention type(s): Other; Other
Intervention description(s): Manual myofascial release will be applied at prone position. Patient's upper thoracic and cervical region will be undressed. Researcher will use direct and indirect myofascial release techniques on upper thoracic and cervical region focusing on trigger point located muscles (most frequently m. trapezius); Patient's upper thoracic and cervical region will be undressed. Researcher will place his hands on points that used for myofascial release however no pressure or release techniques will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients' information and contact will be obtained from physiatrist and willing participant's gender, age and pain onset data will be processed with a random number generator in order to form groups. Patients will divide randomly into two groups as intervention and control with a normal distribution of gender, age and pain onset.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial Release; Manual Therapies
Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14
      days in adult smokers.
    


Intervention name(s): Varenicline Tartrate; Varenicline Tartrate; Varenicline Tartrate; Varenicline Tartrate; Varenicline Tartrate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.; Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.; Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.; The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.; The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mechanisms of Insulin Resistance in Critical Illness: Role of Systemic Inflammation and GLP-1
Condition: Hypoglycaemia
MeSH terms: Insulin Resistance; Hypoglycemia; Inflammation; Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to determine the role of inflammation and the insulin regulating
      hormone GLP-1 during critical illness.
    

Detailed description: 
      Critically ill patients often exhibit hyperglycaemia. Although the cause of this
      hyperglycaemia is probably multifactorial, peripheral insulin resistance is a major
      contributor, similar to type 2 diabetes mellitus (T2D). There are several similarities
      between critical illness and T2D, including the presence of systemic inflammation and
      increased plasma free fatty acids (FFA), all of which may induce insulin resistance in
      healthy volunteers. In critical illness, elevated catecholamines, cortisol, growth hormone
      and glucagon may also contribute to insulin resistance.

      The degree of hyperglycaemia correlates with mortality in ICU patients. van den Berghe et al.
      found that IV infusion of insulin to obtain strict normoglycaemia reduced mortality as well
      as morbidity in critically ill surgical patients and in some medical ICU patients.

      However, insulin increases the risk of hypoglycaemia; this is a major obstacle to strict
      euglycaemia in ICU patients and may explain the inability of others to reproduce the benefits
      reported by van den Berghe et al. Thus, alternatives to insulin for controlling plasma
      glucose (PG) in ICU patients are warranted.

      Aim:

      To study the role of the incretin hormone, glucagon-like peptide (GLP)-1 for glycaemic,
      metabolic, hormonal and inflammatory profile in

        -  critically ill patients in the intensive care unit (ICU) and

        -  healthy volunteers exposed to a standardised systemic inflammation
    

Intervention name(s): GLP-1; Placebo (Saline); TNF-alfa; OGTT; IVGTT
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): GLP-1 1,2pmol/kg/min i.v. infusion for 4 hours; Normal saline (NaCl 0,9%); 1000ng/m2 BSA/hour i.v. infusion for 4-6 hours; Oral glucose tolerance test with 75 g glucose; Intravenous glucose tolerance test with infusion of 20% glucose matching the glucose profile of the corresponding OGTT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GLP-1; Inflammation; Glucose
PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this trial is to demonstrate the safety, tolerability and
      pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral
      doses over 14 days to healthy obese male volunteers.
    

Detailed description: 
      Complexa has developed an oral formulation of CXA-10. The main purpose of this trial is to
      demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its
      metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese
      male volunteers. The pharmacodynamic (PD) effects of CXA-10 on serum biomarkers, some of
      which are elevated in the obese population, will also be investigated.
    

Intervention name(s): CXA-10; CXA-10 placebo
Intervention type(s): Drug; Other
Intervention description(s): CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid; The placebo contains olive oil with BHT (0.08% to 0.10%).
Intervention MeSH terms: CXA-10
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      Primary Objective:

      To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who
      received prior treatment during the TDU13475 or TDU14981 studies.

      Secondary Objectives:

      To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the
      pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in
      patients with MS.
    

Detailed description: 
      The total study duration for a patient is approximately 47 months.

      There is no administration of GZ402668 in the LTS14120 study. Patients who already received
      investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 will be
      followed up to 47 months in the LTS14120.

      Note: Patients from TDU14981 study (sanofi-sponsored) will participate in LTS14120 study. In
      order to keep consistent among all study related documents, the title of the LTS14120 study
      is not amended.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who received study drug in the clinical study TDU13475
A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
Condition: Superficial Mycoses; Dermatomycoses; Candidiasis; Histoplasmosis
MeSH terms: Mycoses; Candidiasis; Histoplasmosis; Dermatomycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Objectives:

        -  To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and
           fed condition in healthy male subjects

        -  To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under
           fed condition in healthy male subjects

        -  To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in
           Korean healthy male subjects
    

Detailed description: 
      Phase I Study divided into 3 parts written as bellows.

      Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose
      under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition
    

Intervention name(s): Lozanoc 50mg; Sporanox 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Lozanoc 50mg single dose under fed and fasted condition; Sporanox 100mg single dose under fed condition
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
Condition: Abnormal Menstrual Cycle
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was done to evaluate the effects of the follicular and luteal phases of the
      menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50
      during propofol anesthesia, in patients with and without preoperative intravenous
      dexmedetomidine .
    


Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
Condition: Arthroplasties; Knee Replacement
Study type: Interventional

Summary: 
      This is a prospective, randomized, longitudinal study of the clinical outcomes of
      osteoarthritis patients treated by two different alignment philosophies for total knee
      replacement. In this study ShapeMatch® cutting guides will be compared to the conventional
      approach.
    


Intervention name(s): OtisMed® ShapeMatch® Technology; Stryker Precision Knee Navigation; Total Knee Replacement; Stryker Triathlon® Total Knee System
Intervention type(s): Device; Device; Procedure; Device
Intervention description(s): The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology; Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.; Prosthetic components to be implanted including
Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Anyu Peibo With Placebo in Treatment of MDD
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are
      effective in the treatment of Depression.

      And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in
      the Chinese Patients with Depression.
    


Intervention name(s): Anyu Peibo
Intervention type(s): Drug
Intervention description(s): Placebo
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Survey Methodologies to Elicit Sensitive Information From Adolescents in Urban India
Condition: Unmarried Male and Female Adolescents in the Age Group 15-19 Years in Pre-Identified Slums in Delhi, India
Study type: Observational

Summary: 
      The goal of this study is to use three different survey methodologies to evaluate whether
      adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive
      health issues differently based on the manner in which questions are asked.
    

Detailed description: 
      Specific Aims and Research Questions Aim 1: To compare adolescents' levels of reporting of
      their own reproductive health knowledge, attitudes and behaviors using three survey
      methodologies: (1) Face-to-face interview (2) Audio-CASI (Computer Assisted Self Interview)
      and (3) a culturally appropriate interactive methodology.

      The following hypothesis will be tested:

      • Overall, adolescents will be more likely to divulge their own reproductive knowledge,
      attitudes and behaviors with Audio-CASI and the interactive method as compared to
      face-to-face interviews. Levels of knowledge, attitudes and behaviors will vary by education,
      age and gender.

      Aim 2: To compare respondents' levels of comfort, accuracy and honesty with the survey
      methodologies (i.e. face to face, audio-CASI and interactive methodology) to their reporting
      of knowledge, attitudes and behaviors related to sexual and reproductive health.
    

Observational model: Defined Population
Time perspective: Other
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in
      "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.
    

Detailed description: 
      Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
    

Intervention name(s): RiVax
Intervention type(s): Biological
Intervention description(s): vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: volunteers
The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will seek to quantify the muscle protein synthetic response to a protein
      beverage consumed orally or through a nasogastric tube in healthy, young individuals.
    

Detailed description: 
      Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h)
      combined with repeated blood and muscle sampling, in order to measure muscle protein
      synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral
      protein ingestion (n=10), or enteral protein administration (n=10).
    

Intervention name(s): Oral Placebo; Oral Protein; Enteral Protein
Intervention type(s): Other; Other; Other
Intervention description(s): A placebo beverage will be consumed orally; A protein beverage will be consumed orally; A protein beverage will be consumed via a naso-gastric feeding tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance
Condition: Covid19 Epidemic Lockdown Impact
MeSH terms: COVID-19
Study type: Observational

Summary: 
      PURPOSE:

      To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian
      Children.

      BACKGROUND:

      The corona virus disease (COVID-19) affected virtually all countries including Egypt as
      records showed 156,397 subjects including all age groups, Adolescents and children represent
      sector in the records, lockdown can contribute to widespread psychological distress and an
      increased risk of physical inactivity consequences shortly. Psychomotor disorders are
      expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess
      the psychomotor condition during and after pandemic lockdown as safe and valid assessment
      tool.

      HYPOTHESES:

      Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.

      RESEARCH QUESTION:

      Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants will be randomly selected from all provinces in Egypt.