bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the
      body), the pharmacokinetics (the body's handling of the drug), and the safety and
      tolerability of vortioxetine, once daily (QD) in healthy men.
    

Detailed description: 
      This study will look at an investigational medicine called vortioxetine to see how the drug
      affects the body and how the body handles the drug.

      The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of
      the following two treatment groups-which remained undisclosed to both the participant and
      study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 20 mg

        -  Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but
           had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was approximately 7 weeks. Participants made 2 visits to the clinic, including
      18 days confinement to the clinic, and were contacted by telephone 1 day and 27 days after
      leaving confinement for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated tablet; Vortioxetine placebo-matching capsules.
Other intervention name(s): Lu AA21004; Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Drug Therapy; pharmacodynamic
Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this protocol is to study the effect of the standard of care in
      hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040
      on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.
    


Intervention name(s): pegylated interferon and ribavirin; TG4040 + SOC; TG4040 + SOC
Intervention type(s): Drug; Biological; Biological
Intervention description(s): 48 weeks; 6 injections; 13 injections
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Vaccine; HCVac; MVA-HCV
Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists
Condition: Work Engagement; Well-being
Study type: Observational

Summary: 
      The aim of this study is to identify factors influencing work engagement and wellbeing in
      German-speaking intensive-care providers and anesthesiologists.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        German-speaking intensive-care providers and anesthetists
Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg)
      and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on
      evening and at night after standard protein meal.
    

Detailed description: 
      Gastric acid secretion can be divided into two phases: the daytime phase and the nocturnal
      phase. Nocturnal acid reflux is presumably more damaging because of loss of salivary
      neutralization. The present study is designed to measure effects of rabeprazole and
      pantoprazole on post-prandial and nocturnal gastric acid secretion and intragastric pH in H.
      pylori-negative volunteers with gastroesophageal reflux disease. These measurement will be
      used to compare the degree of inhibition of gastric acid secretion between the two drugs.
    

Intervention name(s): rabeprazole; pantoprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rabeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; Proton Pump Inhibitors; Gastric pH; Gastric Acid Secretion
Fitball Program Versus Task-oriented Motor Program on Improving Postural Control in Developmental Coordination Disorder
Condition: Developmental Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Interventional

Summary: 
      Children with developmental coordination disorder (DCD) often have poor postural control and
      motor skills that affect their activities of daily living and participation in school
      activities. The aim of this randomized controlled trial is to compare the effects of fitball
      training versus task-oriented motor training for children with DCD.
    


Intervention name(s): Fitball exercise; task-oriented motor training program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised fitball exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.; Task-oriented motor exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor; balance; developmental; physiotherapy
Effect Of Stretching Programme On Shoulder Performance In Volleyball Players With Posterior Shoulder Tightness
Condition: Posterior Shoulder Tightness
Study type: Interventional

Summary: 
      When the dominant arm is compared with the non-dominant arm in overhead athletes there is a
      serious internal rotation limitation in the dominant arm. Due to overhead activity, adaptive
      changes in shoulder joint mobility and flexibility are indicated. Internal rotation
      limitation is often associated with increased external rotation. One of the reason of this
      adaptive change is posterior shoulder tightness which is common in overhead athletes as well
      as in volleyball players. The aim of this study is to determine the effect of stretching
      program on the range of motion, flexibility of posterior shoulder muscles and functional
      performance.
    


Intervention name(s): Stretching exercises
Intervention type(s): Other
Intervention description(s): Stretching exercises will be applied 6 days a week, 30sec / 5 reps
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
Condition: Gastroscopy Time; Early Gastric Cancer; Detection Rate
MeSH terms: Digestive System Neoplasms; Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      This multicenter, prospective, interventional study aims to include 2000 gastroscopic
      procedures and investigate the relationship between procedure time and lesion detection rate
      in tertiary endoscopic centers in China. At the first stage, the researchers observe the
      actual procedure time of gastroscopies without affecting the natural behavior of
      endoscopists. At the second stage, a minimal time limit will be set for each procedure based
      on the observational results of the first stage. The primary study outcome is focal lesion
      detection rate. Secondary outcomes include detection rate of early upper GI cancer, biopsy
      rate and adverse event rate.
    

Detailed description: 
      China is a country with a heavy burden of gastric cancer and esophageal cancer. In 2015, the
      incidence/mortality of gastric cancer and esophageal cancer in China were 680000/500000 and
      220000/200000, respectively. Gastroscopy is the most important means to detect early cancer
      of gastrointestinal tract. However, due to various factors, the miss rate of clinical
      significant lesions by gastroscopy is innegligible. Our previous research results showed that
      the detection rate of early gastric cancer and early esophageal cancer in China was only
      about 15%. This study aims to include 2000 gastroscopic procedures and investigate the
      relationship between procedure time and lesion detection rate in tertiary endoscopic centers
      in China.

      At the first stage, the researchers observe the actual procedure time of gastroscopies
      without affecting the natural behavior of endoscopists. Then, researchers collect the data
      (including focal lesion detection rate, procedure time, detection rate of early upper GI
      cancer, biopsy rate and adverse event rate) and analyze the minimal procedure time. At the
      second stage, a minimal time limit will be set for each procedure. Every stage last two
      months, and potential correlations between lesion detection rate and procedure time will be
      investigated through subsequent statistical analysis.
    

Intervention name(s): Set the minimum time of gastroscopy
Intervention type(s): Other
Intervention description(s): This study contains 2 stages. At the first stage, no interventions are implemented. The researchers just observe the actual procedure time of gastroscopy. At the second stage, a minimal procedure time is set based on the observational results of the first stage.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Screening
Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block
Condition: Anesthesia, Local
Study type: Observational

Summary: 
      Regional tissue oxygenation saturation has been shown to increase in innervated regions after
      sympathetic block. The aim of this prospective observational study was to evaluate the
      changes of regional tissue oxygenation saturation by near-infrared spectroscopy after
      successful femoral nerve block with ropivacaine and determine whether the changes of regional
      tissue oxygenation saturation can be affected by the concentration of ropivacaine.
    

Detailed description: 
      Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood
      flow by vasodilation. The relationship between successful femoral nerve block and the
      variation of regional tissue oxygenation saturation was unclear.
    

Intervention name(s): tissue oxygenation saturation
Intervention type(s): Device
Intervention description(s): tissue oxygenation saturation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve
        block
      
Keywords: Peripheral nerve block
Clinical Study to Test a New Drug to Treat Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive
      design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be
      investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of
      GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and
      pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.

      The primary endpoint is the change from baseline associated with GW856553 versus placebo at
      Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be
      performed throughout the study to potentially adapt the study design by changing the
      randomization ratio and/ or reducing the total number of subjects to be randomized into the
      study. Exploratory analyses will be performed by associating changes in cytokine levels and
      selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive
      clinical and biological markers.
    


Intervention name(s): GW856553; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553; Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lack of interest and energy; Psychomotor retardation; Cytokines; Major Depressive disorder
Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Observational

Summary: 
      The investigators aim to evaluate the levels of serum Vitamin D in children having their
      tonsils removed and appropriate controls. The investigators hypothesize that children
      undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared
      to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with
      indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children age 1-12 years undergoing surgery
      
Biospecimen description: 
      Blood samples
Initiating Early Control of Migraine Pain and Associated Symptoms
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan,
      which is being developed for the acute treatment of migraine with or without aura in adults.
      AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This
      study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo.

      This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who
      successfully complete the screening period and continue to meet all entry criteria will be
      randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of
      migraine pain.
    


Intervention name(s): AXS-07 (MoSEIC meloxicam and rizatriptan); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AXS-07 tablet taken once upon the earliest onset of migraine pain.; Placebo tablet taken once upon the earliest onset of migraine pain.
Intervention MeSH terms: Meloxicam; Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; AXS-07; Meloxicam; Rizatriptan
PPMI Tau PET Imaging
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study
      (PPMI Tau PET Imaging) will evaluate if [18F] PI-2620 facilitates better understanding of Tau
      deposition in the brain in Parkinson's disease (PD).
    

Detailed description: 
      The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study
      (PPMI Tau PET Imaging) is a companion study to the Parkinson's Progression Markers Initiative
      Clinical protocol (PPMI-002; NCT04477785). After consenting to the PPMI Clinical protocol,
      participants interested in completing an additional scan under this study will be asked to
      complete consent, additional activities, and one [18F]PI-2620 PET imaging scan as part of
      this study. Enrollment in the PPMI Tau PET Imaging companion study will facilitate comparison
      of tau deposition to clinical, imaging, blood and CSF tau already acquired in these PPMI
      participants under the PPMI Clinical protocol. The primary goal of this imaging study is to
      test whether positron emission tomography (PET) with [18F] PI-2620 can visualize in vivo
      brain tau deposition in participants with PD. The secondary goal is to evaluate tau
      deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present
      in those individuals.
    

Intervention name(s): [18F] PI-2620
Intervention type(s): Drug
Intervention description(s): Evaluation of the radiopharmaceutical imaging agent PI-2620 in detecting TAU brain burden.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis
Condition: Patients at Ultra-high Risk of Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Cognitive deficits are known to be a core feature of schizophrenia and seem to become
      manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits
      are known to pose a critical barrier to functional recovery. Hence it is of vital importance
      to find intervention strategies that can alleviate these cognitive deficits and consequently
      improve daily functioning, and quality of life, as well as the prognosis for UHR-patients.
      The investigators will examine whether:

        -  Cognitive remediation therapy will be superior to standard treatment in improving
           cognitive functioning in UHR- patients (null hypothesis: No difference between the two
           groups).

        -  Cognitive remediation therapy will be superior to standard treatment in improving
           psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No
           difference between the two groups).
    


Intervention name(s): Cognitive remediation; Standard treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014.
The intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients.; Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling.
Other intervention name(s): Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science.; Social Cognition and Interaction Training (SCIT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultra-high risk psychosis; Schizophrenia prodrome; Cognitive remediation
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
Condition: Migraine
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, parallel group study to evaluate acute pulmonary safety and
      Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation
      powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.
    

Detailed description: 
      The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427
      zolmitriptan inhalation powder in the study populations.
    

Intervention name(s): CVT-427 (zolmitriptan inhalation powder)
Intervention type(s): Drug
Intervention description(s): Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
Intervention MeSH terms: Zolmitriptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult smokers; Asthma; Healthy volunteers
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Condition: Scoliosis; Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months
      apart.
    

Detailed description: 
      The investigators obtained baseline Cobb angles on simple and complex curves, and collected
      previous, earlier studies of each adolescent idiopathic and degenerative scoliosis patient.
      The investigators then taught them to do the side-plank pose with the convex side of lumbar
      and thoracolumbar scoliotic curves downward, and a slightly altered version of the the half
      moon pose of yoga with the convex side of thoracic and cervicothoracic curves downward. The
      half moon pose was altered in that a belt was looped around the horizontal leg's foot, and
      held in a vertically extended upper arm's hand, and pulled tightly in that vertical position.

      Each pose was held as long as the patient could at least once daily.

      Cobb angles were again measured in films taken 4-10 months later.
    

Intervention name(s): Yoga poses
Intervention type(s): Behavioral
Intervention description(s): Patients are asked to perform one or two yoga poses daily for 4-10 months
Intervention model: Sequential Assignment
Intervention model description: Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
Masking: None (Open Label)
Primary purpose: Treatment