bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine
      after single and multiple oral dosing to healthy Chinese men and women.
    


Intervention name(s): Vortioxetine 10 mg single dose; Vortioxetine 20 mg single dose; Vortioxetine 10 mg multiple dose; Vortioxetine 20 mg multiple dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg tablet for oral use, single dose; Two 10 mg tablets for oral use, single dose,; 10 mg tablet for oral use once, daily for 14 days.; Two 10 mg tablets for oral use, once daily for 14 days.
Other intervention name(s): Lu AA21004; Lu AA21004; Lu AA21004; Lu AA21004
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Chitosan is a natural product that is produced commercially through the deacetylation of
      chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan
      has a lipid-lowering effect.

      This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine
      Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and
      effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated
      cholesterol levels and who have not been previously treated with other lipid-lowering agents.
    

Detailed description: 
      Chitosan is a natural product that is produced commercially through the deacetylation of
      chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan
      has a lipid-lowering effect by binding to fatty acids and cholesterol in the gastrointestinal
      tract and restricting their absorption.

      This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine
      Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and
      effective in lowering LDL-cholesterol levels in patients who have not been previously treated
      with lipid-lowering agents and who have cholesterol levels that are mild to moderately above
      the levels recommended by the National Cholesterol Education Program Adult Treatment Panel
      III (NCEP ATP III) guidelines.

      This is a multi-centre, randomized, double-blind, placebo-controlled study. Following a
      4-week Pre-Randomization Phase where patients will be instructed to maintain a stable diet,
      patients will be randomized to one of the following study groups for a 12-week Active
      Treatment Phase:

        -  HEP-40 400 mg three times a day (400 mg TID)

        -  HEP-40 800 mg twice a day (800 mg BID)

        -  HEP-40 800 mg three times a day (800 mg TID)

        -  HEP-40 2400 mg once a day (2400 mg QD)

        -  Placebo, three times a day (placebo)

      The primary objective is to evaluate the clinical benefit of administering HEP-40 chitosan at
      different doses and at different dosing regimens compared with placebo. Clinical benefit will
      be defined as the reduction in LDL-cholesterol after 4 weeks of active treatment.
    

Intervention name(s): HEP-40 chitosan
Intervention type(s): Device
Intervention description(s): Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other intervention name(s): Libracol
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; LDL-cholesterol; chitosan; HEP-40
Cognitive-behavioural Treatment of Chronic Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study:

        -  to compare two cognitive-behavioral treatments
    

Detailed description: 
      128 patients suffering from chronic back pain were randomly assigned to either Wait List
      Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.

      Measures were conducted 6 months before treatment (Wait List Control) immediately before and
      after treatment and at 6-months follow-up.

      25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of
      chronic back pain

      Treatment elements:

      Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about
      themselves and pain by cognitive restructuring, problem-solving training and coping skills
      training

      Behavioural treatment: increasing activity levels (sports, social activities, work), reducing
      medication intake and unnecessary health care utilization Relaxation training: progressive
      muscle relaxation, biofeedback.
    

Intervention name(s): cognitive-behavioral treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive-behavioral therapy; back pain; low back pain; biofeedback; randomized controlled study; EMG biofeedback
Functional Outcome After Cardiac Arrest
Condition: Out of Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Observational

Summary: 
      Descriptive and prognosis study of the functional outcome after cardiac arrest for the
      patients awake within the first 15 days.
    

Detailed description: 
      Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented..
      Survival after out of hospital cardiac arrest has improved and long term follow up of the
      patients is not routinely effective. Patients showing sign of awakening very early are
      considered in a good outcome group. Nevertheless they can experience some restriction and
      difficulties when they try to return to their premorbid level of functioning.

      We aim to study their long term functional outcome and their level of anxiety, depression,
      quality of life and caregiver burden as well as their general cognitive functioning.
      Prognosis factors will be studied in the acute phase.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting an Out of hospital cardiac arrest
      
Keywords: Cerebral anoxia; Functional outcome
An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
Condition: Alzheimer Type Dementia
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of two fixed dose
      (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil
      for treatment for patients with Alzheimer type dementia.
    

Detailed description: 
      Probable Alzheimer type dementia compare INM-176 1200~1600mg/day with Donepezil 5~10mg/day of
      safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase
      III clinical study.
    

Intervention name(s): Aricept; INM-176
Intervention type(s): Drug; Drug
Intervention description(s): Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks; INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
Other intervention name(s): Donepezil HCl; KR-WAP-026
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer disease
Role of Hyaluronic Acid in Bone Healing After Dental Extraction
Condition: Patients With Dental Extraction
Study type: Interventional

Summary: 
      This is a randomized controlled trial with a split mouth design. Patients with an indication
      of lower dental extraction will be asked to join this research project at the Department of
      Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose
      case requires bilateral extraction, one side will serve as an experimental side, whereas the
      other side will serve as a control.

      Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic
      acid will be injected following extraction in one of the two sides with random allocation.

      cone-beam computerized tomography (CBCT) images will be taken for each participant
      immediately post-extraction and at six months post-operatively.
    

Detailed description: 
      I- Clinical examination variables:

      Buccolingual distance and distomesial distance will be measured for each participant at 2
      assessment times: directly post-extraction and six months post-extraction.

      II- Radiographic examination variables:

      Linear measurements Vertical bone fill Bone mineral density
    

Intervention name(s): Hyaluronic Acid
Intervention type(s): Drug
Intervention description(s): This material is going to be injected into the extraction socket in order to promote bone healing.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Food Intake on Pharmacokinetic Profiles of Z-338
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of food intake on plasma concentration of Z-338 in healthy
      volunteers.
    

Detailed description: 
      The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic
      profiles of Z-338 in healthy volunteers by a 3-way cross-over method.
    

Intervention name(s): Z-338
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): YM443
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Z-338; YM443; healthy volunteers
Lean Seafood Intake and Postprandial Metabolism
Condition: Hyperlipidemias; Nutritional and Metabolic Diseases; Nutrition Disorders; Metabolic Diseases; Glucose Metabolism Disorders
MeSH terms: Hyperlipidemias; Metabolic Diseases; Glucose Metabolism Disorders; Nutrition Disorders
Study type: Interventional

Summary: 
      Despite numerous studies of meal components in humans, little is still known about how
      different meals influence on metabolism. The purpose of this study is to a gain knowledge of
      how a balanced test meal with either lean seafood (example:cod) or meat as the main protein
      source will:

        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)

        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at
           end of intervention period)

        3. affect gut microbiota composition
    


Intervention name(s): Lean seafood; Meat, egg, milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Seafood; Meat; Egg; Milk; Postprandial lipid metabolism; Postprandial glucose metabolism; Triglycerides; Cholesterol; Postprandial incretins; Postprandial hormones
DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Condition: Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to learn if researchers can identify through ultrasound images
      and clinical assessment which subjects with carpel tunnel syndrome will do better following
      standard of care non-surgical or surgical treatment.
    


Intervention name(s): Steroid Injection; Carpel Tunnel surgery
Intervention type(s): Drug; Procedure
Intervention description(s): volume and specific steroid drug will be based on the recommendation of the treating clinician; Standard of care carpel tunnel surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be identified among those presenting to the Hand Clinic with a referral
        diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are
        clinically indicated for either a steroid injection or surgery. Those who meet these and
        the inclusion criteria, do not meet the exclusion criteria, and who consent to participate
        will be entered in the study.
      
Keywords: Carpal tunnel
Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement
Condition: Orthodontic Tooth Movement
Study type: Interventional

Summary: 
      This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the
      retraction of maxillary incisors.
    

Detailed description: 
      This single-centered randomized clinical trial evaluated the effects of
      micro-osteoperforations in the retraction of maxillary incisors in patients who required the
      extraction of the first premolars to correct malocclusion. The canine retraction was
      performed in a previous step. The possible effects of micro-osteoperforantions in the
      following parameters were evaluated in the upper arch: anteroposterior incisors and first
      molars displacement, space closure, inclination and length of central incisors.
    

Intervention name(s): Micro-osteoperforations
Intervention type(s): Procedure
Intervention description(s): All micro-osteoperforations were performed only one time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations were performed with an individualized surgical guide and a 1.6 mm diameter stainless steel surgical drill perpendicular to the alveolar bone, 3 mm deep on the buccal surface, and 5 mm, on the palate. The depth of the perforations was controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations were aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation was performed between the two central incisors. The first perforation was performed 6 mm away from the gingival margin, and the second, 5 mm from the first, in the vertical direction.
Other intervention name(s): MOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Micro-osteoperforations; Orthodontic incisors retraction
Perioperative Observation of the Sublingual Microcirculation With SDF
Condition: Surgery
Study type: Observational

Summary: 
      Does sublingual SDF-imaging results correlate with other haemodynamic parameters measured
      perioperatively and with postoperative morbidity/complications.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults undergoing major surgery at one university hospital
      
Keywords: perioperative sublingual microcirculation SDF
Measurement of Psychomotor Recovery After Anesthesia Using 4CRT
Condition: Delayed Recovery From Anaesthesia
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test
      (4CRT) as a measure for recovery of the psychomotor function in patients after general
      anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in
      general anesthesia, will be randomized to the group with pharmacological anxiolytic
      premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients
      will be monitored using 4CRT before and after standardized general anesthesia. The reaction
      time, measured with 4CRT is the primary outcome parameter of the investigation.
    

Detailed description: 
      4CRT is a classical psychological test, used to measure the psychomotor speed. This test
      measures choice reaction time. The participants are instructed to respond by pressing the
      keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer
      (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is
      usually taken as 4CRT outcome.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): The participants receive the pharmacological premedication before the surgery anyway
Other intervention name(s): Dormicum
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Aim to Reduce Movements in Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether an investigational drug, SD-809
      (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive
      dyskinesia.
    


Intervention name(s): SD-809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.; Placebo tablets taken twice daily for 12 weeks.
Other intervention name(s): deutetrabenazine; AUSTEDO®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms
Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.
Condition: Algoneurodystrophy
MeSH terms: Complex Regional Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to compare the analgesic effectiveness of two motor cortex
      neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the
      algoneurodystrophy.
    

Detailed description: 
      -  Entry into the study : After informed consent, patients will be randomised into three
           groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation
           sessions will make the randomization via an interactive web response system (IWRS).

        -  Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of
           Pain Intensity for 1 month.

        -  The beginning of the treatment : after the baseline, sessions of neurostimulation will
           begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per
           week during the two first weeks, two sessions per week during the third week, one
           session during the fourth week and then two sessions per month for four months.

        -  After the end of neurostimulation sessions, patients will be followed for 1month.

      Throughout their participation in the study, patients will complete their VNS report book
      (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after
      neurostimulation).

      Patients will have 5 evaluation examinations:

        -  The first, one just before the beginning of the neurostimulation,

        -  The second, 1 month after the beginning of neurostimulation

        -  The third, 3 months after the beginning of neurostimulation

        -  And the last one, 1 month after the end of neurostimulation.
    

Intervention name(s): rTMS; tDCS; tsDCS
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation
Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish single and multiple dose safety in healthy subjects
      and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study
      will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in
      sputum and mucociliary clearance.
    

Detailed description: 
      The proposed initial trial in healthy subjects and subjects with mild COPD will establish the
      tolerability of PUR118 in these subjects over single and short multi-day dosing periods. The
      study will also provide preliminary data regarding PUR118's potential impact on biomarkers in
      COPD. Finally, this trial will assess PUR118's effect on mucociliary clearance. This is a
      four part study enrolling healthy volunteers in a single ascending dose design (SAD; Part I),
      followed by multiple ascending dose design (MAD; Part II). Contingent on demonstration of
      safety in a healthy subject population, the study will enroll mild COPD subjects for a short
      multi-dose design (Part III) incorporating safety and pharmacodynamic endpoints. Lastly Part
      IV of the trial will assess the effect of PUR118 on mucociliary clearance in mild COPD
      subjects.
    

Intervention name(s): PUR118
Intervention type(s): Drug
Intervention description(s): inhaled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment