bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
      who are taking certain types of antidepressants but continue to have residual depression
      symptoms. Eligible patients will remain on their antidepressant but will be randomized to
      either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is
      to help answer the following questions:

        -  How safe is SPD489 for the supplemental treatment of depression and what are the side
           effects that might be related to it?

        -  Can supplemental SPD489 help patients who still have residual depression symptoms while
           taking an antidepressant?

        -  How much SPD489 should be given to patients with depression who are also taking an
           antidepressant?

        -  How does SPD489 compare to placebo in depressed patients who are also taking an
           antidepressant?
    


Intervention name(s): Antidepressant + SPD489 (Lisdexamfetamine dimesylate ); Antidepressant + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks; Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the tolerability (in terms of drug delivery and
      toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely
      resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients
      will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.
    


Intervention name(s): cisplatin/docetaxel; cisplatin/vinorelbine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cisplatin; Docetaxel; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Small Cell Lung Cancer; NSCLC; Adjuvant chemotherapy for completely resected NSCLC
The Effects of Types of Fruits and Vegetables on Vascular Function
Condition: Blood Pressure; Vascular Stiffness; Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The CIRCUS study is a randomised controlled, cross-over trial to evaluate the effects of
      increased intakes of citrus fruits and cruciferous vegetables on vascular function in 36
      untreated, prehypertensive participants.
    

Detailed description: 
      The study comprises three 14-day dietary intervention periods, preceded by one week run-in
      period and separated by one week wash-out periods, 9 weeks in total. The diet will be fully
      controlled and provided by the researchers. Participants will receive in random order three
      interventions:

        -  1 portion of fruits plus 1 portion of vegetables, of commonly consumed types per day.
           Intakes are at 25th percentile of UK consumption and will exclude citrus fruits,
           cruciferous and allium vegetables.

        -  4 portions of fruits plus 4 portions of vegetables, of commonly consumed types per day
           excluding citrus fruits, cruciferous and allium vegetables.

        -  4 portions of citrus fruits plus 4 portions of cruciferous vegetables per day.
    

Intervention name(s): LFV; HFV; CC
Intervention type(s): Other; Other; Other
Intervention description(s): 1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day; 4 portions of fruits (apples, bananas, grapes, pears) plus 4 portions of vegetables (carrots, cucumber, sweet peppers, tomatoes), of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables.; 4 portions of citrus fruits (clementines, grapefruits, lemons, oranges) plus 4 portions of cruciferous vegetables (broccoli, brussels sprouts, cauliflower, kale, savoy cabbage) per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood Pressure; Vascular Stiffness; Cardiovascular Risk Factor; Fruit and vegetable
Clinical Trial for Liquid Food (Inslow)
Condition: Diabetes
Study type: Interventional

Summary: 
      A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate
      (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve
      glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired
      glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on
      postprandial glycemic responses.
    

Detailed description: 
      The test enteral nutrition formula (Inslow) and the standard balanced formula (Meibalance)
      were administered in a randomized crossover design to 11 healthy people, 13 IGT and 12 type-2
      diabetes, judged by the postprandial state after in taking the two test meals in a random
      order with a washout period of one week. On the day prior to the test day, subjects were
      asked to stay at the same facility and to take the same supper with 450 kcal controlled,
      after 21:00 with only water allowed as ad libitum and not do any exercise. Each participant
      was taken a fasting blood sample, and then requested to consume one of is energetic test
      meals (200 kcal per serving) Inslow or standard balanced formula at 7:00 AM. Subsequent blood
      samples were collected at 30,60,90,and 120 min after meal consumption. The plasma
      concentrations of glucose, insulin, and free fatty acids were measured for each blood sample.
      Plasma glucose was measured by hexokinase method, plasma insulin by serum radioimmunoassay
      method and plasma free fatty acid by enzyme chemical method.Routine blood test and
      biochemical test were performed using the same blood sample only at fasting stage,including
      RBC, WBC, TP, ALP, T-Cho, etc., to confirm the status of each subject. Collected blood was
      applied to analyses at Shanghai Meizhong Clinical Measurement Centre. The enteral nutrition
      meal Inslow was designed by palatinose, dextrin and fiber as carbohydrate for 56%,23% and
      15%, respectively. The standard balanced meal was included dextrin as the main carbohydrate
      for 85%, together with sugar and fiber.
    

Intervention name(s): Inslow; standard balanced formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): carbohydrate adjusted liquid food using palatinose as the major carbohydrate (>50%)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Feedbacks' Influence on Decision Making Processes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this research is to identify and probe the neural networks involved in
      feedback processing. It aims at translating this knowledge to clinical populations in which
      this network is disrupted or compromised.

      It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of
      feedback processing on decision making using different types of feedback (neutral, social and
      monetary) presented either infra- or supra-laminary and 2) probing the role of one structure,
      the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy
      subjects. The interventional part consists in the administration of Galvanic Vestibular
      Stimulation (GVS), which by means of small intensity currents activates the vestibular organs
      and subsequently vestibular-related brain areas. GVS will be delivered to healthy
      participants engaged in behavioural tasks requiring the processing of feedbacks of different
      nature (e.g. social or monetary feedbacks)
    


Intervention name(s): mRI; Effect of Galvanic Vestibular Stimulation on decision making processes
Intervention type(s): Other; Other
Intervention description(s): Neural bases of feedbacks' influence on decision making processes; Galvanic Vestibular Stimulation (GVS) stimulates the vestibular system through low intensity electric currents applied at the basis of the VIII cranial nerve, upon the mastoid processes. In the Right-Anodal condition the positive electric charge is applied through electrodes placed upon the right mastoid and it mainly activates structures within the left brain hemisphere. In the Left-Anodal condition the positive electric charge is applied through electrodes placed upon the left mastoid and it mainly activates structures within the right brain hemisphere. In the SHAM condition, low intensity electric currents are applied 5 cm below the mastoid processes. This condition does not activate the vestibular system and serves as a control condition to account for unspecific activating effects of all electric stimulations (e.g., arousal, discomfort). The three conditions will be applied in three different sessions (i.e. days) in randomized order.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: functional Magnetic Resonance Imaging; Galvanic Vestibular Stimulation; Feedback Processing; Reward, Social, Vestibular System; Cingulate Cortex; Decision-making
Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of cognitive rehabilitation program on
      the improvement of cognitive functions in patients with mild cognitive impairment(MCI).
    

Detailed description: 
      The cognitive rehabilitation program was developed to improve cognitive functions of the
      elderly or patients with cognitive impairments. The study will enroll 40 patients with mild
      cognitive impairment(MCI) between 55 and 75 years of age. Forty subjects will be randomly
      assigned into two groups. Subjects in the intervention group will receive four weeks of
      cognitive rehabilitation training, three times per week and 30 minutes per day. The control
      group will not receive any intervention. The investigator will measure their cognitive and
      brain functions three times at pre-intervention, post-intervention and four weeks after
      intervention to assess the effectiveness of the cognitive training program.
    

Intervention name(s): Cognitive rehabilitation program
Intervention type(s): Other
Intervention description(s): Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Other intervention name(s): Computer-aided Cognitive Rehabilitation Training System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild cognitive impairment; cognitive training program
SmartPICC-1 Feasibility Study Technical Feasibility Study
Condition: Catheter Complications
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the safety and technical feasibility of
      the Piccolo Medical SmartPICC System, indicated for guidance and positioning of commercially
      available central venous catheters, for PICC placement in adults.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and technical feasibility of
      the Piccolo Medical SmartPICC System for PICC placement in adults. The SmartPICC system is
      indicated for guidance and positioning of commercially available central venous catheters. In
      this prospective, single arm (non-randomized), safety and technical feasibility study, adult
      volunteers who meet the protocol entry criteria and are scheduled to undergo PICC placement
      will be recruited. Immediately following placement with use of the SmartPICC System, subjects
      will undergo an assessment of the PICC placement site, as technical feasibility will be
      evaluated as the ability of the SmartPICC System to provide venous navigation for PICC
      placement in the lower superior vena cava (L-SVC), cavoatrial junction (CAJ), or proximal
      right atrium (RA) as confirmed by radiologic review. Safety will be evaluated as freedom from
      serious adverse events (SAEs) directly attributable to the SmartPICC system. Subjects will be
      evaluated at 12-24 hours post-placement to ensure safety, in addition to a review of subject
      medical records 7 days post PICC placement.
    

Intervention name(s): SmartPICC-1 System
Intervention type(s): Device
Intervention description(s): The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system provides a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation during PICC placement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects who have been prescribed a PICC
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b Infection; Poliomyelitis; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep
      B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6
      months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given
      at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in
      South Korean infants that received a birth dose of Hep B and born to mothers documented to be
      serum anti-HBs Ag negative.

      Primary Objective

        -  To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus,
           poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens
           (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B,
           one month after the third dose of combined vaccines.

      Secondary Objectives:

        -  To further study the immunogenicity of the two vaccination schemes, before the first
           dose and one month after the last dose of vaccines.

        -  To study the safety after each and any dose of vaccines administered in the two
           vaccination schemes
    

Detailed description: 
      Study participants who received a first dose of recombinant Hep B vaccine at birth will
      receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses
      of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T
      combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official
      vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.
    

Intervention name(s): DTaP-IPV-Hep B-PRP~T combined vaccine; DTaP-IPV//PRP~T and Hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Pentaxim™; Euvax B®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type b infection; Hepatitis B; DTaP-IPV-Hep - PRP-T vaccine
Turkish Reliability and Validity of FOPQC-SF
Condition: Fear; Pain; Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The aim of this study is to question the Turkish validity and reliability of the "The Fear of
      Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between
      the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric
      Rheumatology Clinic will be included in the study. The sample size of this study was
      determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be
      administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the
      Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity
      Score.
    


Intervention name(s): Fear of Pain Questionnaire for Children Short Form
Intervention type(s): Other
Intervention description(s): administering the questionnaire twice, one week apart.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aimed to assess how stabilization of the trunk and the upper extremity can change
      the parameters of hand/wrist motor coordination and grip strength in dominant and
      non-dominant paretic upper limb, in post-stroke patients and neurologically healthy subjects.
    

Detailed description: 
      The examination of the dominant and non-dominant paretic hand consisted of two motor tasks,
      carried out in two different starting positions: sitting and lying down (supine).

      During the first examination, the subject sat on the therapeutic table (without back
      support), feet resting on the floor. The upper limb was examined in adduction of the humeral
      joint, with the elbow bent in the intermediate position between pronation and supination of
      the forearm, with free wrist and the hand.

      In the supine position, the affected upper limb was stabilized at the subject's body
      (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand
      free). The Hand Tutor device and an electronic hand dynamometer were used for the
      measurements. In each of the starting positions, after putting the glove on (using the Hand
      Tutor Device), the subject was asked to make moves as quickly and in as full a range as
      possible. Finally, the measurement of grip strength with a dynamometer was performed in both
      analyzed starting positions, after completing the range of motion and frequency tests.
    

Intervention name(s): hand motor coordination in a sitting positin; hand motor coordination in a supine position
Intervention type(s): Procedure; Procedure
Intervention description(s): The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand. After putting the glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.; In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free). After putting the Hand Tutor glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dominant hand; non-dominant hand; coordination; grip strength; stabilization; stroke
Diabetes Outcomes and Nurse Case Manager Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will examine whether patients with diabetes who are either 1) newly discharged
      from hospital or 2) referred to an endocrinologist for management will have better diabetes
      outcomes when their care is managed primarily by a dedicated case manager (intervention) than
      by an endocrinologist (standard care) after 6 months of treatment.
    

Detailed description: 
      The study will be a randomized-control trial recruiting patients with type 2 diabetes in a
      specialty care setting from two sources:

        1. referred by family physicians with inadequate glycemic control likely requiring
           exogenous insulin therapy

        2. referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during
           in-patient care & about to be discharged (Appendix 1).

      Patients who meet the inclusion criteria will be randomly assigned into either the NCM group
      or SC group.
    

Intervention name(s): Nurse Case Management; standard diabetologist care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): routine care by diabetologist & team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; outcomes; case management
A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection
Condition: Colon Rectal Resection
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice
      surgery VS transabdominal surgery.
    

Detailed description: 
      To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice
      surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the
      comparison is still unclear.The investigators divide the patients into two groups, and
      compare the differences of postoperative outcomes by statistics.
    

Intervention name(s): transvaginal laparoscopic surgery
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients