bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Compare The Putative Anxiolytic Effect Of 2 New Drugs In Subjects With Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare by neuroimaging techniques and public speaking, the way social anxiety patients
      respond after the administration of GW876008, GSK561679, alprazolam and placebo
    


Intervention name(s): GSK561679 tablet; GW876008 tablet; alprazolam; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A.; GW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base).; Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).; GW876008 placebo tablets will visually match the active GW876008 tablets. GSK561679 placebo tablets will visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that will visually match the active but containing only a filler.
Other intervention name(s): GSK561679; GW876008
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: anxiety,; depression,; fMRI; CRF-1 antagonists,
A Study to Investigate the Effect of SB-705498 on Chronic Cough
Condition: Rhinitis
MeSH terms: Rhinitis; Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled
      capsaicin challenge
    


Intervention name(s): Placebo; SB-705498
Intervention type(s): Drug; Drug
Intervention description(s): SB-705498 placebo; 400 or 600mg oral SB-705498
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
Condition: Memory; Dexmedetomidine
Study type: Observational

Summary: 
      The goal of this study is to determine the effects of dexmedetomidine on memory and recall of
      children who are receiving dexmedetomidine sedation administered for magnetic resonance
      imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for
      diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at
      Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in
      children has not been studied.
    


Intervention name(s): Dexmedetomidine; Memory Test
Intervention type(s): Drug; Other
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children between the ages of 4 and 14 years old either requiring sedation or attempting
        without sedation for MRI imaging will be offered inclusion in the study. Sedation will be
        administered per established and approved BCH sedation guidelines: over 10 minutes, a bolus
        of 2 mcg/kg of dexmedetomidine will be administered intravenously. The sedation process
        will not change for this study. During the bolus, pictures will be shown to the child who
        will be encouraged to name the item in the picture.
The Impact of Educational Materials on Family Behavior
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the research is to learn whether written materials or handouts that are given
      to parents are helpful in changing knowledge or behavior.
    

Detailed description: 
      Few written resources for families have been tested in the primary care setting. Kid STRIDE
      (STRiving to Improve Diet & Exercise) is an educational booklet designed for parents of
      overweight children. We hypothesize that this booklet will benefit a small percentage of the
      overweight and obese population of children as a first-tiered approach to treatment of
      overweight and obese children.
    

Intervention name(s): Booklet on nutrition and physical activity.; Safety Booklet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents will be asked to read the booklet and complete a pre- and post-questionnaire.; Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Child
Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Background:

      Patients who undergo laparoscopic surgical resection of colorectal cancer may experience
      various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation
      of daily activities (e.g., walking capacity). There is also a risk of post-operative
      complications and a prolonged hospital stay due to complications. Patients who underwent
      surgical resection may have experienced chronic pain, anxiety/depression, or diminished
      quality of life. The physical, psychological, and functional aspects of patients' disorders
      imply the necessity of multidisciplinary care, including complementary or traditional
      medicines such as acupuncture. This study aims to assess whether acupuncture treatment,
      combined with an enhanced recovery program after surgery in an inpatient care setting is
      effective than only an enhanced recovery program after surgery.

      Objective:

      To assess the effectiveness and safety of acupuncture combined with an enhanced recovery
      program after surgery to reduce postoperative symptoms and improve functional recovery and
      the patients' quality of life.
    


Intervention name(s): acupuncture; early recovery program after surgery
Intervention type(s): Device; Other
Intervention description(s): Points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4) and Pericardium 6 (PC6) will be used. Electrical stimulation with alternating frequency of 2 to 100 Hz will be applied to the selected points (LI4 to LI11, ST36 to ST37, and bilateral SP6).
Rationale of acupuncture treatments will include both traditional theory of harmonizing gastrointestinal function and strengthening vital energy as well as modern experimental and clinical evidence of regulating gastrointestinal motility and other symptom managements. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience.; An enhanced recovery program after surgery that was designed and is currently implemented by surgeons, anesthetists, dietitians, and nurses will be provided. The program includes preoperative education, early water/food intake, early mobilization, early removal of Foley catheter and drains, structured nursing care, and nutritional support.
Other intervention name(s): fast-track recovery program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: colon; colorectal; cancer; neoplasm
Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin
      regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed
      patients with diabetes
    

Detailed description: 
      We conducted a pilot prospective multicenter study in five French centers (Strasbourg
      University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes)
      designed to evaluate the feasibility and effects of a 3 month treatment regimen with
      rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir,
      respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.

      All patients who were admitted to the nephrology departments and matched the inclusion
      criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the
      study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of
      treatment. It was started during the first dialysis session and then continued for the next
      two days at home under ambulatory conditions. The CGM was continued during the next dialysis
      session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54
      hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of
      treatment. The probe for the system was subcutaneously inserted at the beginning of the first
      dialysis session to analyze interstitial glucose, and it was removed at the end of the second
      dialysis session. Due to the time required for CGM calibration, plasma glucose levels were
      only partially recorded during the first dialysis session.
    

Intervention name(s): Basal-bolus detemir-aspart insulin regimen
Intervention type(s): Drug
Intervention description(s): After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
Other intervention name(s): Levemir; Novorapid
Intervention MeSH terms: Insulin Aspart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Hemodialysis; Continuous glucose monitoring; Insulin analogues
Chinese Versions of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV) Scale and Strengths Difficulties Questionnaire.
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset
      neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and
      society. The diagnosis of ADHD is mainly based on clinical interview of parents and children
      with assistance of teachers' reports. Self-administered rating scales are useful for
      screening, assistance of diagnosis, and measurement of symptom changes over time or due to
      treatment effect. The goals of this study are to establish the norms and psychometric
      properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and
      Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and
      Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.

      Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage
      sampling method. The participants include a school-based sample of 3534 first to eighth
      graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi
      County. Among them, 200students will be reassessed at 2-week interval for the test-retest
      reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist
      (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student
      participants older than 10 years old, their parents, and teachers. The main statistical
      methods include Pearson correlation, intraclass correlation, Chronbach's α for internal
      consistency, and mixed model to address lack of independence within the same classes and
      schools.

      Anticipated Goals: We expect that this study will reach the following objectives:

        1. to obtain the primitive information about the prevalence of ADHD symptoms and
           emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;

        2. to enhance the awareness of school teachers and counselors about ADHD and other
           behavioral/emotional problems among students;

        3. to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for
           future use in clinical, school, and research settings.
    

Detailed description: 
      This protocol was prepared in Chinese
    

Sampling method: Non-Probability Sample
Study population: 
        School-based subjects & Clinical subjects with ADHD
      
Keywords: ADHD, SNAP-IV, SDQ, ASRS, reliability, validity
Application of the 24-hour Recall Methodology Assisted by Digital Photographs for the Analysis of Dietary Intake
Condition: Dietary Intake
Study type: Observational

Summary: 
      With this project, the investigators expect to standardize a reliable and optimized
      methodology based on a 24-hour recall tool assisted by digital photographs with a complete
      output of foods and nutritional information for the Colombian population.
    

Detailed description: 
      After recruitment, participants (20) will receive a detailed explanation of the objectives
      and conditions of the study and will sign the informed consent. Dietary intake assessments
      will be conducted using 24-hour dietary recalls, assisted with digital photographs registry
      of the food and beverages consumed, and a brief description (the two 24 dietary recalls will
      be applied on different and non-consecutive days). Simultaneously, food weighing using a home
      kitchen scale and drink volume measurements will be used as a reference. For the analysis of
      nutritional information, the daily food intake extracted from food photologs will be entered
      into the automated Self-Administered Dietary Assessment Tool (ASA24®). Macro- and
      micronutrient intake using the actual food weights recorded by the participants, will be
      estimated from the USDA FNDDS 2017-2018 database, and polyphenols composition from a phenol
      database.

      On the day of each 24-h dietary recall, participants will collect a 24-h urine sample to
      assess their protein, sodium, and potassium intake. Additionally, the day after each 24
      dietary recall, participants will also provide blood samples to determine circulating levels
      of vitamin C, vitamin B1, vitamin K1, folate, zinc, copper, and beta-carotene; and fecal
      samples to identify vegetable species in feces.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty subjects, general population. Participants should not change their dietary habits
        during the study.
      
Biospecimen description: 
      Feces
    
Keywords: Dietary intake; 24-hour recall; Biomarkers
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Condition: Anxiety Disorders; HIV Infections
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and
      effective in the treatment of HIV-infected patients with generalized anxiety disorder.
    

Detailed description: 
      Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the
      general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders;
      Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the
      most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with
      HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of
      HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the
      general population. It has been shown to be safe in HIV-patients with a tolerable side-effect
      profile. However, whether it can improve GAD in HIV-infected patients has not yet been
      investigated.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Escitalopram; Anxiety Disorder; HIV and AIDS; treatment experienced
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether low dose flu vaccines delivered with
      microneedles into the skin (intradermally) are effective.
    

Detailed description: 
      Influenza vaccination is the primary method for preventing influenza and its severe
      complications. Previous clinical studies demonstrated that delivery of vaccines intradermally
      (into the skin) can achieve good efficacy even with lower doses of the vaccine.

      Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared
      to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular
      needle.
    

Intervention name(s): Flu Vaccine (FLUARIX®)
Intervention type(s): Biological
Intervention description(s): Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Condition: Healthy Volunteers; High Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet
      formulations. These formulations are being tested for the treatment of hypercholesterolemia
      (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The
      treatments participants get are decided by chance. Participants will receive 1 formulation
      for 10 days (first treatment period) and the other formulation for 5 days (second treatment
      period). The study will last up to 96 days. Only men can participate in this clinical study.
    


Intervention name(s): NNC0385-0434 G; NNC0385-0434 F; NNC0385-0434 B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This is a non-pharmacological pilot study showing the improvement of a SMR/theta
      neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild
      Cognitive Impairment.
    

Detailed description: 
      Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in
      elderly with mild cognitive impairment. In this pilot study, the investigators studied
      whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain
      electrical activity in a sample group of elderly patients with mild cognitive impairment.
      Twenty participants performed an electroencephalography recording, a battery of
      neuropsychological tests before the neurofeedback training program (T0), following the
      neurofeedback training program (T1) and 1-month follow-up (T2).
    

Intervention name(s): SMR neurofeedback training to MCI
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta training was recorded at channel Cz according to the international 10-20 system. Theta rhythm was also recorded and, in this case, SMR was stimulated while theta waves were suppressed.A 32 channels system (EEGDigitrcak Biofeedback plus module, Inc Elmiko Medical) was used for the SMR/theta Neurofeedback training.
Other intervention name(s): SMR; neurofeedback
Intervention model: Single Group Assignment
Intervention model description: no randomized, no controlled
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neurofeedback; Electroencephalography; MCI; Alzheimer