bioihbjkbjnl/mcl2 huggingface dataset:
Optimisation of ECT Based on ASTI vs Narcotrend
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe
      depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the
      sympathic response and the postictal EEG-suppression.

      - Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand
      anaesthesia strongly influences the quality of the seizure. Standard treatment is to use
      Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric
      stimulation.

      The aim of the study is to assess if timing of electric stimulation aiming for ar an
      anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than
      standard approach of using ASTI 1-2 minutes.
    

Detailed description: 
      The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe
      depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the
      sympathic response and the postictal EEG-suppression.

      - Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand
      anaesthesia strongly influences the quality of the seizure. Standard treatment is to use
      Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric
      stimulation.

      The aim of the study is to assess if timing of electric stimulation aiming for ar an
      anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than
      standard approach of using ASTI 1-2 minutes.
    

Intervention name(s): Narcotrend
Intervention type(s): Procedure
Intervention description(s): ECT stimulation within an anaesthesia depth range of 41-64
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite
Condition: Malignant Mesothelioma; Pulmonary Complications
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Observational

Summary: 
      RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to
      asbestos or vermiculite in the laboratory may help doctors learn more about changes that may
      occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in
      patients exposed to asbestos or vermiculite.
    

Detailed description: 
      OBJECTIVES:

        -  Identify patients with known asbestos exposure at early stages of disease development
           (i.e., indolent premalignant pleural plaques and fibrosis vs malignant pleural
           mesothelioma).

        -  Determine the expression levels of tumor-associated proteins in these patients.

        -  Analyze samples of serum and pleural effusions obtained from these patients.

        -  Determine the proteomic profile of samples obtained from these patients.

        -  Determine the molecular mechanisms associated with the regulation of the extracellular
           matrix microenvironment proteins (e.g., osteonectin, intelectin, or matrix
           metalloproteins) involved in disease onset and progression.

      OUTLINE: This is a multicenter study.

      Patients undergo collection of body cavity fluid, including pleural effusion, and blood.
      Specimens, including fresh frozen malignant pleural mesothelioma tumor tissue, if available,
      are analyzed for proteomic profile, gene expression profile, and tumor-associated protein
      expression levels.

      PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
    

Intervention name(s): microarray analysis; protein expression analysis; proteomic profiling; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinic
      
Keywords: malignant mesothelioma; pulmonary complications
The Effect of Exercise on Fatigue in White-collar Workers
Condition: Exercise; Fatigue
MeSH terms: Fatigue
Study type: Observational [Patient Registry]

Summary: 
      A survey will be conducted on the Internet for desk workers. The questionnaire; International
      Physical Activity Questionnaire will be filled out to evaluate the exercise level of the
      participants, the visual analog scale to question the general pain levels, and the fatigue
      severity questionnaire to investigate the fatigue levels. The patients will also be divided
      into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an
      evaluation will be made between the groups.
    

Detailed description: 
      A survey will be conducted on the Internet for desk workers. The questionnaire; International
      Physical Activity Questionnaire will be filled out to evaluate the exercise level of the
      participants, the visual analog scale to question the general pain levels, and the fatigue
      severity questionnaire to investigate the fatigue levels. The patients will also be divided
      into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an
      evaluation will be made between the groups.
    

Intervention name(s): Survey
Intervention type(s): Diagnostic Test
Intervention description(s): Survey
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        20-75 years old white-collar worker
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with chronic migraine.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults
Condition: Glycemic Response; Appetitive Behavior
Study type: Interventional

Summary: 
      Assess the impact of 100% grape juice on postprandial glycemic response and subsequent
      appetite, food intake and cognitive function.
    

Detailed description: 
      Investigators earlier clinical work and published literature suggest that the phenolic
      content and strong flavor intensity of 100% Concord grape juice hold potential beneficial
      effects on appetite and glycemia. Investigators aim to better understand the use of 100%
      grape juice modifies appetite and glycemia acutely and over the day using a 24 hour glucose
      monitor.
    

Intervention name(s): Concord Grape Juice; Low flavoniod low essence beverage; Low flavonoid beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Concord Grape Juice; Low flavoniod low essence beverage; Low flavonoid beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Trial on the Effect of E-cigarette Advertising on Cigarette Perceptions in Adolescents
Condition: Attentional Bias; Smoking Cues; Positive Perceptions About Cigarette Smoking; Social Norms; Smoking Susceptibility
MeSH terms: Disease Susceptibility
Study type: Interventional

Summary: 
      This research aims to investigate how exposure to advertising for Electronic Nicotine
      Delivery Systems (commonly called e-cigarettes) may lead to combustible smoking initiation in
      adolescents.
    

Detailed description: 
      [3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic
    

Intervention name(s): E-cigarette ad exposure; non e-cigarette TV commercials
Intervention type(s): Behavioral; Other
Intervention description(s): Participants view a series of e-cigarette TV commercials; Participants view a series of non e-cigarette TV commercials
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Positive Smoking expectancies; e-cigarette advertising; adolescents
Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position
Condition: Adenoid Hypertrophy
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      500 children aged 0-5 years followed since birth by Principal Investigator (PI)since
      January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study
      group) and 500 children aged 0-5 years followed by principal investigator during the same
      years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea,
      vomiting but without AH (control group) were compared. Morbidity and treatment will be
      compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding
      position during the first few years of life in the two groups.
    

Detailed description: 
      The 2 groups are children aged 0-5 years and treated by PI and followed since birth during
      years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and
      control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems
      (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM),
      antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays,
      anomalous laboratory results, emergency room visits and hospitalization rates will be
      compared in the two groups, together with details concerning feeding position during the
      first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction,
      allergy, GER and supine feeding position, will be evaluated.
    

Intervention name(s): infant feeding position
Intervention type(s): Behavioral
Intervention description(s): correlation with allergy, GER or feeding position
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Young infants followed since birth or from the first half of the first year of life,
        followed at least for 5 years by PI, study group (till 500 children) with the diagnosis of
        AH, control group (till 500 children) diagnosed as UTI, GE, vomiting or diarrhea and
        without AH.
      
Keywords: Adenoid hypertrophy; Allergy; Infant Feeding Position; GER; Pneumonia; Bronchitis; Otitis
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
Condition: Japanese Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20
      milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and
      TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese
      healthy adult male participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-438 OD tablet. TAK-438 OD tablet is being
      tested in Japanese healthy adult men. This study will evaluate bioequivalence of single oral
      dose of TAK-438 OD 20 mg tablet without water and TAK-438 20 mg tablet with water (Study 1),
      and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2).

      The study will enroll up to 144 participants in total (Study 1 + 2). In Study 1 and 2,
      participants will be randomly assigned (by chance, like flipping a coin) to one of the two
      treatment groups;

      Study 1:

        -  TAK-438 OD 20 mg tablet without water (Period 1) + TAK-438 20 mg tablet with water
           (Period 2)

        -  TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet without water
           (Period 2)

      Study 2:

        -  TAK-438 OD 20 mg tablet with water (Period 1) + TAK-438 20 mg tablet with water (Period
           2)

        -  TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet with water (Period
           2)

      This single-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 11 days. Participants will make two visits to the clinic and be
      hospitalized for four days each in Periods 1 and 2.
    

Intervention name(s): TAK-438 OD; TAK-438
Intervention type(s): Drug; Drug
Intervention description(s): TAK-438 OD tablet; TAK-438 tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Breast Cancer Risk Reduction: A Patient Doctor Intervention
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The proposed research combines the scientific advances in breast cancer research with health
      information technology (IT) to design a personalized intervention that assesses breast cancer
      risk for women, disseminates important breast health information, and facilitates discussion
      of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal
      computer) based breast cancer risk education (BreastCare) intervention in the primary care
      setting that estimates a woman's individual risk for breast cancer and provides her and her
      physician with personalized breast cancer risk information and recommendations for action.
    


Intervention name(s): BreastCARE
Intervention type(s): Other
Intervention description(s): Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast cancer concern, breast cancer risk perception, breast cancer risk
Outcomes of Phacoemulsification With Torsional Ultrasound
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the differences in intra-operative complications, surgical duration, fluid
      usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial
      phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery
      and at post-operative day 1, 1 month and 3 months.
    

Detailed description: 
      Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon
      Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify
      cataractous lens material in a seamless cutting motion from a tip that oscillates laterally.
      The side-to-side movement of the phaco tip produces minimal repulsion of lens material from
      the phaco tip resulting in improved followability. Clinically this translates into more
      effective lens removal with torsional phaco in comparison to the conventional ultrasound
      mode.to test this in a clinical scenario we undertook this study.
    

Intervention name(s): Torsional ultrasound (INFINITI, Alcon, USA); Longitudinal U/S (Infiniti system, Alcon, USA); Longitudinal U/S (LEGACY 20000, Alcon, USA)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Comparison of inta-operative efficacy and safety; comparison of efficacy and safety; Interrupted energy modality
Other intervention name(s): OZIL technology; traditional ultrasound; Traditional U/S
Intervention MeSH terms: Dipivefrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PACHYMETRY; CELL LOSS; SAFETY; EFFICACY; PHACOEMULSIFICATION; Intraoperative complications; CLOCK TIME; FLUID USED; CORNEAL THICKNESS; ENDOTHELIUM CELL LOSS
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
Condition: Coagulopathy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Modern crystalloid and colloid solutions are balanced solutions which are increasingly used
      in perioperative period. However, studies investigating their negative effect on whole blood
      coagulation are missing. The aim of our study was to assess the effect of modern balanced
      crystalloid and colloid solutions on whole blood coagulation in vivo using rotational
      thromboelastometry.
    

Detailed description: 
      Blood samples were obtained from 30 patients during knee arthroscopy before and after
      administration of 500 ml of modern balanced crystalloid, hydroxyethyl starch (HES) or
      gelatin. Rotational thromboelastometry (EXTEM, INTEM and FIBTEM tests) were performed to
      assess negative effect of fluid solutions on whole blood coagulation.
    

Intervention name(s): hydroxyethyl starch
Intervention type(s): Other
Intervention description(s): After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        healthy patients undergoing knee arthroscopy
      
Keywords: hydroxyethyl starch, gelatin, ROTEM, coagulation
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise
      capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary
      hypertension.
    


Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tadalafil 10mg once daily for 3 months
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Secondary Pulmonary Hypertension
Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions
Condition: Low Level Light Therapy
Study type: Interventional

Summary: 
      The world is facing rapid population aging, the health needs of the elderly are complex, and
      their physical capabilities are degraded, and increased the possibility of having one or more
      chronic conditions. In 1900 to 2000, there were 7,600 million people in the United States,
      aged 65 and above age increased to 4.1% up to 12.6%, by 2050 is expected to increase 20.3%.In
      Taiwan, the elderly population have 83.5% is health and sub-health, in order to allow them to
      perform activities of daily living independently, in particular, need to pay attention to the
      diverse needs of the elderly, Assist the elderly to increase self-care skills, reduce
      disability is a very important issue.
    

Detailed description: 
      From literature review of LED phototherapy can effectively improve symptoms in the elderly,
      such as hair loss, dermatitis, rotator tendonitis, epicondylitis of the tibia, wound healing,
      back pain, patellofemoral pain, spinal neuropathy, chronic pain relief, insomnia and
      depression.

      Comprehensive Phototherapy and Traditional Chinese medicine(TCM) perspective, LED
      phototherapy is the use of physical light energy stimulation and temperature to improve the
      body's microcirculation and meridian dredge, Enhance the body's energy of the health and
      sub-health elderly, increasing physical activity perform daily functions.

      Taiwanese Elderly to take self-care by the dilemmas of the many aspects. There are 21.52%
      physical health problems, affecting work or daily activities are limited; there are 35.12%
      physical or emotional health problems affecting social activities; there are 13.01% incapable
      perform activities of daily living.

      The aim of this study was to explore the effectiveness of LED phototherapy on physiological
      symptoms among elderly in long-term care institutions in Taiwan. To examine the effects of
      physiological symptoms, such as mental state, muscle bone system, metabolism, autonomic
      balance and other meridian energy tests, it is expected to improve the body energy of healthy
      and sub-healthy elderly to increasing physical activity perform daily functions.
    

Intervention name(s): phototherapy protocol
Intervention type(s): Other
Intervention description(s): Pretest：Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs.
Intervention：LED light therapy for 6 weeks, 2-3 times a week, every 30 minutes. Post test：Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: elderly; LED phototherapy; meridian energy; sleep quality; fatigue; cold limbs; long-term care institution
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia
Condition: Spinocerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a preliminary study to determine the safety and efficacy of intravenous immune
      globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in
      clinical measures of disease severity before and after treatment.
    


Intervention name(s): IVIG
Intervention type(s): Biological
Intervention description(s): Intravenous Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment