bioihbjkbjnl/mcl2 huggingface dataset:
Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
Condition: Angina, Unstable; Myocardial Infarction; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Infarction; Cardiomyopathies; Myocardial Ischemia; Coronary Artery Disease; Cardiomyopathy, Hypertrophic; Angina, Unstable; Infarction
Study type: Observational

Summary: 
      This study will examine the relationship between certain measures of heart function and
      exercise capacity in patients with hypertrophic cardiomyopathy (HCM).

      Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study
      of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic
      Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144
      ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme
      Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced
      Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from
      echocardiograms and measures of left ventricular pressure obtained from patients in those
      studies will be analyzed in the current study to assess their influence on exercise capacity.
      No additional tests, treatments or other procedures are required.

      Information from this study may help in the development of improved drug treatments for HCM.
    

Detailed description: 
      NIH Protocols 01-H-0066, Double Blind Placebo Controlled Study of Pirfenidone A Novel
      Anti-Fibrotic Drug in Symptomatic patients with Hypertrophic Cardiomyopathy (HCM) Associated
      with left Ventricular Diastolic Dysfunction and 96-H-0144, Double Blind Placebo-Controlled
      Study of Long-Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and
      Angiotensin II Receptor Blockade (Losartan) On Genetically-Induced Left Ventricular Diastolic
      Dysfunction were undertaken to assess the effect of therapeutic interventions on left
      ventricular (LV) diastolic function. The relationship between baseline measures of diastolic
      function as assessed by noninvasive modalities such as Doppler echocardiography and
      radionuclide angiography, and qualitative and objective measures of functional capacity in
      patients without LV outflow tract obstruction has not been reported. In this protocol we will
      look at measures of LV geometry, relaxation and novel indices of ventricular compliance as
      they may influence measures of exercise capacity. In all cases, we will use pre-existing
      baseline data obtained with informed consent as part of the above protocols.
    

Keywords: HCM; Echocardiography; Diastolic Dysfunction; Enalapril
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Socio-communicative impairments are core deficits in individuals with autism spectrum
      disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial
      expressions, body language, and different tones of voice when communicating with others. They
      can't interpret the thoughts and feelings of others, or predict social events, and the
      impaired social skills may lead to rejection of peers and poor participation in school.

      Social skills training targets the core symptoms of ASD. Empirical support is building for
      cognitive-behavioral intervention approach, social skills training group for verbally fluent,
      school-aged children with ASD. Several studies have shown the efficacy of the social story
      intervention. It is usually provided individually, but we want to use it in the group.
    

Detailed description: 
      Many different intervention program have been used throughout the world. One alternative
      method used to teach children is the social stories method, which was created by Gray (1993)
      to address the social difficulties of children with ASD. The theoretical framework of the
      social stories is based on theory of mind (TOM) hypothesis. Difficulties associated with the
      impaired TOM was addressed by explaining the complex social concepts in simple words and
      often include the description of perspectives of others. Several studies have shown the
      efficacy of the social story intervention. It is usually provided individually, but we want
      to use it in the group.

      In this study, we plan to randomly assign thirty-six 5-7-year-old children with ASD to one of
      two kinds of social skills groups: the social skills group or the play activities group
      (control condition). Group met for 16 weeks, one time per week, one hour each time.
      Participants were recruited between October 2020 and September 2023. Assessment were
      conducted at baseline and endpoint (16 weeks). To empower parents, we would also ask parents
      of participants to attend our treatment and lecture.
    

Intervention name(s): social skill group
Intervention type(s): Behavioral
Intervention description(s): We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Autism,autism spectrum disorder,social skill training
Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)
Condition: Acute Ischemic Stroke; Acupuncture
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      This study will have acupuncture intervention in acute ischemic stroke patients and evaluate
      the effect in neurological function improving by National Institutes of Health Stroke Scale
      (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by
      biomarkers.
    

Detailed description: 
      Acupuncture Treatment in Stroke is a widely practiced in Taiwan, mainland China, and around
      the world. The using in stroke group is countless. Numerous clinical trials have been
      conducted in the medical community to assess efficacy, and the results mostly suggest that
      acupuncture may be an effective, low side effects adjuvant therapy. Ischemic stroke is also
      associated with chronic inflammation-related diseases. In recent years, the anti-inflammatory
      effect of acupuncture was gradually found. So, whether in the basic or in clinical, the
      investigators can deduce that acupuncture may be helpful for stroke as an adjuvant therapy.

      This study evaluates the neurological function of patients with acute stroke by using the
      widely used National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS)
      and Barthel Index. Also, the investigators assess the degree of inflammation by biomarkers.
      Therefore, the purpose of this study is to explore the effect of acupuncture intervention on
      acute ischemic patients and its relationship in anti-inflammatory actions.
    

Intervention name(s): Traditional Acupuncture; Minimal Acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient; non-traditional acupoints in scalp and limbs, with minimal manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Acupuncture; antiinflammatory; NIHSS
Postprandial Inflammation in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid; Inflammatory Response; Dietary Exposure; Diet, Healthy
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional

Summary: 
      Patients with RA will be studied to see whether meals of different content will affect
      inflammation and metabolic variables in the postprandial state. Healthy controls will also be
      invited to examine potentially different responses to patients with RA.
    

Detailed description: 
      The PIRA study aims to evaluate the metabolic and inflammatory effects after a vegan meal or
      a meal containing red meat or fish in patients with RA and matched controls. The study have a
      cross-over design and each participant will have one of three meals every week and then be
      compared to themselves. In addition healthy individuals will be included for the red meat
      meal so that the response from this meal could be compared between patients with RA and their
      matched controls. Blood samples will be collected before the meal (fasting) and every hour
      until 5h. Primary outcome will be high sensitive IL-6. Secondary outcomes will be additional
      inflammation markers such as area under curve for hs-CRP and gene expression in PBMC:s
      regarding genes related to inflammation and, glucose, blood lipids and metabolomics-profile
      in serum and urine.
    

Intervention name(s): Meal based on red meat, fish products or vegan products; Meal based on red meat
Intervention type(s): Other; Other
Intervention description(s): Three meals will be served; Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: postprandial; inflammation; rheumatoid arthritis; RA; diet; PIRA
Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      In both parts, the primary comparisons of interest are between the percentage of patients
      with drug-related adverse events at each dose and placebo during single and multiple dosing
      regimens. Based on these, the primary trial objective is to assess safety and tolerability of
      BI 894416 at each dose.

      Secondary measures of interest are the geometric means of BI 894416 plasma AUC0-∞ and Cmax
      after single dose in SRD part and AUC0-8 and Cmax after single dose as well as AUCτ,ss and
      Cmax,ss after 7 days multiple dosing in MRD part. The objective is to assess the
      pharmacokinetics of BI 894416 following single and multiple administration.
    


Intervention name(s): BI 894416; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 894416 film-coated tablet.; Placebo film-coated tablet matching BI 894416.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will provide information regarding the metabolic pathway of GBT440, the need for
      evaluation of potential drug-drug interactions, and the need for studies in special
      populations. The administration of radiolabeled drug is necessary to fully characterize the
      rates and routes of elimination of GBT440, providing further quantitative information on the
      disposition of GBT440. The results from this study will permit a comprehensive comparison
      between animal and human routes of elimination and metabolic profiles of GBT440.
    


Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): GBT440 capsules followed by single dose of [C14] GBT440 oral suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in
      patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2
      overexpressing tumors and are refractory to treatment with anthracycline, taxanes and
      trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with
      the data from EGF100642 and integrated analysis will be carried out in order to enhance the
      credibility of the study results.
    


Intervention name(s): lapatinib
Intervention type(s): Drug
Intervention description(s): Lapatinib 1500mg QD
Intervention MeSH terms: Lapatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage IV breast cancer; Herceptin; metastatic breast cancer; ErbB1; ErbB2; trastuzumab; lapatinib
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after
      single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment
      as well as healthy volunteers under the same setting.
    


Intervention name(s): CH6001
Intervention type(s): Drug
Intervention description(s): CHF6001 will be administered using the NEXThaler® DPI device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal impairment
Assessment of Surgically Removed Abdominal Wall Endometriomas
Condition: Endometriosis Outside Pelvis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      A retrospective review of all patients who underwent surgery for an anterior abdominal wall
      mass which confirmed by pathology examination as an endometrioma will be completely
      performed. The clinical data will be recorded and pathology report diagnosis will be
      correlated with the clinical data to assess the possible causes of endometrioma in the women
      treated in our tertiary hospital and the efficacy of the surgical excision.
    

Detailed description: 
      Our hospital is a tertiary center for performing Cesarean sections, external endometriosis
      (Endometrioma) is a challenging complication for this operation, many treatment choices are
      available and the most common is the surgical excision, however recurrence could be seen
      after the surgical operation. We assess all patients who underwent surgical excision for
      abdominal wall endometriomas in our hospital by retrieving the medical files and pathology
      reports to study the possible age group,causes and duration of endometriomas. Also the rate
      of enodmetriomas among the previously experienced females with cesarean section operations.
      Pathological diagnosis tools will be also assessed.

      Ethical approval was obtained from the local committee. Results will be statistically
      assessed using SPSS programm.
    

Intervention name(s): Microscopic examination using H&E stained slides
Intervention type(s): Other
Intervention description(s): Reexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required
Other intervention name(s): CD10 immunohistochemistry
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients treated in our hospital and pathologically examined in our hospital
Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy
Condition: HCM - Hypertrophic Non-Obstructive Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the efficacy of ranolazine in improving coronary microvascular and diastolic
      dysfunction in patients affected by HCM evaluating changes in maximum (i.e. during
      dipyridamole-induced coronary vasodilatation) myocardial blood flow (MBF) measured by PET at
      baseline and after 4 months of treatment with ranolazine in patients with non obstructive
      HCM.
    

Detailed description: 
      This pilot study aimed at assessing the effects of treatment with ranolazine, on top of
      optimal standard medical therapy (according to international guidelines), on microvascular
      dysfunction using PET in patients with HCM.

      Thirty months of enrolment are foreseen. Patients enrolled in the study, at the end of the
      titration phase will be treated with ranolazine 750 mg or 500 mg, 1 oral tablet twice a day
      for 4 months on top of standard of care treatment. Visit 0,1,2,3 may be performed 3 days
      before or 3 days after the planned date. Visit 4 and final PET scan may be performed 15 days
      before or 15 days after the planned date.

      This is a superiority study. The sample size calculation is based on the ANOVA model, but the
      statistical analysis will be performed applying the ANCOVA model for the absence of data on
      the correlation between basal and end of study values of the primary variable studied. As
      previously reported (Camici et al. J Am Coll Cardiol 1991; 17:879-86) maximum (i.e. during
      dipyridamole stress) MBF is severely blunted in HCM (1.63±0.58 mL/min/g) compared to control
      subjects (2.99±1.06 mL/min/g). For the primary end-point of the study using a two-sided test
      at 5% significance level, with a power of 90% and a SD of ± 0.7 mL/min/gr, in order to detect
      a change of 0.5 mL/min/gr in maximum MBF before and after treatment, 24 patients valid per
      protocol are required.
    

Intervention name(s): Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die
Intervention type(s): Drug
Intervention description(s): Patients enrolled in the study, at the end of the titration phase will be treated with ranolazine 750 mg or 500 mg, 1 oral tablet twice a day for 4 months on top of standard of care treatment
Other intervention name(s): Ranexa
Intervention MeSH terms: Ranolazine
Intervention model: Single Group Assignment
Intervention model description: A pilot study, one center, open, non-controlled, one group pre-post treatment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of activated charcoal and dosing time on
      the absorption of LY2624803 in healthy subjects. In this crossover study, there are three
      treatments with a washout period of at least 7 days in between treatments. Each subject will
      participate in all three treatments with random assignment to the treatment sequence.
    


Intervention name(s): LY2624803; Activated Charcoal
Intervention type(s): Drug; Other
Intervention description(s): Administered orally (po), once.; Administered po
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
Condition: Bipolar I Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms
      of bipolar I depression and to make sure it is safe in humans.
    


Intervention name(s): RG2417; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1g bid dose escalates to 2g bid for weeks 2-8.; Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
Other intervention name(s): Uridine; Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Depression; Bipolar Disease; Bipolar Disorder; Bipolar; Manic Depression; Manic Depressive Disorder
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate
      cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering
      therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
    

Detailed description: 
      It was already demonstrated by previous clinical trials that statins lower the incidence of
      death and cardiovascular events in patients with coronary artery disease. However, whether
      aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than
      moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients
      with coronary artery disease has not been studied in Japan.
    

Intervention name(s): Pitavastatin 1 mg daily or 4 mg daily
Intervention type(s): Drug
Intervention description(s): Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.
Other intervention name(s): LIVALO Tablet
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pitavastatin; Coronary Artery Disease; Cardiovascular Disease
A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Data suggests that imaging activity of the brain can measure the effects of anti-anxiety
      drugs. This study will investigate the effect of GW876008 on areas of the brain involved with
      thinking and emotion
    


Intervention name(s): placebo; lorazepam; GW876008
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): placebo; lorazepam
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Brain imaging,; fMRI,; stimulation,; pharmacodynamics,; tolerability,; healthy subjects