bioihbjkbjnl/mcl2 huggingface dataset:
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Condition: Antithrombin III Deficiency
MeSH terms: Antithrombin III Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis
      and pulmonary embolism, particularly during certain high risk procedures. The trial focused
      on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical
      procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study
      assessed the incidence of thromboembolic events following prophylactic intravenous
      administration of recombinant human antithrombin (rhAT) to patients with hereditary
      antithrombin (AT) deficiency in situations usually associated with a high risk for
      thromboembolic events.
    

Detailed description: 
      GTC Biotherapeutics established clinical trial sites in Europe, Canada, Australia, Austria
      and Canada. GTC Biotherapeutics provided an international clinical team to support site
      registration requirements once a patient was identified for treatment. GTC Biotherapeutics
      also provided consultation to help evaluate patient eligibility.

      In September 2006, GTC Biotherapeutics modified exclusion criteria 1 (below) to allow for the
      participation of previously excluded patients with the hereditary thrombophilic disorders
      Factor V Leiden and prothrombin gene mutation (G20210A).
    

Intervention name(s): Recombinant human antithrombin (rhAT)
Intervention type(s): Biological
Intervention description(s): Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
Other intervention name(s): Recombinant human antithrombin (Tradename: ATryn)
Intervention MeSH terms: Antithrombins; Antithrombin III
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antithrombin Deficiency, Congenital or Hereditary; Antithrombin III Deficiency; ATIII; Hereditary Antithrombin Deficiency (HD)
The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes
Condition: Pregnancy; Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Aim

        -  Evaluate whether human embryo exposure to physiologic levels of oxygen during culture
           improves the percentage of women who deliver a baby following in vitro fertilization and
           embryo transfer.

      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates
      the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In
      Vitro Fertilization Embryo Transfer (IVF-ET).

      Secondary Aims

      Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during
      in vitro fertilization and embryo transfer

        -  improves embryo cleavage

        -  improves clinical pregnancy rate

        -  reduces multiple pregnancy rate

        -  reduces miscarriage rate

      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates
      the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical
      pregnancy rates and reduces miscarriage rates in clinical IVF-ET.
    

Detailed description: 
      Study Design

      This will be a multi-center, prospective, double-blind clinical trial of physiologic (5%)
      oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension
      with 840 eligible couples recruited to participate. The randomization scheme will be
      coordinated through the central data coordinating center (DCC-Yale) and the randomization
      will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each
      participating site.

      Treatment

      Couples will be randomized to either have their gametes and embryos placed in a physiologic
      (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.
    

Intervention name(s): Atmospheric oxygen tension; Physiologic oxygen tension
Intervention type(s): Procedure; Procedure
Intervention description(s): Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere; Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Infertility; Physiologic Oxygen Tension; Atmospheric Oxygen Tension
Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to assess long term (1 year) respiratory sequelae in children
      surviving an acute respiratory distress syndrome
    

Detailed description: 
      The acute respiratory distress syndrome (ARDS) has a high mortality rate in children. Adverse
      long term sequelae, and in particular respiratory sequelae, have been described mainly in
      adults. Decrease in diffusing capacity, lung volume and exercise tolerance were observed.
      Lung function parameters improve during the follow-up until 6 month after discharge from the
      pediatric intensive care unit (PICU). After that, abnormalities in PFT are observed in a
      significant proportion of patients. Only two studies described long-term sequelae in children
      surviving to an ARDS and their results are conflicting. Two studies carried out in adults
      described the morphologic long-term sequelae by thoracic computed tomography. They showed
      reticular pattern with a striking anterior distribution in most patients evaluated more than
      6 months after discharge from the PICU. There is, to our knowledge, no study describing
      morphologic pulmonary sequelae by thoracic computed tomography in children surviving to ARDS.

      Respiratory assessment: respiratory sequelae in children surviving to the acute respiratory
      distress syndrome will be evaluated 1 year after discharge from the PICU. Assessment will
      include a clinical evaluation (respiratory history and physical examination), respiratory
      function tests and thoracic computed tomography
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children hospitalised in PICU with ARDS and surviving 1 year after the acute phase
      
Keywords: Acute respiratory distress syndrome; Children; Long term respiratory sequelae; Pulmonary function tests; Computed tomography, lung
Endomicroscopy for Assessment of Mucosal Healing
Condition: Crohn´s Disease; Ulcerative Colitis
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,
      Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and
      histologic features including patterns of inflammation, crypt abscesses and granulomas.
      Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for
      gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy"
      of the gastrointestinal mucosa during the endoscopic procedure.

      The main objective of this study is to determine endomicroscopic features of mucosal healing
      in patients with IBD.
    


Intervention name(s): Endomicroscopy
Intervention type(s): Device
Intervention description(s): Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of
        the disease.
Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
Condition: Child Abuse; Child Neglect; Victimization
Study type: Interventional

Summary: 
      Adolescents who have experienced adversity (childhood maltreatment and other forms of broader
      victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias
      modification training (with attention and interpretation bias modification modules) or a
      control condition. Outcome measures include measures of cognitive biases and symptoms of
      psychopathology; in addition, in a subset of adolescents, brain activity data will be
      acquired. All adolescents will complete a feedback form, upon which acceptability of the
      intervention will be assessed.
    

Detailed description: 
      Up to 80 adolescents aged 12-18 years who have experienced adversity (childhood maltreatment
      and other forms of broader victimisation experiences) from India and Nepal will be randomly
      allocated to receive a 5-session cognitive bias modification training (with attention and
      interpretation bias modification modules) or a control condition over a 2-week period.

      Pre and post-assessment measures include measures of attention and interpretation biases and
      symptoms of internalising and externalising psychopathology. In addition, in a subset of
      adolescents, brain activity data acquired using EEG will be acquired either during resting or
      viewing emotional face stimuli. Data from these measures will be used to generate effect
      sizes of changes for each group as well as being used in a limited number of
      significance-testing analysis. All adolescents will complete a feedback form, upon which
      acceptability of the intervention will be assessed.
    

Intervention name(s): Cognitive bias modification training; Control training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): These training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways; These exercises are matched to the task demands of the modules of cognitive bias modification training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effects of High Dose Calcitriol in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This research will examine the effectiveness of calcitriol in treating bone loss in women who
      are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to
      take part in this study. The investigators don't know if bone loss in breast cancer survivors
      should be treated differently than bone loss in other women.
    

Detailed description: 
      The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone
      density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among
      the general population, but little research has been done on breast cancer patients. In
      addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis, while
      increasing tumor apoptosis. Each of those factors could have beneficial effects on breast
      cancer outcomes.
    

Intervention name(s): Calcitriol
Intervention type(s): Drug
Intervention description(s): In pill form, 45 micrograms once a week for 12 weeks
Other intervention name(s): Rocatrol
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Interventional
Phase: Phase 2

Summary: 
      STEMI is a serious type of coronary heart disease, which is a major cause of disability and
      death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss
      from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast
      proliferation leading to myocardial fibrosis .

      Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating
      inflammation and oxidative processes.

      Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation
      of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids
      but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate
      ventricular remodeling, and protect the myocardium
    

Detailed description: 
      1. Ethical committee approval will be obtained from Ethics committee of Faculty of
           Pharmacy, Damanhour University.

        2. All participants should agree to take part in this clinical study and will provide
           informed consent.

        3. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital.

        4. Serum samples will be collected from patients at the time of admission for measuring the
           biomarkers.

        5. Echocardiogram also will be obtained at the time of admission.

        6. All enrolled patients will be divided into two group to receive either Atorvastatin
           (40-80 mg) or Rosuvastatin (20-40mg).

        7. All patients will be followed up during 3 months' period. At the end of 3 months, Serum
           samples will be collected from patients for measuring the biomarkers and Echocardiogram
           will be repeated.

        8. Statistical tests appropriate to the study design will be conducted to evaluate the
           significance of the results.

        9. Results, conclusion, discussion, and recommendations will be given.
    

Intervention name(s): Rosuvastatin 20 mg ,40 mg; Atorvastatin 40mg,80mg
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive one tablet rosuvastatin 20-40 mg every night; patients will receive one tablet Atorvastatin 20-40 mg every night
Other intervention name(s): cholerose; ator
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Statin; remodeling; STEMI
Evolution of Pulmonary Capillary Blood Volume
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Observational

Summary: 
      The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary
      capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide
      (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant
      therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea
      and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic
      (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung
      scan data.
    


Intervention name(s): diffusion NO/CO method
Intervention type(s): Other
Intervention description(s): pulmonary capillary blood volume (Vc), measured by the double diffusion NO/CO method: this method is to inhale during a deep inspiration with a mixture of helium (8-10%), CO (2000 ppm) and NO (20-40 ppm), the O2 (21%)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with a first episode of symptomatic pulmonary embolism
      
Keywords: pulmonary embolism; pulmonary capillary blood volume; double diffusion NO/CO method
Specific Effect of Foot Reflexology on Diaphragm Function
Condition: Musculoskeletal Manipulations
Study type: Interventional

Summary: 
      Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to
      explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators
      proposed a comparison of the evolution of different parameters, quantitative and qualitative,
      to identify biomarkers and highlight the specific effect of RP on the diaphragm function,
      compared to placebo.
    

Detailed description: 
      Many complex, chronic and multifactorial dysfunctions, such as diaphragm dysfunction, are
      refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic
      paths, such as plantar reflexology (RP). This change is essential and will broaden relevant
      solutions to health.

      Despite the very positive benefits of RP highlighted, the methodological quality of trials
      are often poor and there are gaps notably on the description of the intervention, the blind,
      the drop-out rate ... which prevents the meta-analyzes to conclude. Promoting rigorous
      research will play an essential role in the transition to personalized and integrative
      medicine. With the intention of specifying the methods of application and the indications of
      the PR, it is necessary to correctly evaluate and be able to cross-check the different
      information It therefore seems relevant to combine research on the objective physiological
      effects in correlation with the patient's subjective feelings to initiate the scientific
      validation of RP and thus non-drug interventions as recommended by the High Authority for
      Health (HAS). The hypothesis is that through a comparison of the evolution of different
      parameters, quantitative and qualitative, this study will allow to identify biomarkers and
      highlight the specific effect of RP on the diaphragm function, compared to placebo.
    

Intervention name(s): reflexology massage; sham massage
Intervention type(s): Other; Other
Intervention description(s): reflexology massage of the foot zone implicated in diaphragm stimulation; traditional massage of the foot
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: monocentric, interventional, comparative, randomized cross-over study in healthy individuals, with minimal risk and constraints
Masking: Single (Participant)
Primary purpose: Other
Keywords: diaphragm dysfunction; reflexology
Impact of Bariatric Surgery on Women Fertility
Condition: Fertility Issues
MeSH terms: Infertility
Study type: Observational

Summary: 
      Obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal
      change induced by adipose tissue. This prospective cohort study aims to evaluate the impact
      of bariatric surgery induced weight loss on women fertility.
    

Detailed description: 
      Females undergoing sleeve gastrectomy will be assessed for improvement of fertility
      indicators
    

Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Bariatric surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese females undergoing sleeve gastrectomy
The Hormonal and Behavioral Impact of Eating Breakfast
Condition: Eating Behavior
Study type: Observational

Summary: 
      This study is exploring the relationship between food intake behavior and the
      hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who
      regularly eat breakfast.
    

Detailed description: 
      Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal
      and behavioral factors associated with breakfast skipping.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast
        regularly or skipping breakfast regularly.
      
Biospecimen description: 
      Serum and saliva samples will be retained.
    
Keywords: Food intake; Breakfast eating
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Condition: Hormone Receptor Positive Malignant Neoplasm of Breast
MeSH terms: Neoplasms; Breast Neoplasms; Recurrence
Study type: Observational

Summary: 
      This is a prospective study that will assess the impact of MammaPrint on chemotherapy +
      endocrine versus endocrine alone treatment decisions in patients with an Oncotype
      Intermediate Score.
    

Detailed description: 
      The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX
      intermediate score patients will be calculated before and after receiving the MammaPrint
      result.
    

Intervention name(s): MammaPrint
Intervention type(s): Device
Intervention description(s): All subjects
Other intervention name(s): 70 gene profile
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with an Intermediate Recurrence Score
      
Biospecimen description: 
      Patients have the option to agree to the storage of excess samples at Agendia.
Incretin Regulation of Insulin Secretion in Monogenic Diabetes
Condition: Monogenic Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the mechanisms of metabolic control in monogenic
      diabetes patients treated with sulfonylurea medications.
    

Detailed description: 
      Monogenic diabetes patients and healthy matched controls will be admitted to the University
      of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on
      separate days:

        1. Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be
           collected at multiple time points

        2. Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm
           and and blood samples will be collected at multiple time points

        3. OGTT during GLP-1 infusion

        4. IGI during Exendin-9 infusion
    

Intervention name(s): GLP-1; Exendin 9-39
Intervention type(s): Drug; Drug
Intervention description(s): OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion; OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Other intervention name(s): Glucagon-like peptide-1 (GLP-1); Glucagon-Like Peptide 1 (GLP-1) receptor antagonist
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science