bioihbjkbjnl/mcl2 huggingface dataset:
Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension
Condition: Pulmonary Arterial Hypertension (PAH)
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional

Summary: 
      The goals of this study were two-fold. First, the attempt to quantify the relationships
      between pulmonary arterial stiffness, right ventricular function and the efficiency of
      ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH).
      Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness,
      pulmonary vascular resistance, right ventricular function and the efficiency of
      ventricular-vascular interactions in patients with PAH.
    

Detailed description: 
      The goals of this study are to quantify right ventricular-pulmonary vascular interactions in
      different types of PAH, to determine the temporal changes in these interactions with PAH
      progression and to quantify the effects of exercise on right ventricular function. The
      inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of
      the anticipation that this group has worse arterial stiffening than other groups, and
      consequently more inefficient right ventricular-pulmonary vascular interactions, which
      account for their worse prognosis.
    

Intervention name(s): Magnetic Resonance Imaging (MRI) with exercise
Intervention type(s): Device
Intervention description(s): MRI scan with a novel exercise device.
Other intervention name(s): MRI
Intervention model: Single Group Assignment
Intervention model description: Single center, open label, single-arm
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days),
      three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and
      safety of two dose levels of a dual pharmacology molecule with the combined properties of a
      long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115)
      delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    


Intervention name(s): AZD2115 Dose 1; AZD 2115, Dose 2; Placebo MDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD 2115, Dose 1 administered as two inhalations BID; AZD 2115, Dose 2 administered as two inhalations BID; Placebo MDI administered as two inhalations BID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Empowered With Movement to Prevent Obesity and Weight Regain
Condition: Obesity; Weight Loss; Sedentary Lifestyle
MeSH terms: Obesity; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study will help determine the appropriate type, amount and intensity of physical
      activity most beneficial for preventing weight regain after weight loss in older adults.
    

Detailed description: 
      The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45
      kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL)
      intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month
      self-managed follow-up phase with minimal contact, to test our overall hypothesis that
      intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age
      group. The diet element of the intervention is identical across groups, but groups differ by
      activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2)
      intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).
    

Intervention name(s): Weight loss; Exercise; Sitless
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.; Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.; Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
Other intervention name(s): WL; EX; SL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Antihypertensives in Non-cardiac Surgical Population
Condition: Perioperative Antihypertensive
Study type: Observational

Summary: 
      A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to
      investigate current status of antihypertensive drug treatment in non-cardiac surgical
      population.
    

Detailed description: 
      Perioperative changes in blood pressure (BP) are associated with perioperative risks.
      However, there is little information regarding the current status of antihypertensive
      treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged
      between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to
      investigate the application of antihypertensive drugs, systemic involvement, perioperative
      hemodynamics and internal environment to grasp the perioperative impact of different
      antihypertensive drugs, and to further provide a reference for the preoperative
      antihypertensive strategy of surgery patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing elective non-cardiac surgery in Renji hospital
Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients
Condition: Healthy, no Evidence of Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial is studying the side effects and best dose of
      Se-methyl-seleno-L-cysteine in healthy adult men. Studying samples of blood, urine, and
      toenail clippings in the laboratory from healthy men receiving Se-methyl-seleno-L-cysteine
      may help doctors learn more about how Se-methyl-seleno-L-cysteine works in the body.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.

      SECONDARY OBJECTIVES:

      I. To characterize the pharmacokinetics of single oral doses of MSC in healthy adult male
      volunteers.

      II. To evaluate the baseline selenium content of toenail clippings in healthy adult males.

      OUTLINE: This is a multicenter, randomized, placebo controlled, double blind, dose escalation
      study. Participants are randomized to 1 of 2 arms.

      Arm I: Participants receive oral placebo on day 1.

      Arm II: Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5
      participants receive escalating doses of MSC until the maximum tolerated dose (MTD) is
      determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients
      experience dose-limiting toxicity.

      Participants undergo blood, urine, and toenail clipping collection for pharmacokinetic and
      correlative studies. Samples are analyzed for plasma protein levels of selenium for proteomic
      and gene expression, molecular fingerprinting by mass spectrometry, and RNA by gene array
      analysis.

      After completion of study treatment, participants are followed at 7-14 days and at 30 days.
    

Intervention name(s): Se-methyl-seleno-L-cysteine; placebo; pharmacological study; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given orally; Given orally; Correlative studies; Correlative studies
Other intervention name(s): methylselenocysteine; MSC; PLCB; pharmacological studies
Intervention MeSH terms: Selenomethylselenocysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
    

Detailed description: 
      This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the
      efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate
      to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be
      stratified at screening. Approximately 100 subjects are planned to be randomized at
      approximately 35 sites in 6 countries
    

Intervention name(s): MEDI9929; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.; Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema
Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting
Condition: Menopause
Study type: Interventional

Summary: 
      The aim of the study is to investigate if group education about the topic menopause to women
      in PHC can improve women's menopausal symptoms and reduce depression.
    

Detailed description: 
      One hundred twenty women will be included in the study. The survey population consists of
      Swedish-speaking women aged 45-55 years and seek care at Distriktsköterskemottagningen in
      Skene and at the Antenatal clinic in Svenljunga. The selection is done consecutively.

      Method:

      Grouping:The women will be randomly allocated to intervention group and control group
      (60/60).

      The intervention:

      The project includes the implementation of a total of four equivalent group treatments. Two
      of the group education will be at Skene Medical center and two Svenljunga Medical center.
      Group treatments are carried out by the district nurse and midwife in common. Each treatment
      group includes 15 women. A total of 60 women will thus participate in group education..Each
      treatment group consists of two information sessions of 2 hours.

      The first information contains information about the menstrual cycle, hormonal shift,
      urogenital symptoms, and information on prevention and health promotion self-care.

      The other information currently contains information about cardiovascular risk factors during
      menopause, relations, mental health, information about depressive symptoms and for preventive
      measures and health-promoting self-care.

      The control group did not obtain any group education or any other intervention.
    

Intervention name(s): Group education
Intervention type(s): Other
Intervention description(s): Intervention involving two education session with topics common in menopause transition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Climacteric; Education; Mental health; Menopause
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if a higher dose of study drug is more effective in
      preventing relapses in patients with Multiple Sclerosis.
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
      HealthCare Pharmaceuticals, Inc.

      Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
    

Intervention name(s): Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 250 mcg administered s.c.(subcutaneous) every other day; 250 mcg administered s.c. every other day (for patients having received 500 mcg before); 500 mcg administered s.c. every other day; 500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Other intervention name(s): Betaferon; Betaferon; Betaferon; Betaferon
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron
Kinetics of Surfactant Proteins, Phosphatidylcholine and Body Water in Intensive Care Unit (ICU)
Condition: ARDS; Sepsis Syndrome
MeSH terms: Toxemia; Sepsis; Syndrome; Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      Analysis of kinetics of phosphatidylcholine and specific surfactant proteins, total body
      water and water turnover in patients with acute respiratory distress syndrome (ARDS) and in
      intensive care unit (ICU) patients by using non radioactive isotopes as deuterium and
      Carbon-13.
    

Detailed description: 
      Patients with adult respiratory distress syndrome (ARDS) have low concentrations of
      disaturated-phosphatidylcholine and surfactant protein-B and C in bronchoalveolar lavage
      fluid and altered fluid metabolism.

      Injection of stable isotopes such as 13 Carbon Leucine and deuterated water allows the
      analysis of disaturated-phosphatidylcholine and surfactant protein-B and C kinetics, total
      body water and water turnover in patients with ARDS and in human adults with normal lungs
      (controls).
    

Intervention name(s): Injection of 1-13 Carbon Leucine and deuterated water
Intervention type(s): Drug
Intervention description(s): All patients received a constant intravenous infusion of 1 g 1-13 Carbon Leucine (Cambridge Isotope Laboratories, Andover, MA) dissolved in saline for 24 h. Deuterated water (Cambridge Isotope Laboratories, Andover, MA) was administered as a 25 ml bolus at the study start and then, every 12 hours over the next 36 hours, as intermittent boluses corresponding to 0.0625% of fluid intake, to maintain steady state of deuterium enrichment in body water
Other intervention name(s): Isotopes came from Cambridge Isotope Laboratories, MA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children
Condition: Epistaxis; Intubation
MeSH terms: Epistaxis
Study type: Interventional

Summary: 
      Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It
      allows the surgeon easier access to the surgical site than the orthotracheal intubation.
      Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and
      maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the
      nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which
      is reported as the most common side effect.

      In order to reduce these side effects, heating of the tube and use of a tube lubricant
      immediately before intubation have been recommended in children. However, research on whether
      the dry state of the mucosa itself contributes to the development of epistaxis is limited. A
      study in adults reported that pretreatment of the ointment on the mucosa reduced the damage
      to the mucosa. However, its effect on the incidence of epistaxis in children has not been
      studied.

      The purpose of this study is to investigate the effects of pretreatment of nasal ointment on
      epistaxis of nasotracheal intubation in children.
    


Intervention name(s): tarivid ointment
Intervention type(s): Drug
Intervention description(s): Vaseline ointment is applied to both noses.
Intervention MeSH terms: Ofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Assessment of TMAO Formation With Egg Intake Versus Choline Supplement in a Healthy Population
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The objective of this study is to determine the effects of consuming either 3 eggs per day as
      compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma
      concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide
      (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals.
      The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a
      different TMAO response when compared to choline in free supplemental form.
    

Detailed description: 
      Epidemiological data in short term studies, suggests that egg intake does not increase risk
      for cardiovascular disease (CVD). In fact, eggs are a great source of phospholipids
      (phosphatidylcholine) where choline has many metabolic roles, specially in lipid metabolism
      and cell membrane structure. Choline is present in the diet as free choline, which is
      absorbed in the small intestines, or choline esters, which is absorbed intact primarily
      through the lymphatic system. In addition, recent evidence suggests that the choline found in
      eggs may be metabolized by intestinal microbes into trimethylamine N-oxide (TMAO), a compound
      that may increase the risk for CVD. However, it is not known to what extent egg intake may
      contribute to plasma TMAO concentrations.

      Therefore, the objective of this study is to determine the impacts of daily intake of 3 eggs
      versus a choline supplement on plasma TMAO as well as other biomarkers for CVD risk, with the
      goal of determining if the same amount of choline given as phosphatidylcholine from eggs will
      increase plasma choline levels without a concomitant increase in plasma TMAO, such that CVD
      risk is not negatively impacted.
    

Intervention name(s): Eggs; Choline Supplement
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Consumption of 3 eggs per day for breakfast, 4 weeks; Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone
Condition: Acromegaly
MeSH terms: Acromegaly; Pituitary Diseases
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the interest of a six month pre-operative treatment with
      a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a
      pituitary adenoma responsible for acromegaly.
    

Detailed description: 
      Somatotroph pituitary adenoma is the most frequent cause of acromegaly. A transsphenoidal
      removal of the tumor is used as the first line treatment. Somatostatin analogs are used as to
      whether recovery was not obtained after surgery or pituitary surgery was contraindicated.
      Previous studies with somatostatin analogs have shown a drop in plasma GH and IGF-1 levels
      and a reduction in adenoma size in 75 and 25% of patients respectively. Retrospective studies
      suggest that a treatment with somatostatin analogs performed before surgery may be of
      interest to improve anesthesic conditions and surgical outcome. The aim of present study is
      to prospectively evaluate the interest of a first line treatment with a long-acting
      somatostatin analog (Sandostatin) before performing a pituitary surgery in acromegalic
      patients with either a micro or a macroadenoma to improve peri-operative conditions and
      hopefully surgical outcome. After informed consent, untreated acromegalic patients will be
      included and randomly assigned to one of the following treatment procedures : either
      pituitary surgery or a six month treatment with long-acting Sandostatin 30 mg monthly for 6
      months before performing transsphenoïdal adenoma removal. The patients will be evaluated
      before any treatment, on months 3 and 6 of the treatment with Sandostatin (for the patients
      enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. Each
      evaluation will include clinical data, hormone testing and radiological (MRI) investigation.
      The main endpoint will be the rate of recovery proved by a normalisation of GH secretion and
      plasma IGF-1 level. Secondary endpoints will include the evaluation of clinical,
      radiological, biological, anesthesic, surgical and pathological parameters. A comparison
      between the two arms will be performed at entry into the study, at the time of surgery and
      then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.
    

Intervention name(s): Pre-treatment with octreotide
Intervention type(s): Drug
Intervention description(s): Pre-treatment with octreotide
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Acromegaly; pituitary adenoma; octreotide; transsphenoïdal surgery; GH; IGF-1