bioihbjkbjnl/mcl2 huggingface dataset:
Rosuvastatin in Visceral Adiposity
Condition: Abdominal Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether 6 months treatment with the
      cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged
      men.
    

Detailed description: 
      The accumulation of intra-abdominal fat has been suggested to be of primary importance in the
      development of the metabolic syndrome and associated metabolic disturbances and it has been
      hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of
      the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce
      coronary artery disease (CAD) events. Although it is widely accepted that the majority of
      benefit obtained with statins is a direct result of their lipid-lowering properties, they
      also demonstrate additional cholesterol-independent or pleiotropic effects. The results of
      experimental studies have now shown that statins decrease fat mass in the visceral region in
      an animal model. In the present study, we will investigate whether statins can decrease
      visceral obesity in humans.
    

Intervention name(s): Rosuvastatin; Placebo for rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg once daily; once daily
Other intervention name(s): Crestor®
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Kinetics of Blood Platelets Transfused to Healthy Subjects
Condition: Fetal and Neonatal Alloimmune Thrombocytopenia
MeSH terms: Thrombocytopenia; Thrombocytopenia, Neonatal Alloimmune
Study type: Interventional

Summary: 
      The current phase 0 trial is preceding the phase 1/2 trial of a newly developed drug,
      NAITgam, for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) - a
      rare, but potentially very severe bleeding condition in the fetus or newborn. FNAIT may occur
      in women whose blood platelets do not express HPA-1a. If the fetus has inherited HPA-1a from
      the father, the mother's immune system may be stimulated to produce HPA-1a antibodies if
      HPA-1a positive fetal blood platelets enter the maternal circulation during delivery. In a
      subsequent pregnancy, such antibodies will cross the placenta and may reduce the number of
      HPA-1a positive blood platelets in the fetus, which in turn may result in severe bleeding in
      the fetus or newborn.

      The phase 1/2 study of NAITgam will examine NAITgam's ability to eliminate HPA-1a positive
      blood platelets that has been transfused to healthy male subjects, whose blood platelet do
      not express HPA-1a. The ability to quickly eliminate transfused HPA-1a positive platelets is
      considered as a surrogate endpoint for NAITgam's ability to prevent formation of antibodies
      against HPA-1a after delivery of an HPA-1a positive child.

      The current phase 0 trial will examine the survival of blood platelets transfused to healthy
      male individuals without subsequent administration of NAITgam. The natural survival of
      transfused platelet, as determined in the phase 0 trial, will be compared with the survival
      of transfused HPA-1a positive platelets after administration of NAITgam in the phase 1/2
      trial. The aim of the phase 0 trial is first, to determine the dose of blood platelet that
      should be transfused to the healthy subjects in the phase 1/2 trial; and secondly, to
      determine the optimal time point, after transfusion of platelets, for administration of
      NAITgam in the phase 1/2 trial.

      Eight to 24 healthy male subjects will be included in the phase 0 trial. After transfusion of
      platelets, blood samples will be collected at regular intervals to determine the proportion
      of transfused blood platelets. Differences between tissue type antigens between donor and
      recipient will be used to determine the proportion of transfused platelets. Survival of
      transfused platelets will be performed by flow cytometry - a method that can be used to
      quantify very small proportions of cells in the blood. Fluorochrome-conjugated monoclonal
      antibodies against HLA-A2 and HLA-A9 will be used for flow cytometric identification the
      transfused platelets.
    


Intervention name(s): Platelet transfusion
Intervention type(s): Other
Intervention description(s): Transfusion of a platelet dose from 20 × 10ˆ9 to 100 × 10ˆ9.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      We propose to use an inhaled allergen challenge model to explore the individual contributions
      of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination
      product and its components on protection from allergic triggers in asthma
    

Detailed description: 
      Asthma is an increasingly common disease and is essentially caused by an allergic type of
      reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of
      a reaction to triggers like chemicals (house-hold cleaning products, pollution) and allergens
      (house dust mite and cat or dog fur). The airways become blocked, causing shortness of breath
      and wheezing. The purpose of this study is to find out more information about how effective
      the study drugs are at protecting the lungs against allergic triggers of asthma. There are
      three study drugs being investigated in this study: fluticasone furoate on its own, GW642444M
      on its own and a combination of fluticasone furoate (FF) and GW642444M.

      FF is a corticosteroid that is being developed by for the treatment of asthma. A nasal spray
      formulation of FF has been approved for marketing in the USA, Europe and Japan for the
      treatment of hayfever (rhinitis) but the dry powder formulation used in this study is not yet
      approved.

      GW642444M is a long-acting beta2-agonist being developed by GSK for the treatment of chronic
      obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some
      of the muscles around the lungs to relax and open up better (bronchodilation), making
      breathing easier. The combination of FF/GW642444M is being developed as a once-daily
      treatment for both asthma and COPD.

      Study treatment will be taken for 21 days in each period (4 treatment periods: FF alone,
      GW642444M alone, FF/GW64244M combination and placebo) and each subject will receive all
      treatments. On D21 subjects will undergo an allergen challenge, followed by a methacholine
      challenge on D22. The washout between treatment periods will be 21-35 days.
    

Intervention name(s): FF/GW642444M; GW642444M; Fluticasone Furoate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: allergen challenge; early asthmatic response; mild asthma; late asthmatic response
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Condition: Vulvodynia; Dyspareunia; Breast Cancer; Menopause
MeSH terms: Breast Neoplasms; Dyspareunia; Vulvodynia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this protocol is to determine whether pain with sexual intercourse can be
      reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a
      non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.

      The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators
      predict that the localized use of lidocaine will be more efficacious than use of placebo
      liquid.
    

Detailed description: 
      For this study there will be three visits over a 3 month period. Subjects will undergo a
      gynecological exam at the screening visit to determine the severity of pain associated with
      uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so
      subjects can report pain during application of both study drug and placebo. Subjects will
      also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at
      screening visit so that PI can rule out possible infection, disease, or disorders. PI will
      also show subject the area of the vestibule in a mirror so that subject can apply study drug
      at home properly. Subjects will fill out 4 questionnaires about medical and health history,
      cancer history, pain, and distress and sexual activity. Subject will be given a supply of
      either study drug or placebo to take home. The first visit will last approximately 2 hours.

      Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for
      diary review, questionnaires, and examination. The second and third visit examinations will
      be repeats of the examination done at the first visit, but there will be no comparison with
      placebo, the PI will use only study drug during the touch test. The second and third visits
      will last approximately 1 hour.

      Subjects will fill out questionnaires throughout study participation. Topics include; medical
      and health history, cancer history, pain, distress and sexual activity. Subjects will also
      fill out a diary that charts tampon test completed from home, sexual activity performed, pain
      levels and study drug application days.
    

Intervention name(s): Topical liquid lidocaine; Topical saline
Intervention type(s): Drug; Drug
Intervention description(s): active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule; saline applied to the vestibule mucosa will not reverse the local tenderness
Other intervention name(s): water
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vulvodynia; Dyspareunia; Breast Cancer; Menopause; Vaginal dryness; Painful intercourse
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of intravenous magnesium in
      shortening the duration of a pain crisis and to determine the health-related quality of life
      and short term outcomes of children treated with intravenous magnesium during an acute pain
      crisis.
    

Detailed description: 
      It is well known that children with sickle cell disease are at risk for acute pain crises.
      The usual treatment for these pain crises, intravenous fluids and pain medicines such as
      morphine, has changed little over the past three decades. In a pilot study, the addition of
      intravenous magnesium to standard therapy decreased length of stay; however, this study was
      not randomized, not blinded, not placebo-controlled, and not adequately powered to assess
      safety.

      We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about
      208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium
      sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will
      return for a routine clinic visit up to 3 months after discharge for a baseline assessment.
      Patients will also complete health-related quality of life measures at 4 timepoints
      throughout the study.
    

Intervention name(s): Intravenous Magnesium Sulfate; Normal Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses; (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; Magnesium Sulfate; Pediatric
Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients
Condition: Anxiety Postoperative
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aims of this study were firstly, to evaluate the changes in the anxiety level after deep
      sedation with various intravenous sedative agents using salivary cortisol level in pediatric
      dental patients and secondly, to compare clinical effectiveness of this sedative agents,
      perioperative complications, recovery time and adverse effects.
    

Detailed description: 
      This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high
      anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1
      (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23)
      was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS)
      anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and
      after the drug administration. Perioperative vital signs, depth of sedation were recorded at
      intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery
      time were recorded in the follow-up form.
    

Intervention name(s): Dental Treatment
Intervention type(s): Procedure
Intervention description(s): Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental anxiety; Deep Sedation; Ketofol; Propofol; Salivary Cortisol
Effect of Pilates on Balance and Spinal Curvature In Upper Crossed Syndrome
Condition: Postural; Defect
MeSH terms: Spinal Curvatures
Study type: Interventional

Summary: 
      The study will be conducted to investigate the effect of Pilates exercise on spinal curvature
      and balance in patients with the upper cross syndrome. .
    

Detailed description: 
      Upper crossed syndrome (UCS) is the most common postural dysfunction in the musculature of
      the shoulder girdle /cervicothoracic region, which creates joint dysfunction, particularly at
      the atlanto-occipital joint, cervicothoracic joint C4-C5 segment, glenohumeral joint and
      T4-T5 segment. Pilates is designed as a program that will work with other exercise programs
      to strengthen, rebalance and realign the body. Pilates trains individuals to identify their
      own musculoskeletal strengths and weaknesses and equips them with the knowledge to correct
      and rebalance their entire body mechanics (Worth,2004) thus, the focus is also placed on
      improving personal body awareness which further decreases the risks of strain or injury that
      can occur with imbalances. forty patients with UCS will be allocated randomly into two
      groups; one experimental group will receive pilates exercise and postural correction twice a
      week for four weeks, and the control group will receive postural correction exercise along
      twice a week for four weeks
    

Intervention name(s): Pilates exercises; postural correction exercise
Intervention type(s): Other; Other
Intervention description(s): Each Pilates session will last for one hour. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centering which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the craniocervical junction). A pilates exercise program will consist of 11 levels of treatment program.; the patients will receive postural correction exercises, stretches, and exercises to the pectoralis major, elevator scapulae, upper trapezius, serratus anterior, rhomboids, and deep neck flexors. The stretches included sitting chair stretches, Brugger's, wall angels, and doorway stretches. The exercises included push-up-plus, head-neck-retraction, and Kibler squeeze
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pilates exercise and postural correction group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pilates exercise; upper cross syndrome; balance; spinal curvature
Fibromyalgia Integrative Training for Teens
Condition: Juvenile Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this pilot randomized trial is to determine whether the fibromyalgia
      integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy
      (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).

      Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in
      pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).

      Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions
      in functional disability and depressive symptoms at final study assessment (i.e., 3-month
      follow up).
    

Detailed description: 
      CBT has been found to have beneficial effects on improving coping among adolescents with JFM
      and increasing patients' ability to engage in daily activities. The purpose of this study is
      to evaluate whether CBT can be enhanced with specialized neuromuscular training, in the new
      fibromyalgia integrative training (FIT Teens) intervention, to produce stronger pain
      reduction than CBT alone. Neuromuscular training originates from the field of pediatric
      sports medicine and has been successfully used for injury prevention but has never before
      been utilized for pain management in JFM. This type of training emphasizes education and
      proper training in fundamental movement skills prior to the initiation of more vigorous
      physical activity and exercise. It is expected that the neuromuscular training integrated
      with established CBT techniques will enhance patients' ability to engage in exercise and to
      achieve better JFM pain control. Adolescents with JFM will be randomly assigned to receive
      either the 8-week FIT Teens intervention or an 8-week CBT program with assessments at
      baseline, post-treatment and 3-month follow-up.
    

Intervention name(s): Fibromyalgia integrative training; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Combined intervention with neuromuscular exercise training and cognitive behavioral therapy; Therapy focused on training in behavioral pain coping skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: juvenile fibromyalgia; pain in children; musculoskeletal pain; cognitive behavioral therapy; coping skills training
The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy
Condition: Contrast-induced Nephropathy; Acute Kidney Injury; Acute Coronary Syndrome
MeSH terms: Acute Kidney Injury; Kidney Diseases; Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration
      of intravascular iodinated contrast media, is an important cause of morbidity/mortality
      following coronary angiographic procedures in high-risk patients. Despite preventative
      measures intended to mitigate the risk of CIN, there remains a need for an effective
      intervention. Dietary inorganic nitrate therapy, which through its chemical reduction in the
      body delivers nitric oxide has shown promise in attenuating CIN, but its effectiveness in
      preserving long-term renal function is unknown.
    

Detailed description: 
      The NITRATE-CIN trial is a single-centre, randomised double-blinded placebo-controlled trial,
      which plans to recruit, over a period of 2 years, 640 patients presenting with acute coronary
      syndromes (ACS) who are at risk of CIN.

      Patients will be randomised to either dietary inorganic nitrate therapy or placebo.

      The primary endpoint will be the development of CIN (KDIGO criteria). A key secondary
      endpoint will be whether nitrate therapy impacts upon persistent renal impairment over a
      3-month follow-up period. Additional secondary endpoints include the measurement of serum
      renal biomarkers (e.g. neutrophil gelatinase-associated lipocalin) and urinary albumin at 6,
      48 h and 3 months following administration of contrast.

      Findings from NITRATE-CIN will potentially demonstrate that nitrate attenuates
      contrast-induced acute and chronic kidney injury and influence future clinical practice
      guidelines in at-risk patients undergoing coronary angiographic procedures.
    

Intervention name(s): Potassium Nitrate; Potassium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days; Potassium Chloride capsules for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Nitric Oxide; Nitrite; Acute Kidney Injury; Acute Coronary Syndrome
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and
      extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in
      healthy male subjects. There is no formal research hypothesis to be statistically tested for
      this study.
    


Intervention name(s): BMS-955176
Intervention type(s): Drug
Intervention description(s): Single dose of drug on Day 1
Intervention MeSH terms: BMS-955176
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other