bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig)
      nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a
      3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches
    


Intervention name(s): Zolmitriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg nasal spray
Other intervention name(s): Zomig
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Zolmitriptan; ZOMIG; migraine; headache response; headache; headache pain
Investigation of the Effect of Dietary Nitrate Treatment on Endothelial Function and Platelet Reactivity in Hypercholesterolemics.
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Diets rich in fruit and vegetables reduce the risk of strokes and heart attacks, however the
      exact cause of this beneficial effect is uncertain. Evidence suggests that certain
      vegetables, including beetroot and the green leafy vegetables, possess high inorganic nitrate
      concentrations. The investigators recent evidence suggests that inorganic nitrate provides a
      source of gas called nitric oxide in the body that exerts a number of beneficial effects upon
      the heart and blood vessels . The investigators have previously shown that beetroot juice
      ingestion improves blood vessel (vascular endothelial) and platelet function in healthy
      volunteers. Studies by the investigators show that these effects are due to conversion of
      nitrate to nitrite by symbiotic (helpful) bacteria (located on the tongue) and subsequent
      conversion of nitrite to nitric oxide in blood vessels. The investigators now wish to explore
      whether dietary nitrate, via its beneficial effects on platelets and blood vessels, might
      improve indices of atherosclerotic disease progression in high risk individuals
      (hypercholesterolemics). Recruits will have high cholesterol and no known atherosclerosis and
      will not yet be on any anti-cholesterol medications. Volunteers will consume a daily dose of
      beetroot juice or placebo nitrate-free juice for six weeks. Vascular function will be
      assessed using non-invasive techniques at the beginning and at the end of the study using
      ultrasound measurement of flow mediated dilatation (FMD) of the brachial artery in the arm
      and pulse wave analysis (PWA) and pulse wave velocity (PWV) to measure arterial compliance.
      To assess impact on platelet function, blood samples will also be taken at the start and at
      the end of the study.
    

Detailed description: 
      Please refer to brief summary.
    

Intervention name(s): beetroot juice
Intervention type(s): Dietary Supplement
Intervention description(s): 250mls daily beetroot juice
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The success of assisted reproductive technologies (ART) is critically dependent on optimizing
      protocols for controlled ovarian stimulation to provide adequate numbers of good quality
      oocytes and embryos. This optimization is mainly valuable to a group of infertility patients
      (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for
      an additional 2.6% of the infertility patients who manifest a high response to gonadotropin
      and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive
      research was carried out and led to the introduction of GnRH antagonist, as an alternative to
      Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing
      Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that
      a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH
      antagonist regimen is safe, well tolerated and results in a good clinical outcome. This
      protocol is now frequently applied in the US and Europe.

      Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful
      in determining individualized clinical management strategies for low and high responders and
      thus avoiding cancellation. Such prediction when based on reliable scientific evidence is
      valuable in consulting patients about their chances of success. A large number of studies
      have been performed, which used certain clinical, ultrasonographic and hormonal markers
      (called predictive factors), to try to optimize a COS protocol for patients who were
      down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models
      have also been used to adjust the starting dose of FSH to prevent a too low or too high
      ovarian response. To date, however, none have been performed for women undergoing ovarian
      stimulation with a GnRH antagonist protocol.

      The primary objective of this randomized, open-label, multicenter clinical trial was to
      identify one or more factors capable of predicting ovarian response in women treated with a
      daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use
      oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH
      antagonist for assisted reproduction, the trial evaluated also whether intervention with oral
      contraceptives affects the accuracy of predictive models for ovarian response.
    


Intervention name(s): Marvelon
Intervention type(s): Drug
Intervention description(s): oral contraceptive 1 tablet daily for 14 to 21 days
Intervention MeSH terms: Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite improved treatment, cardiovascular disease remains one of the most common diseases
      and causes of death in the Western world. Hypercholesterolemia is a well known risk factor
      for developing cardiovascular disease. Prevention and treatment are based in part on lowering
      LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment
      and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a
      mean 10%. Further lowering of LDL cholesterol by means of food supplements have been
      demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy
      protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of
      action responsible for the cholesterol lowering in these two food supplements are different,
      so there is a reason to expect an additive cholesterol lowering effect during concomitant
      treatment with both substances. The investigators want to investigate whether concomitant
      treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet
      results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than
      single treatment with each of the substances.
    


Intervention name(s): Psyllium husks; Isolated soy protein; Isolated whey protein; Microcrystalline cellulose
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Oral suspension, oral use, two daily dosages consisting of 5 grams each; Oral suspension, oral use, 30 grams once per day; Oral suspension, oral use, 30 grams once per day; Oral suspension, oral use, two daily dosages consisting of 5 grams each
Intervention MeSH terms: Psyllium; Calcium polycarbophil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this
      study is to determine if dulaglutide (LY2189265) affects how warfarin works. The study
      involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide +
      warfarin) separated by a minimum washout period of 24 days. In Treatment 1, the participant
      will receive 10 milligrams (mg) of warfarin on Day 1. In Treatment 2, the participant will
      receive a 1.5-mg dose of dulaglutide (LY2189265) as an injection on Day 1 and then a 10 mg
      dose of warfarin on Day 3. Participants will be randomly assigned into different treatment
      sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2.
      Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.
    


Intervention name(s): dulaglutide; Warfarin
Intervention type(s): Biological; Drug
Intervention description(s): Administered subcutaneously; Administered orally
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine
      whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect
      on lung function in patients with CF than placebo (0.17% saline).
    


Intervention name(s): P-1037; Hypertonic Saline; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): P-1037 is a novel ENaC inhibitor; 4.2% saline solution; 0.17% saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal
      hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.
    


Intervention name(s): HMG-CoA reductase inhibition (atorvastatin)
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: HMG-COA reductase inhibition; GFR; RPF; FE; CL
Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a humanized monoclonal antibody
      (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)
    

Detailed description: 
      A phase II, randomized, double-blind, placebo-controlled study to:

        1. Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with
           psoriatic arthritis (PsA).

        2. Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of
           subjects with PsA
    

Intervention name(s): efalizumab
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)
Condition: Vision Loss
MeSH terms: Blindness; Vision Disorders
Study type: Observational

Summary: 
      The loss of central vision causes difficulty not only in reading but also in faces
      recognition, and in particular in the identification of facial expression, objects or spaces.
      These visual deficits have been mainly studied in relation with reading, which is the main
      complaint of these kind of patients. However, there are not enough data regarding perception
      of objects and spaces in this population. Then, the objectives are to study the
      visual-spatial abilities in individuals with vision loss, and altered cognitive processes,
      (2) to develop clinics tools for early detection and quantification of visual-spatial
      deficits and (3)to understand the capacities of normal peripheral vision in order to test the
      possibility of potential training for use of peripheral vision when central vision is
      impaired by an ophthalmic pathology.
    


Intervention name(s): vision tests
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with eye disease causing loss of central or peripheral vision
      
Keywords: Vision loss; Object recognition; Space recognition
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Determine the long-term efficacy and safety of L-cysteine in the prevention
      photosensitivity in patients with erythropoietic protoporphyria.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are
      administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch.

      Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure,
      and have blood tested 3 times a year.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): cysteine hydrochloride
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: erythropoietic protoporphyria; inborn errors of metabolism; porphyria; rare disease
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of
      Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation
      already approved in adults.
    

Detailed description: 
      Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed
      combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the
      NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol
      6 ug DPI according to a cross-over design.
    

Intervention name(s): free comb. beclomethasone DPI and formoterol DPI; CHF 1535 50/6 NEXT DPI
Intervention type(s): Drug; Drug
Intervention description(s): free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).; four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma children NEXT DPI LABA ICS inhalation
A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate whether the treatment with IFN gamma
      can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by
      pre-clinical evidence in an animal model of the disease.
    

Detailed description: 
      This is a Phase 2 clinical trial. A total of 10 FRDA patients will be recruited All subjects
      will be treated with a dose of 100-150-200-micrograms of IFN gamma 1b (Imukin®)
      subcutaneously, with an interval of 14 days, for a total of 3 injections.
    

Intervention name(s): gamma interferon
Intervention type(s): Drug
Intervention description(s): IFN gamma 1b (Immukin ®) will be administered by subcutaneous route at day 0, 14 and 28 at a dose of 100, 150 and 200 ug respectively.
Other intervention name(s): Imukin
Intervention MeSH terms: Interferons; Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: frataxin, gamma interferon, Friedreich ataxia
The Optimization of Bioavailability From Iron Supplements: Study 2
Condition: Iron Deficiency; Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem
      worldwide, especially in women of reproductive age and young children. Iron supplementation
      is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron
      bioavailability from different supplementation regimens and how to optimize bioavailability
      in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg
      body weight for 3 months is reported to be the most effective method to rapidly increase iron
      stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe
      supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing
      that the splitting would increase iron bioavailability compared with one single high dose.
      However, there is no scientific evidence for this assumption; to the contrary, results from a
      recent study suggest that iron bioavailability from a second supplementation dose of iron
      after a first supplementation dose of iron is impaired due to increased hepcidin levels. To
      address this bioavailability issue, the present study will determine iron absorption from 120
      mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg
      iron per day administered for 3 consecutive days. The investigators hypothesize that the iron
      bioavailability from the single daily dose will be lower than that from the 2 doses. By
      measuring also hepcidin, this study will provide important insights on the iron
      bioavailability from a single dose of iron and on the same amount iron split into two doses
      (b.i.d. administration).
    


Intervention name(s): Single oral iron dose of 120 mg per day for 3 consecutive days; Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron bio-availability; Hepcidin; Iron absorption
Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and
      neoplastic cells. Because of the potential importance of such a capability, the investigators
      undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell
      lines as well as an initial sample of clinical cases. This goal was pursued by investigating
      four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical
      squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to
      neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to
      non-neoplastic squamous cells in cytological preparations. The clinical material was also
      stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes.
      The investigators found that all CellDetect®-stained cells exhibited one of the two
      tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm,
      whereas the differentiated phenotype changed the color to blue/green.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 archival cervical biopsy cases with the following diagnoses: normal, 22 cases; CIN-2/3,
        18 cases; squamous cell carcinoma, 20 cases.
      
Keywords: Zetiq CellDetect ® stain; distinct red/purple color to the cytoplasm of neoplastic; distinguishes green/blue stained non-neoplastic cells and tissues
Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus, Type 2; Surgery; Tooth Extraction Status Nos
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will evaluateand compare intraoperative and postoperative clinical parameters
      related to discomfort and wound heeling, as well as laboratory wound healing parameters after
      piezosurgical and conventional surgery approach during complex exodontia in healthy and
      patients with Diabetes Mellitus Type 2
    


Intervention name(s): piesosurgical extraction; conventional extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach; exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: piesosurgery; exodontia; diabetes mellitus