bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Condition: Insulin Resistance; Dyslipidemia
MeSH terms: Insulin Resistance; Dyslipidemias
Study type: Interventional

Summary: 
      We hypothesized that short-term treatment with haloperidol induces insulin resistance through
      a mechanistic route that is independent of weight gain. We therefore treated healthy
      non-obese men with haloperidol for 8 days, and studied the impact of these intervention on
      glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution
      technology and indirect calorimetry.
    


Intervention name(s): Haloperidol
Intervention type(s): Drug
Intervention description(s): Haloperidol 3 mg/day for 8 days
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Insulin resistance; Dyslipidemia; Haloperidol
The Effect of Olive Leaf Extract Administration on Cardiovascular Health
Condition: Overweight and Obesity; Elevated Cholesterol
MeSH terms: Overweight; Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of daily supplementation of OLECOL
      for a period of 8 weeks on cardiovascular risk markers.
    


Intervention name(s): OLECOL; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Olive leaf extract; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Olive leaf extract; Cardiovascular health; Cholesterol
BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male
      subjects suffering from erectile dysfunction as compared to placebo- To assess the influence
      of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile
      dysfunction following treatment with vardenafil as compared to placebo
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity; Matching placebo tablets orally prior to sexual activity
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vardenafil; Erectile dysfunction; SSES-E (sexual self-efficacy scale - erectile function)
The Safety Evaluation of Aminophylline and Ambrisentan When Administered Orally Alone and in Combination to Healthy Volunteers
Condition: High Altitude Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with
      the primary objective of testing the safety and tolerability of combined oral doses of
      aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess
      the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when
      administered alone or in combination. It is hypothesized that the combination of these drugs
      is generally safe, and that no drug interaction can be observed.
    

Detailed description: 
      This is a Phase I, three period, two sequence, single-center, open-label, randomized,
      crossover study design. Periods I and II consist of the oral administration of either a
      single dose of aminophylline or ambrisentan alone, followed by a 48 hour wash out interval.
      Subsequently, Period III consists of the simultaneous administration of both drugs. All
      subjects are to be confined to the Duke Clinical Research Unit throughout all treatment
      periods [Study Day -1 to Study Day 6 (discharge)]. A sufficient number of healthy adult
      subjects will be consented in order to enroll 24 and complete 16 subjects who complete all
      three periods. Replacement of subjects is permitted, if necessary.

      Qualified subjects will be randomized into one of two sequences consisting of three Periods
      as indicated below:

      -------------Period 1-----Period 2-----Period 3

      Sequence A: Treatment 1 Treatment 2 Treatment 3

      Sequence B: Treatment 2 Treatment 1 Treatment 3

      TREATMENTS:

      Treatment 1: Aminophylline 500 mg (corresponding to 395 mg theophylline).

      Treatment 2: Ambrisentan 5 mg.

      Treatment 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg.

      After completion of each treatment period, the subjects will proceed to the next period
      provided no Stopping Rules criteria have been met
    

Intervention name(s): Aminophylline; Ambrisentan; Aminophylline plus ambrisentan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug will be administered as a single oral dose of 500mg, followed by a 48h washout period.; Drug will be administered as a single dose of 5mg, followed by a 48h washout period; Drugs will be given as single doses of 500mg (aminophylline) and 5mg (ambrisentan), followed by a 48h washout period
Other intervention name(s): Letairis
Intervention MeSH terms: Ambrisentan; Aminophylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High altitude induced fatigue; High altitude induced pulmonary Hypertension
Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Observational

Summary: 
      To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with
      the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.
    

Detailed description: 
      Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary
      prevention after a first thrombotic complication are known to be at higher risk of recurrent
      thrombotic events despite INR values in the therapeutic range. It ist also known that
      antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin
      time and INR).

      The primary objective of this study is to determine the prevalence of interfering
      antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring
      the INR using different thromboplastins and the CoaguChek system for INR self-assessment.
      Test results were compared to measurements of the phospholipid-independent chromogenic factor
      X.

      The second objective of this study is to evaluate the incidence of recurrent thrombotic
      events during 1-year follow-up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with antiphospholipid syndrome requiring long-term treatment with vitamin-K
        antagonists (N=40) Pateints without antiphospholipid antibodies treated with vitamin-K
        antagonists (N=100)
      
Biospecimen description: 
      Plasma samples.
    
Keywords: Antiphospholipid syndrome; Antiphospholipid antibodies; Vitamin-K antagonists; International normalized ratio; Chromogenic factor X
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88
      may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may
      also help docetaxel work better by making tumor cells more sensitive to the drug. Giving
      docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving
      docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small
      cell lung cancer.

      PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they
      work when given together compared to docetaxel alone in treating patients with stage IIIB or
      stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with
           stage IIIB or IV non-small cell lung cancer.

      Secondary

        -  Determine the efficacy markers of docetaxel and PI-88 in these patients.

        -  Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in
           patients whose disease has been controlled with docetaxel and PI-88 combination therapy.

        -  Determine the safety and potential efficacy of PI-88 alone as third-line therapy in
           these patients.

      OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
      of 2 treatment arms.

        -  Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.

        -  Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88
           subcutaneously once daily on days 1-4, 8-11, and 15-18.

      In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity. Patients in arm II with stable or responding disease
      after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I
      with progressive disease or unacceptable toxicity before the completion of 6 courses may
      receive PI-88 alone as third-line therapy.

      PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
    

Intervention name(s): PI-88; docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): PI-88+docetaxel; docetaxel only
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare absorption of salmeterol and fluticasone from
      Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide
      Diskus
    


Intervention name(s): salmeterol-fluticasone; salmeterol-fluticasone; salmeterol-fluticasone; salmeterol-fluticasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Seretide Diskus 50/250 µg/dose; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg)
      versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C,
      TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and
      90 days later at the Final Visit. Secondarily, to measure the effect of chromium picolinate
      (600 μg Cr) + biotin (2 mg) versus placebo on patient quality of life, fasting and
      post-prandial blood sugar levels, fasting insulin, and anti-hyperglycemic medication usage.
    

Detailed description: 
      There will be an Initial Pre-Screening Contact, two office visits (Baseline and Final), and
      two mid-study phone contacts with the subject during the course of the study. Volunteers will
      take either chromium picolinate (600 μg Cr) + biotin (2 mg) (n=400) or placebo (n=200) once
      daily just prior to the morning meal for 90 days. Assessments for glycosylated hemoglobin,
      lipid profiles, and quality of life will be taken at the Baseline Visit. After 90 days
      another set of assessments will be taken at the Final Visit for comparison with the baseline
      values. All subjects will under go a brief physical exam, a medical history assessment, and a
      comprehensive concomitant medications assessment as well as provide blood and urine samples
      at the baseline and final visits to ensure subject safety is maintained. The subject will be
      contacted, by a central call center, between visits at Day 30 and Day 60 to ensure study
      compliance by reminding the subject to take all doses of study product, perform the daily
      blood glucose monitoring, and complete the study diary daily.
    

Intervention name(s): Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
Intervention type(s): Drug
Intervention MeSH terms: Chromium; Biotin; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chromium; chromium picolinate; type 2 diabetes mellitus; HbA1c; hyperglycemia; cholesterol
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Condition: Brain Tumors With Ill-defined Margins
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate whether stereotactic indigo carmine injection can
      safely increase the extent of tumor resection.
    

Detailed description: 
      Low grade gliomas are brain tumors with usually poorly defined borders between tumor and
      normal brain. This characteristic of low grade gliomas makes the gross total resection of the
      tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of
      recurrence and progression into a more malignant tumor can be decreased with a more
      aggressive surgical resection. An aggressive attempt to achieve a gross total resection may
      result in the resection of normal brain and therefore neurological injury. For this reason,
      the more common error is to subtotally resect the tumor leaving significant volumes of tumor
      behind. Many techniques have been introduced to safely increase the extent of resection,
      since the extent of resection is associated with a higher survival rate. Each one of these
      techniques has several shortcomings. The current study will assess whether the intraoperative
      stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of
      extent of tumor resection. In the first step of the study the safety and the correlation
      between resection of stained tissue/extend of tumor resection will be assessed. If the
      results are satisfactory, then the second step will ensue. In the second step we will assess
      the utility of indigo carmine as an additional adjunct to guide tumor resection.
    

Intervention name(s): Indigo carmine
Intervention type(s): Drug
Intervention description(s): During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.
Other intervention name(s): Indigotindisulfonate sodium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain tumor; resection; indigo carmine dye
CoolSculpting the Upper Arm Study
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized
      surface applicator for non-invasive subcutaneous fat reduction in the upper arm.
    

Detailed description: 
      This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform
      treatments in the upper arm for the reduction subcutaneous fat reduction.
    

Intervention name(s): CoolSculpting device with vacuum applicator.
Intervention type(s): Device
Intervention description(s): The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
Condition: Embryo Implantation
Study type: Interventional

Summary: 
      This study is a randomized controlled clinical trial to compare the pregnancy outcomes of
      infertile women with frozen embryo transfer. The study population in frozen embryo transfer
      cycles receive three doses of human chorionic gonadotropin (HCG) to recognize the
      effectiveness of HCG on pregnancy outcomes in Reproductive Biomedicine Research Center, Royan
      institute, Tehran Iran.
    

Detailed description: 
      During implantation, the biochemical crosstalk between the endometrium and embryo has a very
      important role. The endometrium secrets cytokines and growth factors that modulate embryonic
      differentiation and early development. One of the important molecular messages between the
      embryo and endometrium is human chorionic gonadotropin (HCG). HCG is expressed by the
      blastocyst before the implantation, while increasingly produced after implantation by the
      syncytiotrophoblast. In order to study the direct effect of HCG on the endometrium at
      implantation, this randomized, controlled clinical trial evaluated whether HCG
      supplementation would be beneficial for pregnancy outcomes of cryopreserved-thawed embryo
      transfer with estrogen/ progesterone replacement cycles at Royan Institute.

      Block randomization method is designed by epidemiologist using STATA software version 13 and
      the number of blocks considered is 6. The random allocation list for patients is solely
      available to the epidemiologist. In order to hide the random allocation process, a total of
      200 envelopes are prepared, and only the methodologist has been aware of table of random
      numbers. When the doctor declared the patient's eligibility, the methodologist provided the
      doctor with the envelope. The group will be selected and based on the type of group mentioned
      in the envelope.
    

Intervention name(s): The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles
Intervention type(s): Drug
Intervention description(s): Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.
Other intervention name(s): The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human chorionic gonadotropin; frozen embryo transfer; infertility; assisted reproduction technology; estrogen/ progesterone replacement cycles
Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases
Condition: Children With Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Chronic Disease
Study type: Interventional

Summary: 
      The number of studies concerning health related quality of life (HRQL) in children with food
      allergy is very limited.

      Only one study to date has compared HRQL of a group of children with food allergy to data
      published on general population and other chronic diseases. This study concluded to lowest
      HRQL scores in food allergic children compared to type 1 diabetes mellitus with important
      impact on scores concerning social activities.
    

Detailed description: 
      Primary aim:

      To compare generic HRQL score in children with food allergy with other chronic diseases and
      with healthy chidren in an homogeneous socio-cultural context.

      Secondary aims :

        -  To compare generic and specific HRQL scores in children with food allergy

        -  Identifify in chidren with food allergy, clinical factrors assocated with lowest scores
           in order to improve our management.

      Methods

      Generic HRQL questionnaire (CHQ-87) will be distributed :

        -  after hospital consultation for patients

        -  in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the "
           Food Allergy Independent Measure " will also distributed to chidren with food allergy.
    

Intervention name(s): filling questionnary to quality of life
Intervention type(s): Other
Intervention description(s): filling questionnary to quality of life
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Health related quality of life, food allergy, children, chronic diseases