bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
Condition: Contraceptives, Oral
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study a comparison was made on the influence of missing pills on follicular ripening.
      By missing a given number of pills, an effect on "contraceptive robustness" of the two
      investigated contraceptive pills was measured by ultrasound comparison of follicular size and
      other parameters which indicate how far ovulation might be.
    


Intervention name(s): YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300); Yasminelle (SH T 00186 D)
Intervention type(s): Drug; Drug
Intervention description(s): SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each; SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral contraceptive; Ovulation; Missing pills; Intake compliance; Cycle control
ABG Oxidative Stress Study Protocol-1
Condition: Healthy
Study type: Interventional

Summary: 
      This is a proof of concept study that evaluates the response to oxidative stress in healthy
      men after taking plant concentrates.
    

Detailed description: 
      Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome,
      cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is
      associated with protective effects on the investigators health. The strategy to prevent
      chronic disease development and in making up the nutritional gap in the investigators diet
      has shifted from vitamins and minerals supplementation to whole foods and whole food
      products.

      The objectives is to evaluate the effect of oxidative stress response of plant concentrate
      blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence
      the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly,
      collecting additional information on whether blends of plant concentrate have other potential
      health benefits.

      This study will test the dose-response of blends of plant concentrates. Healthy men (n=60)
      with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment
      duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be
      performed.Genes associated with oxidative stress will me monitored. The outcome of this study
      will help us understand how to design and develop future antioxidant related products.
    

Intervention name(s): Plant concentrate A; Plant concentrate B; Plant concentrate C; Plant concentrate D
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.; Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.; Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.; Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: antioxidant
Health Education in Improving the Understanding of Medical Information
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Understanding the risk of disease and prevention and screening activities to lower
      disease risk may help individuals make informed medical decisions.

      PURPOSE: This randomized clinical trial is studying how well health education materials help
      participants understand medical information.
    

Detailed description: 
      OBJECTIVES:

        -  Compare medical data interpretation skills in participants of low or high socioeconomic
           status who receive a general education primer (entitled "Know Your Chances:
           Understanding Health Statistics") vs a health education booklet (entitled "The Pocket
           Guide to Good Heath for Adults").

      OUTLINE: This is a randomized, controlled study. Participants are stratified according to
      socioeconomic status (low vs high). Participants are randomized to 1 of 2 intervention arms.

        -  Arm I (control): Participants receive a health education booklet entitled "The Pocket
           Guide to Good Health for Adults," published by the Agency for Health Care Research and
           Quality, which contains general information about disease risk and reducing risk by
           following recommended prevention or screening activities.

        -  Arm II (primer): Participants receive a general education primer entitled "Know your
           chances: Understanding health statistics," which teaches how to understand disease risk
           and the benefits and risks of intervention.

      Within 2 weeks after receiving the education material, participants in both arms complete a
      survey, including a medical data interpretation test, STAT-interest, STAT-confidence, and
      user ratings of the education materials.

      PROJECTED ACCRUAL: A total of 555 participants were accrued for this study.
    

Intervention name(s): AHRQ staying healthy booklet; Risk primer
Intervention type(s): Other; Other
Intervention description(s): educational booklet about prevention; Know your chances booklet
Other intervention name(s): AHRQ guide to staying healthy; Know your chances
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: unspecified adult solid tumor, protocol specific
High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim is to investigate whether strength training or high intensity interval training is
      effective in improving insulin sensitivity, cardiovascular outcomes, body composition and
      reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

      Few studies have examined the effect of strength training alone on insulin sensitivity,
      reproductive outcomes and body composition in women with PCOS. Most previous studies on
      aerobic exercise in PCOS have applied moderate exercise intensity.
    


Intervention name(s): strength training; interval training
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): resistance training; high-intensity exercise; aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; resistance training; insulin resistance; high intensity interval training
Study of the Effects of Xenin-25 in Humans With and Without Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released
      into the blood immediately after ingestion of a meal and plays an important role in
      regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes
      mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This
      study is being conducted to determine whether a hormone called xenin-25 can restore the
      activity of GIP in persons with T2DM.
    

Detailed description: 
      Each eligible participant will be administered an oral glucose tolerance test so he/she can
      be assigned to the group with "normal glucose tolerance", "impaired glucose tolerance"
      (between normal and diabetic), or type 2 diabetes mellitus. Each study subject will then be
      administered a graded glucose infusion (GGI) on 4 separate occasions. For the GGI, an
      intravenous glucose infusion will be started at a rate of 1 mg x kg-1 x min-1 for 40 min,
      followed by 2, 3, 4, 6, and 8 mg x kg-1 x min-1 (40 min for each step). A primed-continuous
      infusion of vehicle alone, GIP alone, xenin-25 alone, or the combination of GIP plus xenin-25
      (each peptide at a dose of 4 pmoles x kg-1 x min-1) will be initiated at the same time the
      glucose infusion is started. Blood samples will be collected before and during the GGI for
      the measurement of glucose, insulin, C-peptide, glucagon, GIP and xenin-25 levels.
    

Intervention name(s): Placebo; Glucose-dependent Insulinotropic Polypeptide (GIP); Xenin-25; Glucose-dependent Insulinotropic Polypeptide plus Xenin-25
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous infusion of 1% human albumin in normal saline; Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline; Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline; Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
Other intervention name(s): Vehicle alone; GIP; Xenin; GIP plus Xenin
Intervention MeSH terms: Gastric Inhibitory Polypeptide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes; Blood Sugar; Xenin-25; GIP; Insulin
Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
Condition: Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      No prospective randomized clinical trial assessed the performance of this new device in a
      clinical setting. Consequently the aim of this study is to determine clinical performance of
      this new device compared with conventional DLT.

        -  Trial with medical device
    

Detailed description: 
      In several clinical situations and surgical procedures single-lung ventilation (SLV) is
      essential. Especially during thoracic surgery SLV and collapse of the operated lung, while
      ventilating the other side of the lung is the most frequented indication. In these cases the
      double lumen tube (DLT) is the most widely used device.

      The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or
      the right side of the lung- dependent of the model of the tube. Endotracheal intubation with
      DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more
      difficult to place and are especially likely to provoke airway injuries. Furthermore,
      placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of
      experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral
      position as well as during surgical procedure is relatively frequent. Tube displacement from
      its proper position above the carina, respectively in the main bronchus, may result in
      life-threating complications and airway lacerations.

      The anesthetist may detect tube misplacement from indirect clinical signs including increased
      airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical
      situations, verification of tube position using fibreoptic bronchoscopy is indicated.
      Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of
      skill as well as expensive infrastructure.

      The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed
      clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT
      with an embedded video imaging device and light source at its tip and integrated cable with
      connector. However, after correct tube placement, the video imaging device is focused on the
      main carina, indicating the correct position of the bronchial cuff in the left main bronchus.
    

Intervention name(s): ET View Double Lumen Tube; conventional Double Lumen Tube
Intervention type(s): Device; Device
Other intervention name(s): VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel); conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Yogurt on Minimal Hepatic Encephalopathy
Condition: Cirrhosis; Minimal Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a special yogurt can improve performance on
      certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.
    

Detailed description: 
      Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal
      hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not
      treated because of perceived subclinical nature of this condition and the adverse effects and
      expense of available medications such as lactulose or rifaximin. There is evidence that small
      intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in
      murine and human studies. Probiotics are live bacteria that can modify the indigenous
      intestinal bacterial flora and have been recently used in the treatment of hepatic
      encephalopathy in patients with cirrhosis.

      Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function
      and inflammatory markers of bacterial translocation and psychometric test performance in
      cirrhotic patients with MHE in a prospective pilot trial.

      Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt
      to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without
      yogurt supplementation. All patients will undergo liver function tests, basic metabolic
      panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All
      patients will also undergo psychometric testing with number connection test A, digit symbol
      test, block design and inhibitory control test at baseline and 60 days. Regular questioning
      about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and
      review of intake diary will be done at 30 and 60 days from patients randomized to yogurt
      supplementation.

      Importance: There has been only one human study on the modification of gut flora as a
      therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic
      liver disease and comprised of Chinese patients, therefore etiologies of liver diseases
      studied were different from those predominant in the United States. Since MHE can adversely
      affect quality of life and overall prognosis, simple, targeted therapies are needed to treat
      it. We believe that our pilot study will help delineate human gut flora as a definite target
      for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this
      subject.
    

Intervention name(s): Yogurt Supplementation
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minimal Hepatic Encephalopathy; Cirrhosis
A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade
Condition: Patients With Pace Makers But no Evidence of Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This
      will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin
      effect on QT and QTc will also be assessed in atrially paced patients at two different pacing
      rates with and without autonomic blockade
    


Intervention name(s): GTN; Moxifloxacin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
A Safety Study of LY2811376 Single Doses in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of
      LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.
    

Detailed description: 
      This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and
      investigator-blind, placebo-controlled, randomized, 3 period, crossover study. Part 1 will
      assess the safety and tolerability of LY2811376 single doses, how the body handles the drug,
      and the drug's effect on the body. Part 2 is a subject- and investigator-blind,
      placebo-controlled, randomized study to assess the safety and tolerability of a LY2811376
      single dose, how the body handles the drug, and the drug's effect on the body including in
      cerebrospinal fluid.
    

Intervention name(s): LY2811376; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsules; Oral capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling
Condition: Head and Neck Squamous Cell Cancer
MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess the effect of metformin in tumor metabolism in
      patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20
      expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Hypoxia; Wounds and Injuries
Study type: Interventional

Summary: 
      In this current study, the examiners examine some of the mechanisms of how Acute Intermittent
      Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is
      accomplished both with the use of a load cell to determine elbow strength changes and high
      density grid electromyography (EMG) to record bicep muscle activations before and after bouts
      of AIH
    

Detailed description: 
      It has been shown previously that there is an increase in strength in survivors of spinal
      cord injury after brief bouts of Acute Intermittent Hypoxia. In this study, participants are
      fitted with a high density EMG electrode on the biceps brachii, and attached to a load cell
      at the wrist, they are asked to flex and extend their elbow at various levels of intensity.
      This is performed before and after the 30 minute session of AIH. The investigators hope to
      identify specific types of motor units of the upper extremity of survivors of spinal cord
      injury after AIH to help further our understanding of what mechanisms may be causing the
      known increase in muscle strength post AIH
    

Intervention name(s): Acute Intermittent Hypoxia
Intervention type(s): Other
Intervention description(s): Acute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session
Other intervention name(s): AIH
Intervention model: Single Group Assignment
Intervention model description: Every participant in this study will receive the intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Intermittent Hypoxia; Motor Unit; Upper Extremity
Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Condition: Urticaria; Autoimmune Diseases; Immune System Diseases; Skin Diseases
MeSH terms: Urticaria; Skin Diseases; Chronic Urticaria; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal
      Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.
    

Detailed description: 
      Chronic urticaria is a distressful disease, which negatively affects the quality of life.
      Pathogenesis isn't exactly clear, treatment is relatively palliative and results are usually
      suboptimal. 30-40% of the patients have autoimmune origin. Patients are forced to use
      immunosuppressive treatments which have systemic effects. Some of the treatments have effects
      as severe as the disease itself.

      Mesenchymal stem cells (MSCs) are the most common used cells in clinical trials. These cells
      can provide efficient immunosuppression in severe conditions like immunosuppressive resistant
      Graft versus Host Disease. With this study at the first time and quite a different approach
      from conventional treatment, it will be tried an experimental treatment that used in the MSCs
      for the chronic autoimmune urticaria patients without of definitive treatment.
    

Intervention name(s): Autologous mesenchymal stem cell
Intervention type(s): Biological
Intervention description(s): Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.
Other intervention name(s): Autologous adipose tissue derived mesenchymal stem cell
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cell; Chronic autoimmune urticaria