bioihbjkbjnl/mcl2 huggingface dataset:
Estrogen and Graft Atherosclerosis Research Trial (EAGER)
Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if postmenopausal hormone replacement therapy in women following coronary bypass
      surgery would reduce the occurrence of graft occlusion and delay the development of graft
      atherosclerosis.
    

Detailed description: 
      BACKGROUND:

      Coronary atherosclerosis is a major cause of death in women in the United States. Although
      coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia, it
      does not alter the underlying process. Patients may present several years later with
      recurrent symptoms that may be a result of occlusion of saphenous vein grafts, development of
      atherosclerotic disease in vein grafts, or progression of underlying disease. Any
      intervention that can reduce the rate of progression of coronary atherosclerosis following
      bypass surgery would provide significant benefit for women following bypass surgery and
      possibly for other women with atherosclerotic disease. Observational studies suggest that
      postmenopausal estrogen replacement therapy is associated with a reduction in cardiac
      morbidity.

      DESIGN NARRATIVE:

      The study was a randomized, double-blind, controlled trial. Subjects were randomized to
      conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass
      surgery. Graft occlusion and development of vein graft atherosclerosis were measured by
      comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease
      severity and extent performed at six months and three and a half years after randomization.
      The primary outcome variables included the occurrence of graft occlusion at six months and
      the change in severity and extent of atherosclerosis in the saphenous vein grafts over three
      years. The trial determined the influence of hormone replacement therapy on the primary
      outcome variables.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): hormone replacement therapy; estrogens; medroxyprogesterone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Hormones; Estrogens
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Test of Novel Drug for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid
      cessation during a one-week "practice" quit period for each condition in smokers with a high
      interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and
      cognitive impairment will help assess the mechanism to support quit smoking attempts.
    

Detailed description: 
      We aim to test the proof of principal that an alpha-7 PAM drug, JNJ-39393406, promotes
      smoking cessation when compared to placebo. We have developed, tested, and validated an
      efficient Phase 2a screening procedure that optimally combines the validity of randomized
      clinical trials with the practicality of lab- based medication studies. Notably, it employs a
      within-subject, cross-over design comparing active versus placebo effects on quitting smoking
      to maximize statistical power without a large sample, in contrast to the large samples needed
      for between-groups randomized treatment conditions. Using this procedure, we will evaluate
      effects of JNJ-39393406 vs. placebo on short-term smoking abstinence in smokers who already
      have a high interest in quitting soon. We predict that, compared with placebo, JNJ-39393406
      will increase days of abstinence, identifying initial evidence of efficacy for smoking
      cessation. Our main dependent measure is days of very stringent biochemically validated
      (expired CO<5 ppm) 24-hr smoking abstinence, with post-quit withdrawal and cognitive function
      as secondary measures. Potential for adverse side-effects will be assessed at each visit.
    

Intervention name(s): Active JNJ Drug; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.; Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
Other intervention name(s): JNJ-39393406
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: crossover
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Condition: Colorectal Neoplasms; Breast Neoplasms
MeSH terms: Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical trial is to investigate whether the therapeutic response of
      chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver
      metastases from breast cancer and colorectal cancer will be included. Computer Tomography
      (CT) will be performed as a baseline scan before treatment start. Two metastases in each
      patients liver will be preselected and randomized to either "target lesion" to be treated or
      "control lesion" to serve as internal control. The patients will receive conventional
      treatment with chemotherapy according to national guidelines. After intravenous chemotherapy
      infusion the patients will receive the experimental treatment. The target lesion will get
      focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be
      administered intravenously. The investigators will measure the difference in response between
      FUS- treated and -untreated lesions on the post-treatment CT scan.
    


Intervention name(s): SonoVue; Focused Ultrasound
Intervention type(s): Drug; Procedure
Intervention description(s): consists of microbubbles containing sulfur hexafluoride stabilized by phospholipids.
Bolus doses à 1,0ml administered every 3.5 minutes , repeated 9 times. Total duration of treatment: 31,5 minutes. This treatment will be repeated maximally 4 times at 2 or 3 week intervals, depending on the patient's diagonse and treatment protocol.; ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two liver metastases in every patient are preselected on baseline computer tomography. These will be randomized to either 1) target lesion to be treated or 2) control lesion. Difference in response (pre- and post-treatment measure) between treated lesions and control lesions will be the primary outcome of the trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contrast Agent BR; SonoVue; Ultrasonic Therapy; Neoplasm Metastasis; Liver; Microbubbles
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Investigate urinary leukotriene E4 levels and determine if there is a correlation with
      severity of obstructive sleep apnea. The investigators then would like to determine a
      threshold level which could then be used for confirmation of diagnosis of obstructive sleep
      apnea (OSA).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Otolaryngology practice
      
Biospecimen description: 
      urine sample
    
Keywords: obstructive sleep apnea
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Condition: Alcoholism; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in
      Alaska natives with alcohol dependence. The study will also examine whether a combination of
      naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone.
      Alaska Native individuals will be recruited into a 16 week outpatient study.
    


Intervention name(s): sertraline; naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): 16 week outpatient study; 16 week outpatient study
Other intervention name(s): Zoloft; Revia
Intervention MeSH terms: Naltrexone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol Dependence
A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      An exploratory study to evaluate the effect of MEDI0382 on energy balance in overweight and
      obese participants with type 2 diabetes mellitus
    

Detailed description: 
      An exploratory Phase 2a, randomised, double-blind, placebo-controlled study to evaluate the
      effect of MEDI0382 on energy balance in overweight and obese participants with type 2
      diabetes mellitus
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0382 will be administered subcutaneously, titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.; Placebo will be administered subcutaneously for 16 days in the single-blind treatment period in both MEDI0382 and placebo arms, and SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period in placebo arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type II; Obesity; MEDI0382
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish safety, tolerability, pharmacokinetics and
      pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on
      pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as
      described below:

        -  Part I will be a randomized, double-blind, placebo-controlled, sequential, single
           ascending dose study.

        -  Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple
           ascending dose study.

        -  Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover,
           food effect study.
    


Intervention name(s): CT-G11; CT-G20; CT-G11 Placebo; CT-G20 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet of CT-G11 Experimental Drug; oral tablet of CT-G20 Experimental Drug; oral tablet of Placebo; oral tablet of Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
ClearView Predicate Comparison Testing
Condition: Healthy
Study type: Observational

Summary: 
      This study serves as a comparison study between the EPIC ClearView and a predicate device.
    

Detailed description: 
      The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to
      be used to determine autonomic response as psychological indicators by measuring the
      electrical resistance of the skin. The EPIC ClearView is a non-invasive digital
      bioelectrography instrument that is used to assess the electrophysiology of humans. The
      measurements are digital photographs taken in a brief exposure to an electric field. These
      measurements are quantified to produce a standardized Response Scale.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women ages 18-85.
      
Keywords: Ambulatory adults with no apparent health conditions
Comparison Between Conventional vs. Endoscopic Lumbar Discectomy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      This study is aimed to compare between the results of conventional lumbar discectomy and the
      newly used technique in our department; endoscopic lumbar discectomy in neurosurgery
      department Assiut university hospitals, so that we can offer our patients the best service in
      an updated and minimally invasive way.
    

Detailed description: 
      Lumbar discectomy is one of the most common operation performed worldwide for lumbar-related
      symptoms. Lumbar disc herniation accounts for only 5% of all low back pain problems but is
      the most common cause of radiating nerve root pain, sciatica.

      Mixter and Barr described the first surgical procedure to remove the herniated lumbar disc in
      1934 through a laminectomy and durotomy, with later enhancement by Semmes, who described
      approaching the herniated disc through hemilaminectomy and retraction of the dural sac. This
      became popularized as the "classical discectomy technique.

      During the latter half of the 19th century, more techniques were developed to remove the
      herniated disc with minimal invasiveness. The first herniated disc excision using a
      microscope (microdiscectomy) was performed by Yasargil in 1977, which was the standard
      surgical procedure at the time In 1993, Mayer and Brock and then in 1997, Smith and Foley
      described endoscopic discectomy techniques. With these minimally invasive techniques, authors
      demonstrated decreased soft tissue manipulation, operative time, blood loss, and hospital
      stay, allowing early recovery.

      In this study we try to evaluate clinical and radiological outcomes of percutaneous
      endoscopic translaminar discectomy at our hospital.
    

Intervention name(s): Conventional open lumbar discectomy; Percutaneous Endoscopic Translaminar lumbar discectomy.; Easy Go system Endoscopy
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Removal of single level lumbar disc herniation through conventional discectomy.; Removal of single level Lumbar disc herniation using endoscope.; This system will be used to remove herniated disc in endoscopic group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lumbar disc herniation; endoscopic discectomy; open discectomy; comparative study; Translaminar; surgery
Management of Women With an Incomplete Miscarriage
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation,
      that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal
      bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or
      'incomplete' according to whether or not tissues are retained in the uterus. If a woman has
      minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage.
      However; if the pregnancy is still inside the uterus but the cervix is open, this is
      described as an 'inevitable miscarriage', which it will not usually be possible to save the
      fetus.

      From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold
      standard management' for miscarriage to remove the retained placental tissue. It is quickly
      performed and removed almost all the retained products of conception. However, the routine
      surgical evacuation of the uterus associated with higher rate of morbidity and mortality and
      should be limited for special indications.

      Many studies compared the effectiveness of medical treatment compared to surgery in
      management of incomplete abortion. There is only one study compared the curettage with
      expectant management in those women after medical therapy.However; none of them, looked at
      the effectiveness of the second chance of medical treatment in management of incomplete
      abortion in trial to avoid the surgical intervention after failure of previous medical
      treatment. So we think that the immediate evacuation using surgical intervention is truly
      unnecessary in most cases of failed medical abortion and the patients may get benefit from
      another trial of medical treatment.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose vaginally
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Condition: Paralysis; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Paralysis
Study type: Interventional

Summary: 
      This study is to determine if non-invasive electrical stimulation of the spinal cord can help
      improve hand and arm function in people with paralysis who suffered a cervical spinal cord
      injury.
    

Detailed description: 
      This study is to determine if non-invasive electrical stimulation of the spinal cord can help
      improve hand and arm function in people with paralysis who suffered a cervical spinal cord
      injury. The investigators hypothesize that this stimulation can revive spared function in the
      spinal cord of individuals who are clinically paralyzed, but who have some remaining
      connections between the brain and spinal cord. Our research has demonstrated that modifying
      the activation state of the spinal cord or awakening the spinal cord can benefit people with
      paralysis years after a spinal cord injury. This method and device have not yet been approved
      by the FDA for the treatment of paralysis and are under investigation. This study if
      successful will help provide further evidence that could be use to gain FDA approval.
    

Intervention name(s): Transcutaneous Electrical Spinal Cord Stimulation
Intervention type(s): Device
Intervention description(s): A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other intervention name(s): Prototype device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; quadriplegia; tetraplegia; stimulation
Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK598809 is being developed as an innovative treatment for substance dependence and
      potentially other compulsive behavioral disorders. This study will evaluate the safety,
      tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.
    


Intervention name(s): GSK598809; Placebo; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.; Subjects will receive matching placebo capsules to GSK598809 orally with water.; Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
Other intervention name(s): GSK598809/Placebo
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: repeat dose,; placebo,; Safety,; pharmacodynamics,; tolerability,; GSK598809; pharmacokinetics,
Repeated Exposure to Umami Taste on Taste Perception, Hedonics, and Satiety
Condition: Umami Taste Perception
Study type: Interventional

Summary: 
      The purpose of this study is to determine how repeated dietary exposure to umami taste
      affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult
      subjects will consume a low glutamate vegetable broth daily for one month, where the
      experimental group's broth is supplemented with the umami-rich stimuli of monosodium
      glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).

      The investigators hypothesize that repeated dietary exposure to umami taste will:

        1. diminish umami suprathreshold intensity perception and hinder the ability to
           discriminate varying MSG concentrations

        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense
           umami stimuli

        3. decrease satiation and decrease the satiating effect of a test meal
    


Intervention name(s): Supplementation of diet with MSG; No supplementation of diet with MSG
Intervention type(s): Other; Other
Intervention description(s): Subjects eat normal diet and consume 8 ounces of vegetable broth with added MSG one time per day for 1 month; Subjects eat normal diet and consume 8 ounces of low glutamate vegetable broth without MSG (sodium-matched with NaCl) one time per day for 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science