bioihbjkbjnl/mcl2 huggingface dataset:
Patient Experience Study of Deoxycholic Acid Injection
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to determine the safety of deoxycholic acid subcutaneous
      (SC) injections in the submental area and to evaluate the effects of four interventions,
      relative to placebo in the submental area, particularly with regard to assessment and
      management of pain, bruising, and swelling/edema.
    

Detailed description: 
      This study evaluated the effects of four interventions, pre- and post-subcutaneous injections
      of deoxycholic acid injection relative to placebo in adults with submental fullness.
      Participants were randomized to either deoxycholic acid injection or placebo in a ratio of
      4:1 and to one of four patient experience management paradigms.

      Participants were required to visit the research facility on 10 separate occasions for
      protocol-defined treatments, procedures, tests, and observations.
    

Intervention name(s): Deoxycholic Acid Injection; Placebo; Cold Compress; Lidocaine / Epinephrine; Loratadine; Ibuprofen; Compression Chin Strap
Intervention type(s): Drug; Drug; Other; Drug; Drug; Drug; Other
Intervention description(s): Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection; A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.; Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.; Loratadine 10 mg orally from Day -7 until Day 7; Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.; A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Other intervention name(s): ATX-101; Kybella
Intervention MeSH terms: Loratadine; Ibuprofen; Lidocaine; Epinephrine; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Survey About Hot Flashes in Women Going Through the Menopause
Condition: Menopause; Vasomotor Symptoms
Study type: Observational

Summary: 
      This study is an online survey of women in and around menopause with moderate to severe hot
      flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes
      often occur during menopause. They can disrupt a woman's daily life.

      This study is about collecting information only. There will be no treatment in this study.

      This study will provide information about how many women have moderate to severe hot flashes
      in menopause. It will also provide details on women's experiences with hot flashes.

      Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women
      in this study will already be taking part in consumer panels. Women will be contacted based
      on their age. They will be asked if they would like to take part in this study.

      Firstly, the women will answer questions about whether they are in menopause or are getting
      close to menopause. They will also be asked how severe their hot flashes are.

      From their answers, some women will be asked to complete an online survey. These will be
      women who are in menopause and have moderate to severe hot flashes. They will provide more
      details about how hot flashes have impacted their lives. Also, they will answer questions on
      how hot flashes affect their quality of life. Finally, they will answer questions about their
      experiences when they visited their doctor about their hot flashes.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Peri- and post-menopausal women with moderate to severe VMS symptoms
      
Keywords: Menopause; Vasomotor Symptoms
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the
      diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery
      disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures
      depending on different status of metabolic diseases. The investigators also aimed to analyze
      the risk factors associated with number and severity of stenosis as well as plaque
      characteristics using logistic regression models.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those who had undertook a computed tomographic angiography (CTA) with 64-slice MDCT from
        January 2nd 2006 until August 21st 2008. Reasons for exam include screening in asymptomatic
        subjects, diagnosis in patients with angina pectoris, follow up after percutaneous coronary
        intervention or coronary artery bypass grafting, differential diagnosis in chest pain and
        so on.
      
Keywords: coronary heart disease; Multidetector row cardiac computed tomography; type 2 diabetes; metabolic syndrome
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate whether education about the neurophysiology of
      pain is able to improve central pain inhibition in patients with Fibromyalgia.
    


Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): Education about the neurophysiology of pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Brain Functions Underlying Visuospatial Attention Deficits in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Background:

      - A special brain circuit is important for helping us keeping an eye open for things that are
      going on around us, even when we are not directly paying attention to them. This circuit
      seems to work differently in people with schizophrenia than in other people, which may
      explain specific deficits with broad monitoring observed in people with schizophrenia.
      Researchers want to compare brain function in people with schizophrenia and healthy
      volunteers to find out more about how these brain circuits work and affect attention.

      Objectives:

      - To study how the brain performs broad visual monitoring in people with schizophrenia.

      Eligibility:

        -  Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.

        -  Healthy volunteers between 18 and 55.

      Design:

        -  Participants will be screened with physical and psychological exams. They will have a
           medical history. Tests for drug and alcohol use will also be done.

        -  Participants will have two study visits. The first is a training visit and the second is
           a scanning visit.

        -  At the training visit, participants will practice computer-based tests of focus, memory,
           and concentration. They will also answer questions about mood, psychiatric symptoms, and
           smoking habits.

        -  At the scanning visit, participants will perform the computer-based tasks that they
           practiced at the training visit. They will have magnetic resonance imaging while they
           perform these tasks.
    

Detailed description: 
      Objective: To test a neural circuit explanation for a visuospatial attention abnormality seen
      in schizophrenia. Specifically, the aim is to test whether broad monitoring deficits may be
      based on a disruption of the so-called sentinel function of the default network. Because the
      default network is modulated by nicotinic compounds, such finding would implicate a possible
      remediation strategy.<TAB>

      Study population: 24 people with schizophrenia, 24 matched healthy control subjects.

      Design: A group comparison of attention task performance and associated brain activity as
      measured by functional Magnetic Resonance Imaging.

      Outcome measures: Measures of attention task performance (reaction time, accuracy), BOLD
      signal within regions of the default network, degree of temporal association of BOLD signal
      with trial-by-trial reaction time.
    

Time perspective: Other
Keywords: Default Network; Schizophrenia; fMRI; Spatial Attention; Sentinel Function
Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project
      under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation
      and secondary prevention of ischemic stroke is same or better than that of WM.
    

Detailed description: 
      As a multi-site randomized controlled clinical trial,through a central system,patients were
      randomly assigned to the intervention group or the control group.In the intervention group,
      patients were treated with the traditional Chinese medicine comprehensive rehabilitation
      program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese
      medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine
      health education. In the control group, patients were treated with Western-based treatment
      plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day
      after the treatment and the 14 days after treatment, each patient was evaluated for the
      following three clinical indications: (1)evaluation of neurological deficits by U.S. National
      Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form
      Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the
      modified Ashworth spasticity rating scale.
    

Intervention name(s): acupuncture, massage and basic TCM treatment; rehabilitation and WM basic treatment
Intervention type(s): Other; Other
Intervention description(s): During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education.
After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.; there two steps:
during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education
After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet
Other intervention name(s): 863 TCM project for ischemic stroke-TCM group; 863 TCM project for ischemic stroke-WM group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Traditional Chinese Medicine; Rehabilitation
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a
      long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.
    


Intervention name(s): NNC0113-0987; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation; Once-daily doses for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Answer ALS: Individualized Initiative for ALS Discovery
Condition: Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Flail Arm ALS; Progressive Muscular Atrophy; Monomelic Amyotrophy; Motor Neuron Disease; Asymptomatic ALS Gene Carriers; Healthy Controls
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Atrophy; Muscular Atrophy, Spinal; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      Creation of a large repository of induced pluripotent stem cells (iPSC), bio-fluid samples
      (blood and spinal fluid (optional)), and cell lines for ALS gene identification. This will be
      combined carefully with collected measures of the pattern of the symptoms people with ALS
      have and how these change over time. People with other motor neuron diseases and healthy
      controls will be included as comparisons
    

Detailed description: 
      Patients will have 5 study visits; screening, 3, 6, 9 and 12 months. There will be a one year
      post-participation follow-up period, during which they will receive an email or phone call
      interview once every 3 months. During the first year, samples will be collected, breathing,
      muscle strength, spasticity, general function and cognitive behavior will be assessed.
      Healthy controls will have 2 study visits during which blood samples will be collected and
      questionnaires given.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with ALS, Primary Lateral Sclerosis Flail Arm ALS Progressive Muscular Atrophy
        Monomelic Amyotrophy Motor Neuron Disease Asymptomatic ALS Gene Carriers
      
Biospecimen description: 
      plasma, serum, DNA, Cerebrospinal fluid, induced pluripotent stem cells,
    
Keywords: ALS; stem cell; biomarker; disease progression
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      topotecan in different dosing schedules may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well topotecan works in treating patients with
      recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of topotecan, in terms of frequency and duration of
           tumor response, in patients with recurrent platinum-sensitive ovarian epithelial,
           fallopian tube, or primary peritoneal cancer.

        -  Determine the nature and degree of toxicity of this regimen in these patients.

      Secondary

        -  Determine the duration of progression-free survival and overall survival in patients
           treated with these regimens.

        -  Determine the effects of prognostic variables (i.e., initial performance status, age,
           and mucinous or clear cell histology) in patients treated with these regimens.

      OUTLINE: This is a multicenter study.

      Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
      days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued
      for this study within 15-30 months.
    

Intervention name(s): topotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Topotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
Appetite Regulation by Human Chemosignals From Tears and Plasma
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is closely related to metabolic diseases and its prevalence is sharply increasing.
      However, there is no safe and effective treatment for obesity so far, the investigators need
      a breakthrough idea to curtail the constant threat of obesity. It has been recently
      demonstrated that emotional tears of women can modify sexual responses, one of basic
      instincts, in men. As appetite and food intake is another basic instinct, chemosignals from
      tears and plasma may modify appetite and eating behavior in humans.
    


Intervention name(s): Sniffing emotional tears; Sniffing trickled saline; Sniffing fasting plasma; Sniffing postprandial plasma
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): A band-aid soaked 100μl of emotional tears will be applied just below nostrils.; A band-aid soaked 100μl of trickled saline will be applied just below nostrils.; A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.; A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.
Other intervention name(s): Emotional tears; Trickled saline; Fasting plasma; Postprandial plasma
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Emotional tears; Postprandial plasma; Chemosignal; Obesity; Appetite; Food intake
Foley Catheter vs Double-balloon Catheter
Condition: Pregnancy Termination; Catheter
Study type: Interventional

Summary: 
      The efficiency of double-balloon and Foley catheters in the second trimester medical
      termination of pregnancies will be compared.
    

Detailed description: 
      Women will be randomised into two groups. Foley catheter was applied to one group and double
      balloon catheter to the other group. After catheter expulsion or if the catheters did not
      spontaneously expulsed after 24 hours, i.v. oxytocin infusion will be started. Abortions will
      be considered successful if there will be no need of another method for abortion.
    

Intervention name(s): pregnancy termination
Intervention type(s): Device
Intervention description(s): Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: second trimester pregnancy termination; double-balloon catheter; foley catheter
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Condition: Nasal Congestion
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was to determine if the drug worked to relieve nasal congestion experienced by
      people with seasonal allergies.
    

Detailed description: 
      Subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in phase
      of the study on Day -7 (prerandomization, Visit 1). Baseline symptom scores were established
      during this run-in phase.

      Subjects with moderate nasal congestion who took at least 80% of their study medication
      during the run-in phase were eligible for enrollment in the two-week double-blind phase of
      the study and were randomized on Day 1 (randomization, Visit 2). They were treated for two
      weeks with their assigned medication. The severity of signs/symptoms were evaluated by the
      subjects every morning and night and by the investigator at each visit on Day 7 and Day 14.

      In addition, the subject and investigator provided a global evaluation of response to
      treatment on Day 7 and Day 14. Safety was evaluated by adverse events reported during the
      study, vital signs, and the incidence of somnolence.
    

Intervention name(s): Diphenhydramine 50 mg; Diphenhydramine 25 mg; Pseudoephedrine 120 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Three times daily: two diphenhydramine 25 mg capsules
Twice daily: one pseudoephedrine-matching placebo tablet; Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
Twice daily: one pseudoephedrine-matching placebo tablet; Three times daily: two diphenhydramine-matching placebo capsules
Twice daily: one pseudoephedrine 120 mg tablet
Other intervention name(s): Active: Lot # 070PB6 Formula # W015990-0002; Active: Lot # 070PB6 Formula # W015990-0002; Active: Lot # INT-06-115 Formula # W015721-0004
Intervention MeSH terms: Diphenhydramine; Promethazine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis, nasal congestion
A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in
      Mexican healthy volunteers under fasting conditions. The study will be an open label, single
      dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged
      between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0
      kg/meter (m)^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered
      trademark of the GSK group of companies.
    


Intervention name(s): Eltrombopag
Intervention type(s): Drug
Intervention description(s): Eltrombopag 50 mg per tablet for oral route of administration will be sourced locally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: eltrombopag 50 mg; healthy volunteers; pharmacokinetic; single-dose; Open-label; fasting