bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
Condition: Acne
Study type: Observational

Summary: 
      The aim of the study is to understand the structural and functional modifications of the
      host, the microorganisms, and their interactions (host/microorganism relationship) before and
      after the RV3278A - ET0943 product application
    


Intervention name(s): RV3278A - ET0943 cosmetic product; RV4632A - RY1845 cosmetic product
Intervention type(s): Other; Other
Intervention description(s): RV3278A - ET0943 study product is applied twice a day on the face during the whole study.; RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects are enrolled during their usual medical care and/or from the database of the
        investigational sites.

        The subjects corresponding to eligibility criteria may receive a phone call, a letter or an
        e-mail proposing to participate to the study.
      
Biospecimen description: 
      Sebum and comedones constituents
    
Keywords: Comedones; Lipids; Blackheads; Host/Microorganism Relationship; Micro comedones
Advanced Ovarian Cancer and Sexuality Phase 1
Condition: Ovarian Cancer; Sexual Function
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      Women with Advanced Ovarian Cancer (AOC) suffer from severe sexual side effects from
      treatment. The prevalence of the sexual issues is not known.

      The degree to which these sexual side effects is affected by treatment is also not known, as
      the literature in this area focuses on post-treatment analysis.

      Specific Aim #1 (Quantitative Phase): To determine the prevalence and types of sexual
      difficulties using self-report questionnaires in women about to receive treatment for Stage
      III or IV Ovarian Cancer at the BCCA and over time, and to correlate these symptoms with
      degree of cancer symptoms, well-being, depressive symptoms, and relationship satisfaction
    

Detailed description: 
      Hypothesis 1a: Compared to baseline pre-treatment data, and to existing data for women with
      early-stage gynaecologic cancer, rates of sexual difficulties will be significantly higher
      and frequency of sexual intercourse will be significantly lower in women with advanced
      ovarian cancer. We hypothesize that difficulties specifically in the domains of sexual
      desire, sexual distress, and genital pain will be the most common types of sexual dysfunction
      to characterize women with advanced ovarian cancer.

      Hypothesis 1b: We hypothesize that the degree of sexual symptoms will be significantly
      greater at 3 months and 10 months post-treatment than compared to pre-treatment, and that
      sexual difficulties may be significantly greater at 3 months post-treatment than at 10-months
      post-treatment.

      Hypothesis 1c: We hypothesize that degree of sexual difficulty and sexual distress will be
      significantly correlated with (a) overall well-being; (b) depressive symptoms; and (c)
      relationship satisfaction.

      Hypothesis 1d: As an exploratory analysis, we will investigate the relationship of ovarian
      cancer-related variables (i.e., type of treatment, duration of treatment, number of
      medications), and demographic variables (i.e., age, relationship duration, education) on each
      of the hypotheses in 1a - 1c.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women diagnosed with advanced ovarian cancer
      
Keywords: Advanced Ovarian Cancer; Sexual Function
Food Exposure Therapy in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      This is a research study to determine whether a medication called D-cycloserine (DCS) in
      combination with a type of psychotherapy called Exposure Therapy is helpful to patients with
      anorexia nervosa.
    

Detailed description: 
      This is a research study to determine whether a medication called D-cycloserine (DCS) in
      combination with a type of psychotherapy called Exposure Therapy is helpful to patients with
      anorexia nervosa. DCS is approved by the FDA as an antibiotic medication, but has not been
      approved by the FDA for the treatment of anorexia nervosa. Past studies have found that DCS
      together with Exposure Therapy can help people with height phobia, social phobia, and
      obsessive compulsive disorder. Anorexia nervosa often includes phobia-like fears, obsessive
      thoughts, and compulsive rituals, so the current study aims to determine whether DCS paired
      with Exposure Therapy can also help people with anorexia nervosa. Anorexia nervosa is a
      disorder characterized by self-starvation, extreme weight loss, and difficulty maintaining a
      normal weight. You have been asked to participate in this study because you have been given a
      diagnosis of anorexia nervosa. In this study you will receive one of three therapies:
      Exposure Therapy with DCS, Exposure Therapy with placebo (inactive medication), or Treatment
      as Usual. You will participate in a total of four test meals in a laboratory setting. A total
      of 70 individuals with anorexia nervosa will participate in this study. Twenty individuals
      who have never had an eating disorder will participate in one portion of this study.
    

Intervention name(s): Exposure Therapy + D-Cycloserine; Exposure Therapy + Placebo; Supportive Psychotherapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Exposure therapy with d-cycloserine medication; Exposure therapy with placebo medication; Supportive psychotherapy
Intervention MeSH terms: Cycloserine
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inpatients receiving treatment for anorexia nervosa
Lactobacillus Farciminis and Hyperalgesia
Condition: Inflammation; Pain
MeSH terms: Hyperalgesia; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a
      hyperalgesia on response to thermal stimulation. A comparaison of results before and after
      three weeks of treatment will be made.
    


Intervention name(s): Lactobacillus farciminis; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule per day. Each capsule containing 4*109 CFU; 1 capsule per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammation; Pain
Burst Suppression Anesthesia for Treatment of Severe Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine if the antidepressant effects of deep anesthesia via
      propofol are related to EEG burst suppression.
    

Detailed description: 
      Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments
      of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and
      after treatment.
    

Intervention name(s): Diprivan
Intervention type(s): Drug
Other intervention name(s): Propofol
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
Condition: Excessive Somnolence
MeSH terms: Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of VSF-173 compared to
      placebo in treatment of induced excessive sleepiness.
    


Intervention name(s): VSF-173
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Single Dose Study to Evaluate Dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Condition: Major Depressive Disorder (MDD
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced,
      single dose, dose proportionality study.
    

Detailed description: 
      Single dose study to evaluate dose-proportionality of Vortioxetine Hemihydrobromide Orally
      Disintegrating Tablets (5 mg, 10 mg and 20 mg) in healthy adult human subjects under fasting
      conditions.

        -  To evaluate dose proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating
           Tablets (5 mg, 10 mg and 20 mg) in healthy, adult, human subjects under fasting
           conditions.

        -  To monitor the safety and tolerability of the subjects.

      An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced,
      single dose, dose proportionality study.
    

Intervention name(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg; Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 10mg; Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg; Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 10mg; Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg
Other intervention name(s): SF001 ODT 5mg; SF001 ODT 10mg; SF001 ODT 20mg
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400
      tablets from the same drug product batch.
    


Intervention name(s): PN400
Intervention type(s): Drug
Intervention description(s): 500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics study
Fiber and Water Improve Bowel Habit in Humans
Condition: Dietary Habits; Bowel Dysfunction
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of
      life, fecal characteristics and microbiota) measured during a week of monitoring followed by
      randomization to a 14 days course of increased fiber in diet or increased fiber and water
      intake, with repetition of parameters measuring at the end.
    

Detailed description: 
      Demographic and clinical data were collected and recorded in the first interview after
      signing the informed consent. The protocol was composed of two phases. The baseline phase
      lasted 7 days, when participants reported their usual diet on a food dairy in the first 3
      days, between Sunday and Tuesday. Calculation of nutrient intake was performed using ADS
      nutri software (UFPEL, Pelotas, Brazil). Participants approved for the next phase were then
      randomized to fiber and fiber+water groups, which lasted 14 days. During this period
      participants were asked to report their intestinal habits including bowel movements,
      graduation of straining and subjective stool consistency. Participants were instructed to
      rank straining using a Likert scale from 1 (minimum) to 5 (maximum), and the Bristol scale
      for stool consistency. In the last day of treatment phase (Saturday) participants collected
      feces and urine of 24 hours, and responded a symptoms questionnaire. Food and liquid intake
      were recorded on a diary during the last 3 days of treatment for comparison with the baseline
      phase stage.
    

Intervention name(s): Fiber; Fiber and Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men), keeping the usual liquid intake; Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men) plus 2 liter of water/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to investigate the differences in the biomechanical properties of the dorsal
      trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared
      with their typically developing peers, and the effect of these biomechanical properties on
      balance and functional mobility performance.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with unilateral spastic cerebral palsy (GMFCS level I-II, spasticity
        level MAS ≤ 2) and their age-matched typically developing peers.
      
Keywords: postural balance; muscle properties; mobility; paralysis; children
Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery
Condition: Motor Evoked Potential Monitoring; General Anesthesia; Neurosurgery; Brain Tumor; Spine Tumor; Cerebral Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce
      neural damage during neurosurgery.

      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in
      clinical use. But there have been no reports about the effect of changing NMB agent on
      efficacy of MEP monitoring.

      Therefore, the investigators performed a randomized controlled trial to evaluate the effect
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.
    

Detailed description: 
      Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce
      neural damage during neurosurgery.

      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in
      clinical use. But there have been no reports about the effect of changing NMB agent on
      efficacy of MEP monitoring.

      Therefore, the investigators performed a randomized controlled trial to evaluate the effect
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.
    

Intervention name(s): MEP monitoring with continuous infusion of vecuronium during general anesthesia; MEP monitoring with continuous infusion of cisatracurium during general anesthesia
Intervention type(s): Other; Other
Intervention description(s): MEP monitoring with continuous infusion of vecuronium during general anesthesia; MEP monitoring with continuous infusion of cisatracurium during general anesthesia
Intervention MeSH terms: Anesthetics; Cisatracurium; Vecuronium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Motor evoked potential monitoring; General Anesthesia; Neurosurgery; Cisatracurium; Vecuronium
Study of Weight Loss Using Gastric Stimulation in Obese Patients
Condition: Obesity; Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of an implanted device that stimulates the
      stomach to help obese patients lose weight.
    

Detailed description: 
      The purpose of this study was to evaluate efficacy and safety of the IGS system in a
      population of patients with a BMI between 35 and 55 kg/m2.

      SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which
      all subjects were implanted with the IGS system.
    

Intervention name(s): Transcend II Model 8848
Intervention type(s): Device
Intervention description(s): All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Morbid Obesity; SHAPE; IGS; Implantable Gastric Stimulator
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv
Condition: Newborn Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      ABSTRACT Purpose: This research was done for the purpose of determining the impact of breast
      milk smell administered to term infants hospitalized in neonatal intensive care units (NICU)
      due to physiological jaundice on their bilirubin levels, length of remaining in phototherapy
      and comfort.

      Material and Method: It is an experimental, randomisation, controlled research. Target
      population of the research consisted of a total of 72 term infants who were hospitalized in
      the NICU of Bilecik Bozuyuk Public Hospital and met the sample selection criteria. Our
      research includes two groups. Breast milk smell group and control group. The infants were
      assigned to the groups via randomization method. Sample assignment to the groups was
      performed using stratification and blocking methods. The infants meeting the research sample
      selection criteria were stratified according to their postnatal age and then assigned to each
      group equally (blocking) by lot. However, two infants in the control group were excluded from
      the research at the request of their parents as the research continued. Thus, the research
      was completed with a total of 72 infants; 37 in the breast milk smell group and 35 in the
      control group. In the research, the data were collected using "Personal Data Collection
      Form", "Phototherapy Follow-up Chart" and "Neonatal Comfort Behavior Scale". The data were
      analyzed using the SPSS (Statistical Package for Social Sciences) 21.0 (IBM corp. Relased
      2012. IBM SPSS Statistics for Windows, version 21.0 Armonk, NY: IBM corp.) package software.
    


Intervention name(s): breast milk smell
Intervention type(s): Other
Intervention description(s): yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.
Other intervention name(s): kontrol grubu
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: newborn; phototherapy; breast milk smell
Pharmacokinetic Characterization of the Active, Separated System With PK Controller (Fentanyl Iontophoretic Transdermal System, 40 Mcg Fentanyl Per Activation).
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      "This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence
      design. A total of 54 eligible subjects will receive three total treatments; one with
      intravenous (IV) infusion and two with the Study System. Each subject will be randomly
      assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate),
      Study System Treatment B (170 mcAmp), and one of three additional Study System treatments
      (140 mcAmp or 200 mcAmp or 230 mcAmp) "
    

Detailed description: 
      "The Study System is a single-use system that consists of two parts: a Drug Unit containing
      10.8 mg fentanyl hydrochloride, and a Controller that supplies the dosing current. The two
      parts are packaged separately and assembled immediately prior to use. The Study System will
      be applied to the upper, outer arm of each subject. Fentanyl will be delivered from the Study
      System via transdermal iontophoresis using a current of 170 mcAmp (Treatment B), 140 mcAmp
      (Treatment C), 200 mcAmp (Treatment D), or 230 mcAmp (Treatment E). Each subject will be
      randomly assigned to a treatment sequence consisting of Treatment A (IV fentanyl citrate),
      Study System Treatment B (170 mcAmp), and one of three additional Study System treatments
      consisting of Treatment C (140 mcAmp), Treatment D (200 mcAmp), or Treatment E (230 mcAmp).
      Each subject will therefore receive a total of three treatments (A and B and either C, D, or
      E).

      The specific treatments are outlined in detail below:

        -  Treatment A: Fentanyl citrate (equivalent to 80 mcg fentanyl) administered over 20
           minutes by IV infusion every hour through 23.33 hours.

        -  Treatment B: Two consecutive 40 mcg fentanyl doses each delivered over 10 minutes by the
           Study System (170 mcAmp) every hour through 23.33 hours.

        -  Treatment C: Two consecutive 35 mcg fentanyl doses, each delivered over 10 minutes by
           the Study System (140 mcAmp) every hour through 23.33 hours.

        -  Treatment D: Two consecutive 50 mcg fentanyl doses, each delivered over 10 minutes by
           the Study System (200 mcAmp) every hour through 23.33 hours.

        -  Treatment E: Two consecutive 54 mcg fentanyl doses, each delivered over 10 minutes by
           the Study System (230 mcAmp) every hour through 23.33 hours.

      Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before
      the start of each fentanyl treatment and ending approximately 11 hours after completion of
      each treatment "
    

Intervention name(s): Fentanyl; Naltrexone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fentanyl; Naltrexone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this protocol is to to compare the clinical utility of two dosage tapering
      regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: opiate dependence