bioihbjkbjnl/mcl2 huggingface dataset:
CSD190101: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after
      using investigational snus products (A19010-F and B19010-F).
    

Detailed description: 
      This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine
      pharmacokinetic parameters after use of two smokeless tobacco products A19010-F and B19010-F
      in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days
      and randomized to one of two investigational product (IP) (A: A19010-F and B: B19010-F) use
      sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a
      PK assessment for plasma nicotine concentrations, and then subjects will use the other
      product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
    

Intervention name(s): A19010-F; B19010-F
Intervention type(s): Other; Other
Intervention description(s): A snus product; A snus product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+
Condition: Anti-aging; Photoaging
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the efficacy and tolerance of a
      moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe
      facial photodamage.
    

Detailed description: 
      This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick
      Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe
      overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming
      Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility
      was confirmed. These products were used twice daily as instructed for a minimum 3 days prior
      to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer
      SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use
      the Facial Moisturizer given at Screening in the evening.

      Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject
      self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and
      12). Full face images were also completed post-application at Baseline.

      A total of 34 subjects completed the study.
    

Intervention name(s): Sunscreen Moisturizer; Gentle Cleansing Lotion; Facial Moisturizer
Intervention type(s): Other; Other; Other
Intervention description(s): A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.; A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).; A provided facial moisturizer (Goodier) was used 1x daily (PM).
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Intervention model description: Open label, 12-week study. 39 female subjects were recruited, 35 to 60 years, Fitzpatrick Skin Type I-VI, with moderate-severe overall facial photodamage.
Masking: None (Open Label)
Primary purpose: Treatment
fMRI Study of tES in Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a functional MRI study that will examine the effects of noninvasive transcranial
      electrical stimulation (tES) on brain function in individuals with Major Depression.
    

Detailed description: 
      The purpose of this research study is to understand how a kind of brain stimulation, called
      transcranial electrical stimulation (tES), affects brain function in people with major
      depression.

      tES delivers low electrical current to the head using electrodes applied to the skin, and is
      described as a "neuromodulation" or "neurostimulation" technique. This study uses a specific
      kind of tES called "transcranial direct current stimulation", or tDCS, where a constant
      (unchanging) electrical current is passed between two electrodes on the head.

      Neuromodulation methods like tES have shown promise in changing brain function, as well as
      treating some brain disorders like major depression. Yet, how tES brain function remains
      unclear. To better understand how tES works, the investigators will use MRI (a type of brain
      scan) to measure brain function during tES in people with major depression.
    

Intervention name(s): Transcranial Electrical Stimulation (tES)
Intervention type(s): Device
Intervention description(s): In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.
Other intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Condition: Vaginal Lesion
Study type: Observational

Summary: 
      The main objective of this study is to assess whether the presence of abnormal vaginal flora
      (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of
      delivery. For this, the primary endpoint will be the proportion of vaginal lesions according
      to the presence or absence of abnormal vaginal flora.

      A more precise qualitative and quantitative study of vaginal flora isolated from pregnant
      women and its association with vaginal lesions will also be conducted.
    


Intervention name(s): Bacteriological analysis of vaginal sample
Intervention type(s): Biological
Intervention description(s): Bacteriological analysis of vaginal sample
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of all consecutive women meeting inclusion/exclusion criteria
        and delivering at the Nîmes University Hospital, France during an inclusion period of 6
        months.
      
Keywords: Perineal tear; Perineal lesion; Vaginal flora; Birth
Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone
Condition: Pelvic Organ Prolapse; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators have performed colposacropexy in women with uterovaginal prolapse for many
      years with satisfactory results.

      This study was designed to compare whether, in the treatment of patients with uro-genital
      prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure
      such as mini-sling is associated with a reduction of post-operative urinary incontinence
      (correction of pre-existent urinary incontinence and prevention of masked urinary
      incontinence).
    


Intervention name(s): POP repair plus mini-sling; POP repair
Intervention type(s): Procedure; Procedure
Intervention description(s): For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum.
A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh.; For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pelvic organ prolapse; urinary incontinence; sacropexy; sling
A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of multiple doses of probenecid on the
      multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers.
      Safety and tolerability will also be assessed.
    

Detailed description: 
      This will be a single-center, open-label (identity of study treatments will be known to
      volunteers participating in the study as well as to study staff) study to assess the effects
      of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and
      its metabolites in healthy volunteers. The study will last up to approximately 49 days
      (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a
      Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth)
      one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in
      sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15
      to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days
      when both canagliflozin and probenecid are taken, both doses must be taken at approximately
      the same time.
    

Intervention name(s): Canagliflozin/Probenecid
Intervention type(s): Drug
Intervention description(s): Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).
Intervention MeSH terms: Canagliflozin; Probenecid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Canagliflozin (JNJ-28431754); Pharmacokinetic; Probenecid
Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus
Condition: Sacrococcygeal Pilonidal Disease
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      The investigators want to share our study that is the "Comparison of Modified Limberg Flap
      Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the
      Surgical Treatment of Sacrococcygeal Pilonidal Sinus.
    

Detailed description: 
      Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far,
      many options regarding the surgical treatment of the disease has been described, the
      consensus about treatment stills remains unsatisfactory, as all the surgical methods have
      encountered with different rate of recurrences. Our aim in this study is to compare the
      widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap
      Transposition and relatively less used technique Lateral Advancement Flap Transposition with
      Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications,
      surgical site infections in the first 6 months.
    

Intervention name(s): Flap Transposition Procedures
Intervention type(s): Procedure
Intervention description(s): Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: flap; pilonidal sinus; vas; recurrence
Stress-induced Drinking in Emerging Adults: the Role of Trauma History
Condition: Trauma; Posttraumatic Stress Disorder
MeSH terms: Wounds and Injuries; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      This project is the first to use a clinical laboratory method in emerging adults to test the
      hypothesis that a trauma history with or without concommitant posttraumatic stress disorder
      (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The
      study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on
      these outcomes. It will also examine the relationship between stress reactivity and
      subsequent stress-induced drinking in these samples. The goal of this program is to better
      understand the relationship between stress and factors related to the development and
      maintenance of alcohol problems in early adults, so that ultimately, better treatments may be
      developed that reduce the incidence and severity of alcohol related problems.
    

Detailed description: 
      This study will be conducted with a 3 x 2 between subjects design. The between groups factors
      are (1) trauma group (3 levels: Control, Trauma Exposed with, and without PTSD) and (2)
      exposure to stress (2 levels: yes and no). To decrease intra-group variability, trauma type
      will be limited to interpersonal trauma. Potential participants will be screened over the
      phone. Those meeting basic eligibility criteria will complete an assessment at the MUSC
      Institute of Psychiatry, and those meeting final eligibility criteria will be scheduled for
      the laboratory session to be completed at the Clinical and Translational Research Center
      (CTRC).

      Half of each trauma history group will receive the Trier Social Stress Test (TSST); the other
      half will receive a no-stress control condition. Baseline and post-stress objective and
      subjective measures of stress reactivity will be collected. Following the stress task, all
      participants will be given a priming dose and subsequently presented with an alcohol taste
      test. The primary analyses will examine the effect of trauma group membership on response to
      stress and subsequent voluntary drinking. Based on power analyses using preliminary data from
      similar samples, a sample size of 240 participants (40 per cell) is required.
    

Intervention name(s): Trier Social Stress Test (TSST); No stress condition
Intervention type(s): Behavioral; Other
Intervention description(s): The TSST is a standardized psychological stress challenge where a participant performs a speech and mental math task in front of 3 unfamiliar individuals, in order to evoke an HPA axis stress response in a laboratory setting.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        21-30 year olds
G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients
      with metastatic colorectal cancer.

      PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia
      during first-line treatment with chemotherapy and bevacizumab in patients with metastatic
      colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to
           obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with
           metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are
           homozygous for allele UGT1A1*28 (genotype 7/7), a promoter of the gene coding for enzyme
           UGT1A1.

      Secondary

        -  Evaluate the objective response rate at 6 months of treatment with FOLFIRI and
           bevacizumab according to RECIST criteria.

        -  Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to
           NCI-CTC v. 2.0.

        -  Determine progression-free and overall survival.

        -  Determine the time to treatment failure.

      OUTLINE: This is a multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90
      minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
      Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every
      2 weeks in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 2-3 months for up to 5 years.
    

Intervention name(s): bevacizumab; filgrastim; fluorouracil; irinotecan hydrochloride; leucovorin calcium
Intervention type(s): Biological; Biological; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Pilot Study : New Sensors to Monitor Apnea During Sedation
Condition: Sleep Apnea, Obstructive; Anesthesia
MeSH terms: Apnea; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea
      During Sedation With Propofol in TCI Mode
    

Detailed description: 
      In 2016 , monitoring of propofol sedation , currently recommended by the American Society of
      Anaesthesiology and European companies includes among others, a pulse oximeter (SpO2) and a
      continuous measurement of CO2 exhaled by an appropriate device (CapnoLine). This monitoring
      does not allow to anticipate the occurrence of obstructive apnea .

      The anticipation of the occurrence of apnea or airway obstruction using this type of
      monitoring could allow the anesthesiologist to act earlier on the titration of propofol and
      maintaining the airway. This would avoid the side effects associated with hypoxemia and
      hypercapnia and therefore further improve patient safety .

      This pilot study tests the JAWAC system to detect those apneas.

      This is an interventional diagnostic study on the JAWAC monitoring system validation in a
      prospective cohort of patients undergoing sedation in order to provoke sleep apnea. Indeed ,
      sedation technique is already used with propofol during snoring provocation tests in patients
      at risk for sleep apnea.
    

Intervention name(s): JAWAC system + Capnoline + Spo2
Intervention type(s): Device
Intervention description(s): measure mandibular mouvements + etCO2 + pulse oxymetry, respectively
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Propofol; Deep Sedation; Anoxia; Hypercapnia
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
Condition: Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional

Summary: 
      This is a research study of head cooling. Its goal is to determine whether cooling babies'
      heads can reduce or prevent brain damage that may have resulted from temporarily reduced
      oxygen supply to the brain. In this study, half of the babies (selected at random) will have
      a special cooling cap with circulating water placed on their head for 72 hours to lower the
      temperature of their brain. The rest of the baby's body will be maintained at a defined
      temperature by a standard overhead radiant heater. The study protocol includes the taking and
      analysis of blood samples, performance of brain wave tests, imaging of the brain by
      ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be
      assessed at 18 months of age.
    

Detailed description: 
      The objective of this study is to determine whether head cooling with mild systemic
      hypothermia in term infants following perinatal asphyxia is a safe procedure that improves
      survival without neurodevelopmental disability. Outcome will be assessed by survival and
      neurological and neurodevelopmental testing at 18 months of age.

      Within 6 hours of birth, infants will be randomized to either a non-cooled control group with
      rectal temperature kept at 37+/-0.5 degC or to head cooling with mild systemic hypothermia as
      follows. A cooling device capable of circulating cool water in a temperature-regulated manner
      through a cap fitted around the infant's scalp will cool the head. The core rectal
      temperature of the infant will be maintained at 34.5+/-0.5 degC by adjusting the cap water
      temperature. The infant's rectal, nasopharyngeal, scalp (fontanel), and skin (abdominal)
      temperatures will be continuously monitored. Also, metabolic, cardiovascular, pulmonary and
      coagulation laboratory measurements will be assessed at predefined time points. Cooling will
      be maintained for 72 hours, followed by four hours of rewarming, with the goal of raising the
      rectal temperature to normal body temperature by 0.5 degC per hour. The outcome measure of
      severe neurodevelopmental disability and survival rates at 18 months of age will be assessed
      by blinded, independent observers.
    

Intervention name(s): Cool-Cap
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonatal; hypoxic; ischemic; encephalopathy; HIE; birth asphyxia; neonatal encephalopathy; Asphyxia Neonatorum; hypothermia, therapeutic; brain cooling; selective head cooling
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the signs and symptoms of dry eye after cataract surgery between subjects
      randomized to receive intraoperative dexamethasone in addition to the use of a standard
      topical post-op treatment regimen.
    

Detailed description: 
      Forty patients requiring cataract surgery will be randomized to treatment of post-operative
      inflammation with a single intraoperative dexamethasone injection plus a standard course of
      topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will
      be administered at baseline, 1 week and 3 weeks following surgery.
    

Intervention name(s): dexamethasone intraocular suspension, 9%; Prednisolone Acetate 1% Oph Susp
Intervention type(s): Drug; Drug
Intervention description(s): single dose intracameral corticosteroid; topical ophthalmic steroid drop
Other intervention name(s): Dexycu
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled prospective study.
Masking: Single (Participant)
Primary purpose: Prevention