bioihbjkbjnl/mcl2 huggingface dataset:
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
Condition: Contraception; Contraception, Postcoital
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,
      randomized, prospective design was chosen with a washout of 21 days between the two study
      periods. Treatment groups were balanced with the same number of male healthy volunteers who
      were randomly assigned to the study drug administration sequences.
    


Intervention name(s): Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Levonorgestrel (Postday)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of one 0.75 mg coated tablet; Single dose of one 0.75 mg tablet
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with severe refractory ulcerative colitis (UC) or those who received placebo in
      study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy
      will be evaluated.
    

Detailed description: 
      Patients with severe refractory ulcerative colitis (UC) or those who received placebo in
      study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for
      a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index
      (DAI) score and other efficacy scores will be evaluated during the drug administration
      period.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): FK506
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative colitis; Tacrolimus; FK506; Treatment outcome
Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively
      transports substrates out of the intracellular compartment. One of the major sites of its
      action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial
      cells and involved in limiting the access of substrates such as antidepressants to the
      central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently
      identified showing a different treatment response to antidepressant drugs depending on the
      genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP
      will be associated with significantly different brain levels of the antidepressant
      escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of
      antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause
      a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated
      subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than
      lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy
      subjects with different genotypes of the above mentioned SNP will be differently affected
      after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression
      in lymphocytes and metabolic changes will be assessed.
    


Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): escitalopram 4 mg
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have
      been described in severe obstructive sleep apnea (OSA), and are reverted by continuous
      positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these
      biomarkers in mild-moderate OSA.
    

Detailed description: 
      The investigators aimed to compare NOx and U-NE levels and blood pressure (BP) between male
      patients with mild-moderate and severe OSA and determine the impact of 1 month of CPAP
      therapy on these parameters.

      The investigators undertook a prospective study of 67 consecutive OSA patients (36
      mild-moderate, 31 severe). Measurements of plasma NOx at 11 pm, 4 am and 7 am, 24-h U-NE and
      ambulatory BP were obtained at baseline and after 1 month of CPAP.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
Other intervention name(s): Automated pressure setting device (AutoSet Spirit, ResMed)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep apnea; CPAP treatment; Plasma nitrate; Urinary norepinephrine; Blood pressure
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain; Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The aim of the present study is to quantify the relative contribution of variables obtained
      during a physical fitness evaluation and a short screening questionnaire in determining the
      short-term and long term risk of persistent disabling low back pain in patients with chronic
      low back pain. It has been hypothesized that patients with higher physical fitness will
      present a lower risk of persistent disabling low back pain and so, a lower score on the
      questionnaire.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        volunteer with chronic nonspecific low back pain will be recruited among the university's
        community, its outpatients' chiropractic clinic and through advertisements in the local
        newspaper. They will first be screened by clinicians at the outpatients' chiropractic
        clinic in order to assess for the various inclusion and exclusion criteria.
      
Keywords: chronic low back pain; prognostic factors; disabling low back pain; lumbar muscle activity; start back screening tool; physical evaluation
Study for the RevLite Laser System for Facial Solar Lentigines
Condition: Facial Solar Lentigines
MeSH terms: Lentigo; Facies
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of the Revlite Laser System for
      treatment of facial solar lentigines
    

Detailed description: 
      Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
    

Intervention name(s): Revlite Laser System
Intervention type(s): Device
Intervention description(s): Revlite Laser System for the Treatment of Facial Solar Lentigines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function
Condition: Eye Health; Vision; Cognitive Function
Study type: Interventional

Summary: 
      VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and
      vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive
      health while helping to provide protection against blue throughout the day. In this pilot
      trial, approximately 16 participants will be recruited and randomly assigned to experimental
      and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their
      respective study condition for 60 days. Prior to and following the 60 day supplementation
      period, participants will undergo a series of optometry and cognitive examinations to
      quantify eye health and cognitive function outcomes.
    

Detailed description: 
      The study design is a randomized, double-blind, placebo-controlled, parallel design, pilot
      trial. In this pilot trial, approximately 16 participants will be recruited and randomly
      assigned to experimental and placebo conditions. Participants will consume 1 serving (2
      softgels) per day of their respective study condition for 60 days. All study-related
      procedures will be carried out at 2 locations, The Applied Science and Performance Institute,
      as well as at True Eye Experts. Both locations are in Tampa, FL. All screening for the study
      and the signing of all IRB documents will be held at the Applied Science and Performance
      Institute. Optometry eye examination at Day 0 and Day 60 will be conducted under the
      supervision of a board-certified O.D. at the True Eye Experts location. Computer-based
      cognitive assessments using a program called CNS Vital Signs will be carried out at Day 0 and
      Day 60 at the Applied Science and Performance Institute. The following exams will be carried
      out: Verbal Memory, Visual Memory, Composite Memory, and Cognitive Attention.
    

Intervention name(s): VisionPure Dietary Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will consume two softgels capsules of the Treatment (VisionPure) once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.; Subjects will orally consume two softgel capsules of Placebo once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fish Oil; Vitamin D; Antioxidant; Eye Health; Cognitive Function; Vision Health
Measurement of Hormone Levels in Patients Receiving 17-HPC for Preterm Delivery
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to measure hormones in the blood known to affect the timing of
      delivery after a single injection of 17-P in order to help understand its mechanism of action
      in preventing preterm delivery.
    

Detailed description: 
      A recent study by Meis and colleagues published in the New England Journal of Medicine in
      June 2003 demonstrated a 33% reduction in the rate of preterm delivery in patients with a
      previous history of preterm delivery who then used weekly 17-P injections in the subsequent
      pregnancy.

      This is a milestone in the prevention of preterm delivery and is the reason you have chosen
      to receive treatment with 17-P.

      However, how 17-P works to prevent preterm delivery is unclear. Knowledge of the mechanism of
      action of 17-P would help in selecting patients for treatment and may be useful in monitoring
      the efficacy of therapy.

      Studies have suggested that the timing of delivery depends on a type of placental clock,
      affected by levels of corticotropin-releasing hormone (CRH) and progesterone (P).

      CRH can be thought to act as an accelerator, and P as a brake. Serial injections of 17-P
      beginning in the second trimester of pregnancy may prevent preterm delivery by maintaining
      progesterone dominance, and be reflected in increased levels of progesterone and/or 17-P, or
      decreased levels of cortisol and/or CRH. These are the hormones that will be measured in this
      study.

      Results of the study will be important whatever the outcome. If there is no measurable change
      in the hormones measured, this is important to know and investigation of other markers can be
      pursued. If there is a measurable change in the hormones measured, then this pilot study
      could serve to support a larger more definitive study, which could lead to very valuable
      information relating to the practical use of 17-P for the prevention of preterm delivery.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
AZD7687 Multiple Ascending Dose Study
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of AZD7687 following multiple ascending dose administrations in in
      overweight to obese but otherwise healthy male subjects
    


Intervention name(s): AZD7687; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.; Oral suspension, once daily. Totally 8 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Safety; tolerability; PK; healthy; overweight; obese
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and the safety of the treatment.
    


Intervention name(s): docetaxel and cisplatin
Intervention type(s): Drug
Intervention description(s): 4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy in terms of overall survival of AZD6244 in combination with
      dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation
      positive advanced cutaneous or unknown primary melanoma
    


Intervention name(s): AZD6244; Dacarbazine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral capsules, 75mg twice daily; 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle; Placebo
Other intervention name(s): selumetinib; DTIC
Intervention MeSH terms: Dacarbazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BRAF mutation positive; advanced melanoma; Advanced cutaneous melanoma; Unknown primary melanoma
Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology
Condition: Carotid Artery Plaque; Ultrasonic Diagnosis
MeSH terms: Carotid Stenosis
Study type: Observational [Patient Registry]

Summary: 
      OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk
      factors for unstable carotid plaque. This study was designed to evaluate whether carotid
      intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced
      ultrasound (CEUS).

      METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared
      to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with
      CD34 and MMP9 staining.
    

Detailed description: 
      1. To enroll 50 cases of patients suffering from carotid artery stenosis continuously, the
           investigators perform contrast enhanced ultrasound on patients for identifying the
           vulnerable plagues and taking high resolution MR inspection to analysis those plagues at
           the same time.

        2. All patients undergo carotid endarterectomy. The vulnerable ingredients of carotid
           plaques such as intraplaque neovascularization and bleeding are identified by
           pathological examination and immunohistochemical staining.

        3. To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with
           high resolution MR.

        4. The investigators divide patients into the stable group and the vulnerable group based
           on the results of CEUS inspection. To analysis the incidence of postoperative
           complications such as stroke and mortality within 30 days and to compare the differences
           between the two groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the patients suffering from carotid artery stenosis
      
Keywords: Carotid Artery Plaque; Contrast Enhanced Ultrasound; Plague Histopathology
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser
      treatment in patients with stress urinary incontinence. Eligible subjects will be randomized
      to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits
      3, 6 and 12 months following the last treatment.
    

Detailed description: 
      Following a screening visit, eligible subjects will be enrolled into the study. Subjects will
      be randomized into either laser treatment or sham treatment. Each subject will receive 3
      treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last
      treatment.

      Further demographic information and patient history will be obtained from the subjects'
      electronic files.
    

Intervention name(s): carbon dioxide laser; sham laser
Intervention type(s): Device; Device
Intervention description(s): carbon dioxide laser; sham laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis
Condition: Pharyngitis
MeSH terms: Pharyngitis; Laryngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to assess the clinical efficacy and safety of meloxicam
      suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or
      nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with
      a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis
    


Intervention name(s): Meloxicam; Diclofenac; Nimesulide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Diclofenac; Meloxicam; Nimesulide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Condition: Alzheimers Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to
      investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending
      intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for
      the treatment of Alzheimer's Disease.
    

Detailed description: 
      This study uses a parallel group design, with participants recruited in 5 planned sequential
      cohorts. Additional cohort(s) may be added if dose escalation stopping criteria are not met
      after cohort 5. Participants will receive a single IV dose of either RO7126209 or placebo.
      RO7126209 doses will be administered in ascending order. After the starting dose, subsequent
      doses will be selected in an adaptive manner during study conduct based on emerging safety,
      tolerability and PK data.
    

Intervention name(s): RO7126209; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed.; Participants will be administered a single intravenous dose of matching placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients
Condition: Antioxidative Stress; End Stage Renal Disease on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who
      were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid
      groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and
      after three months for all patients.
    


Intervention name(s): Alpha lipoic acid; Selenium
Intervention type(s): Drug; Drug
Intervention description(s): 20 patients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.; 23 patients who received Selenium 200µg once daily with their routine therapy just a
Intervention MeSH terms: Thioctic Acid; Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxidative stress; Antioxidants; mitochondrial function; CoQ10; miRNA-126; Hemodialysis