bioihbjkbjnl/mcl2 huggingface dataset:
Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization
Condition: Infertility; Ovulation Induction; In-Vitro Fertilization
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the
      convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating
      hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also
      in in-vitro fertilization (IVF).
    


Intervention name(s): GONAL-f®
Intervention type(s): Drug
Intervention description(s): GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
Other intervention name(s): Follitropin alpha
Intervention MeSH terms: Follicle Stimulating Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Ovulation induction; Gonal-F; Follitropin alpha; Controlled ovarian stimulation
Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion
Condition: Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Observational

Summary: 
      The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of
      pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the
      pleural effusion location and size. The VRI system uses pressure sensors (electronic
      stethoscopes) to record the energy created by the airflow in the lungs during breathing.
    

Detailed description: 
      The accumulation of excess fluid in the pleural cavity of the lungs, known as pleural
      effusion, is a common clinical condition that may be the result of trauma or disease.
      Diagnosis and management of pleural effusion can be done by X-Ray or ultrasound; however
      X-Ray emits radiation, requires a special room and expert personnel, while ultrasound
      requires a high level of expertise to perform and analyze. The VRI device is non-invasive and
      radiation free. The VRI device is a simple method to image the lungs in a regional manner to
      examine changes that occur during pleural effusion.

      Comparison: X-ray and ultrasonography evaluations of pleural effusion, compared to VRI
      acoustic imaging evaluations.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with pleural effusion
      
Keywords: pleural effusion; lung sounds; acoustic monitoring
Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      [S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in
      healthy volunteers using a novel methodology
    


Intervention name(s): [S,S]-Reboxetine
Intervention type(s): Drug
Intervention MeSH terms: Reboxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Equipment; Supplies
To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations
Condition: NSCLC; Healthy Volunteers; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label and uncontrolled study to evaluate the comparative PK of EQ143
      following oral single dose administration in adult healthy volunteers different racial and
      ethnic populations.

      A total of one (1) single dose cohort is planned at 110 mg of EQ143. EQ143 is an approved
      therapy in China at the 110 mg dose for the treatment of patients with Epidermal Growth
      Factor Receptor (EGFR) T790Mmutation-positive, metastatic non-small cell lung cancer (NSCLC),
      who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy.

      A total of 45 (15 Caucasian, 8 Black/African American and 7 Hispanic/Latino, and 15 ethnic
      Chinese)
    


Intervention name(s): aumolertinib
Intervention type(s): Drug
Intervention description(s): EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg
Other intervention name(s): EQ143
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease
Condition: Non Alcoholic Fatty Liver Disease; Steatohepatitis; Hypertriglyceridemia; Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypertriglyceridemia
Study type: Interventional

Summary: 
      To explore whether there is a different response to omega-3 fatty acid rich diet with respect
      to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor
      allele (GG) and the common allele homozygous (CC) of PNPLA3.

      Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will
      lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention
      than the common allele homozygous supplementation.
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD) is emerging as one of the most common complications
      of childhood obesity. It is associated with and predicts the metabolic syndrome, independent
      of overall obesity. Increased ALT levels are associated with deterioration in insulin
      sensitivity and glucose tolerance, as well as with increasing free fatty acid (FFA) and
      triglyceride levels. The prevalence of metabolic syndrome and prediabetes increases with the
      increases in hepatic fat content in a cohort of obese adolescents.

      Fatty liver, independent of visceral and intramyocellular lipid content plays a central role
      in the impairment of liver, muscle and adipose insulin sensitivity in obese adolescents.
      Thus, fatty liver disease may be the hepatic component of the metabolic syndrome.

      Omega 3 fatty acids lower plasma triglyceride concentrations. The subjects entering the omega
      diet study will be consuming an omega rich diet that is tailored to their caloric needs. This
      calculation is based on the patient's weight, age, and gender with the purpose of not
      modifying their weight at all. Weight maintenance is a very important factor in this arm of
      the study. They will be on the diet for 12 weeks.
    

Intervention name(s): Omega diet
Intervention type(s): Other
Intervention description(s): Eligible subjects will receive omega rich diet for 12 weeks with weekly appointments to obtain food records, draw serum samples and provide meals.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fatty liver; hypertriglyceridemia; elevated liver enzymes
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
      determine the effect of ranolazine when added to metformin on glycemic control in adults with
      type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment
      with stable metformin therapy in addition to diet and exercise.
    


Intervention name(s): Ranolazine; Placebo to match ranolazine; Metformin; Placebo to match metformin; Diet; Exercise
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral; Behavioral
Intervention description(s): Ranolazine tablet(s) administered orally; Placebo to match ranolazine for the duration of the study; Metformin tablet(s) administered orally once daily; Placebo to match metformin for the duration of the study; Participants are instructed to continue the diet regimen prescribed by their physician.; Participants are instructed to continue the exercise regimen prescribed by their physician.
Other intervention name(s): Ranexa®
Intervention MeSH terms: Metformin; Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The aim of the study is to develop robust analytical protocols for first-void urine sample
      preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for
      improved diagnosis of cervical (pre)cancer lesions.
    

Detailed description: 
      In total 100 women will be included in this trial, women diagnosed with abnormal cytology
      results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy
      exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM device,
      prior to their colposcopy exam at the clinic. The collected urine samples will be used for
      the development and optimisation of robust analytical protocols for first-void urine sample
      preparation and biomarker assays.

      During colposcopy, the cervix will be visually inspected, whether or not combined with a
      biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by
      using a colposcope that gives an illuminated, magnified view of the cervical region. It often
      includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this fluid will
      be collected and serve as the intermediate step between biomarkers in cervicovaginal
      secretions and urine.
    

Intervention name(s): First-void urine collection; Cervicovaginal lavage fluid collection
Intervention type(s): Other; Other
Intervention description(s): One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).; During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.
Other intervention name(s): FV urine; VagLav
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort of women involves 100 women, diagnosed with an abnormal smear and/or high risk
        HPV infection (cytology results already available) requested for colposcopic examination.
        During this colposcopic examination, cervical samples are collected and send to the
        pathology laboratory. In addition, these women are asked to collect a first-void urine
        sample with the Colli-PeeTM device and fill in a questionnaire, prior to their colposcopy
        exam at the clinic (UZA), during which a cervicovaginal lavage fluid sample will be
        collected as well.
      
Biospecimen description: 
      First-void urine samples and Cervicovaginal lavage fluid (VagLav) samples
    
Keywords: Human Papillomavirus; Biomarker; Self-sampling; First-void urine; Cervicovaginal fluid; Colposcopy
To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure
Condition: Acute on Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Hepatorenal Syndrome
Study type: Interventional

Summary: 
      Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin
      Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney
      injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response:
      Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline
      (iii) No response: No regression of acute kidney injury

      Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or
      for a maximum of 7 days after rescue treatment will be followed.

      If intolerant to terlipressin, excluded from study and rescue treatment will be given in form
      of noradrenaline or octreotide and midodrine.
    


Intervention name(s): Nor adrenaline + albumin; Terlipressin + albumin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Terlipressin; Epinephrine; Racepinephrine; Norepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism and Efficacy of Rehabilitation Approaches
Condition: Cerebrovascular Accidents
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Identify the possible mechanisms and the relative effectiveness of existing rehabilitation
      approaches that target upper extremity deficits of stroke patients on the ground that these
      approaches are based on neuroplasticity principles and sound motor control theories.
    

Detailed description: 
      Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined
      therapy were made. Stroke patients will receive one of these three approaches and be
      evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The
      evaluation will include clinical measures of motor function, ADL, and quality of life,
      kinematic performance, and activation patterns of cortex.
    

Intervention name(s): Constraint-induced therapy (CIT); Bilateral arm training (BAT); Combined therapy (CT); Control intervention
Intervention type(s): Other; Other; Other; Behavioral
Intervention description(s): restraint of the unaffected arm and practice of the affected arm; bilateral symmetric, repetitive arm training; combined different treatment approaches; Conventional treatment program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke rehabilitation; cortical reorganization; kinematic analysis
Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
Condition: Atherogenic Dyslipidaemia; Abdominal Obesity
MeSH terms: Obesity; Dyslipidemias; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum
      Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels
      compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to
      assess the tolerability and safety of once-a-day administrations of oral doses of GFT505
      during 28 days.
    

Detailed description: 
      The study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede
      a 4-week double-blind treatment period and a 2-week follow-up period.

      During the screening period, patients will be asked to start or continue adequate diet and
      exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). For
      patient taking any lipid-regulating medication, a minimum of 8-week wash-out from
      lipid-regulating therapies (fibrates, statins, …) is required.
    

Intervention name(s): GFT505 80mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast; hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherogenic-dyslipidaemia; PPARs
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418)
      compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month
      period followed by an additional three months of treatment on elagolix.
    

Detailed description: 
      The study followed a parallel-group design in which participants were randomized (1:1:1:1) to
      one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once
      daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg
      (monthly). Blinding was achieved using a double-dummy design. Following 12 weeks of dosing,
      participants continued in the study for an additional 12 weeks; participants randomized to
      elagolix continued to receive their assigned dose and participants randomized to placebo or
      leuprorelin acetate were re-randomized to receive one of the two doses of elagolix (150 mg
      q.d. or 250 mg q.d.) for 12 weeks in a double-blind fashion. Six weeks after the last dose of
      the study drug at the end of Week 24, a follow-up visit was performed (end of Week 30).

      There was no pre-specified primary efficacy end point as there was no single key efficacy
      outcome measure in this exploratory Phase 2 study. For purposes of results reported here,
      Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain
      is designated as the primary outcome measure.
    

Intervention name(s): Leuprorelin Acetate Depot; Elagolix; Placebo to Elagolix; Placebo to Leuprorelin Acetate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection; Elagolix tablets administered orally; Placebo tablet administered orally; Saline solution administered as an intramuscular injection
Other intervention name(s): Prostap SR; NBI-56418; Orilissa™
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bone mineral density,endometriosis,pelvic pain
3-months Success Rate of Direct Pulp Capping With Biodentine®
Condition: Dental Pulp Capping
Study type: Observational

Summary: 
      Biodentine® is a most recent material for direct pulp capping. The aim of this study is to
      determine the 3 months success rate (defined as clinical and radiographic successes together)
      of direct pulp capping realized with Biodentine®.
    

Detailed description: 
      Context : When a pulpal exposure happens on a vital tooth (without irreversible
      inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2,
      MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct
      pulp capping is poorly documented.

      Objective : The main aim of this study is to determine the 3 months success rate (defined as
      clinical and radiographic successes together) of direct pulp capping realized with
      Biodentine®. The other aims are to determine the factors which have an influence over the
      success or the failure of direct pulp capping.

      Method : The patient's non-opposition is obtained after a loyal explanation of the study in
      order to collect clinical data, if a pulpal exposure (<2mm) happens on a vital tooth during
      decy excavation.

      The operator registers the following data: age of the patient, type of the concerned tooth,
      volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp
      bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a
      radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then
      realized.

      A statistical analysis will be performed to determine the success rate (binomial distribution
      with p=0.05). The predictive factors of success or failure will be analyzed with a logistic
      regression (with p=0.05).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients with a small pulp exposure (<2mm) created during carie removal on a vital
        tooth
      
Keywords: direct pulp capping, biodentine
Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose
      administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)
    


Intervention name(s): BMS-986165; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive BMS-986165.; Participants will receive fluvoxamine.
Intervention MeSH terms: Fluvoxamine; Deucravacitinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Microelectrodes in Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of this study is to test microelectrodes in intracranial monitoring to see if
      they will provide novel information on the epileptic potential of the implanted brain tissue.
      A secondary objective is to investigate the activity of single neurons during specific
      cognitive tasks.
    

Detailed description: 
      The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain
      patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG)
      recording. In this type of EEG recording, electrodes are placed on the brain surface or
      inserted into the brain through an opening in the skull. In addition to standard electrode
      recording, this study will use ultra thin microelectrodes. Microelectrodes are only several
      micrometers thick and are useful because they are able to record the activity of single
      neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery
      and tremendous research potential in cognitive neuroscience.
    

Intervention name(s): Microelectrodes
Intervention type(s): Device
Intervention description(s): Microelectrode implantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic