bioihbjkbjnl/mcl2 huggingface dataset:
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
Condition: Cancer of Prostate; Cancer of the Prostate; Prostate Cancer; Prostatic Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate
      cancer, who were enrolled from January 2011-June 2013. These patients were recruited
      throughout North Carolina, and also in partnership with institutions across the country.
      Patients enrolled before they start treatment, and are then followed prospectively through
      treatment and then afterwards. This observational study collects information on quality of
      life, cancer control, and health care received inclusive of treatment and management of
      subsequent effects including complications and recurrence. The objective of this study is to
      examine comparative outcomes among different modern prostate cancer treatment options in this
      cohort of patients.
    

Detailed description: 
      Localized prostate cancer treatment options is consistently a "highest priority" comparative
      effectiveness research (CER) topic according to the Institute of Medicine, Agency for
      Healthcare Research and Quality (AHRQ), and other summary reports. Patients urgently need
      information on the comparative outcomes of modern treatment options to guide decision-making
      for this disease that causes significant burden based on its high prevalence, mortality and
      treatment effects on quality of life. The status quo as it pertains to prostate cancer is
      significant overtreatment causing potential patient harm, rapid diffusion of new/expensive
      technologies without proven benefit and patients lacking high quality research evidence to
      balance direct-to-consumer advertising and guide individualized decision-making.

      NC ProCESS is a population-based cohort designed specifically to address well-described
      knowledge gaps. It was designed in close collaboration with the unique AHRQ consortium
      stakeholder group, which included representatives from patients, clinicians and policymakers.
      Stakeholders helped define study design to emphasize "real-world" patients and select
      patient-centered and relevant outcomes, and have been involved throughout assembly of this
      patient cohort. The diverse cohort is well-represented by "hard to reach" patients;
      enrollment before treatment avoids biases with participation and recall. As clinical trials
      are not feasible to address the central questions in prostate cancer CER, this prospective
      study will yield the highest level of evidence to inform patients and other stakeholders.
      With an assembled cohort, this study is necessary to examine comparative outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
Condition: Minimally Conscious State; Vegetative State
MeSH terms: Persistent Vegetative State
Study type: Observational

Summary: 
      Analyze the behavioral response of patients with disorders of consciousness through olfactory
      stimulation, compare the response of olfactory stimulation in patients with different
      consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first,
      third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the
      Coma Recovery Scale-Revision (CRS-R).
    

Detailed description: 
      Previous studies suggested that olfactory stimulus have some effect on some patients with
      disorders of consciousness. Then, the aim of the present study is to know the prognostic
      value of olfactory stimulation and the diagnosis for DOC patients. DOC patients were
      recruited (standard diagnosis procedure is 5 times CRS-R testing within 10 days). The
      different stimuli were as follows: 1) 1-octene-3-ol, odor. 2) pyridine, odor. 3) water. We
      presented these stimuli randomly, and we recorded the patient's CRS-R scale behavioral
      response and response to olfactory stimulation. Analyze the behavioral response of patients
      with disorders of consciousness through olfactory stimulation, compare the response of
      olfactory stimulation in patients with different consciousness, and analyze the impact of
      olfactory stimulation on diagnosis; After the first, third, and sixth months of initial
      enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision
      (CRS-R).
    

Intervention name(s): Coma Recovery Scale-Revised
Intervention type(s): Diagnostic Test
Intervention description(s): Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected three stimuli: 1) 1-octene-3-ol, 2) pyridine, 3) water. We presented these three stimuli in front of the patients nose for 3 seconds.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with disorders of consciousness
      
Keywords: disorders of consciousness; prognosis prediction; minimally conscious state; vegetative state; olfactory stimulation
Regulation of Lipoprotein Metabolism in Obese Men
Condition: Obesity; Dyslipidemia; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low
      HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key
      characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that
      the risk of CVD is increased in subjects with the MetS. The precise reason for this remains
      unclear, but appears to be closely related with dyslipidaemia. Effective management of
      dyslipidaemia is important to reduce the risk of CVD in these subjects.

      Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis
      by fish oils improve lipoprotein metabolism in visceral obese men.
    

Detailed description: 
      The study employed a factorial study design, stable isotopy and mathematical modelling to
      examine the independent and combined effects of decreasing cholesterol substrate availability
      with atorvastatin and decreasing triglyceride substrate availability with fish oils on
      lipoprotien kinetics (apoB, apoA, apoC-III and chylomicron remnants) in insulin-resistant men
      with visceral obesity.
    

Intervention name(s): Atorvastatin; Fish oils
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: lipoprotein metabolism; cardiovascular disease; obesity
A Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This is a model development, open label, no therapeutic treatment, three sequential group,
      short term-gluten challenge study in subjects with celiac disease. Immune responses are
      evaluated following gluten challenge.

      Approximately fifteen subjects with celiac disease will be enrolled in up to three sequential
      groups (5 subjects per group).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of approximately 15 subjects (male or female) with celiac disease will be enrolled.
        Subjects must be positive for the HLA-DQ2.5+ haplotype. The disease should be well
        controlled through gluten-free diet. They must have followed a strict gluten free diet
        prior to screening with no symptoms that would suggest accidental gluten ingestion during
        that time.
      
Biospecimen description: 
      The ICF relates that biospecimens will be retained at the central laboratory or another
      secure storage facility. It does make it clear samples will be destroyed after 5 years. Or
      that subjects can withdraw and have their samples destroyed.
    
Keywords: Celiac Disease; Gluten; Immune Response; Challenge
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug levels, safety, and tolerability of
      BMS-986278 in healthy Chinese participants.
    


Intervention name(s): BMS-986278; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days.; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair
Condition: Sexual Dysfunction; Hernia, Inguinal; Other Chronic Postoperative Pain
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      Previous studies have reported that about 3 % of patients who have had open inguinal
      herniorrhaphy had a visceral, ejaculatory-related pain.

      The investigators want to assess this problem among patients after laparoscopic inguinal
      hernia repair with(self-administered questionnaire study).
    


Sampling method: Non-Probability Sample
Study population: 
        Patients who have had a laparoscopic inguinal hernia repair
      
Keywords: Groin hernia; chronic pain; Persistent postoperative pain; Laparoscopic inguinal herniotomy; Sexual dysfunction
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate whether the volume
      of water administered with NN9924 affects the anatomical location (stomach or proximal small
      bowel) of tablet erosion.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.
Other intervention name(s): NN9924
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Probiotics on Gingivitis
Condition: Gingivitis; Chronic
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of the study is to assess the effect of oral probiotics containing Streptococcus
      salivarius M18 on gingivitis and oral hygiene in young adults.
    

Detailed description: 
      This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of
      the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral
      hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess
      the effect of oral probiotics, the following parameters will be used: gingival index, GI;
      gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the
      Quigley-Hein Plaque Index, TMQHPI).
    

Intervention name(s): Dentoblis; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dissolve the tablets in the mouth once a day for 4 weeks; Dissolve the tablets in the mouth once a day for 4 weeks
Other intervention name(s): Probiotic: Streptococcus salivarius M18
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment double-blind, randomized, two-arm parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Desaturation Validation of INVSENSOR00012
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to compare the accuracy of a noninvasive measurement of oxygen
      saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial
      blood samples will be collected from healthy adult subjects while undergoing a desaturation
      procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's
      arterial oxygen concentration is approximately 70%. During the desaturation, the subject's
      hand and arm without the arterial line will be subjected to motion.After completing the
      desaturation, the gas mixture will be returned to room air concentrations.
    


Intervention name(s): INVSENSOR00012
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine how preservative free tafluprost ophthalmic solution
      (0.0015%) is distributed in blood circulation after ocular administration in children who
      have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general
      will also be assessed.
    


Intervention name(s): Preservative free tafluprost opthalmic solution
Intervention type(s): Drug
Intervention description(s): 0.0015% eye drops q.d, in both eyes for 7 to 9 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain control is a signiﬁcant challenge in medical practice. Inadequate pain
      control could decrease patient's satisfaction, delay postoperative ambulation, increase the
      incidence of pulmonary and cardiac complications and cause the development of chronic
      postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and
      opioid consumption.

      The addition of regional techniques to general anesthesia showed better pain management and
      less consumption of opioids compared to the traditional techniques.

      The aim of this study is to compare the effectiveness of ultrasound guided erector spinae
      plane block versus quadratus lumborum block regarding postoperative analgesia in patients
      undergoing laparoscopic sleeve gastrectomy.
    


Intervention name(s): Group Erector Spinae Plane Block (ESPB); Group Quadratus Lumborum Block (QLB); Group (C) (Control group)
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg "; Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg "; Where patients will be operated under general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate
Condition: Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I open label study is conducted to assess the potential pharmacokinetic
      interaction of Raxone® with midazolam in healthy male volunteers
    


Intervention name(s): Raxone (idebenone 150 mg); Midazolam 2,5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10; Midazolam (2,5 mg single oral dose) on days 1, 3 and 10
Intervention MeSH terms: Midazolam; Idebenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study in Adult Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess whether LY2216684 is superior to placebo in the
      treatment of adult patients with major depressive disorder.
    


Intervention name(s): LY2216684; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks; Dose: 3 tablets QD for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical study to investigate if a single dose of an approved drug product (glycopyrrolate
      Inhalation Solution) reduces trapped air in the lungs of participants with chronic
      obstructive pulmonary disease. This study is accepting male and female participants over the
      age of 40. The study will be conducted at one site located in the United States.
    

Detailed description: 
      This is a single center, randomized, double-blind, placebo-controlled, single-dose, 2-way
      crossover study in approximately 20 adult subjects ≥ 40 years of age with COPD. The study is
      designed to evaluate the effect of a single dose of GIS on lung hyperinflation. The two study
      treatments, both administered using the Magnair device.

      The study will randomize 10 subjects per treatment sequence, for a total of 20 subjects. At
      the Sponsor's discretion, additional subjects may be enrolled in an effort to achieve at
      least 20 completers, with no more than 24 subjects randomize.

      The study will consist of a Screening period, a randomized 2-way cross-over treatment period
      during which subjects will receive two single-doses each separated by a 7-day washout period,
      and a follow-up 7 (± 2) days after the last study drug dose.

      This study is designed to test the hypothesis that in adults with COPD subjects as
      characterized by the study inclusion/exclusion criteria, after 2 cross-over periods of
      treatment, the primary null hypothesis for this study is that the mean change of RV from
      baseline at 6 hours postdose for a single dose of GIS is equal to the mean change of RV from
      baseline at 6 hours postdose for a single dose of placebo inhalation solution (PIS). The
      alternative hypothesis is that these means are different.
    

Intervention name(s): Glyocopyrrolate Inhalation Solution administered by Magnair; Placebo administered by Magnair
Intervention type(s): Combination Product; Drug
Intervention description(s): glycopyrrolate Inhalation Solution 25mcg, single dose; Placebo Inhalation Solution
Other intervention name(s): LONHALA
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers
Condition: Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and
      safety of orally administered MEK inhibitor trametinib as the second line in subjects with
      advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary
      endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage
      of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four
      tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily
      regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese
      population.

      Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose
      of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until
      disease progression or withdrawal from the study treatment, all subjects will receive one
      tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational
      research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers
      for biological activity, and sensitivity or resistance to treatment with trametinib .
    


Intervention name(s): Trametinib (single tablet); Trametinib (Multiple tablet)
Intervention type(s): Drug; Drug
Intervention description(s): The drug substance is blended with inert; The drug substance is blended with inert
Intervention MeSH terms: Trametinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; second line monotherapy; GSK1120212 (trametinib); MEK inhibitor; locally advanced or metastatic biliary tract cancers