bioihbjkbjnl/mcl2 huggingface dataset:
Deep-Learning for Automatic Polyp Detection During Colonoscopy
Condition: Screening Colonoscopy
Study type: Interventional

Summary: 
      The primary objective of this study is to examine the role of machine learning and computer
      aided diagnostics in automatic polyp detection and to determine whether a combination of
      colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma
      detection rate compared to standard colonoscopy.
    


Intervention name(s): Computer Algorithm
Intervention type(s): Device
Intervention description(s): This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
Condition: Type 2 Diabetes Mellitus; Hepatic Impairment
MeSH terms: Liver Diseases; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835,
      PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1
      of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and
      matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be
      conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).
    


Intervention name(s): Ertugliflozin 15 mg
Intervention type(s): Drug
Intervention description(s): Tablet
Intervention MeSH terms: Ertugliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      Recent evidence has shown that kidney volume predicts the likelihood of developing renal
      insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth
      of cysts and the harm they do to kidney function. Recent studies indicate that the rate of
      kidney volume increase is hastened by excess dietary protein, salt, and potential net acid
      precursors, and slowed by increased water intake sufficient to lower plasma vasopressin
      levels.

      Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the
      end-stage, but there is currently no specific diet prescription that takes potentially
      harmful dietary elements into account for ADPKD patients in the earliest stages of the
      disease. This study will examine a novel diet for ADPKD created by the researcher termed the
      ADPKD diet.
    


Intervention name(s): ADPKD Diet
Intervention type(s): Other
Intervention description(s): Diet specifically designed for people with ADPKD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ADPKD; PKD; Kidney Disease; ADPKD diet
Lymphocytic Subsets and Cytokine Production With H. Pylori Infection
Condition: Duodenal Ulcer; Gastric Ulcer; Dyspepsia
MeSH terms: Stomach Ulcer; Duodenal Ulcer; Ulcer; Dyspepsia
Study type: Interventional

Summary: 
      The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets
      in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori
      therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of
      mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing
      immune mechanisms responsible for the chronicity of the disease and its associated lesions.
    

Detailed description: 
      Helicobacter pylori, a Gram-negative spiral bacterium, has been first isolated from a patient
      with chronic active gastritis since 1982. Recent studies strongly suggest that chronic
      infection with H. pylori is tightly associated with chronic gastritis, peptic ulcer, and
      gastric carcinoma. However, only a minority of infected people develop signs and symptoms of
      gastric pathology. Thus, both host and microbial factors may lead to different outcomes of
      infection. In spite of high prevalence in general population and increasing clinical
      attention has been paid on this infection, the knowledge of pathogenic mechanism of H. pylori
      infection is still limited and little is known about the role of host immune response in the
      pathogenesis of disease.The aims of this study are 1) to determine the cytokines produced by
      both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before
      and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and
      distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define
      possible contributing immune mechanisms responsible for the chronicity of the disease and its
      associated lesions.
    

Intervention name(s): immune response
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: H. pylori、immune response、lymphocytic subsets、cytokine
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
Condition: Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal
      Resection (EMR) site following complete removal of the lesion, or will not receive clips and
      proceed with standard of care.
    

Detailed description: 
      The outlined literature suggests that colonic post EMR bleeding may be prevented by the use
      of prophylactic endoscopic clips. There has thus far been no prospective study to confirm
      this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled
      trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for
      the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given
      the significantly increased rate of bleeding in the proximal colon, clip placement in this
      location may have the greatest benefit. If it is proven that such a prophylactic technique is
      effective and safe, it may lead to significantly decreased patient morbidity and health care
      resources associated with the management delayed bleeding.
    

Intervention name(s): Endoscopic Clip
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of Stannsoporfin in Neonates
Condition: Nutritional and Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a
      single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term
      and near-term newborns admitted to the well-baby nursery and enrolled with "intention to
      treat".
    

Detailed description: 
      For purposes of analysis, 2 patient populations are defined. One population consists of those
      babies who did not develop severe hyperbilirubinemia (TSB <9 mg/dL) during the first 36 hours
      of age. This population is referred to as the untreated population of screened but not
      randomized patients. The second population of babies was defined as those infants who develop
      severe hyperbilirubinemia. These infants were randomized to treatment with either
      stannsoporfin or the sham injection and will be the focus of the efficacy and safety
      analysis. This population was referred to as the treated population.

      The treated population was used for the efficacy and safety analysis. These infants were
      randomized to either stannsoporfin or the sham injection treatment group.
    

Intervention name(s): stannsoporfin; Sham Injection
Intervention type(s): Drug; Other
Intervention description(s): Intramuscular injection of stannsoporfin to treat jaundice.; nothing
Intervention MeSH terms: Tin mesoporphyrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Kernicterus; Neonatal Jaundice; Newborn Jaundice; Hyperbilirubinemia; Stannsoporfin
"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to identify the most appropriate method for managing patients with
      AF recurrences after the first ablation procedure, through the diagnostic data stored by a
      subcutaneous AF monitor.
    


Intervention name(s): Circumferential PVI and subcutaneous cardiac monitor implantation
Intervention type(s): Procedure
Intervention description(s): The left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Percutaneous continous monitoring; ablation
Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was to evaluate the efficacy and safety of Chidamide in combination with
      exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.
    

Detailed description: 
      This study including two parts: (1) Part A, open-label design, 20 patients will be enrolled
      and receive 30 mg Chidamide BIW and 25 mg exemestane QD. The main object of part A is to
      evaluate the pharmacokinetic and pharmacodynamic profile of Chidamide when in combination
      with exemestane. (2) Part B, randomized and double-blinded design, 328 patients will be
      assigned randomly in a 2:1 ratio to experiment group (30 mg Chidamide BIW + 25 mg exemestane
      QD) and control group (placebo BIW + 25 mg exemestane QD), to evaluate the efficacy and
      safety of Chidamide when in combination with exemestane in patients with locally advanced or
      metastatic estrogen receptor-positive breast cancer progressing on endocrine therapy.
    

Intervention name(s): Chidamide; exemestane; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg, administered orally twice per week (BIW); 25 mg, PO daily; Administered orally twice per week (BIW)
Other intervention name(s): CS055; Aromasin; Simulation tablet of Chidamide
Intervention MeSH terms: Exemestane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chidamide; breast cancer; exemestane; Estrogen Receptor
Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      Male and female healthy volunteers. Patients must also possess a full current driving license
      (for at least one year), and be a regular car driver.
    

Detailed description: 
      The study is a single centre, randomised, double blind, placebo controlled 2-way crossover
      design in a group of 32 healthy male and female volunteers. The medications under
      investigation are eszopiclone and placebo. Volunteers will receive the study medications and
      placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day
      3 of each treatment period. Each treatment period will be separated by at least a 7-day
      washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor
      Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was
      changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): eszopiclone 3 mg; Placebo tablet
Other intervention name(s): S-Zopiclone; Lunesta
Intervention MeSH terms: Eszopiclone; Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Next day driving
Pupillography as Screening Tool for Brain Insulin Resistance
Condition: Obesity
Study type: Interventional

Summary: 
      Cerebral insulin action is important in the regulation of whole body glucose metabolism.
      However, the cerebral insulin action differs between individuals - there is a so called
      cerebral insulin resistance. The influence of central insulin action on peripheral metabolism
      seems at least partially mediated via the autonomous nervous system. A noninvasive method to
      measure autonomic function is the pupillography. The aim of the study is to find out whether
      pupillography can be used to assess central insulin activity. Thus, pupillography will be
      performed in 30 normal weight and 30 overweight subjects before and after application insulin
      intranasally.
    


Intervention name(s): human insulin; placebo; Pupillography
Intervention type(s): Drug; Drug; Diagnostic Test
Intervention description(s): human insulin administered as nasal spray; placebo administered as nasal spray; Autonomic tone will be adressed by pupillography using the F2D2 (Amtech Germany) device.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to establish the tipranavir-ritonavir steady-state
      dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the
      effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to
      establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the
      short-term safety and tolerance of this drug combination will be evaluated.
    


Intervention name(s): TPV low 1; TPV low 2; TPV medium; TPV high 1; TPV high 2; RTV low; Ritonavir high; Radiolabelled erythromycin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estimation of Functional Liver Reserve Using Cholinesterases
Condition: Hepatocellular Carcinoma; Cirrhosis; Liver Neoplasm; Liver Disease
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Liver Diseases; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in
      cirrhosis is of paramount importance to properly select candidates for surgical resection.
      Together with the value of bilirubin, the presence/absence of ascites and esophageal varices,
      and the rate of residual liver volume, which are our current parameters to measure functional
      liver reserve, the investigators sought to investigate the value of preoperative
      cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for
      HCC.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The records of approximately 245 consecutive patients who were referred at our Unit because
        of HCC were reviewed. Among those, 191 (78%) were submitted to surgery, and 181 (74%) were
        resected. The patients excluded from surgery were addressed to symptomatic treatments
        because of advanced disease or impaired liver functional reserve, or to percutaneous
        ablation therapy according to our policy. Among resected patients, there were 145 (80%) men
        and 36 (20%) women, with median age of 67 years (range 36-87 years).
      
Keywords: hepatocellular carcinoma; liver tumor; cirrhosis; liver resection; tumor staging; liver disease staging
Screening for Advanced Heart Failure Treatment (SEE-HF)
Condition: Advanced Heart Failure; CRT and/or ICD
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients
      are underserved. The purpose of this prospective, observational study is to obtain
      multi-center data on the proportion of patients with CRT and/or ICD who are candidates for
      advanced heart failure treatment and obtain insights into patient and physician decisions
      regarding referral for advanced heart failure therapy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients with CRT and/or ICD, EF </= 40% and in NYHA III-IV
      
Keywords: Thoratec Corporation
Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary aim of the trial

        1. to verify safety and tolerability of expanded human fetal neural stem cells

        2. to verify safety and tolerability of a microsurgery human fetal neural stem cells
           transplantation model

        3. to recognize each change in patient's quality of life

      Secondary aim of the trial

        1. assessment of the impact of human neural stem cells transplantation on the disability of
           ALS in a clinically significant and measurable way

        2. Assessment of the impact of human neural stem cells transplantation on mortality (all
           causes)
    

Detailed description: 
      18 patients diagnosed as definite ALS according to the El Escorial criteria will be recruited
      during two years. The patients will be divided into 3 groups with different severity. Each
      group will be less compromised than the group that went before them. Their breathing
      measurements must be at least 60%. Subjects will receive injections of the human foetal
      neural stem cells into the spinal cord. A variety of tests and examinations will take place
      every month for the first year and every three months for the next two in order to monitor
      the course of the disease and the adverse events.
    

Intervention name(s): Human Neural Stem Cells
Intervention type(s): Biological
Intervention description(s): Surgical microinjection of human neural stem cells on spinal cord of ALS patients
Other intervention name(s): Human Neural Stem Cells Suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: amyotrophic lateral sclerosis; motor neuron disease; stem cells; safety; ALS-FRS-Functional scale R and FVC (%) variation; Survival analysis; Changes in quality of life scales
Acute Intervention to Reduce Distress Following Sexual Assault
Condition: Drug Use; Drug Abuse; Posttraumatic Stress Disorder
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate whether a brief intervention in video format
      delivered in the post assault medical exam setting and including education about assault
      reactions and instruction in and modeling of successful coping strategies would reduce post
      assault drug use or abuse and PTSD symptoms as compared to standard care.
    

Detailed description: 
      The intervention being evaluated was shown at the time of the post assault medical exam and
      includes two main components: preparation for the medical exam; and information about and
      modelling of coping strategies that may help women cope in the aftermath of assault. The
      intervention content is delivered via video. Intervention and standard care groups were
      compared with regard to measures of substance use and abuse and symptoms of PTSD and other
      potentially comorbid problems including symptoms of depression or other anxiety.
    

Intervention name(s): PPRS
Intervention type(s): Behavioral
Intervention description(s): Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rape; Secondary prevention; Intervention
Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Condition: Juvenile Idiopathic Arthritis; Joint Inflammation
MeSH terms: Arthritis; Arthritis, Juvenile; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine
      sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared
      with dinitrous oxide (N2O) which has already been proven safe and effective sedation method
      during painful procedures in pediatric patients.

      In earlier studies the median VAS during intra-articular corticosteroid injections with
      patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with
      intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.
    


Intervention name(s): Dexmedetomidine; Sedatives/Hypnotics,Other
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection); Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
Other intervention name(s): Dinitrous oxide
Intervention MeSH terms: Dexmedetomidine; Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sedation; pediatrics; intranasal sedation; dexmedetomidine; dinitrous oxide; intra-articular joint injection