bioihbjkbjnl/mcl2 huggingface dataset:
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Condition: Lynch Syndrome
MeSH terms: Colorectal Neoplasms, Hereditary Nonpolyposis; Syndrome
Study type: Interventional

Summary: 
      This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo
      carmine chromoendoscopy) in patients having Lynch Syndrome
    

Detailed description: 
      Chromoendoscopy using indigo carmine dye is recommended every 1 to 2 years in patients having
      Lynch Syndrome (LS). However, it is a time-consuming procedure, requiring a prior learning
      and has an additional cost, the reason why it is not yet systematically practiced in all
      endoscopy centers. The "Narrow Band Imaging" (NBI) is a recent virtual chromoendoscopy
      technique using optical filters at the light source of the endoscope to highlight the
      vascular structures of the mucosa by pressing a button. NBI is currently used to better
      characterize dysplasia lesions in the esophageal, gastric, and colon mucosa. A new generation
      (3rd generation) of NBI is currently available on some endoscopes, it can deliver more
      brightness and contrast, and could allow for better detection of flat lesions. Until today,
      no study has directly compared colonic chromoendoscopy with Indigo carmine to virtual
      chromoendoscopy with NBI (3rd generation) in LS patients. The hypothesis that this research
      aims to verify is that the new generation NBI system might do at least as well as indigo
      carmine in colonic adenoma detection in LS. This study aims to compare colonoscopy with
      virtual chromoendoscopy using 3rd generation NBI system to chromoendoscopy with indigo
      carmine in LS patients, in a back-to-back, prospective non inferiority design, in which all
      patients will have both techniques in the following order: NBI first followed by Indigo
      carmine.
    

Intervention name(s): Colonoscopy
Intervention type(s): Procedure
Intervention description(s): A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Indigo carmine chromoendoscopy; Narrow band imaging; Colonoscopy
RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
Condition: Phobic Disorders
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their
      combination, (2) investigate the patterns of change and the mechanisms of action involved
      during treatment by using psycho-physiological assessments in order to delineate some of the
      cognitive, behavioural and physiological mechanisms in the patients' response to CT, to
      paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be
      selected and randomised into four treatment conditions. The first group (N=25) will be
      treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group
      (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo
      and clinical management (N=25). All patients will have 12 weeks of treatment in the acute
      phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd
      and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The
      4th group will have placebo for 24 weeks and clinical management. The patients will be
      assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12
      weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.

      Measures are based on all three main sources; self-report inventories, clinical assessments
      by independent raters and psycho-physiological assessments.
    


Intervention name(s): Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Intervention type(s): Drug
Intervention description(s): Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
Other intervention name(s): Paroxetine
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phobic disorders; Therapy, cognitive; Paroxetine
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of
      three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at
      commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of
      investigational vaccine against a post-market inactivated polio vaccine.
    

Detailed description: 
      This study is a randomized, double-blinded, and positive-controlled clinical trial. A total
      of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1
      to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by
      Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary
      vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each
      dose of vaccination will be carried out. Venous blood should be collected from all the
      subjects before and 30 days after the three-doses primary vaccination, for the neutralizing
      antibody assay, and further to evaluate the immunogenicity.
    

Intervention name(s): Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age; Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age; Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age; Three doses control wIPV at the schedule of 2,3,4 months of age
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age; Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age; Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age; Three doses control wIPV at the schedule of 2,3,4 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of naldemedine in the
      treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who
      are not using laxatives.
    


Intervention name(s): Naldemedine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Other intervention name(s): S 297995; Symproic®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid-induced Constipation
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of
      palmo-axillo-plantar hyperhidrosis
    

Detailed description: 
      This is a pilot study that investigates the efficacy of video-assisted endoscopic
      sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

      Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis
      in a single setting.
    

Intervention name(s): Staged ETS
Intervention type(s): Procedure
Intervention description(s): Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Multiple Doses of ALXN2050 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, placebo-controlled, randomized, double-blind (participant and
      investigator blind, sponsor open), multiple-ascending dose study conducted in healthy
      participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics
      and pharmacodynamics of ACH-0145228 (ALXN2050).
    


Intervention name(s): ALXN2050; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder-in-capsule (PIC).; PIC.
Other intervention name(s): ACH-0145228 (formerly); ACH-5228
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Complement; ALXN2050; ACH-0145228; Pharmacokinetics; Pharmacodynamics; Safety
Second Follow-up Study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as
      well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined
      regarding different clinical and blood/ sputum derived biomarkers at the investigators'
      research center.

      Of this cohort, 116 subjects were re-invited for the first follow-up study Ribolution II
      (NTC02522026) after 3 years (+/- 6 months) and data on the clinical course and treatment
      changes was obtained.

      This second follow-up study will re-examine all available subjects regarding disease course
      and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/
      transcriptome biomarkers for their potential to indicate disease progression. In addition,
      biobanking of respective biosamples for potential future COPD biomarker research will be
      conducted.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with chronic obstructive pulmonary disease (COPD) GOLD stage I to IV, healthy
        smokers and healthy non-smokers
      
Biospecimen description: 
      blood, sputum
Food-Effect Study in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of
      lasmiditan in healthy participants.
    

Detailed description: 
      An open-label, cross-over, two-period, randomized, sequential study in order to investigate
      the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of
      lasmiditan will be administered with the participants in fed and fasted states.
    

Intervention name(s): Lasmiditan
Intervention type(s): Drug
Intervention description(s): 2 discrete doses separated by 6 days.
Other intervention name(s): COL-144; LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
Condition: Spinal Diseases
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to compare the safety and effectiveness of
      ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain
      associated with DDD in the lumbosacral spine. There will be separate study arms for one and
      two level cases.
    


Intervention name(s): ProDisc; Spinal Fusion
Intervention type(s): Device; Procedure
Intervention description(s): Total disc replacement with ProDisc; A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Phase 1 Safety Study of Dengusiil in Healthy Adults
Condition: Prevention of Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to assess safety and tolerability of a single subcutaneous dose of
      Dengusiil in healthy adults of 18 to 45 years of age. In this study, immune response to
      Dengusiil will also be assessed over a period of 6 months and vaccine viremia will also be
      assessed over a period of 12 days after administration of vaccine.
    


Intervention name(s): Dengusiil; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Dengusiil is provided as lyophilized powder to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted vaccine is injected as a single 0.5 mL subcutaneous (SC) dose.; Placebo is supplied as a vial of lyophilized powder containing all the components of the vaccine except dengue virus serotypes (DENV1, 2, 3 and 4) to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted product is injected as a single 0.5 mL subcutaneous (SC) dose.
Other intervention name(s): Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4); Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      determine the dose-response relationship for body weight and five escalating doses of NNC
      90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral
      hypoglycemic agent (OHA).
    


Intervention name(s): liraglutide; metformin
Intervention type(s): Drug; Drug
Intervention description(s): Injected subcutaneously once daily; 1000 mg twice daily, administered orally
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Condition: Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show superiority of simeprevir (SMV) in combination with
      sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite
      of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in
      combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in
      study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior
      relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in
      this study.
    

Detailed description: 
      This is a Phase 3, open-label (all people know the identity of the intervention), single-arm,
      multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening
      period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period
      (until 24 weeks after end of treatment). The duration of the subjects' participation will be
      approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir
      along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be
      evaluated as percentage of subjects with sustained virologic response at Week 12 after the
      end of treatment. Subjects' safety will be monitored throughout the study.
    

Intervention name(s): Simeprevir; Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.; Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
Other intervention name(s): TMC435
Intervention MeSH terms: Sofosbuvir; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Genotype 4 chronic hepatitis C; Simeprevir; Sofosbuvir
Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
Condition: Anorexia Nervosa; Bariatric Surgery; Weight Change, Body
MeSH terms: Obesity, Morbid; Body Weight; Anorexia; Body Weight Changes; Anorexia Nervosa
Study type: Interventional

Summary: 
      In this study, when patients diagnosed with AN started treatment and their weight increased
      by 10%; On the other hand, it was aimed to compare the changes in serum adipokine levels
      observed in morbidly obese patients before bariatric surgery and when they lost 10% of their
      post-op weight with both anthropometric measurements, biochemical parameters, and values of
      healthy volunteers.
    

Detailed description: 
      The most characteristic feature of obesity is the increase in adipose tissue. On the
      contrary, in anorexia nervosa, there is a decrease in adipose tissue enough to impair
      neuroendocrine functions. Adipose tissue is formed by loosely binding lipid-filled cells
      called adipocytes and is now considered an important part of energy metabolism. Adipokines it
      secretes play a role in many physiological processes of the body such as nutrition, appetite,
      energy balance, insulin, and glucose metabolism, lipid metabolism, regulation of blood
      pressure, vascular remodeling, coagulation, and inflammation.

      Therefore, changes in the amount of body fat in these two patient groups, which are at the
      two ends of the spectrum, affect both the biochemical parameters and physiological functions
      of the patients in different ways. It is expected that both adipokine levels and biochemical
      parameters will approach the values of healthy subjects with a decrease in adipose tissue of
      clinically morbidly obese patients and an increase in adipose tissue of patients with AN.
      However, in some studies comparing the parameters of patients with constitutionally weak
      patients and patients with AN, results contrary to expectations were obtained. In this study,
      we compared the extent to which weight changes changed adipokines and correlated with
      biochemical parameters based on healthy and normal-weight volunteers.
    

Intervention name(s): Bariatric surgery-RYGB; Dietary intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): After the creation of a 15-25-cc gastric pouch from the upper stomach, transection of proximal jejunum 70 cm from Treitz ligament also called "alimentary tract" and anastomosis of the distal end of jejunum to the gastric pouch, and thereafter, anastomosis of the proximal end of transected jejunum to the distal part of the jejunum at 150 cm below the site of transection (jejunoileal anastomosis).; High-calorie medical nutrition program to ensure weight gain
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipocytokines; leptin; adiponectin; omentin; apelin; IL-6; Anorexia Nervosa; Bariatric Surgery; fat mass
Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate in ALS patients the regulatory T cell early response to
      two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days
      comparatively to placebo.
    

Detailed description: 
      This is a phase II study on ld-IL-2 as a therapeutic agent for ALS which aims at defining the
      activity and safety of a range a doses for subsequent use of the best dose in a phase II/III
      trial. For ethical reasons, ld-IL-2 must be tested as an add-on therapy to riluzole hence all
      patients will need to be treated with riluzole for at least three months prior to entry. A
      randomized (1:1:1), placebo-controlled, double-blind, parallel group trial will be carried
      out to assess ld-IL-2 activity on regulatory T cells and immuno-inflammatory markers in ALS
      patients treated for 3 months (5 days every four weeks repeated three times).

      The secondary objectives of this study are:

      A. To evaluate maintenance of Tcell response after three repeated 5-day courses at one course
      every four weeks for 12 weeks.

      B. To evaluate the safety of ld-IL-2 therapy in an ALS population, with an overall follow-up
      of 6 months (up to 15 weeks after last administration); C. To evaluate functional changes
      throughout the study; D. To evaluate changes in other pre-defined blood cytology parameters,
      and a blood biomarker for axonal damage.
    

Intervention name(s): Placebo; 1.0 MIU IL-2 per day; 2.0 MIU IL-2 per day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).; Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).; Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).
Other intervention name(s): Aldesleukine; Proleukin; Aldesleukine; Proleukin
Intervention MeSH terms: Aldesleukin; Interleukin-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low-dose interleukin 2