bioihbjkbjnl/mcl2 huggingface dataset:
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
Condition: Stomach Neoplasms; Indocyanine Green
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer
      using in laparoscopic gastrectomy with lymph node dissection for gastric
      adenocarcinoma（cT1-4a, N-/+, M0）.
    

Detailed description: 
      Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its
      application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma
      is at the stage of cases accumulation, method studying and clinical research. There is no
      prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in
      laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma.

      On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection
      for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to
      operate and no radiation pollution way, to predict the positive lymph nodes in gastric
      adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric
      adenocarcinoma.
    

Intervention name(s): Indocyanine Green Tracer
Intervention type(s): Drug
Intervention description(s): Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Other intervention name(s): ICG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Neoplasms; Indocyanine Green Tracer; Laparoscopic Gastrectomy; Lymph Node Dissection
The Safety, Acceptability and Efficacy of Alena
Condition: Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder (Social Phobia)
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The present study is a randomised controlled trial that seeks to investigate the safety,
      acceptability and efficacy and safety of the Alena CBT programme as a treatment for social
      anxiety disorder.
    

Detailed description: 
      This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week
      intervention period and a 2-week follow-up post intervention. Participants are randomly
      allocated to receive access to the Alena CBT programme or to a wait list control group, in a
      1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark
      and Wells model.
    

Intervention name(s): Cognitive Behavioral Therapy programme
Intervention type(s): Behavioral
Intervention description(s): This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RCT; CBT
Using an API to Commercialize an Evidence-Based Weight Loss Intervention
Condition: Weight Loss; Health Behavior
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study will test the effectiveness of a mobile application that uses an Application
      Program Interface (API) to distribute evidence-based weight loss interventions. Half of the
      participants will receive this API-based application, and the other half of the participants
      will use a non API-based application.
    

Detailed description: 
      The purpose of this study is to test a weight loss app that uses an API to disseminate an
      evidence-based weight loss intervention. The investigators hypothesize that, over the course
      of 12 months, participants using the Leaner app will have lost more weight than those in the
      attention control group.

      Participants (n=206) will be randomly assigned to use either the intervention app
      (intervention arm; n=103) or a weight loss app of their choosing (attention control arm;
      n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.

      Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis.
      Observed weight vs. time plots will be analyzed for all participants to discern general
      trends in weight change. The model will include an intervention effect, a time effect, an
      intervention by time interaction, and a random intercept.

      In exploratory analysis, investigators will examine weight change across subgroups of
      interest; investigators will add the subgroup variable and its interaction with the
      intervention indicator to the primary model. All analyses will be evaluated at the 0.05
      significance level.
    

Intervention name(s): API App; Non-API App; fitness tracker; scale
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale; Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.; fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app; Connected scale that will transfer weight information to app
Other intervention name(s): wearable; weight
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to
      antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50
      milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week
      double-blind treatment period) is compared to adjunctive placebo based on the change from
      baseline to 12-week endpoint in depressive symptoms as measured by the total score on the
      Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive
      Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant
      therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram
      per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects
      with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better
      understanding of the relationship between CRP and clinical changes.
    

Detailed description: 
      A double-blind, placebo-controlled, multicenter study of sirukumab as adjunctive treatment to
      a monoaminergic antidepressant in adults with major depressive disorder. Participants will be
      randomly assigned to receive either placebo or sirukumab 50 milligram (mg) at a ratio of 1:1
      at Day 1, 28 and 56. Participants will primarily be assessed for change from baseline in
      Hamilton Depression Rating Scale (HDRS17) score at Week 12. Safety will be monitored
      throughout the study.
    

Intervention name(s): Sirukumab 50 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.; Participants will receive matching placebo on Day 1, 28 and 56.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depressive disorder, major; Sirukumab
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
Condition: Obsessive-compulsive Disorder; Ocd
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal
      of suffering. Many patients benefit from established treatments, the mainstay of which are
      cognitive behavioral therapy and a group of antidepressant medications known as serotonin
      reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established
      therapeutic strategies. New avenues of treatment are urgently needed.

      Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin
      or dopamine; but increasing evidence suggests that functional disruptions of a different
      neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are
      therefore interested in using medications that target glutamate as novel treatment options
      for those OCD patients who do not benefit from established treatments.

      One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral
      sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric
      disorders due to its ability to moderate excessive glutamate. In preliminary studies, in
      which the investigators treated patients with riluzole (in addition to their established
      pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control
      group), the investigators have found about 40-50% of patients to substantially improve over
      2-3 months.

      While immensely promising, these preliminary studies do not prove riluzole is truly a new
      beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is
      needed for that purpose. The investigators are therefore now recruiting patients to
      participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other
      OCD medications they are taking.
    


Intervention name(s): riluzole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg PO bid, 12 weeks; placebo, 1 capsule PO bid, 12 weeks
Other intervention name(s): Rilutek (Sanofi-Aventis)
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obsessive-compulsive disorder; OCD; glutamate; riluzole; augmentation; treatment
Roflumilast In-Vitro Basophil Release
Condition: Allergy; Asthma
Study type: Observational

Summary: 
      This study is looking for allergic asthmatics. Lung and allergy testing will be done to
      verify. If qualified, blood will be drawn for laboratory studies.
    

Detailed description: 
      Non-smoking allergic asthmatics will be verified using pulmonary function, skin prick
      testing, exhaled nitric oxide and serum IgE. If qualified, blood will be drawn, treated with
      study medication and then stimulated with the allergen to which the subject is allergic.
      Mediators including Histamine, IL-13, IL-4, and leukotrienes will be measured.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Allergic Asthma, non-smoker
      
Biospecimen description: 
      Polymorphal Blood Mononuclar Cells will be stimulated to release various cytokines. The
      supernatant of the stimulations will be stored for batched analysis.
    
Keywords: Interleukin 13; Interleukin 4; Leukotrienes; Basophil Histamine Release
Pain in Newborn Heel Blood Collection
Condition: Infant, Newborn, Disease; Pain, Acute
MeSH terms: Infant, Newborn, Diseases; Acute Pain
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effect of white noise and therapeutic touch on pain
      in newborn heel blood collection.Questions including the sex of the newborns, postnatal age,
      gestational age, birth weight, height, head and chest circumference, feeding style,
      nutritional status in the last half hour, and previous heel blood collection were collected
      with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the
      pain levels of newborns.
    


Intervention name(s): White Noise; Yakson Touch
Intervention type(s): Other; Other
Intervention description(s): Orhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used.; In order to transfer the Ki energy to the baby, he took a deep breath and gathered the universal energy in his palms, intending the baby's well-being and healing. The researcher applied the Yakson touch by covering the abdomen and chest of the newborn with his right hand (dominant hand) while the newborn was in the supine position, and supported the baby's back and hips with his left hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the
      treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a
      round-edged instrument until small petechiae appear. This so called "sha", considered as the
      removal of blood stasis by traditional practitioners, will fade within a few days. Normally,
      this treatment is not considered as painful, but as relaxing and easing tense muscles.

      In this study, the investigators will investigate the effectivity of Gua Sha massage in
      treating chronic neck pain. The investigators will research effects on subjective pain
      intensity, neck pain specific disability and haptic perception.
    


Intervention name(s): Gua Sha; Thermotherapy
Intervention type(s): Other; Device
Intervention description(s): Single Gua Sha treatment of the neck and shoulder region; Single use of a mud heat pad on the neck and shoulder region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; massage; hyperthermia, induced; touch perception; randomized controlled trial
High Flow Oxygen Therapy Effect on Healthy Subjects
Condition: Healthy Volunteers; Diaphragm; Respiratory Rate
Study type: Interventional

Summary: 
      The use of high-flow nasal cannula (HFNC) has increased. Diaphragmatic ultrasonography is a
      tool that, as a noninvasive complement to esophageal pressure (Pes) measurement, allows the
      evaluation of diaphragm function and reflects, through the diaphragm thickening fraction
      (DTf), the magnitude of diaphragmatic fiber recruitment. The objective of this study was to
      evaluate the impact of HFNC therapy on the DTf in healthy subjects. Second, this study aimed
      to assess the behavior of the respiratory rate (RR) and the work of breathing in these
      subjects.
    


Intervention name(s): High flow nasal canula
Intervention type(s): Device
Intervention description(s): Measurement of diaphragm thickening fraction, respiratory rate and esophageal pressure swing with calculation of diaphragmatic pressure-time product without the use of HFNC and with the use of HFNC at 20 and 40 Liters per minute
Other intervention name(s): diaphragm thickening fraction; esophageal pressure swing; Respiratory rate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: High flow nasal canula; High flow nasal canula therapy; Diaphragm thickening fraction; Work of breathing; Respiratory rate
A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients
      who are on the waiting list for kidney transplant and have previously undergone
      desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.
      At study entry, the patients will have an available deceased or live donor with a positive
      crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific
      Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.
    

Detailed description: 
      The study will assess the IdeS efficacy in creating a negative crossmatch test (XM) in
      patients who exhibit donor specific antibodies (DSA) and have a positive crossmatch test to
      their available live or deceased donors. The first 3 patients in this study will receive a
      kidney from a deceased donor. The study will primarily examine the efficacy of IdeS in
      creating a negative XM. The first 3 patients will receive one dose of 0.25 mg/kg BW IdeS on
      study day 0. If it is considered safe and negative crossmatch test is not achieved after the
      first dose, an additional IdeS infusion can be given within 2 days of the first infusion. The
      dose schedule may be increased to 0.5 mg/kg BW given once or twice after the first 3 patients
      have been tested. The decision to escalate the dose will be done after evaluation of safety
      and efficacy.
    

Intervention name(s): IdeS; Kidney transplantation
Intervention type(s): Drug; Procedure
Intervention description(s): One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.; Performed following IdeS treatment
Other intervention name(s): IgG endopeptidase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Condition: Visual Acuity; Astigmatism; Anisometropia
MeSH terms: Astigmatism; Anisometropia
Study type: Interventional

Summary: 
      The purpose of this study is to establish if LFR-260 (investigational device) is not inferior
      in effectiveness to a traditional phoropter (control device) when applied in visual acuity
      test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide
      information of the visual capabilities of the patient. The test will be provided and
      supervised by a qualified eye care provider. The informed consent, screening, randomization
      (into the order of visual test device used), (visual) device testing (to include precision
      testing, remote and offsite testing) will all occur at a single visit.
    


Intervention name(s): LFR-260 portable phoropter; Traditional phoropter (Standard of Care)
Intervention type(s): Device; Device
Intervention description(s): Portable unit to evaluate visual refractive state of the patient; Standard unit for evaluating visual refractive state of the patient
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ocular
Evaluation of the TRANSEND Program
Condition: Pediatric Patient Transfer to Adult Service:Transition Program
Study type: Observational

Summary: 
      "Transend" is a program designed to promote the transition of young patients with endocrine
      or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital.
      The main objective of the study is to compare the rate of patients lost to follow-up at 24
      months after the transfer of pediatrics between the Transend group and the (historical)
      control group.
    

Detailed description: 
      Adolescence and early adulthood represent important periods for young people suffering from
      chronic diseases. Several observational studies show needs not covered by care services at
      this period and significant lost to follow-up rates. "Transend" is a program designed to
      promote the transition of young patients with endocrine or metabolic diseases when they
      arrive in the adult sector at La Pitié-Salpétrière hospital (Paris, France). Since September
      1, 2016, approximately 500 patients benefited from it.
    

Intervention name(s): survey
Intervention type(s): Behavioral
Intervention description(s): Behavioral study of patients who are in the "Transend" Program (compliance in follow-up visits after transfert from pediatric to adult care in the 24 months)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Young patients with endocrine or metabolic diseases
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.
Condition: Tuberculosis (TB)
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three
      doses of primary vaccination followed by a booster dose after completion of primary
      vaccination course. Booster vaccination will be given only to subjects receiving the
      candidate tuberculosis vaccines and not to the subjects receiving active comparators or
      control.
    

Detailed description: 
      The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In
      addition, 2 active comparator groups of volunteers will receive the vaccine alone without an
      immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true
      effect of the candidate tuberculosis vaccine (Mtb72F/AS02).
    

Intervention name(s): Mtb72F/AS02.
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Response to the Conventional Periodontal Treatment Based on the Blood Group Phenotypes.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      The aim of this study is to find out if one blood group phenotype is more responsive than the
      others to the nonsurgical periodontal treatment.
    

Detailed description: 
      To the best of our knowledge, this is the first (research) randomized clinical trial that
      assesses how patient respond to the nonsurgical periodontal treatment based on their blood
      group phenotype.
    

Intervention name(s): nonsurgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth. An initial session will be conducted to remove supra gingival plaque and calculus. another appointment is set to perform full moth scalling and root planing.
Other intervention name(s): Conventional periodontal treatment; scalling and root planing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from chronic periodontitis