bioihbjkbjnl/mcl2 huggingface dataset:
CellFX Treat & Resect Low-Risk BCC Feasibility Study
Condition: BCC - Basal Cell Carcinoma; BCC; Excision Margin
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional

Summary: 
      This prospective, multicenter, study is designed to evaluate the safety and effectiveness of
      the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and
      nodular) for complete histological clearance of the target lesion followed by surgical tumor
      excision 60 days post-treatment.
    

Detailed description: 
      The study will enroll healthy adult subjects with confirmed low-risk (superficial and
      nodular) BCC lesion(s) by biopsy, excluding BCCs located on the face, neck, scalp, axilla,
      hands, feet, and genitals not exceeding 1.5 cm. Macrophotography of all study BCCs will be
      captured and clinically assessed by the site investigator for characterization of healing and
      scar appearance prior to and post-surgical excision. All subjects will be followed at 3, 7,
      14, 30 and 60-days post-CellFX procedure and at 14, 30 and 60-days post-excision. Adverse
      events will be documented.
    

Intervention name(s): CellFX System
Intervention type(s): Device
Intervention description(s): Nano-Pulse Stimulation (NPS)
Intervention model: Single Group Assignment
Intervention model description: CellFX System
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CellFX; Nano-Pulse Stimulation; NPS; Clearance
Training in Goal-directed Attention Regulation for Individuals With Brain Injury
Condition: Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      Brain injuries affect the lives of numerous Veterans. This study examines how the brain is
      affected by injury and how rehabilitation training for attention dysfunction may change brain
      functioning.
    

Detailed description: 
      Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat
      Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits
      in 'executive control' and 'attention' functions. Such abnormalities may directly contribute
      to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive
      and motor domains. Effective treatments would potentially make a major impact in improving
      functional outcomes, but consistently effective treatments are not available. The overall
      goal of this research is to improve the investigators' understanding of plasticity in brain
      function after TBI and to develop improved cognitive neurorehabilitation treatments. The
      intervention involves individual and group-based training in cognitive skills.
    

Intervention name(s): training in goal-directed attention regulation; brain health education; computer-assisted training in goal-directed attention regulation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): training in goal-directed attention regulation; brain health education workshops; computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2.
Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: attention; rehabilitation; training; functional MRI; executive function; brain injury
Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with
      the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and
      placebo control. The main purpose of the study was to investigate the effects of each
      treatment on the control of plasma glucose as well as the secretion of insulin and glucagon
      following a standard meal.
    


Intervention name(s): DG3173; Saline; Octreotide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Condition: Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol
      dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a
      6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial
      therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced
      medication management intervention will accompany all treatment conditions. Follow-up
      assessments will be completed at 9 and 12 months after treatment.
    


Intervention name(s): Cognitive-Behavioral Therapy; Naltrexone; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week; Daily dosing 100 mg for 24 weeks; Pill Placebo daily dosing 24 weeks
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder; Naltrexone; Cognitive Behavior Therapy
Analysis of the Enteric Nervous System Using Colonic Biopsies
Condition: Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive
Study type: Interventional

Summary: 
      The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and
      other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy)
      based upon the detection of pathological alpha-synuclein species in routine colonoscopic
      biopsies.
    


Intervention name(s): colonoscopy or rectosigmoidoscopy
Intervention type(s): Procedure
Intervention description(s): Usual procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: biopsies, enteric nervous system, biomarker
A Multifaceted Prompting Intervention for Urban Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The overall goal of this project is to evaluate whether a multifaceted prompting
      intervention, administered in the urban primary care office setting, reduces morbidity among
      urban children with asthma. This study builds on our experience with a pilot study in two
      urban continuity clinics, in which we found that prompting clinicians about asthma severity
      and care guidelines at the time of an office visit resulted in improved preventive care
      delivery to inner-city children. This type of prompting program has the potential to
      substantially improve care for impoverished children with asthma, and we propose to
      establish: 1) whether these findings can be replicated in a similar study including a larger
      sample of urban children from different types of practices, and 2) whether the positive
      effects can be enhanced by more specific prompting directed towards both the provider and the
      caregiver and by providing practice-level supports and feedback. We hypothesize that children
      receiving a multifaceted prompting intervention (MPI) will experience less asthma-related
      morbidity (defined by symptom-free days at the 2-month follow-up) compared to children
      receiving usual care. Our secondary hypothesis is that children receiving the MPI will
      receive improved preventive asthma care (defined by guideline-based corrective actions taken
      at the index visit) compared to children receiving usual care.
    


Intervention name(s): Multifaceted Prompting Intervention MPI
Intervention type(s): Behavioral
Intervention description(s): Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to
      four hours at each of the visits in order to take measurements on binocular functional visual
      performance.
    


Intervention name(s): Hioxifilcon A Test; Hioxifilcon A With Cosmetic Ring Control
Intervention type(s): Device; Device
Intervention description(s): contact lens made with hioxifilcon A material; contact lens made with hioxifilcon A material with a cosmetic ring on the lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery
Condition: Prevalence of Germs; Spinal Surgery; Anterior Disc Disease; Modic 1
Study type: Observational

Summary: 
      Low back pain is one of the most frequent reasons for consultation in rheumatology. There is
      a strong correlation between low back pain, and the presence of a type of Modic 1 signal on
      MRI.

      The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on
      T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the
      endplates after gadolinium injection; it corresponds to a replacement of normal cancellous
      bone of fibrovascular tissue.

      The origin of this inflammatory process Modic 1 into the vertebra is still unknown.

      infectious hypothesis was raised, including contamination by germs called "slow-growth" such
      as Propionibacterium acnes (PA).

      Many studies interesting Bacteriological analysis of disc material found the presence of
      bacteria (prevalence between 0 and 54%).

      A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo
      in low back pain with Modic 1; a show effectiveness of this treatment on the different
      clinical parameters evaluated.

      However skin contamination is not formally excluded, particularly in patients previously
      infiltrated (including epidural).

      Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc
      disease, and the possible presence of PA or other slow-growing bacteria in samples obtained
      discal posterior approach would be related to intraoperative contamination or during
      preoperative spinal infiltrations The main objective is to assess the prevalence of germs
      slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type
      1 Modic.
    


Intervention name(s): Bacteriological analysis of disc
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Disc samples taken during spine surgery during installation of disc prostheses or inter
        somatic cages made by anterior approach in type discopathies Modic.

        Fragments disc withdrawn during cures herniated disc surgeries by posterior way.

        Patients were recruited from the orthopedic service and Neurosurgery at Henri Mondor
        Hospital in Creteil
      
Biospecimen description: 
      Disc
    
Keywords: Modic 1; low back pain
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
Condition: SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group,
      Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in
      Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)
      Infection.
    

Detailed description: 
      'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein
      as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor
      as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and
      virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.
    

Intervention name(s): CT-P59
Intervention type(s): Biological
Intervention description(s): administered
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Condition: Prophylaxis of Organ Rejection
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg
      tablets under fed conditions.
    


Intervention name(s): Mycophenolate Mofetil
Intervention type(s): Drug
Intervention description(s): Prophylaxis of Organ Rejection
Other intervention name(s): CellCept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the effectiveness of misoprostol versus uterine
      straightening by bladder filling for pain relief in menopausal patients undergoing office
      hysteroscopy.
    

Detailed description: 
      Several studies revealed that cervical ripening with misoprostol is effective in reducing
      pain especially in postmenopausal patients. A recent randomized controlled trial revealed
      that uterine striating by bladder filling prior to office hysteroscopy is associated with
      reduced pain perception and easier introduction of hysteroscope through the cervix.

      The aim of this study is to compare the effectiveness of misoprostol versus uterine
      straightening by bladder filling for pain relief in menopausal patients undergoing office
      hysteroscopy.
    

Intervention name(s): Misoprostol; Bladder Filling
Intervention type(s): Drug; Other
Intervention description(s): Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).; Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used.
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Misoprostol, Office hysteroscopy ,Pain
Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of
      ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis
      knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to
      each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via
      measurements of vital signs and clinical laboratory tests at baseline and at various time
      points during the study, patient monitoring, and by the documentation of adverse events.
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of
      once daily administration of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to
      placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment
      WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.A
      total of 360 evaluable patients are planned in this study: 250 mg (n=120); 200 mg (n=120);
      150 mg (n=60); placebo (n=60).

      Safety will be assessed via measurements of vital signs and clinical laboratory tests at
      baseline and at various time points during the study, patient monitoring, and by the
      documentation of adverse events.
    

Intervention name(s): ATB-346 low dose; Placebo; ATB-346 mid-dose; ATB-346 standard dose
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients; Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients; Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients; Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
Other intervention name(s): Active comparator; Non-active comparator; Active comparator; Active comparator
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; WOMAC; NSAID; Pain
The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation
Condition: Increased Intra Ocular Pressure (IOP)
MeSH terms: Ocular Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the effect of preoperatively administered intra venous
      magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal
      intubation in adult patients scheduled for elective non ocular surgery
    


Intervention name(s): Magnesium Sulfate; normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: IOP; ophthalmic anesthesia; magnesium sulfate
Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer
Condition: Esophageal Carcinoma
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, participants with advanced or metastatic squamous cell carcinoma of the
      esophagus that has progressed after first-line standard therapy will be randomized to receive
      either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel
      or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong
      overall survival (OS) as compared to treatment with standard therapy.
    


Intervention name(s): camrelizumab; Docetaxel; Irinotecan
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks; Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks; Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks
Other intervention name(s): SHR-1210
Intervention MeSH terms: Docetaxel; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Factors for AD-Associated Switch to Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The present study aimed at identifying clinical risk factors for switch into (hypo)mania or
      mixed states, within 8 weeks after introduction of an antidepressant or after increasing its
      dosage.
    

Detailed description: 
      Treatment of bipolar depression with antidepressants is strongly debated for the
      methodologically poor and insufficient data supporting their use and the widely held belief
      that antidepressants can induce new episodes of abnormal mood elevation or accelerate the
      rate of cycling. The present study aimed at identifying clinical risk factors for switch into
      (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after
      increasing its dosage, in a prospective, longitudinal design.
    

Intervention name(s): Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.
Intervention type(s): Drug
Intervention description(s): Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
Other intervention name(s): Selective Serotonin Reuptake Inhibitors; Serotonin-Norepinephrine Reuptake Inhibitor; Tricyclics Antidepressants
Intervention MeSH terms: Norepinephrine; Antidepressive Agents; Antidepressive Agents, Tricyclic; Serotonin; Selective Serotonin Reuptake Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Bipolar I and II disorder patients.
      
Keywords: Switch