bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections
Condition: Intravitreal Injection; Ocular Rinse; Age-Related Macular Degeneration; Diabetic Macular Edema; Cystoid Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Edema
Study type: Interventional

Summary: 
      This is the first randomized controlled trial looking into post-injection rinse volume of
      standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after
      injections.
    

Detailed description: 
      Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI)
      application for intravitreal injections (IVI) affects patients' ocular surface irritation.

      Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142
      subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse
      respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized
      Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours
      post-injection, were analyzed.
    

Intervention name(s): OSDI questionnaire; SPEEDII questionnaire
Intervention type(s): Other; Other
Intervention description(s): Ocular Surface Disease Index; Standardized Patient Evaluation of Eye Dryness II questionnaire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Disposition of Carbon-14-Labeled LY2886721 ([^14C]-LY2886721) Following Oral Administration in Healthy Human Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study is being conducted to determine the metabolism and physiological
      disposition of radiolabeled LY2886721 after a single dose in healthy male participants.
    


Intervention name(s): LY2886721
Intervention type(s): Drug
Intervention description(s): Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Absorption; Distribution; Metabolism; Excretion
Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of
      iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous
      sulphate) in women with iron deficiency anaemia.
    


Intervention name(s): Tardyferon 80 mg
Intervention type(s): Drug
Intervention description(s): Oral administration (2 tablets)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Image Location and Performance of Left Bundle Branch Pacing
Condition: Cardiac Pacing; Pacing Therapy
Study type: Observational

Summary: 
      This is a prospective, multi-site, non-randomized, data collection study. The purpose of this
      study is to investigate the correlation between pacing sites and ECG morphology or pacing
      parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to
      assess the long-term performance of pacing lead during LBBP.
    

Detailed description: 
      His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including
      high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing
      inappropriate pacing management, damage to the His bundle during implantation. On the other
      hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with
      the pacing lead tip at the left side of the ventricular septum, has recently initiated and
      been widely practiced in China because of easy implantation, relatively narrow paced QRS
      duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by
      a low pacing output.

      As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP
      implantation and understand mechanisms of LBBP therapy, physicians often do imaging
      assessment of the pacing lead in patients implanted with LBBP based on clinical necessity.

      Additionally, there is no report of mid/long-term correlation between lead location and
      ventricular electrical activity, nor mid/long-term pacing lead performance assessment during
      LBBP.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients indicated for LBBP and implanted with pacing lead for LBBP.
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Condition: Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures
      and are associated with pelvic pain, menstrual disorders, obstetrical complication and
      infertility.

      Womed Leaf is a medical device specifically designed for intrauterine use that prevents
      intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls
      separated during healing. It is then naturally discharged through the cervix and vagina in
      less than 30 days.

      The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical
      conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.
    

Detailed description: 
      Intrauterine adhesions (IUA) are defined as "fibrous strings at opposing walls of the uterus
      and/or cervix leading to partial or complete obliteration of the cavity". IUAs are the major
      long-term complication of intrauterine procedures and are associated with pelvic pain,
      menstrual disorders, obstetrical complications and infertility.

      Womed Leaf™ is a sterile, degradable polymer film specifically design for intrauterine use.
      It is inserter in the uterus like an intrauterine device. Once released it will self-deploy
      into the uterine cavity to form a mechanical barrier keeping uterus walls separated during
      healing, for several days, thus preventing the formation or recurrence of intrauterine
      adhesions. It is degraded and discharged naturally through the cervix and vagina in less than
      30 days.

      The PREG1 clinical investigation is a prospective multicenter, single arm study, designed to
      evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic
      myomectomy as well as its efficacy in preventing IUA at second look hysteroscopy.
    

Intervention name(s): Womed Leaf
Intervention type(s): Device
Intervention description(s): Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: myomectomy; Intrauterine adhesion; hysteroscopy
Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children
Condition: Relapsed Solid Tumors; Refractory Solid Tumors; Relapsed Leukemia; Refractory Leukemia
MeSH terms: Neoplasms; Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the use of carfilzomib in combination with cyclophosphamide and
      etoposide for children with relapsed/refractory solid tumors or leukemia. The medications
      cyclophosphamide and etoposide are standard drugs often used together for the treatment of
      cancer in children with solid tumors or leukemia.

      Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults
      with multiple myeloma (a type of cancer). However, this drug is not approved to treat
      children with relapsed/refractory solid tumors or leukemia. With this research, we plan to
      determine the DLTs and MTD of Carfilzomib given in combination with cyclophosphamide and
      etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors.
    

Detailed description: 
      Part 1 of the study will include a dose escalation based on Dose limiting toxicities (DLTs)
      until the MTD or highest dose level is reached, whichever comes first.

      At the MTD or highest dose level (if no MTD is reached), an additional 6 patients will be
      enrolled to further evaluate safety of the regimen (Part 2).

      Part 2 of this study will enroll additional patients at the highest tolerable dose found in
      Part 1 in order to get more information on side effects and make sure the dose is tolerable

      Once an MTD is determined for Strata A or B, if the Study Principal Investigator determines
      that the study treatment should not be further pursued due to safety or enrollment barriers,
      the expansion Part or the study will be discontinued.
    

Intervention name(s): Carfilzomib; Cyclophosphamide; Etoposide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias
Intervention MeSH terms: Cyclophosphamide; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumors; Leukemia; Relapsed; Refractory
PET Imaging of mGLuR5 With Drug Challenge
Condition: Major Depressive Disorder; Post-Traumatic Stress Disorder (PTSD)
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study is designed to look at that involvement of a process in the brain called the
      glutamate system in depression. Participants will undergo a screening session, up to two
      functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission
      Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET
      scans, a drug (either ketamine or n-acetyl cysteine) will be administered.

      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine
      (NAC) will lead to a decrease in mGluR5.

      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills
      after drug challenge.

      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in
      MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.

      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5
      availability due to differences in ABP688 radiotracer infusion.
    

Detailed description: 
      Aim 1: To determine the acute effect of medication-induced glutamate release on mGluR5
      availability in human subjects. Hypothesis 1: We hypothesize administration of ketamine or
      n-acetylcysteine (NAC) will lead to a decrease in mGluR5 availability.

      Aim 2: To determine if glutamate release via administration of ketamine or NAC has pro
      cognitive benefits.

      Hypothesis 2: We hypothesize an improvement in memory and attentional skills after drug
      challenge.

      Aim 3: To determine if there is synaptogenesis detectable by PET and MRI post ketamine or NAC
      within a week of drug challenge (at the time of greatest antidepressant response). Hypothesis
      3: We hypothesize an increase in mGluR5 availability and change in MRI measures, post drug
      challenge as compared to baseline, signifying synaptogenesis.

      Aim 4: To determine if there is a difference in reduction of mGluR5 availability after
      ketamine administration when radiotracer is administered bolus as compared to bolus to
      constant infusion in the same subjects (ABP688 radiotracer only).

      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5
      availability due to differences in ABP688 radiotracer infusion.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): All subjects will receive ketamine to induce glutamate release in the brain
Other intervention name(s): ketamine IV
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Depression; Ketamine; PET; PTSD
The Changes of ETT Cuff Pressures After Head and Neck Positions Placed for Adenotonsillectomy and Tonsillectomy in Children
Condition: Endotracheal Tube Cuff Pressure; Adenotonsillectomy; Tonsillectomy; Position
Study type: Observational

Summary: 
      The main purpose of this study was to assess the effect of each of position (neck extension
      by under-shoulder pillow and Crowe-Davis retractor use) during adenoidectomy and
      adenotonsillectomy on the intracuff pressure of ETTs in children.
    

Detailed description: 
      The cuff of the endotracheal tube seals the extraluminal airway to facilitate
      positive-pressure ventilation and reduce subglottic secretion aspiration. As increase or
      decrease of ETT intracuff pressures can lead to many morbidities. A total of 140 patients
      younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy
      operation, were included in the study . A standardized general anesthetic was given and
      cuffed endotracheal tubes by the assistance of video laryngoscope were placed in all
      patients. The pilot balloon of each endotracheal tube was connected to the pressure
      transducer and standard invasive pressure monitoring was set to measure intracuff pressure
      values continuously. The first intracuff pressure value was adjusted to 18.4mmHg (25cm H2O)
      at supine and neutral neck position. The patients then were given appropriate position for
      the surgery. These positions were neck extension and placement of mouth gag These positions
      were neutral position, extension by under-shoulder pillow and placement of the mouth gag. The
      intracuff pressures were measured and noted after each position, at every 5th minute while
      the operation and before the extubating. If intracuff pressure deviated from the targeted
      value of 20-30cm H2O at any time, it was set to 25cm H2O again.
    

Intervention name(s): Intracuff pressure measurement
Intervention type(s): Other
Intervention description(s): The intracuff pressures were measured and noted after each position (neck extension and placement of mouth gag), at every 5th minute while the operation and before the extubating.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients younger than 18 years, who were scheduled for elective adenoidectomy or
        adenotonsillectomy operation, were included in the study .
      
Keywords: Pediatric Surgery; Endotracheal Tube Cuff Pressure; Adenotonsillectomy; Tonsillectomy; Position
Esophagectomy in Patients With Liver Cirrhosis
Condition: Esophageal Cancer; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Retrospective and confounder adjusted comparison of perioperative and longterm outcomes of
      patients requiring an esophagectomy for esophageal cancer with and without concomitant liver
      cirrhosis.
    


Intervention name(s): surgery
Intervention type(s): Procedure
Intervention description(s): retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        retrospective analysis of a prospective maintained database of EC patients operated at the
        institution between 2012 to 2016
      
Keywords: esophagectomy
The Norwegian Stroke in the Young Study II
Condition: Ischemic Stroke at a Young Age
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational [Patient Registry]

Summary: 
      NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young
      adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and
      plaques and consequences of stroke are examined by standardized diagnostics.
    

Detailed description: 
      NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound
      examination of pre-cerebral and femoral arteries, and standardized examinations performed by
      speech therapists, occupational therapists and physiotherapists.

      The ultrasound-protocol for carotid and femoral arteries is the same as previously performed
      in the NOR-SYS study. The Methods have been published before.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with documented ischemic stroke at a young age (< 50 years) in Norway
      
Biospecimen description: 
      EDTA-blood and serum will be collected for future analysis
    
Keywords: Young ischemic stroke; Risk factors; Causes; Consequences
A Study of Gantenerumab in Participants With Mild Alzheimer Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
      will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer
      disease. Participants will be randomized to receive either gantenerumab subcutaneously every
      4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if
      on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).

      A positron emission tomography (PET) imaging substudy will be conducted within the main
      study. Eligible participants who provide separate informed consent will undergo PET imaging
      scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain
      amyloid load over time.
    


Intervention name(s): Placebo; Gantenerumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Placebo SC injection Q4W.; Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
Condition: Eosinophilic Gastritis; Eosinophilic Gastroenteritis
MeSH terms: Gastroenteritis; Gastritis; Eosinophilic Esophagitis; Enteritis; Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects
      of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than
      placebo control (alternative hypothesis) in reducing the number of eosinophils per high power
      field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo
      versus no difference between AK002 and placebo control (null hypothesis).
    


Intervention name(s): AK002; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophil; EG; EGE; Eosinophilic gastrointestinal disorders; EGID
Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia
      symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of
      the present study is to compare, in a controlled setting, the efficacy and the tolerability
      of quetiapine extended release with amitriptyline in the treatment of patients with
      fibromyalgia
    


Intervention name(s): amitriptyline; quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks; initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
Other intervention name(s): Tryptizol; Seroquel XR
Intervention MeSH terms: Amitriptyline; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; quetiapine; amitriptyline
[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      [14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and
      Excretion Following Oral Dosing to Healthy Male Subjects.

      Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and
      PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of
      [14C]PRC-4016 to healthy male subjects.

      To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal
      excretion of radioactivity.

      To examine the profile of metabolites in plasma, urine and faeces. To further assess the
      safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.
    


Intervention name(s): [14C]PRC 4016 (Icosabutate)
Intervention type(s): Drug
Intervention description(s): Single oral dose
Other intervention name(s): Icosabutate
Intervention model: Single Group Assignment
Masking: None (Open Label)