bioihbjkbjnl/mcl2 huggingface dataset:
Retinal Therapy Guided by 3D OCT Image Analysis
Condition: Age-Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Observational

Summary: 
      The main purpose is to find a better way to predict the timing of treatments given to
      patients with Wet Age-related macular degeneration using image analysis.
    

Detailed description: 
      The study focuses on making better use of advanced three-dimensional imaging and analysis to
      allow physicians to know when a treatment is being effective and thus not overuse it. The
      study will examine how 3-D optical coherence tomography and related image analysis can be
      used to assess changes in the macula and retina of patients' eyes. These changes can reveal
      how well a person is responding to anti-VEGF treatment and thus help doctors provide proper
      treatment timing and care.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The proposed research will be carried out in patients diagnosed with Choroidal
        Neovascularization associated with AMD selected from retina care clinic.
      
Keywords: Retina; AMD; OCT
A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are: to confirm the superiority of TAU-284 over placebo after
      two weeks of administration to pediatric patients with perennial allergic rhinitis, and to
      investigate the dose response, safety, and plasma concentrations of TAU-284.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative
      study to confirm the superiority of TAU-284 over placebo after two weeks of administration of
      TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic
      rhinitis, with "the change from baseline in total nasal symptom score (total score for the
      three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary
      endpoint; and to investigate the dose response, safety, and plasma concentrations of TAU-284.
    

Intervention name(s): TAU-284; TAU-284; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAU-284 Low; TAU-284 High; Placebo
Intervention MeSH terms: Bepotastine besilate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists
The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus With Periodontal Disease
MeSH terms: Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Aim:

      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy
      plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who
      have periodontitis.

      Materials and methods:

      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and
      randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type
      II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than
      110 have), and also with periodontal disease are chronic moderate (at least in three areas
      Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical
      examination and radiographic signs are being); Takes place. The initial HbA1c Patients should
      be between 7-9 percent over the past three months has changed his medication also found the
      necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness,
      bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its
      absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group
      1": (12 patients) was treated with oral hygiene instruction, Scaling, and root planing, and
      doxycycline for 15 days; and "Group 2": (12 patients) has the same treatment but with
      placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated
      hemoglobin (HbA1c) level, will be reevaluated.
    

Detailed description: 
      Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive
      enzymes in periodontal disease
    

Intervention name(s): Doxycycline Group; placebo Group
Intervention type(s): Drug; Drug
Intervention description(s): Oral doxycycline 100mg was taken within 15 days; Oral placebo was taken within 15 days
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Validation of Receptor Occupancy Simulation
Condition: Dopamine Receptor Occupancy; Medication Satisfaction; Prolactin Level; Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      -  To estimate dopamine receptor occupancy by aripiprazole using computer simulation

        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the
           antipsychotics

        -  To validate the simulation result by comparing the receptor occupancy from the
           simulation with that from the patients
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with schizophrenia who is in the steady sate of antipsychotic treatment
Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The purpose of the current study is to evaluate the efficacy of administering a probiotic in
      adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.
    

Detailed description: 
      Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be
      assigned to placebo or probiotic groups and take either placebo or probiotic dietary
      intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score
      (TNSS) will be compared over 8 weeks between the two treatment groups.
    

Intervention name(s): Probiotic; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: grass pollen; allergic rhinitis; TNSS; miniRQLQ
Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Condition: Healthy Adults; Stroke Patients
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Mirror therapy has recently attracted increasing attention; however, most patients have the
      difficulties to perform mirror therapy due to limited imaginary ability. A mirror robotic
      hand system was developed, which consisted with a wearable exoskeletal hand, sensor glove,
      and a control box. The patient's unaffected hand wears the sensor glove, the affected hand
      wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and
      intransitive tasks as the mirror group, and then makes the affected hand do the same
      movements driven by the exoskeleton robotic hand. The investigators hypothesize that
      combining both approaches might facilitate the sensorimotor cortex that controls movement and
      might augment somatosensory input and further treatment efficacy. This study is aimed at
      investigating the effects of Mirror therapy and robotic mirror therapy on motor cortical
      activations in healthy adults and stroke patients using electroencephalography. All
      participants will perform the conditions of resting, moving right hand with or without
      robotic hand as the baseline data, then they will do mirror therapy using the right hand as
      active hand, or wearing robotic hand doing mirror therapy in random sequence.
      Electroencephalography (EEG) assessment will be done to assess the neurophysiologic effects
      of the different interventions. The investigators will use a questionnaire to assess the
      subjective opinion about the different interventions.

      combined with execution (video AOE). The investigators will use the pair-t test to assess the
      within subjects differences in EEG and the questionnaire results.

      This study will be done during 2020/02/01 - 2021/03/31.
    


Intervention name(s): robotic hand
Intervention type(s): Device
Intervention description(s): mirror therapy with robotic hand
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mirror therapy; robotic mirror therapy; Electroencephalography; stroke
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
Condition: B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301
      and rituximab in patients with CD20+ B-cell Lymphoma
    


Intervention name(s): IBI301; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): IBI301 375mg/㎡; Rituximab 375mg/㎡
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known if combination chemotherapy given after surgery
      is more effective than surgery alone for non-small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      following surgery with that of surgery alone in treating patients who have stage I, stage II,
      or stage IIIA non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a
      vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in
      patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the
      frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns of
      failure, second malignancies, and toxic effects associated with each treatment regimen.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
      institution, type of prior surgery, and pathologic stage. Each participating center will
      determine which combination chemotherapy regimen and which of three cisplatin doses will be
      given to all patients treated at that center. The treatment group receives cisplatin combined
      with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4
      courses, depending on the dose of cisplatin. The second group receives no adjuvant
      chemotherapy. Treating institutions determine prior to entering the trial which patients
      receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease
      only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For
      patients in the treatment group, radiotherapy begins 3-4 weeks after the last course.
      Patients are followed at 6 months, then annually.

      PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.
    

Intervention name(s): cisplatin; etoposide; vinblastine sulfate; vindesine; vinorelbine tartrate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Etoposide; Vinorelbine; Vinblastine; Vindesine
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage III non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
Condition: Tuberculosis; Tuberculosis, Pulmonary
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted
      at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2
      placebo). Subjects will participate in only one cohort.

      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be
      collected for the safety and PK assessment of sutezolid.

      Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor,
      in conjunction with the Principal Investigator, has determined that adequate safety,
      tolerability and PK from the previous cohort has been demonstrated to permit proceeding to
      the next cohort.

      Interim PK analyses will be performed for the dose escalation decisions to reconsider the
      sampling time points as the study progresses. All samples will be sent for analysis and the
      bioanalytical lab will be unblinded and only run the analysis on active treatment subjects.
      Data from the analysis used for the escalation meetings will only include active treatment
      subjects, and will be blinded by subject.

      Subjects will be housed in the clinic from at least 24 hours prior (from Day -2), until 48
      hours (Day 3) after dosing. Subjects will be contacted via a phone call for follow-up
      questioning about adverse events 7 days later (Study Day 10).
    


Intervention name(s): Sutezolid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sutezolid supplied as tablets and matching placebo for oral administration.; Matching Sutezolid placebo
Other intervention name(s): PNU-100480; Placebo Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tuberculosis; TB; Sutezolid; pulmonary tuberculosis
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance
      and routes of excretion of ODM-201 in healthy volunteers.
    

Detailed description: 
      6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively
    

Intervention name(s): ODM-201 300 mg tablet; intravenous14C-ODM-201; 300 mg 14C-ODM-201 oral solution
Intervention type(s): Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers
Influence of Yoga in Patients With Neurocardiogenic Syncope
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Syncope is a common problem that many clinicians may encounter in various outpatient
      settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self
      limited episode of systemic hypotension. Patients are usually managed with education on
      syncope, anxiety management, and coping skills.

      It has been established that practice of Yoga could relieve stress and anxiety. In a
      different study, they also found that Yoga positively influences cardiovascular function by
      decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve
      control over the autonomic nervous system and able to control functions like heart rate,
      blood pressure and respiratory rate.

      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators
      propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms
      associated with these episodes.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Includes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurocardiogenic Syncope; Yoga
Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study will utilize a pre/post mix method design

      Quantitative data will be gathered through surveys (including satisfaction questionnaires)
      administered pre/post workshops.

      Qualitative data will be obtained through interviews post- workshop and consultations.
    


Intervention name(s): Workshop
Intervention type(s): Other
Intervention description(s): Participants will engage in three 1 hour workshops about trauma informed care. They will complete pre and post measure before engaging in the workshops
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: occupational therapy; trauma informed care
Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers
Condition: Cornea Ulcer
MeSH terms: Corneal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective study involved 14 patients aged > 18 years with RCUs not responding to
      conventional treatment. All patients were treated with E-PRP drops (one drop),
      preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin
      A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the
      treatment initiation. In each visit, the following parameters were assessed: best corrected
      visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva,
      presence of abnormal discharge and symptoms reported.
    

Detailed description: 
      The present prospective study involved 14 patients aged > 18 years with RCUs not responding
      to conventional treatment. All patients were treated with E-PRP drops (one drop),
      preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin
      A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the
      treatment initiation. In each visit, the following parameters were assessed: best corrected
      visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva,
      presence of abnormal discharge and symptoms reported.
    

Intervention name(s): Autologous platelet-rich plasma (PRP) eye drops
Intervention type(s): Biological
Intervention description(s): Autologous platelet-rich plasma (PRP) eye drops are used as a sole or adjunctive therapy in many ophthalmological conditions including dry eye, macular holes, retinitis pigmentosa and perforated corneal ulcers. Actions of PRP in these conditions are attributed to the plethora of growth and healing factors concentrated in different PRP preparations.
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers
    

Detailed description: 
      A Phase 1 study in healthy volunteers to assess the safety and pharmacokinetics of ST20 after
      oral administration of a single-dose. In addition, a comparison of the pharmacokinetics and
      exposure of a single dose of ST20 under fasting and non-fasting conditions will be assessed.
    

Intervention name(s): Sodium ST20
Intervention type(s): Drug
Intervention description(s): single administration of oral dosage form
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: healthy volunteers
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
Condition: Acute Coronary Syndromes; Non ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Syndrome; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in
      ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.
    


Intervention name(s): Sub Lingual Ticagrelor
Intervention type(s): Drug
Intervention description(s): 180mg sub-lingual ticagrelor
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSTEMI
Pathways to Fatherhood
Condition: Family Research
Study type: Observational

Summary: 
      The purpose of this study is to better understand the decision-making process that gay
      couples go through in order to have children.
    

Detailed description: 
      The purpose of this study is to better understand treatment considerations, obstacles,
      motivations, and outcomes for gay men through a survey based questionnaire study.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Enrolled subjects will complete a questionnaire to ascertain information on treatment considerations, obstacles, motivations, and outcomes encountered on their pathway to fatherhood.
Observational model: Family-Based
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Gay men who sought or are currently seeking family building services at an infertility
        practice through third party reproduction