bioihbjkbjnl/mcl2 huggingface dataset:
Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery
Condition: Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Observational

Summary: 
      This study evaluates the structural parameters, by spectral domain optical coherence
      tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in
      patients that received endoscopic endonasal approach for the removal of an intra-suprasellar
      pituitary adenoma compressing the optic nerve.
    

Detailed description: 
      The primary outcome was to detect the changes in visual acuity, retinal structural and
      vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal
      of an intra-suprasellar pituitary adenoma compressing the optic nerve.

      The secondary outcome was to identify potential biomarker that could predict the functional
      recovery at 1 year follow up.
    

Intervention name(s): Endoscopic Endonasal Pituitary Surgery
Intervention type(s): Procedure
Intervention description(s): Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 4 years with pituitary adenoma. They did not present other
        ophthalmological and neurological diseases.
Evaluation of Esthetics Around Immediate Implants in VIP - CT Grafted vs Non-grafted Sites.RCT
Condition: Buccal Bone Loss in Immediate Implants
Study type: Interventional

Summary: 
      An array of soft tissue augmentation techniques have been employed concomitant to implant
      placement, as free connective tissue grafts or pedicle grafts for keratinized tissue
      thickening in attempt not only to augment the soft tissue for better resistance to
      inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.

      Results obtained from the literature were controversial regarding the need of soft tissue
      augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature
      was found, that monitored the ridge alterations following implant placement.

      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and
      buccal bone resorption during the process of remodeling in a measurable way.
    

Detailed description: 
      Alveolar bone remodeling following extraction could not be prevented by immediate implant
      placement. Soft tissue augmentaion techniques have been suggested in order to overcome the
      alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether
      soft tissue augmentation procedures actually have a protective role in preserving buccal bone
      thickness in immediate implants.

      Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal
      bone resorption and pink esthetics around immediately placed implants in maxillary anterior
      teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth
      randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous
      vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented
      implant sites (control group). Buccal bone changes were assessed at implant placement (0) and
      at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by
      cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9,
      12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the
      patients.
    

Intervention name(s): VIP graft
Intervention type(s): Procedure
Intervention description(s): surgical soft tissue grafting concomitant to implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
In-vivo Analysis and Clinical Evaluation of the Performance of a Fractional CO2 Laser System (eMatrixCO2)
Condition: Aesthetic Dermatology
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will:

      Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to
      determine the dynamics of their development over time following treatment.

      Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic
      dermatological procedures requiring the ablation, vaporization, excision, incision, or
      coagulation of soft tissue.
    


Intervention name(s): Ablation and skin resurfacing
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The analgesic approach in labor can be done in different ways, among which the neuraxial
      approach has shown the best analgesic results and fetal outcomes. Currently, programmed
      epidural intermittent bolus has been included in the neuraxial approach for a better
      distribution of the solution into the epidural space as compared with the continuous infusion
      strategy. In this study, the investigators seek to compare both strategies in 132 laboring
      women.
    


Intervention name(s): Bupivacaine and Fentanyl Initial Dose; Bupivacaine and Fentanyl: Continuous Epidural Infusion; Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus; Rescue Bolus; Lidocaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution); 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour); A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour; Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.; If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Intervention MeSH terms: Lidocaine; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: analgesia, epidural; labor pain; patient satisfaction
Prospective Biomarkers of Bone Metabolism in Hemophilia A
Condition: Hemophilia; Bone Disease
MeSH terms: Bone Diseases; Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture
      outcome data demonstrating the clinical significance of decreased BMD and altered bone
      biomarkers in the hemophilia population. This study demonstrates that PwH have an increased
      risk of fracture compared to the general population and that the issue of bone health will
      increase in importance as the PwH population ages.
    

Detailed description: 
      This is a pilot study to determine the impact of factor replacement on bone biomarkers in up
      to 20 hemophilia A subjects. Subjects will be recruited over 1 year for the 5-day protocol.

      Following a 72-hour washout period, factor levels and bone biomarkers will be followed before
      and after 50 units/kg replacement on Day 1 and 20 units/kg replacement on Day 3. Each subject
      can serve as their Figure 4. Fracture rates in PwH compared to historic controls.
    

Intervention name(s): Advate
Intervention type(s): Drug
Intervention description(s): Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.
Other intervention name(s): Antihemophilic Factor (Recombinant)
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemophilia; bone disease; clinical study; biomarkers
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Condition: Fistulizing Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of filgotinib as compared to
      placebo in establishing combined fistula response at Week 24. Participants will have the
      option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if
      they meet eligibility requirements.
    


Intervention name(s): Filgotinib; Placebo to match filgotinib
Intervention type(s): Drug; Drug
Intervention description(s): Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Other intervention name(s): GS-6034; GLPG0634
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Determine the Safety and Dose of EN001 in Patients With Duchenne Muscular Dystrophy(DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, Dose-escalation, Phase 1 Clinical Trial to Determine the Safety and Dose of EN001
      in Patients with Duchenne Muscular Dystrophy(DMD)
    

Detailed description: 
      It is the first in human (FIH), 3+3 design clinical trial to evaluate the safety and
      tolerability and determine the maximum tolerated dose (MTD) of EN001 (allogeneic umbilical
      cord-derived mesenchymal stem cells) in the treatment of Duchenne Muscular Dystrophy (DMD).
    

Intervention name(s): EN001; EN001
Intervention type(s): Drug; Drug
Intervention description(s): EN001 intravenously (IV) in the treatment of Duchenne Muscular Dystrophy (DMD) Dosage for each group is as follows.
Dose group A (Low dose): 5.0x10^5 cells/kg; EN001 intravenously (IV) in the treatment of Duchenne Muscular Dystrophy (DMD) Dosage for each group is as follows.
Dose group B (High dose): 2.5x10^6 cells/kg
Other intervention name(s): EN001 (allogeneic umbilical cord-derived mesenchymal stem cells); EN001 (allogeneic umbilical cord-derived mesenchymal stem cells)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
Condition: Stress Ulcer Prophylaxis
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously
      demonstrated prevention of bleeding events) during treatment period in proportion of patients
      for the prevention of upper GI bleeding.
    

Detailed description: 
      Stress related upper Gastrointestinal (GI) bleedings are important events associated with
      morbidity and mortality among seriously ill patients. Data from the literature suggest that
      stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events
      and is thus an important therapy in high-risk patients. Esomeprazole has the potential to
      reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal
      damage and facilitating coagulation. This study is to reveal whether intravenous (iv)
      esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is
      tolerated by Chinese seriously ill patients.
    

Intervention name(s): Esomeprazole; Cimetidine
Intervention type(s): Drug; Drug
Intervention description(s): iv esomeprazole 30 min intermittent infusions given for maximum 14 days; iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Other intervention name(s): Nexium; Tagamet
Intervention MeSH terms: Esomeprazole; Cimetidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: SUP; Upper GI bleeding; Seriously ill patients
Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study is a single arm, open-label, pilot study to assess midline frontal theta (MFT)
      power as measured by stimulus-locked electroencephalogram (EEG) before and after treatment
      with AKL-T01 for improving attention in pediatric participants ages 8-12 years old with
      attention deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      All participants enrolled in this study will not be taking medications for attention deficit
      hyperactivity disorder (ADHD), including stimulants, for the duration of the study.
      Participants who are taking ADHD medications prior to Day 0 must have been stable off of
      medications for at least 30 days per parent report, or washout of medications at a Screening
      visit 3 - 7 days prior to Day 0.

      At Baseline / Day 0, all eligible participants will complete both resting-state
      electroencephalogram (EEG) and a perceptual discrimination task (PDT)-locked EEG.

      All participants will then play AKL-T01 for approximately 25 minutes per day, 5 days per
      week, for 4 weeks at home.

      At Follow-up / Day 28, participants will repeat both resting-state and PDT-locked EEG.
    

Intervention name(s): AKL-T01
Intervention type(s): Device
Intervention description(s): AKL-T01 digital treatment is a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty based on the user's ability. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. Performance on these tasks are assessed in isolation and when performed together to calculate a performance index for each individual user. A personalized multitask treatment regimen is automatically configured and delivered to the user and is optimized adaptively to increase multitask performance. As players proceed through the treatment periodic recalibration occurs to maintain an optimal difficulty level.
Intervention model: Single Group Assignment
Intervention model description: Intervention group will be compared to historical controls.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Inattention
Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis; Healthy
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients
      with rheumatoid arthritis (RA).
    


Intervention name(s): anti-IL-20; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single s.c. injection (per dose cohort); Single s.c. injection (per dose cohort)
Other intervention name(s): NN8226; NN8226
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
Condition: LBW; Preterm
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      - Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of
      deaths among premature and low birth weight LBW infants. Even if the infants are born in
      facilities, incidences of cold stress are possible due to insufficient resources, space and
      incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo
      Mother Care is a well-known intervention to address the issues related to preterm births,
      such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC
      interventions for preterm infants, no interventional study has been found in literature in
      Pakistani context. Looking at the potential benefits of KMC in reducing the related
      complications of prematurity, the study aims to identify the effectiveness of KMC among
      preterm and LBW infants born in secondary hospital of Aga khan University hospitals.

      Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and
      LBW infants as compared to the usual care.

      Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome
      among experimental and control group.

      Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of
      suspected infections during hospitalization.

      Hypothesis II Ha: There is a difference in length of stay among experimental group and
      control group.

      Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four
      weeks.

      Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and
      control after discharge from hospital.
    


Intervention name(s): Kangaroo Mother Care; Standard Care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: effects; KMC; LBW; preterm; temperature; breastfeeding; secondary hospitals
Contrast Sensitivity and Diabetic Macular Edema
Condition: DIABETES MELLITUS; DIABETIC RETINOPATHY; MACULAR EDEMA
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Study type: Observational

Summary: 
      Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be
      modified by different pathologies or by age. The purpose of this study is to identify the
      changes that could be in relationship with the course of diabetic retinopathy comparing with
      diabetic patient without retinopathy and in patients with diabetic macular edema so if it is
      a difference, research for therapeutic strategies to improve it in this patients.
    

Detailed description: 
      Contrast sensitivity is defined as a subjective measurement, it is the ability to separate
      the image between figure and background, taking into account the minimum amount of light
      required; it is evaluated by the contrast threshold, which is the smallest amount of contrast
      needed to be able to see a target and solve their characteristics, would be his reciprocal
      value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have
      decreased compared to contrast sensitivity studies international; further that contrast
      sensitivity in older groups of 41 years is decreased high frequency.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic patients attended at Ophthalmology service in a general hospital
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Emergencies
Study type: Interventional

Summary: 
      The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to
      Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a
      technologically simple solution using unidirectional daily text messages to consisting of
      educational materials, trivia questions and challenges promoting healthy lifestyle choices
      and reminders to check blood sugar, take medications and go to clinic appointments. The
      investigators believe TExT-MED will improve health outcomes including blood glucose control
      and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and
      can be quickly adapted to other practice environments.
    


Intervention name(s): Daily text messages
Intervention type(s): Other
Intervention description(s): 2-3 times daily text messages regarding diabetes care and healthy lifestyle choices
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
Condition: Brain Injuries; Olfaction Disorders
MeSH terms: Brain Injuries; Olfaction Disorders; Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of the study is to see whether patients with chronic smell impairment after brain
      injury benefit from a treatment that consists of corticosteroids, and then olfactory training
      in 3 months.
    


Intervention name(s): corticosteroids; olfactory stimulation
Intervention type(s): Drug; Behavioral
Intervention description(s): stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Olfactory perception; Adrenal cortex hormones; Steroids; Education
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Condition: Asthma; Healthy Subjects or Volunteers
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability
      of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
    

Detailed description: 
      This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and
      tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered
      as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.
    

Intervention name(s): Tralokinumab 300 mg
Intervention type(s): Biological
Intervention description(s): Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other intervention name(s): CAT-354
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Healthy Subjects or Volunteers; Tralokinumab; CAT-354
BOTOX® Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with upper limb spasticity.
    


Intervention name(s): botulinum toxin Type A; Normal Saline (Placebo)
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.; Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
Other intervention name(s): BOTOX®; onabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment