bioihbjkbjnl/mcl2 huggingface dataset:
A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
Condition: Head and Neck Carcinoma
Study type: Interventional

Summary: 
      This trial studies examines the impact of virtual reality (VR) experiences and Fitbit
      wearable activity devices on postoperative recovery after head and neck surgery. Virtual
      reality has shown to help rehabilitation and pain control primarily in non-surgical fields,
      and researchers are interested in using this to help postoperative pain control. Early
      mobilization after surgery is also important, and may increase lung capacity, improve
      gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of
      virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic
      use among hospitalized patients after head and neck surgery.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization,
      compared to patients not utilizing daily VR therapy.

      II. Evaluate the effectiveness of daily ambulation goals using Fitbit devices during
      hospitalization, compared to patients without daily ambulation goals.

      III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during
      hospitalization.

      EXPLORATORY OBJECTIVES:

      I. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during
      hospitalization on reducing pain scores, anxiety, depression, and length of stay, and
      improving sleep quality, hospital satisfaction, and disposition on discharge.

      OUTLINE: Patients are randomized to 1 of 4 groups.

      GROUP 1: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily
      on weekdays and 2 times daily on weekends, and wear Fitbit daily with a goal of 2,000 steps
      until the day of discharge, or until 14 days after surgery. Pre and post-VR pain scores will
      be obtained for each VR use. Sleep data may also be evaluated from Fitbit devices.

      GROUP 2: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily
      on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after
      surgery. Pre and post-VR pain scores will be obtained for each VR use.

      GROUP 3: Beginning postoperative day 1, patients wear Fitbit daily with a goal of 2,000 steps
      until the day of discharge or until 14 days after surgery. Sleep data may also be evaluated
      from Fitbit devices.

      GROUP 4: Patients do not use VR or wear Fitbit.
    

Intervention name(s): Fitbit; Questionnaire Administration; Virtual Reality Device
Intervention type(s): Device; Other; Device
Intervention description(s): Wear Fitbit; Ancillary studies; Use VR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.
Condition: Adverse Effect
MeSH terms: Pre-Eclampsia; Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the suitable infusion dose of norepinephrine for
      prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia
      undergoing cesarean section.
    

Detailed description: 
      Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and
      neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with
      exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia
      are apparently higher than healthy parturients, placental hypoperfusion is more common.
      Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia
      for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous
      blood flow (provided that hypotension is avoided) which contribute to increase placental
      perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia
      hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a
      potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction
      for use in parturients undergoing cesarean section. But the suitable infusion dose of
      norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study
      is to investigate the suitable infusion dose of norepinephrine for prophylaxis against
      post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean
      section.
    

Intervention name(s): Normal saline; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline infusion simultaneous with subarachnoid block; Different infusion dose of norepinephrine simultaneous with subarachnoid block
Other intervention name(s): NS; Vasopressors
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Norepinephrine; Postspinal anesthesia hypotension; Preeclampsia; Cesarean section; Dose-finding
Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      This study seeks to assess the acceptability, compliance, and preference for iron
      supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study
      seeks to assess front line health worker perceptions and experiences regarding ease of
      implementation of each strategy and delivery strategy preference.
    

Detailed description: 
      The specific aims of this study are to assess the acceptability of, compliance, and
      preference for two delivery vehicles for pediatric prophylaxis iron supplementation
      (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in
      Bihar India delivered through home visits by front line health workers. Additionally, this
      study seeks to assess front line health worker perceptions and experiences regarding ease of
      implementation of each strategy and delivery strategy preference.
    

Intervention name(s): Iron and Folic Acid (IFA); Micronutrient Powders (MNP); Iron Plus Strategy Counseling
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): 1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month.; One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following:
Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base; Mothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets.
Intervention MeSH terms: Iron; Trace Elements; Folic Acid; Micronutrients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to evaluate the PK and excretion of a single oral dose of
      [14C]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days
      prior to dosing); a treatment phase (from dosing until discharge from the unit, a minimum of
      7 days and a maximum of 14 days); and discharge procedures.
    

Detailed description: 
      This is an open-label study to evaluate the PK and excretion of a single oral dose of
      [14C]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days
      prior to dosing); a treatment phase (from dosing until discharge from the unit, a minimum of
      7 days and a maximum of 14 days); and discharge procedures.

      After meeting eligibility criteria, approximately 6 healthy male subjects will check into the
      clinical unit (Day -1), and the following morning, receive a single oral suspension of
      rodatristat ethyl 600 mg containing a mixture of [12C]-rodatristat ethyl and
      [14C]-rodatristat ethyl to contain approximately 600 microcuries (μCi) of radioactivity (Day
      1). After fasting 10 hours overnight, the dose will be administered with a standard-calorie
      meal. Following dosing, serial whole blood and plasma PK samples, and urine and feces will be
      collected until discharge. Subjects will stay in the clinic until at least Day 7. Subjects
      will be discharged if total recovery (urine and feces combined) of the administered
      radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2
      consecutive days in which a fecal sample is collected. If not, subjects will remain in the
      clinic until these criteria are met but not longer than 15 days (which includes Day -1).
      Plasma and urine samples will be analyzed for total radioactivity, rodatristat ethyl,
      rodatristat, M15, and any other identified metabolites (if applicable). Blood and fecal
      samples will be analyzed for total radioactivity, rodatristat ethyl, rodatristat, and
      metabolite(s).
    

Intervention name(s): Radio-labeled rodatristat ethyl 600 mg
Intervention type(s): Drug
Intervention description(s): Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; PAH
Top Down Versus Step Up Strategies in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The study prospectively compares two treatment algorithms for newly diagnosed Crohn's
      disease: one 'aggressive' treatment with early introduction of immunomodulators and
      biologicals and one 'standard treatment' with corticosteroids and only later introduction of
      immunosuppressives and biologicals if disease activity requires that.
    

Detailed description: 
      This two year open-label randomized trial compares the early use of combined
      immunosuppression to conventional management in patients with active Crohn's disease who have
      not previously received glucocorticoids, antimetabolites, or infliximab. Patients assigned to
      combined immunosuppression receive azathioprine and 3 infusions of 5 milligrams per kilogram
      of body weight of infliximab at weeks 0, 2, and 6. Retreatment with infliximab and, if
      ultimately necessary, corticosteroids are used to control disease activity. Patients assigned
      to conventional management receive corticosteroids followed, in sequence, by azathioprine and
      infliximab. The primary outcome measure is remission without corticosteroids and without
      bowel resection at weeks 26 and 52.
    

Intervention name(s): infliximab+azathioprine; methylprednisolone or budesonide
Intervention type(s): Drug; Drug
Intervention description(s): infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg; methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper
Other intervention name(s): remicade/imuran; Medrol, entocort, budenofalk
Intervention MeSH terms: Methylprednisolone; Budesonide; Infliximab; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease; immunomodulators; biologicals
Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
Condition: Hilar Cholangiocarcinoma; Biliary Obstruction
MeSH terms: Cholangiocarcinoma; Klatskin Tumor
Study type: Interventional

Summary: 
      The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable
      hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized
      into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who
      receive intraductal RFA before biliary stenting. Immediate complications as well as long term
      stent patency and patient survival would be studied.
    

Detailed description: 
      Study design: randomized single-blind control trial Study population: patient with
      unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary
      stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival
      Intervention

        1. Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed
           enveloped

        2. All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before
           biliary stent.

        3. Monitor for adverse event during hospitalization and during follow up

        4. Follow up as outpatient in 4-weekly interval with monitoring of serum liver function
           test as routine
    

Intervention name(s): ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
Intervention type(s): Device
Intervention description(s): Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hilar cholangiocarcinoma; Biliary obstruction; Radiofrequency ablation
VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome
Condition: Dry Eye Syndrome; Sjogren's Syndrome; Xerophthalmia
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Xerophthalmia; Syndrome
Study type: Interventional

Summary: 
      To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye
      syndrome and Sjögren's syndrome
    

Detailed description: 
      Method: This study wants to evaluate the Chinese herbal tea VGH-DESJS-1 on Nourishing Yin and
      Moistening Dryness the ocular dryness from dry eye syndrome (DES) and Sjögren's syndrome
      (SJS). One hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60
      Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC). DES, SJS,
      and NHC received VGH-DESJS-1 daily during 8 weeks for the evaluation before and after the
      subjects receiving the VGH-DESJS-1. Moreover, we could use the Whole-genome genotyping,
      Schirmer's test, Tear breakup time (TBUT), Cytokines, Ocular Surface Disease Index (OSDI),
      EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index
      (PSQI), Ford Insomnia Response to Stress Test (FIRST), Traditional Chinese Medicine (TCM)
      pattern, TCM tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability, and it
      could be applied for the goal of holistic health care.

      Expected Results:

        1. To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue
           diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, and
           Cytokines for DES, SJS, and NHC.

        2. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS.

        3. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES.

        4. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for SJS.

      Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Chinese herbal tea, Nourishing
      Yin and Moistening Dryness
    

Intervention name(s): Chinese herbal tea VGH-DESJS-1
Intervention type(s): Other
Intervention description(s): Chinese herbal tea VGH-DESJS-1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dry Eye Syndrome; Sjogren's Syndrome; Xerophthalmia; Chinese herbal tea; Nourishing Yin and Moistening Dryness
A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout
Condition: Depression; Anxiety; Stress; Insomnia; Optimism; Interpersonal Disengagement; Professional Fulfillment; Work Exhaustion; Self-reported Medical Errors; Physician Burnout
MeSH terms: Depression; Burnout, Psychological
Study type: Interventional

Summary: 
      The primary objective of the study was to determine whether the yoga-based breathing and
      meditation program SKY could improve wellness indicators in currently practicing physicians.
      The hypothesis of this study is that SKY is effective in reducing anxiety and depression,
      increasing subjective optimism, and reducing physician burnout in healthy, actively
      practicing physicians.
    

Detailed description: 
      Physicians are exposed to high stress and strain that results in burnout, affecting not only
      them, their families, patients, but the whole healthcare system. Thus there is an urgent need
      to develop methods to increase resiliency of physicians. A comprehensive yoga breathing and
      meditation-based online program (Sudarshan Kriya Yoga, or SKY) is a potential approach to
      mitigate physician burnout. This is a randomized clinical trial assessing the potential
      efficacy of SKY compared to a stress management education (SME) training as control,
      conducted online. Both groups received training for three consecutive days, 1,5 hours per
      day, through group video conference. Active physicians participated in the study from
      November 2021 to March 2022. Of the 280 physicians who showed interest and prescreened, 238
      were eligible and randomized to receive either the SKY or the control intervention.
    

Intervention name(s): Meditation and breathing program : Sudarshan Kriya Yoga (SKY); Stress management education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The SKY sessions (3x1,5 h on consecutive days) included online instruction in gentle stretches ('office yoga' in a sitting position), specific breathing exercises and meditation, and discussion of cognitive/behavioral coping skills. After the 3-day program, participants asked to practice the techniques once a day for about 30 min. In addition, there were weekly group exercise sessions of 1 hour where all participants were asked to join.; This control intervention included viewing of educational videos on stress management and group discussions, where the sessions were equal in length to the SKY intervention. There were also weekly follow-up sessions as in the SKY group where the educational points were reviewed and experiences of the subjects during the previous week was discussed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: physician burnout; medical doctor; burnout; stress; depression; wellness; meditation; breathing exercise
Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma
Condition: Open-Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may
      have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the
      results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs
      between the eyes only when placed in the supine position. Unique effects of this latent
      asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.
    

Detailed description: 
      Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow have
      been implicated to be one of the important factors to affect visual field progression.
      However, there was no study to investigate them in medically well-controlled open-angle
      glaucoma patients. So we want to find the unique patterns.

      Study 1. Subjects : Patients with medically well controlled open angle glaucoma Method : IOP
      and peripapillary retinal blood flow were measured for 24 hours. The relationship between the
      two were studied.

      Study 2. Of the patients enrolled in study 1 , those on the same medical regimen for both
      eyes were analyzed for the presence of a latent asymmetric IOP and it's influence and
      association with visual field and diurnal IOP fluctuation.
    

Observational model: Natural History
Time perspective: Other
Keywords: open-angle glaucoma; diurnal fluctuation; intraocular pressure; peripapillary retinal blood flow; latent asymmetric intraocular pressure
Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a
      single dose (intravenous infusion) in patients with active rheumatoid arthritis in
      combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.; Placebo to AIN457
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Rheumatoid Arthritis