bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Pau d' Arco in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A single arm, open-label trial evaluating safety and tolerability of encapsulated Tabebuia
      avellanedae in 12 generally healthy women aged 18-45 with primary dysmenorrhea (PDM). This
      will be the first study evaluating the safety and tolerability of Tabebuia avellanedae in
      PDM. We also aim to collect proof-of-concept mechanistic data supporting the hypothesis that
      Tabebuia avellanedae reduces PGE2 concentration in vivo in women with PDM.
    

Detailed description: 
      This is a single arm, open-label trial evaluating safety and tolerability of 1,050 mg/day of
      encapsulated Tabebuia avellanedae every day for 2 months, as well as effects of the treatment
      on quality of life, pain intensity, and pain interference, in 12 generally healthy women aged
      18-45 with PDM. Outcomes of this study include questionnaires to evaluate: safety and
      tolerability using standardized adverse events scales (primary); participant reported
      measurements of quality of life, pain intensity, and pain interference around menses
      collected on validated instruments (secondary); and blood concentration of PGE2 and
      high-sensitivity C-reactive protein (tertiary). The protocol followed the SPIRIT guidelines
      and fulfilled the SPIRIT checklist.
    

Intervention name(s): Pau d' Arco
Intervention type(s): Dietary Supplement
Intervention description(s): Encapsulated herbal Pau d' Arco.
Intervention model: Single Group Assignment
Intervention model description: Single arm, open-label trial evaluating safety and tolerability.
Masking: None (Open Label)
Primary purpose: Other
Keywords: primary dysmenorrhea; dysmenorrhea; tabebuia avellanedae; tabebuia impetiginosa; pau d' arco; taheebo bark; menstrual pain; pelvic pain; menstrual cramps; painful menstruation; menstrual distress; herbal medicine; phytomedicine; complementary therapy; complementary medicine; alternative therapy; alternative medicine; traditional medicine; plant extracts; supplement
Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
Condition: Hypertension Secondary
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the
      effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic
      Management (ICM) on Blood Pressure (BP) control and patient activation for BP management
      following stroke
    

Detailed description: 
      The Feasibility phase will allow for a period in which to pilot implementation and evaluation
      of all systems for data acquisition, clinical management, and collection of 3-month outcomes.
      The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group.
      Randomization will be performed at the participant level, stratified by center, age (18-74,
      75+), and race (Black/African American, non-Black/African American).
    

Intervention name(s): Intensive Clinic Management (ICM); Intensive tailored telehealth management (ITTM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial; A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypertension; Hypertension after stroke
Study of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong Kong,
      the total number of hip fracture cases is anticipated to increase substantially in the
      future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip
      fracture usually causes severe pain and takes long time (4-8months) to recover due to
      impaired healing capability in osteoporotic bones and limited mobility. Consequently, the
      patients will recover very slowly as a result of low physical activities to provide
      inadequate mechanical stimulation. It is also known that mechanical, vascular and biological
      factors are the keys for fracture healing.

      Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to
      provide whole-body vibration signals for mechanical stimulation, which has been proven to be
      good in enhancing bone and muscle performance, as well as blood circulation. Our previous
      study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted
      from enhanced callus formation and maturation. Application of LMHFV on osteoporotic fractures
      could shorten the period of complete callus bridging by 30%. Our clinical trial on normal
      elderly also demonstrated improved muscle performance with good compliance, which is also a
      critical factor for fracture healing.

      In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture
      healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle
      recovery, thus improving implant mechanical stability and rehabilitation in elderly patients.
      The hip fracture elderly patient will be recruited and randomized into control or treatment
      group. They will be assessed on the fracture healing at fixed time point. The findings of
      this study will provide very useful scientific data to support the application of LMHFV for
      hip fracture patients.The ultimate goal is to enhance the fracture healing and rehabilitation
      in elderly patients.
    


Intervention name(s): Low-magnitude high - frequency vibration treatment
Intervention type(s): Device
Intervention description(s): stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone Mineral Density; Vibration; Rehabilitation; Fracture healing rate
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the
      efficacy and safety of JZP-258.
    

Detailed description: 
      Subjects will be transitioned to JZP-258 based on their treatment status at study entry. All
      subjects will begin JZP-258 treatment at the beginning of this period and continue through
      Week 12. They will be treated with JZP-258 alone for the final two weeks of this 12-week
      period. Once the JZP-258 dose has been optimized per the Investigator's judgment, these
      subjects may enter the 2-week Stable-Dose Period with that dose. Subjects are eligible to
      enter the Double-Blind Randomized-Withdrawal Period if the dose of JZP-258 remains unchanged
      during the Stable-Dose Period and, in the judgment of the Investigator, no clinically
      significant worsening in narcolepsy symptoms or clinically significant adverse events due to
      JZP-258 treatment have occurred. Subjects will return for a Safety Follow-up visit 2 weeks
      after the Double-Blind Randomized-Withdrawal Period. Subjects who complete the double-blind
      treatment period during the Main Study are eligible to enter a 24-week Open-Label Extension.
      During this period subjects will receive open label JZP-258. Subjects will return for a
      Safety Follow-up visit 2 weeks after the Open-Label Extension Period.
    

Intervention name(s): JZP-258; Placebo
Intervention type(s): Drug; Other
Intervention description(s): JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate; Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial [United States Pharmacopeia/ National Formulary])
Other intervention name(s): Xyrem®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis
Condition: DVT
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The study is designed as a prospective comparative study. All patients will receive
      prophylactic anticoagulation according to routine hospital protocol after surgery. A bedside
      ultrasound examination will be performed by a trained anesthesiologist prior to the surgery
      and then daily beginning on postoperative day 2 until patient discharge.
    

Detailed description: 
      Recent studies conducted at the emergency department evaluated the usefulness of an
      abbreviated bedside compression ultrasound test for diagnosis of Deep Venous Thrombosis (DVT)
      in the proximal region. This abbreviated ultrasound test conducted in the groin and popliteal
      regions to assess the compressibility of the femoral and popliteal veins required as little
      as 3.5 min to complete 15 and can be easily mastered by residents with minimum training.
      These studies showed a promising sensitivity ranging from 70% to 100% and a specificity
      ranging from 75.9% to 99.6%.

      Anesthesiologists are now well-trained in performing ultrasound scans as they perform
      ultrasound-guided peripheral nerve blocks routinely. Scanning for significant proximal DVT
      could potentially be anesthesiologists' extended role as they follow up patients who
      underwent orthopedic surgeries for postoperative pain control as part of the acute pain
      service.
    

Intervention name(s): Ultrasound assessment of DVT
Intervention type(s): Procedure
Intervention description(s): Using Ultrasound in assessing DVT in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
Intervention model: Single Group Assignment
Intervention model description: Patients who have symptomatic DVT undergo diagnostic venous duplex examination.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DVT; TKA; THA; Hip Fracture; High risk; Ultrasound; U/S
The Effects of an Aromatic Botanical Extract on Respiratory Health.
Condition: Respiratory Health
Study type: Interventional

Summary: 
      This study is a randomized, double blind, placebo controlled, intervention study evaluating
      the effect of an aromatic botanical extract on overall respiratory health among otherwise
      healthy adults.
    

Detailed description: 
      After being informed about the study and providing informed consent, patients with
      respiratory complaints will be randomized into a double blind placebo controlled trial of the
      botanical extract.
    

Intervention name(s): Teramune Botanical Extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Combination blend of aromatic plant extracts in an emulsifier carrier.; Emulsifier carrier without active supplement ingredients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Condition: Oral Mucositis
MeSH terms: Hematologic Neoplasms; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine efficacy and toxicity of recombinant human
      epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive
      chemotherapy with stem cell transplantation in patients with hematologic malignancies.
    

Detailed description: 
      Oral mucositis is one of the most common adverse events during chemotherapy and affects
      quality of life of patients receiving chemotherapy in relation to the dose of drugs. However,
      there is only one drug (palifermin) approved by the US FDA for the prevention of oral
      mucositis and the other methods to prevent or treat oral mucositis are just empirical and
      lack evidences. The results of recent study demonstrated promising efficacy and minimal
      toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral
      mucositis in head and neck cancer patients undergoing radiotherapy (Wu HG, et al. Cancer
      2009;115(16):3699-3708). This clinical trial is a double-blind randomized prospective
      single-institutional phase II study to evaluate efficacy and toxicity of recombinant human
      epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive
      chemotherapy with stem cell transplantation in patients with hematologic malignancies.
    

Intervention name(s): rhEGF + povidone iodine, chlorhexidine, & nystatin; Placebo + povidone iodine, chlorhexidine, & nystatin
Intervention type(s): Drug; Drug
Intervention description(s): Topical application of 50 µg/mL rhEGF solution twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%) & nystatin (5,000IU/mL) three times a day.
Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC>1000/µL for 3 days) or disappearance of oral mucositis.
For each application of rhEGF, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva.; Topical application of placebo drug twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%), and nystatin (5,000IU/mL) three times a day.
Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC>1000/µL for 3 days) or disappearance of oral mucositis.
For each application of placebo drug, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva.
Other intervention name(s): Nepidermin; Easyef(R); Placebo
Intervention MeSH terms: Iodine; Chlorhexidine; Chlorhexidine gluconate; Cadexomer iodine; Povidone-Iodine; Nystatin; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: oral mucositis; intensive chemotherapy; stem cell transplantation; epidermal growth factor
Followup of Infants Fed Non-routine Infant Formula
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to compare physical development of infants fed one of three
      study formulas.
    


Intervention name(s): Infant formula
Intervention type(s): Other
Intervention description(s): Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)
Arm 2. partially hydrolyzed infant formula with probiotics
Arm 3. extensively hydrolyzed infant formula with probiotics
Other intervention name(s): No other names are applicable to the 3 intervention arms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Physical development
Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing
      lights of patients with photosensitive epilepsy, using EEG as a readout.
    


Intervention name(s): BGG492; BGG492; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Photosensitive Epilepsy, photic stimulation, electroencephalogram
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label study to assess the safety and intrapulmonary
      pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects.
      Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g
      taniborbactam) administered intravenously every 8 hours. Following the sixth dose of
      cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
    


Intervention name(s): cefepime-taniborbactam
Intervention type(s): Drug
Intervention description(s): IV infusion
Intervention MeSH terms: Cefepime
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)
Condition: Respiratory Syncytial Virus Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Observational

Summary: 
      This is a prospective, multicenter, observational study in participants who completed the
      24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the
      treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of
      this study is to better understand the clinical and demographic correlates of asthma and
      atopic disorders in children (through the age of 6 years) with a history of severe
      RSV-induced bronchiolitis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study sample includes participants who completed all visits of Protocol 272 from
        approximately 38 study sites worldwide. Participants enrolled in Protocol 272 were 3- to
        24-month-old children with their first or second episode of "severe" RSV-induced
        bronchiolitis.
      
Keywords: Asthma
The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers
Condition: Gut Microbiota; Gastrointestinal Symptoms
MeSH terms: Gastrointestinal Diseases; Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study
      with healthy volunteers. A total of 100 male and female volunteers will be included. The
      volunteers will be randomized into one of 10 groups, each of 10 participants, consuming
      either active product in various mixes and doses (9 groups) or placebo product (1 group) for
      2 weeks. The 9 groups receiving active product will receive either one of two Human Milk
      Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of
      the study is establishing the effects of various compositions and doses of HMOs on the faecal
      flora and on gastrointestinal symptoms in health adults.
    


Intervention name(s): HMO; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Human milk oligosaccharides; Microbiota; Prebiotics
Liposome Bupivacaine for ANKLE Blocks
Condition: Hallux Valgus (Bunions)
MeSH terms: Hallux Valgus
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even
      result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture
      of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative
      analgesia and decreases opioid consumption as compared to bupivacaine alone or to general
      anesthesia.
    


Intervention name(s): Liposome bupivacaine
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg
      for patients with Alzheimer's disease. Investigators randomly divide participants into three
      groups according to the dose escalation method; no titration, 15mg of donepezil for a month
      before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to
      23mg.
    

Detailed description: 
      High dose of donepezil is currently prescribed for patients with Alzheimer's disease who
      showed poor response in lower dose, however the side effect profiles according to dose
      titration method were not clarified yet. This study aims to confirm which titration method
      would show better safeties and tolerabilities in the high dose donepezil treatment.
      Investigators include patients with moderate to severe dementia who were diagnosed as
      probable Alzheimer's disease and treated with donepezil 10mg at least 3 months before the
      study. The study duration is for 12 weeks and the titration duration is the first 4 weeks of
      the study. Investigators evaluate the side effects profiles and vital signs at every 4 weeks
      and measure blood laboratory tests at screening and the last visit.
    

Intervention name(s): donepezil
Intervention type(s): Drug
Intervention description(s): using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Other intervention name(s): aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; donepezil
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, randomized, three-period crossover study will evaluate the effect of
      co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu
      and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine
      or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between
      treatments. Anticipated time on study is up to 11 weeks.
    


Intervention name(s): oseltamivir [Tamiflu]; rimantadine
Intervention type(s): Drug; Drug
Intervention description(s): multiple oral doses; multiple oral doses
Intervention MeSH terms: Oseltamivir; Rimantadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)