bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      populationbased analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling based on age, gender, self injection or not,
           time on treatment, medical history at time of enrollment

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (above, below
           or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        Easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; easypod™; Growth hormone; Pediatric subject
Bioequivalence Study Of Pediatric Appropriate Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing
      to the 80 mg commercial atorvastatin calcium tablet formulation.
    

Detailed description: 
      Determination of Bioequivalence
    

Intervention name(s): Atorvastatin; Atorvastatin pediatric appropriate formulation
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 80 mg atrovastatin tablet; A single dose of pediatric appropriate atorvastatin 80 mg formulation
Other intervention name(s): Atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiovascular Diseases
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,
      works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
    

Detailed description: 
      This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate
      release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover
      trial in participants with Parkinson disease.
    

Intervention name(s): Parcopa; carbidopa-levodopa (Sinemet)
Intervention type(s): Drug; Drug
Intervention description(s): at subjects current stable dose of comparator; at subjects current stable dose
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; time to "on"; delayed on
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease; GERD; Heartburn
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid
      Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in
      infants age 30 days up to 1 year.
    


Intervention name(s): nizatidine (axid); nizatidine (axid); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nizatidine (axid); nizatidine (axid); placebo
Intervention MeSH terms: Nizatidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gastroesophageal reflux disease; GERD; heartburn
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      A trial of combination of two drugs for the treatment of refractory lupus nephritis.
    

Detailed description: 
      Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis:
      a 12-month prospective study
    

Intervention name(s): low dose combination of MMF and Tac
Intervention type(s): Drug
Intervention description(s): mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Other intervention name(s): Cellcept and Prograf
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lupus; nephritis; glomerulonephritis; nephropathy; refractory
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will provide insight into whether a nutritional supplement, nicotinamide riboside
      (NR), improves memory and brain blood flow in older adults with low memory abilities.
      Overall, this project has the potential to identify a novel, safe and cost-effective strategy
      for decreasing age-related memory loss.
    


Intervention name(s): Niagen®; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 250 mg capsules (4 capsules daily); placebo
Other intervention name(s): nicotinamide riboside chloride
Intervention MeSH terms: Niacinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: blood pressure; arterial stiffness; cerebrovascular function; cognitive function
Probiotics and Its Associated Factors on Aflatoxin Biomarkers
Condition: Aflatoxicosis
Study type: Interventional

Summary: 
      The study will be aimed to investigate the effect of probiotic intervention and its
      associated factors on aflatoxin biomarkers among healthy subjects in Serdang and Kajang,
      Selangor
    

Detailed description: 
      The study will be a randomized, double-blind, placebo-controlled, parallel intervention that
      conducted for 12 weeks and followed-up for 4 weeks among healthy adults under living
      condition in Serdang and Kajang, Selangor. 164 subjects will be recruited for the
      intervention study, where 82 subjects will be randomly allocated to the probiotic or placebo
      group. Probiotic and placebo drinks (80 ml) will be prepared in the form of bottle. Placebo
      drink will have similar taste, colour, physical appearance, and nutritional value as
      probiotic drink but contain no LcS. Morning urine samples (15 ml), weight status, and dietary
      intake will be collected every two weeks from week 0 to week 12 and follow up until week 16
      at community centre. Whereas, fasting blood samples (5 ml) and physical activity will be
      collected every four weeks for 16 weeks at the community centre.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Other; Other
Intervention description(s): Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.; Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized , double-blind, placebo-controlled, parallel trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: probiotics; aflatoxin biomarkers; healthy subjects; intervention
Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T Cell Lymphoma
Condition: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type; Early Stage; Anlotinib; Peg-aspargase; Sintilimab; Phase Two; Open; Radiotherapy
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to investigate the treatment of previously untreated stage I-II Extranodal
      NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with
      radiotherapy.

      The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the
      second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response
      rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities.
    


Intervention name(s): Sintilimab
Intervention type(s): Drug
Intervention description(s): Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy
Other intervention name(s): Peg-aspargase; Anlotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this study is to investigate the clinical efficacy of entire papilla preservation
      technique with and without the adjunct of amelogenins (EMD) and bone substitutes.
    

Detailed description: 
      The present study is designed as a single-centre, parallel group, randomized, controlled
      clinical trial comparing the efficacy of EPP with or without biomaterials. Each patient will
      contribute with a single intrabony defect. Three months after completion of initial
      periodontal therapy, all the experimental sites will be accessed with the "EPP" technique
      (Aslan et al., 2017a) and carefully debrided. EDTA gel will be applied on the instrumented
      root surfaces. A combination of EMD and deproteinized bovine-derived bone substitute will be
      applied in the test group (EPP EMD + BS), while the control group (EPP) will not receive any
      regenerative biomaterial. Patients will be enrolled in a stringent maintenance programme with
      recalls on a weekly basis for the first month and then monthly controls for professional
      tooth cleaning up to 1 year. Clinical parameters will be recorded immediately before
      regenerative surgery (baseline) and 12 months after the regenerative periodontal surgery.
    

Intervention name(s): Procedure: Periodontal surgery with entire papilla preservation (EPP) technique; EMD application; Bone substitutes application
Intervention type(s): Procedure; Device; Device
Intervention description(s): After local anesthesia injection an modified flap is designed according to minimally invasive microsurgical techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.; Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.; Following the application of EMD, filling the bone defect with bone substitutes.
Other intervention name(s): Amelogenins application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Magnesium and Dexmedetomidine in Pheochromocytoma
Condition: Phaeochromocytoma Crisis; Hemodynamic Instability
MeSH terms: Pheochromocytoma
Study type: Observational

Summary: 
      Anesthesia management of pheochromocytoma excision surgery is associated with severe
      hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes
      requiring sodium nitroprusside administration between the group treated with
      magnesium-dexmedetomidine and conventional group in pheochromocytoma.
    


Intervention name(s): Magnesium-Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively
Intervention MeSH terms: Dexmedetomidine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients' data who were aged 18-75, had the American Society of Anesthesiologists
        classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor
        sizes < 5 cm and body mass index (BMI) <35 kg.m-2 were examined, who were evaluated
        according to Endocrine Society Practice Guideline and provided the Roizen criteria.
      
Keywords: Magnesium; Dexmedetomidine; Nitroprusside; Pheochromocytoma
High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may
      kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      high-dose radiation with chemotherapy may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy
      with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage
      IV nasopharyngeal cancer.
    

Detailed description: 
      OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting
      toxicity.

      Phase I

        -  Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks
           beginning on day 1.

        -  Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5
           and 22-26.

        -  Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy,
           patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30
           minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the
           absence of disease progression or unacceptable toxicity.

      In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to
      phase II.

      Phase II

        -  Patients are treated as in phase I. Patients are followed every 3 months for 1 year,
           every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
    

Intervention name(s): cisplatin; fluorouracil; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx
Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury
Condition: Gait Disorders, Neurologic; Gait Disorder, Sensorimotor
MeSH terms: Spinal Cord Injuries; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor
      recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls,
      subacute and chronic patients will be assessed at two timepoints with 3 month standard
      rehabilitation inbetween. The specific assessments will require the participant to acitvely
      modulate their gait pattern to fullfill specific task constraints. Their performance will be
      assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the
      adaptive capacity that the patient retains. Sensitivity and specificity of these markers will
      be determined. With more sensitive descriptors of gait function and quality, locomotor
      rehabilitation for SCI can be better designed and smaller effects can be accurately measured.
    


Intervention name(s): Standard locomotor therapy
Intervention type(s): Behavioral
Intervention description(s): Typical clinical therapy.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic; community sample
Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken
      together in healthy volunteers
    


Intervention name(s): Ticagrelor; Venlaflaxin
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg oral immediate release tablets, single dose on days 1 and 9; 37.5 mg oral immediate release tablets, administered twice daily on days 4-8
Intervention MeSH terms: Ticagrelor
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phase 1; ticagrelor; venlafaxine
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People
      between 12 and 75 years old can take part in the study. The study is open to people who had
      GPP flare-ups in the past but whose skin is clear or almost clear when they join the study.
      The purpose of the study is to test 3 different doses of a medicine called spesolimab and to
      see whether it helps to prevent GPP flare-ups.

      Participants are put into 4 groups by chance. Three groups get different doses of spesolimab.
      The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any
      medicine.

      Spesolimab and placebo are given as an injection under the skin. Participants are in the
      study for about 1 year and 4 months. During this time, they visit the study site about 15
      times. For the first 11 months, participants get spesolimab or placebo injections every
      month. At the study visits, the doctors check participants' skin for signs of a new GPP
      flare-up. The doctors also check the general health of the participants.

      If a participant has a GPP flare-up during the study, more visits may be necessary. In case
      of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
    


Intervention name(s): Spesolimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection; Solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Hypoxia
Study type: Interventional

Summary: 
      Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Moderate intensity strength training has been shown to improve strength and mobility in
      persons with MS. It was suggested that whole-body vibration training (WBVT) is effective to
      improve muscle strength, such as resistance training, resulting from both neural and
      structural adaptations. On the other hand, traditional strength training in hypoxia has
      garnered much attention. This method has shown improvements in isometric strength and
      increases in muscle size.
    

Detailed description: 
      -  Crossover.

        -  13 patients with multiple sclerosis were recruited.

        -  Patients performed two sessions: whole-body vibration training in normoxia condition and
           whole-body vibration in hypoxia condition.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Whole-body vibration training in hypoxia and normoxia condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: neuromuscular disease; whole-body vibration; hypoxia; strength
Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Single dose oral bioequivalence study of Riociguat 2.5 mg film coated tablets and 'Adempas'
      (Riociguat) 2.5 mg Filmtabletten (film coated tablets) in healthy adult male subjects under
      fasting conditions.
    


Intervention name(s): Riociguat film coated tablets; Adempas Filmtabletten
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of 2.5 mg Riociguat; 1 tablet of 2.5 mg Riociguat
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other