bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma
Condition: B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical study was to investigate the safety, tolerability, and
      pharmacokinetics/pharmacodynamics of Bruton tyrosine kinase (BTK) inhibitor zanubrutinib
      (BGB-3111) in Chinese participants with B-cell lymphoma by conducting in two stages, the
      first stage being the safety assessment of dose and the second stage being the dose
      expansion.

      Part I: Safety evaluation - according to the results of preclinical toxicological trials and
      the results of the phase I clinical study conducted in Australia and New Zealand, two
      regimens of zanubrutinib 320 milligrams (mg) daily (160 mg twice daily [BID]), administered
      in the morning and at night, or 320 mg once daily [QD]) and "3+3" design was adopted for the
      assessment. The recommended dose and method of administration of the phase II clinical study
      was determined according to the Part I results.

      Part II: Dose expansion - this stage was to further evaluate the preliminary anti-tumor
      effects of zanubrutinib in Chinese participants with follicular lymphoma (FL) or marginal
      zone lymphoma (MZL), approximately 20 participants with relapsed or refractory FL or MZL were
      to be enrolled. The recommended Phase 2 dose (RP2D) was used in Part II.
    


Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Intervention description(s): Zanubrutinib is a white to off-white solid that is slightly hygroscopic. The drug product was formulated as 20-mg (blue, size 3) and 80-mg (white, size 0) hard gelatin, opaque oral capsules. Zanubrutinib is classified as a Biopharmaceutics Classification System Class II compound.
Other intervention name(s): BGB-3111
Intervention MeSH terms: Zanubrutinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
Condition: Overweight; Obesity; Weight Loss Maintenance
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal
      Replacements (MR) and a condition focusing on the nutritional changes to the home food
      environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the
      diet and psychosocial outcomes. A second aim is to determine the degree to which the specific
      targets of the experimental interventions do in fact change in the anticipated direction
      during the intervention and to evaluate whether such changes might account for improvements
      in weight loss maintenance. This study is important because it could provide the first
      evidence that the current standard of care for obesity lifestyle treatment could be improved
      by the addition of MRs or a program of comprehensive nutritional change.
    


Intervention name(s): Behavior Therapy; Meal Replacements; Nutritrol
Intervention type(s): Behavioral; Dietary Supplement; Behavioral
Intervention description(s): Weight loss using CBT and continued CBT during weight loss maintenance.; Weight loss using CBT and meal replacements.; To make widespread nutritional changes to participants personal food environments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutritional Intake; Psychosocial Outcome
Pyruvate Kinase Deficiency Epidemiological Study (PIECE)
Condition: Pyruvate Kinase Deficiency
MeSH terms: Anemia, Hemolytic, Congenital Nonspherocytic; Pyruvate Metabolism, Inborn Errors
Study type: Observational

Summary: 
      Pyruvate kinase deficiency (PKD) is the most common red cell glycolytic enzyme defect causing
      hereditary non-spherocytic hemolytic anemia, caused by mutations in the PKLR gene. The main
      goal of this study is the diagnosis of pyruvate kinase deficiency in patients who exhibit
      chronic anaemia and/or splenomegaly and/or judiance and/or hyperbilirubinemia and/or history
      of prolonged neonatal jaundice and/ or cholelithiasis of undetermined aetiology.
    

Detailed description: 
      Pyruvate kinase deficiency is the most common red cell glycolytic enzyme defect causing
      hereditary non-spherocytic hemolytic anemia, caused by mutations in the PKLR gene. PKLR
      encodes a pyruvate kinase that catalyzes the transphosphorylation of phosphoenolpyruvate into
      pyruvate and ATP. The current treatment options are red cell transfusions, chelation and
      splenectomy.

      This is an international, multicentre, epidemiological and observational study.

      The patients fulfilling the inclusion criteria will be enrolled into the Study and
      genetically tested for PKLR mutations via Next generation sequencing (NGS). Any mutation
      being detected by NGS, will be confirmed by Sanger sequencing.

      PKLR-positive samples (homozygous or compound heterozygous for pathogenic variants) will be
      analysed for the identification of potential biomarkers via liquid chromatography multiple
      reaction-monitoring mass spectrometry (LC/MRM-MS) and compared to a merged control samples in
      order establish a PKD specific biomarker.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients older than 5 years and younger than 30 years old, with high suspicion of PK
        deficiency, due to chronic anaemia or cholelithiasis or cholecystitis of undetermined
        aetiology
      
Biospecimen description: 
      Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)
    
Keywords: Pyruvate Kinase Deficiency; Chronic anaemia; Biomarker
Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine mean or median of fractional exhaled nitric oxide
      (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma
      exacerbation according to the global initiative for asthma guideline.
    

Detailed description: 
      From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as
      non-invasive, easily to perform, less time consume, has direct association with severity of
      inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and
      monitoring the treatment in asthmatic patients.

      In Thailand, this field of study is less extend, especially in children population. The
      investigators hypothesized that patients with asthma exacerbation may have high level of
      fractional exhaled nitric oxide (FeNO) than non exacerbation group.

      It is therefore desirable to examine the association between fractional exhaled nitric oxide
      (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main
      objective of this research.
    

Intervention name(s): FeNO measurement
Intervention type(s): Other
Intervention description(s): FeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)
      
Keywords: bronchial asthma; fractional exhaled nitric oxide (FeNO); asthma exacerbation
Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Condition: Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract
      of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to
      reduce the risk of hemorrhage known to be associated to the transurethral resection of
      prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the
      GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce
      the length of catheterization to facilitate outpatient surgical management of prostate
      adenoma.

      In the investigators study, the investigators propose to evaluate the failure rate of an
      early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS
      in selected patients on general anesthesia or spinal anesthesia. To this end, the
      investigators realize a national multicenter prospective study including 300 patients. The
      effectiveness of this model of management is defined by absence of a need for
      re-catheterization in the post -operative period of 24 hours.
    


Intervention name(s): Catheter
Intervention type(s): Other
Intervention description(s): The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours, indications for resondage being cases of acute urinary retention (AUR ) or macroscopic hematuria necessitating a washes with drainage . Patients are followed for a period of 3 months with a post-operative visit at 30 days and a last follow-up visit at 90 days during which the effectiveness is evaluated by conventional means of clinical indicators ( flowmetry , postvoid residue, volumetry of the prostate , IPSS scores , QoL , EVA, IIEF ... ).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dry Needling Versus Graston Technique in Active Myofascial Trigger Points on Upper Trapezius
Condition: Trigger Points
Study type: Interventional

Summary: 
      This study will compare the effects dry needling and Graston technique in active myofascial
      trigger points on upper trapezius. Half of the study participants will receive dry needling
      whereas other half will receive Graston technique.
    

Detailed description: 
      This is a single blinded randomized controlled trial, will be conducted at Rawal General &
      Dental Hospital, Islamabad. Both dry needling and Graston Techniques are used to release
      active Myofascial Trigger points with different mechanism.

      Dry needling is technique in which without any medication or injection, dry needles are
      inserted into hyper irritable points in muscle. Graston technique is done with specially
      designed tools to locate knots within muscle by running the tools over the skin.

      This study is planned with objectives to compare both treatment techniques on active
      myofascial trigger points in patients with neck pain. Effects of these will be measured on
      Neck Pain, Range of Motion, functional status and trigger points.
    

Intervention name(s): Dry Needling Group; Graston Technique Group
Intervention type(s): Other; Other
Intervention description(s): Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points.
The treatment will be continued for 2 weeks with 2 sessions per week.; Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed.
Later, lubricant will be applied to the skin, and Graston technique will be applied using instrument over the active myofascial trigger points in upper trapezius.
The treatment will be continued for 2 weeks with 2 sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two treatment groups of participants, One group will receive Dry Needling whereas other will receive Graston technique for treatment of Myofascial Trigger points.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trigger Area; Myofascial Pain Syndromes; Instrument assisted soft tissue tecnique
Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      This study is designed to determine whether a functional difference exists between the
      laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received
      neuromuscular blockade.
    


Intervention name(s): i-gel airway (Intersurgical Ltd., Wokingham, England); Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): supra-glottic airway device; supra-glottic airway device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Perceived Stress and Anxiety Levels of Nurses
Condition: Stress; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study was conducted to determine the effect of web-based progressive relaxation
      exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety.
      In this randomized controlled clinical trial, nurses working in the pandemic hospital were
      randomly assigned to the control and intervention groups.
    

Detailed description: 
      The coronavirus disease-2019 (COVID-19) epidemic increases the stress and anxiety level of
      nurses due to many factors. This study was conducted to determine the effect of web-based
      progressive relaxation exercises applied to nurses working in a pandemic hospital on
      perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in
      the pandemic hospital were randomly assigned to the control and intervention groups. The
      Web-Based Relaxation Exercises Program was trained and implemented online for 4 weeks by a
      trainer for the intervention group.The Perceived Stress Scale (PSS) and the State-Trait
      Anxiety Inventory (STAI) were completed online by participants in both groups before and
      after the intervention
    

Intervention name(s): Progressive Relaxation Exercises
Intervention type(s): Other
Intervention description(s): The trainer performed the PRE exercise online with the nurses. The video recording of the progressive relaxation exercises was shared with the nurses participating in the study on WhatsApp groups. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. The PRE application was reminded daily from the WhatsApp group for the nurses to apply regularly to the sessions and not to disrupt the sessions. Nurses shared the messages stating that they were doing the PRE application on a daily basis for four weeks on WhatsApp groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Anxiety; Pandemics; Nurse; Stress
Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients
Condition: Xerostomia; Chronic Renal Failure
MeSH terms: Xerostomia; Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      End-stage renal disease patients undergoing hemodialysis can present alteration in flow,
      concentrations and composition of saliva affecting oral health. This randomized
      placebo-controlled trial aims to evaluate the effectiveness of photobiomodulation therapy
      (PBM) in salivary parameters in chronic renal failure (CRF) patients undergoing hemodialysis.
      Forty-four patients with CRF on hemodialysis self-responded two questionnaires for oral
      health and salivary gland function perception. Thereafter, patients were clinically evaluated
      for the diagnosis of hypofunction of salivary glands and were randomly allocated into two
      groups: PBM group (n = 21), which received three irradiations of laser at ʎ = 808 nm, 100 mW,
      142 J/cm2 and 4 J per point; and a placebo group (n = 17) that consisted of laser protocol
      with the device switched off. Patients were first submitted to sialometry and after to PBM or
      placebo intervention at baseline, 7 and 14 days. Non-stimulated and stimulated saliva were
      collected for salivary volume investigation and biochemical analysis of total protein,
      calcium and urea concentrations.
    


Intervention name(s): Photobiomodulation; Placebo
Intervention type(s): Radiation; Radiation
Intervention description(s): Patients received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point.; The same laser protocol was followed but with the device switched off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic
      arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis,
      motility, secretion and proliferation, the observed antitumor effects of epothilones have
      been attributed to their ability to initiate cell death by inhibiting such processes.
      Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines,
      equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor
      activity in a range of xenograft models, including paclitaxel-resistant xenografts.
      Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug
      resistant activity overexpressing p-glycoprotein.
    


Intervention name(s): Epothilone D (KOS-862)
Intervention type(s): Drug
Intervention MeSH terms: Epothilones; Desoxyepothilone B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epothilone D; tubulin polymerization
Motion Characteristics of the Foot and Ankle as Measured by Durometer Readings
Condition: Foot Motion Characteristics
Study type: Observational

Summary: 
      The purpose of this study is to determine the motion characteristics of the foot and ankle
      with a durometer as a method of measurement.
    

Detailed description: 
      This study will assess and establish the motion characteristics of the foot and ankle with
      the use of a durometer as a measure of motion patterns.

      The durometer is a device commonly used in materials testing that measures displacement
      through the use of a piezoelectric sensor configured to detect motion a in the form of a
      reflected wave back from the surface being tested.
    

Intervention name(s): Durometer analysis
Intervention type(s): Behavioral
Time perspective: Prospective
STudy of Asthma Adherence Reminders
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To determine whether electronic adherence monitoring with feedback and reminder alarms can
      improve adherence and health outcomes in childhood asthma.
    

Detailed description: 
      This study will investigate whether adding an electronic adherence monitor to inhaled
      steroids, and feeding this information back to patients and families can improve adherence
      and outcomes in childhood asthma. The devices will also sound twice daily reminder alarms to
      act as direct medication prompts. This intervention will be compared to a control group in
      which adherence is monitored, but with no feedback or alarms.
    

Intervention name(s): Activated Smartinhaler or Smartturbo; Feedback of adherence data; Deactivated Smartinhaler or Smartturbo
Intervention type(s): Device; Other; Device
Intervention description(s): Medication reminder alarms; Review of adherence data with action planning; Alarms deactivated and no feedback
Other intervention name(s): Electronic adherence monitor; Electronic adherence monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Condition: Infection by Streptococcus Group B
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: The primary objective is to evaluate the safety and tolerability of a potential
      vaccine against Group B streptococcus.

      Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year
      following the first dose.
    

Detailed description: 
      Part A: Subjects will receive 2 doses of the vaccine, GBS-NN, and will be followed for 12
      weeks after the first dose of the vaccine. The following safety endpoints will be evaluated
      to support this objective: local and systemic reactogenicity; adverse events; laboratory
      tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition
      hereto, immunological parameters will be evaluated.

      Part B: Subjects will receive one or 2 doses of GBS-NN, and will be followed for 12 months
      after the first dose of the vaccine. The following safety endpoints will be evaluated to
      support this objective: local and systemic reactogenicity; adverse events; laboratory tests;
      urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto,
      immunological parameters will be evaluated.
    

Intervention name(s): GBS-NN vaccine
Intervention type(s): Biological
Intervention description(s): Three dose levels will be administered, with and without Alhydrogel®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and
      supratherapeutic doses.
    

Detailed description: 
      -  Part A of the study will assess clinical safety data of TRV130

        -  Part B of the study will assess the effect of single dose TRV130 on QTc
    

Intervention name(s): TRV130; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment