bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Varenicline on Smoking Reminders
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Varenicline is the best smoking cessation agent to date; however it is only effective in a
      subgroup of smokers and is associated with undesirable side effects in other subgroups. To
      understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion
      functional magnetic resonance imaging and a functional candidate gene association approach
      using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic
      varenicline administration in smokers. Brain and behavioral responses to smoking cues will be
      will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat
      smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats.
      For the purposes of the clinical trial portion of the study, the change from cigarettes per
      day at Baseline to the last day of treatment will be reported.
    


Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.; Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Other intervention name(s): Chantix; Sugar Pill
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smokers; fMRI; varenicline
Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway
Condition: General Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the facial measurements for determining the proper
      sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors
      and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared
      with the length between mouth corner and mandible angle.
    


Intervention name(s): the length between incisor and mandible angle; the length between mouth corner-mandible angle
Intervention type(s): Device; Device
Intervention description(s): the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) which size is the length between incisor and mandible angle; the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) of which size is the length between mouth corner and mandible angle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Airway Management; Ventilation
A Study of Zanubrutinib in Patients With ITP
Condition: Immune Thrombocytopenia; Bruton Tyrosine Kinase
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib
      for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
    

Detailed description: 
      The investigators are undertaking a prospective trial of 10 adults with ITP in China.
      Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Platelet count, bleeding and other
      symptoms were evaluated before and after treatment. Adverse events are also recorded
      throughout the study.
    

Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Intervention description(s): Zanubrutinib 80mg po qd 6 weeks
Intervention MeSH terms: Zanubrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis
Condition: Intrabony Periodontal Defect
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      To assess the effectiveness of advanced PRF+ as compared to open flap debridement in
      treatment of periodontal intraosseous defects in stage III periodontitis patients.
    

Detailed description: 
      The application of platelet concentrates characterized by high concentrations of platelets
      and growth factors have been applied and investigated as possible periodontal regenerative
      therapy. The application of platelet rich fibrin in management of intraosseous and furcation
      defects produce more favorable outcome compared to open flap debridement.

      A-PRF+ represents the latest generation of platelet concentrates that could provide sustained
      and increased release of growth factors and could serve as an autologous cost-effective
      membrane in periodontal tissue regeneration procedures
    

Intervention name(s): Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD); Open flap debridement (OFD) alone
Intervention type(s): Procedure; Procedure
Intervention description(s): Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures; Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stage 3 periodontitis; A-PRF; Advanced platelet rich fibrin; open flap debridement; OFD; 2-wall intraosseous defect; 3-wall intraosseous defect
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Open-label, long-term extension study available to participants who have completed
      CNMAu8.201.
    

Detailed description: 
      This open-label, long-term extension study is only available to participants who have
      completed CNMAu8.201 (VISIONARY-MS). The Week 48/End-of-Study Visit for study CNMAu8.201
      (VISIONARY-MS) will serve to establish the Baseline for electrophysiological, functional,
      morphological vision testing, as well as the neurological and outcome assessments.
      Participants will receive open-label CNM-Au8 throughout the study. All participants will
      receive a daily dose of 30 mg CNM-Au8 for the entire open-label, long-term extension study.
      The dose for participants may be adjusted once efficacy and safety data from study CNMAu8.201
      becomes available, which may occur after participants have already started this study. Based
      upon a review of data and Sponsor or PI recommendation, this open-label, long-term extension
      study may be discontinued once each participant reaches her/his 48-week visit.
    

Intervention name(s): CNM-Au8
Intervention type(s): Drug
Intervention description(s): 30 mg of CNM-Au8
Intervention model: Single Group Assignment
Intervention model description: Open-Label, Long-Term Extension.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS; RMS; Multiple Sclerosis; Demyelination; Remyelination; Optic Neuropathy; Optic Neuritis; Gold; Nanocrystal; Multifocal VEP; Full Field VEP; Low contrast letter acuity
A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria
Condition: Diabetic Nephropathy; Type 2 Diabetes Mellitus
MeSH terms: Diabetic Nephropathies; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary
      albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to
      study the safety and efficacy of the medication in this patient population.
    


Intervention name(s): Placebo; CCX140-B
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsules once daily; CCX140-B capsules once daily (Group B)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics
Condition: Abnormal Respiratory Airway Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary
      mechanics in intensive care patients.
    

Detailed description: 
      The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary
      mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this
      study. Patients are divided into two random groups, Group P (propofol) and Group D
      (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and
      dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial
      blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP,
      cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway
      pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded.
      This parameters are evaluated with Drager Evita 4 ventilator and recorded on
      5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey
      Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and
      recorded.

      The primary outcome measures are airway resistance and peak airway pressure. Secondary
      outcome measure is sedation score.
    

Intervention name(s): propofol; dexmedetomidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: peak airway pressure; airway resistance; sedation; intensive care
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
Condition: Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability, and
      pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week
      (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease
      (CKD) not requiring dialysis.
    

Detailed description: 
      This study in participants with CKD not requiring dialysis was conducted in 2 parts
      (designated Part 1 and Part 2). Part 1 evaluated roxadustat doses at 1.0 and 2.0
      milligrams/kilograms (mg/kg). Part 2 evaluated roxadustat doses at 0.7, 1.5, and 2.0 mg/kg.

      On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study
      until evaluation of a report of a death due to fulminant hepatic failure in a participant
      with CKD in a FibroGen-sponsored clinical trial of another hypoxia inducible factor-prolyl
      hydroxylase inhibitor (HIF-PHI) (FG-2216) being investigated for treatment of anemia in
      participants with CKD and other diseases. The clinical hold resulted in early termination of
      Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this
      study started.
    

Intervention name(s): Roxadustat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Capsule
Other intervention name(s): FG-4592
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Kidney; Chronic Kidney Disease; CKD; Stage 3 or 4 Chronic Kidney Disease; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Blood count; Erythropoietin
Brief Shame Intervention Study
Condition: Shame; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The current project will develop and test a brief 2-session shame intervention in individuals
      diagnosed with social anxiety disorder (SAD). Using a non-concurrent multiple baseline
      design, the investigators will determine whether the brief shame intervention leads to
      reductions in trait self-reported shame and state shame in response to an in vivo stressor
      task. The investigators will also evaluate the effect of changes in shame on trait SAD
      symptoms.
    


Intervention name(s): Shame Intervention
Intervention type(s): Behavioral
Intervention description(s): In the Shame Intervention, participants will meet with a therapist and learn to: 1) Recognize the experience of shame, 2) Understand the connection between shame and social anxiety, 3) Identify shame triggers and vulnerabilities, 4) Identify the thoughts and behaviors that keep participants stuck in shame, and 5) Learn how to use new, healthier thoughts and behaviors that will help participants move through and decrease shame.
Intervention model: Single Group Assignment
Intervention model description: non-concurrent multiple baseline design
Masking: None (Open Label)
Primary purpose: Treatment
Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered
      alone & in combination with MMX® Mesalazine/mesalamine
    


Intervention name(s): Metronidazole + MMX Mesalazine/mesalamine placebo; Metronidazole + MMX Mesalazine/mesalamine
Intervention type(s): Drug; Drug
Intervention description(s): Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally; Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
Other intervention name(s): Lialda
Intervention MeSH terms: Metronidazole; Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Intake, Eating Behavior, Physical Activity Level and Their Relationships With Glycemic and Weight Control in Hong Kong Chinese Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus in Obese
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The objective of this study is to describe and examine the dietary intake, eating behavior
      and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association
      with weight and glycemic control at baseline and 1 year follow-up. The investigators
      hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern
      and low physical activity level are associated with poorer glycemic and weight control, and
      there will be no improvement with weight and glycemic control under usual care after 1 year.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hong Kong Chinese T2DM patients referred to the Prince of Wales Hospital (PWH) diabetes
        centre
Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the bioavailability of a generic product of amlodipine
      with that of a reference product when administered to healthy volunteers under fasting
      conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future
      Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the
      reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine
      obtained from two formulations will be used to access the interchangeability of the products
    

Detailed description: 
      The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a
      washout period of two to three weeks. During each session, the subjects will be administered
      a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet
      10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be
      collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of
      amlodipine will be determined by a validated assay. The non-compartmental method will be used
      to analyze the plasma concentration-time data and calculate the main pharmacokinetic
      parameters such as Peak plasma concentration (Cmax), Time to maximum concentration (Tmax),
      Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination
      half-life (T1/2). Analysis of Variance (ANOVA) will be conducted on logarithmically
      transformed Cmax, AUC0-last and AUC0-inf. The two one sided tests will be used to calculate
      the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to
      assess the bioequivalence of the two products
    

Intervention name(s): BF-Amlodipine Tablet 10mg; Norvasc Tablet 10mg
Intervention type(s): Drug; Drug
Intervention description(s): BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited; Norvasc Tablet 10mg will be used as a comparator drug for the BE study
Other intervention name(s): Amlodipine Tablet 10mg; Amlodipine Tablet 10mg
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
TAPB vs. Caudal for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Condition: Anesthesia, Recovery Period
Study type: Interventional
Phase: Phase 4

Summary: 
      Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional
      anesthesia technique for providing postoperative lower abdominal analgesia. Complications
      associated with TAPB are very rare and pose a lower overall risk to the patient receiving a
      TAPB versus a caudal block, which is considered the gold standard for pediatric lower
      abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to
      caudal block initially in providing postoperative pain control but would show improved pain
      relief beyond the anticipated caudal duration.
    

Detailed description: 
      The study design was a double-blinded randomized controlled trial. A minimum of 44 children
      between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a
      low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES),
      episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and
      at 6 hour intervals through 24 hours from the time of the block placement.
    

Intervention name(s): Caudal Epidural; Transversus Abdominis Plane Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound Guided Caudal Block; Ultrasound Guided Transversus Abdominis Plane Block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Transversus Abdominis Plane Block; Caudal Epidural; Pediatric Pain control; Pain control for Lower Abdominal Surgery
Cognitive Functions After COVID-19
Condition: COVID-19 Acute Respiratory Distress Syndrome; Cognitive Decline
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Cognitive Dysfunction
Study type: Observational

Summary: 
      This study was aimed to evaluate the post-infection cognitive functions of adult individuals
      with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in
      the study. Cognitive functions of individuals with COVID19 compared with healthy individuals.
    

Detailed description: 
      This study was aimed to evaluate the post-infection cognitive functions of adult individuals
      with COVID-19. Fifty COVID-19 patients, aged between 18-50 years, who had positive RT-PCR
      test in the last 60 days and later recovered, were included in the study. The study group was
      compared with the control group consisting of 50 healthy individuals in whom gender, age and
      education year has not difference significantly. Participants' global cognitive skills were
      measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory
      functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the
      Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical
      Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills
      were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms
      were evaluated with the Neuropsychiatric Inventory (NPI). The study group was evaluated
      between 21 and 60 days from the onset of the disease.
    

Intervention name(s): Neuropsychometric Test
Intervention type(s): Behavioral
Intervention description(s): Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
Other intervention name(s): Montreal Cognitive Assessment Test (MoCA); Clock Drawing Test; Öktem Verbal Memory Processes Test (Ö-SBST); Digit Span Forward Test; Digit Span Backwards Test; Categorical Fluency; Phonemic Fluency; Stroop Test; Trail Making Test A; Trail Making Test B; Rey-Osterrieth Complex Figure Test (ROCF); Neuropsychiatric Inventory (NPI)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: Cognitive Functions; COVID-19; Attention; Executive Functions; Memory; Neurophysiology