bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites
Condition: Arrhythmia, Cardiac
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites
    

Detailed description: 
      This will be a Phase 1, randomized, open-label, single-dose, three-period, crossover study to
      assess the bioequivalence of propafenone hydrochloride manufactured at two different sites in
      healthy adult volunteers. Approximately 36 subjects will receive a 3 single doses of
      propafenone hydrochloride 425mg, each administered separately, in the fasted state with a 7
      day washout period between doses. Propafenone hydrochloride is an antiarrhythmic indicated to
      prolong the time to recurrence of symptomatic atrial fibrillation in patients with episodic
      (most likely paroxysmal or persistent) atrial fibrillation who do not have structural heart
      disease. A follow-up visit will occur 7-10 days after the final dose of study drug.
    

Intervention name(s): Propafenone
Intervention type(s): Drug
Intervention description(s): Comparison of drug from 2 manufacturing sites
Intervention MeSH terms: Propafenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; RYTHMOL SR®; Atrial fibrillation; Propafenone; Pharmavokinetics
Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism
Condition: Pulmonary Embolism and Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Embolism and Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound
      procedure (together defined as the APT Procedure) as a treatment for acute submassive
      pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or
      equal to [≤]14 days) PE with normal systemic arterial blood pressure (greater than [>] 90
      mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio,
      that is; RV/LV ratio greater than or equal to [≥] 0.9). Participants with submassive PE will
      be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with
      r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1
      mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2
      mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a
      study participant in this arm.
    

Detailed description: 
      This study is designed to investigate the lowest recombinant tissue plasminogen activator
      (r-tPA) dose-ultrasound treatment time required to achieve the same reductions in thrombus
      burden and associated improvement in physiologic parameters demonstrated in ULTIMA (EKOS 08
      [NCT01166997]) and SEATTLE II (EKOS 09 [NCT01513759]). Results of this study are intended to
      inform the study design for further studies of the Acoustic Pulse Thrombolysis (APT)
      Procedure. Analysis of the first 100 evaluable participants in the United States study
      suggested a degree of equipoise between treatment groups 1, 2 and 3 of the protocol and
      therefore the sample size has been extended and additional sites in the United Kingdom (UK)
      National Health Service included, with a view to adding to the findings of the OPTALYSE study
      from sites in the UK and increasing the number of participants treated by treatment protocol.
    

Intervention name(s): Ekosonic® Endovascular Device ultrasonic infusion catheter; Recombinant tissue plasminogen activator
Intervention type(s): Device; Biological
Intervention description(s): r-tPA will be administered via EKOS.; Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm.
Other intervention name(s): Acoustic Pulse Thrombolysis Procedure (APT Procedure); EKOS; r-tPA
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Condition: Geographic Atrophy; Dry Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase II study is to determine the efficacy of fenretinide in the
      treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular
      degeneration (AMD).
    


Intervention name(s): Fenretinide
Intervention type(s): Drug
Intervention description(s): Once daily 30 minutes after the evening meal for 24 months
Intervention MeSH terms: Fenretinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry Age Related Macular Degeneration; Geographic Atrophy
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on
      the result of trabeculectomy in primary term of intraocular pressure (IOP).
    

Detailed description: 
      Prospective interventional clinical trial

      Single center, outcome assessor-masked, active control, randomized controlled trial
    

Intervention name(s): Bevacizumab; Mitomycin C
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application; Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Other intervention name(s): Avastin; MMC
Intervention MeSH terms: Bevacizumab; Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trabeculectomy; bevacizumab; intraocular pressure
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
Condition: Multiple Myeloma and Malignant Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic
      stem cells into the peripheral blood in patients with multiple myeloma.
    


Intervention name(s): KRN125(pegfilgrastim), PLR001(plerixafor); KRN8601(filgrastim), PLR001(plerixafor)
Intervention type(s): Drug; Drug
Intervention description(s): 7.2 mg of KRN125 in Day 1 Single subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.; 400 ug/m2 of KRN8601 from Day 1 to the end date of the Apheresis Once daily subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endothelial Dysfunction and Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aim of the study is to progress in the understanding of the early retinal vascular and
      neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel
      Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels
      and to assess how it varies in presence of various stimuli. Then, we will be able to assess
      if a vascular and/or a neural dysfunction is present early in patient with diabetes.
    

Detailed description: 
      Twenty patients with type 1 diabetes without diabetic retinopathy and without arterial
      hypertension will be compared with 20 sex and aged-matched healthy control subjects. To
      assess the presence of retinal endothelial dysfunction, the variations of the diameters of
      the retinal vessels will be assessed using the Dynamic Vessel Analyzer, before and after
      flicker light stimulation, sublingual nitroglycerin, neosynephrine eyedrops, and isometric
      contraction. To assess the presence of peripheral endothelial dysfunction, the
      microcirculation of the forearm skin will be studied using iontophoresis with acetylcholine
      delivery, and heat delivery, both coupled with blood flow measurement using laser Doppler. An
      intravital capillaroscopy of the phalanx skin will be performed. The serum levels of CRP,
      ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin will also be measured.
    

Intervention name(s): Trinitrin; Neosynephrine 10% collyrium; Iontophoresis with acetylcholine delivery; Dynamic Vessel Analyzer
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose; Neosynephrine 10% collyrium: 2 drops; Iontophoresis with acetylcholine delivery; Dynamic Vessel Analyzer
Intervention MeSH terms: Phenylephrine; Acetylcholine; Nitroglycerin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 1 diabetes: Diabetes duration >= 5 years, age >= 18 and <= 60 years old,
        patients with no visible diabetic retinopathy, and no arterial hypertension

        Healthy subjects: Sex and age-matched control healthy subjects
      
Keywords: Type 1 diabetes mellitus; Diabetic retinopathy; Pathogenesis; Dynamic Vessel Analyser; Endothelial dysfunction
Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease
Condition: Sacrococcygeal Fistula; Pilonidal Sinus; Pilonidal Disease; Pilonidal Disease of Natal Cleft
MeSH terms: Pilonidal Sinus; Fistula
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated
      Sacrococcygeal pilonidal disease
    

Detailed description: 
      This is a single center randomized controlled clinical trial consisting in 2 treatment
      groups.

      All patients admitted at University Hospital of Tarragona Joan XXIII with Sacrococcygeal
      pilonidal disease were likely to enter in the study. All patients with uncomplicated
      sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice.

      When the patients met the criteria and after consenting the admission in the study, they were
      included and were operated. The patients were randomly assigned to the phenolization group or
      conventional-surgery group. A unique anesthetic and surgical protocol were established for
      both groups.

      Patients in the phenolization group underwent curettage with an otorhinolaryngology spatula
      and endocavitary phenol with an abocath needle until complete coagulation of the cyst.
      Patients in the conventional-surgery group were referred to conventional surgery consisting
      of complete excision of the cyst and closure by second intention. Both groups were managed
      without admission and discharged within a few hours if they met ALDRETE criteria. They were
      followed daily by the home hospitalization team

      The main endpoint was short or medium-term recurrence of sacrococcygeal disease. The number
      of recurrences per group and the time from surgery to recurrence were assessed. Secondary
      endpoints included degree of satisfaction and sick leave
    

Intervention name(s): phenolization; Conventional surgery
Intervention type(s): Drug; Procedure
Intervention description(s): In case of phenolization group, an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.; In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Condition: Liver Transection During Laparoscopic Liver Resection
Study type: Interventional

Summary: 
      Background: until now, there is no agreement about the safest and feasible method for liver
      parenchyma transection during laparoscopic liver resection.

      Study design: prospective, randomized, single-center The purpose of the study: comparison of
      short-term results of two methods of parenchyma liver transection during laparoscopic liver
      resection
    


Intervention name(s): liver transection during laparoscopic liver resection
Intervention type(s): Procedure
Intervention description(s): liver transection during laparoscopic liver resection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups will be compared. Group 1: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
Group 2: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal liver metastases; hepatocellular carcinoma; intrahepatic cholangiocellular carcinoma; tumor of liver; focal nodular hyperplasia liver; hemangioma liver
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability based on the incidence of adverse
      experiences of buprenorphine sublingual spray (0.5 milligrams [mg] three times daily [TID])
      compared with standard post-operative narcotic therapy in participants with postoperative
      pain. Standard post-operative narcotic therapy is defined as morphine intravenous (IV)
      injection (4 mg TID) followed by oxycodone hydrochloride tablet (10 mg TID).
    


Intervention name(s): Buprenorphine Sublingual Spray; Morphine; Oxycodone Hydrochloride; Zofran
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg Sublingual Spray; 4 mg Intravenous Injection; 10 mg tablet; 4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea
Intervention MeSH terms: Morphine; Oxycodone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Community Study of Outcome Monitoring for Emotional Disorders in Teens
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study is being done to compare three types of talk therapies for youth who struggle with
      emotional and behavioral problems (e.g., anxiety, sadness, worries) in Community Mental
      Health Clinics in Connecticut (CT) and Florida (FL).
    


Intervention name(s): Unified Protocol for Adolescents (UP-A); Youth Outcomes Questionnaire; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a transdiagnostic treatment for adults with emotional disorders. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.; The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.; Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional

Summary: 
      This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an
      on-time administration of the third dose with delayed administration of the third dose. All
      participants would receive the first and second doses according to schedule. They would be
      randomized to either vaccine at 6 months or vaccine at 12 months.

      Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post
      third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual
      timing control group (C):

      H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified
      non-inferiority margin.
    

Detailed description: 
      The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that
      a large percentage of women in this age group are attending college, a good place to access
      them would be through the student health services on college campuses. However, the HPV
      vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college
      calendar year and the immunogenicity of alternative schedules is unknown. If the
      immunogenicity of an altered schedule is good, then higher vaccination rates may be
      achievable.

      Aims:

        1. Determine if delay in the third dose is immunologically non-inferior to the standard
           administration schedule (1 month post-dose 3).

        2. Determine the side effect profile of a delayed third dose, in comparison to the standard
           schedule
    

Intervention name(s): Quadrivalent human papillomavirus vaccine on-time administration; Quadrivalent human papillomavirus vaccine delayed administration
Intervention type(s): Biological; Biological
Intervention description(s): The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.; The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
Other intervention name(s): Gardasil; Gardasil
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Papillomavirus Vaccine
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Condition: Disruptive Behavior; Aggression; Anger; Irritability; Noncompliance
MeSH terms: Aggression; Problem Behavior
Study type: Interventional

Summary: 
      This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive
      behavior such as irritability, anger and aggression in children and adolescents. CBT will be
      compared to Supportive Psychotherapy (SPT) and participants of this study will be randomly
      assigned (like the flip of a coin) to receive CBT or SPT. Participants will be also asked to
      complete functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks
      (recordings/images of brain activity) before and after treatment.
    

Detailed description: 
      Cognitive-behavioral therapy (CBT) is a behavioral intervention that consists of 12 weekly
      sessions. During CBT children are taught various skills for coping with frustration and
      parents are taught various strategies for managing situations that can be anger provoking for
      their child. This study is conducted to examine whether reduction of behavioral problems
      including anger outbursts, irritability, aggression and noncompliance after CBT may be
      paralleled by changes in areas of the brain responsible for emotion regulation and social
      perception.
    

Intervention name(s): Cognitive-Behavioral Therapy for Anger and Aggression; Supportive Psychotherapy (SPT)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: child; cognitive behavioral therapy; CBT; aggression; disruptive behavior; treatment; frustrative non-reward; irritability
Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
Condition: Growth Hormone Deficiency; Cardiac Function
MeSH terms: Dwarfism, Pituitary; Acromegaly; Endocrine System Diseases
Study type: Observational

Summary: 
      To test the hypothesis that both lack and excess of growth hormone (GH) is associated with
      cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and
      after treatment.
    

Detailed description: 
      It is an open prospective noninterventional clinical study. Treatment and follow-up will be
      according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients
      will be treated with daily subcutaneous GH injections. Patients with acromegaly will be
      treated with either transsphenoidal surgery or by medical treatment with long acting
      somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment
      modalities.

      Patients will be examined by Cardiac MRI before treatment and after one year of treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with GHD based on an insufficient stimulation of GH-secretion during
        Pyridostigmin-GHRH test.

        Patients with acromegaly based on an insufficient supression of GH-secretion during oral
        glucose tolerance test
      
Keywords: The GH-system and cardiac function