bioihbjkbjnl/mcl2 huggingface dataset:
Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Glaucoma encompasses a collective group of optic neuropathies characterized by progressive
      degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive
      appearance of the optic disc, and a pattern of visual loss
    

Detailed description: 
      Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian
      market. It contains the PG analog tafluprost. Better tolerability, higher adherence to
      treatment and improvement of patients' quality of life are associated with using
      preservative-free eye drops.
    

Intervention name(s): Preservative-free tafluprost eye drops
Intervention type(s): Drug
Intervention description(s): This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Intervention model description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops.
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab
      followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
    

Detailed description: 
      Induction chemotherapy combined with Radio chemotherapy:

      Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during 14
      days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1; repetition
      day 22 and 43 (3 cycles)

      Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy:

      Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m²
      bid, on each radiation day during the first 4 weeks of RCTx

      Surgery according to TME-criteria (total mesorectal excision) in compliance of an
      interruption of min. 14 days after RCTx
    

Intervention name(s): preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine
Intervention type(s): Drug
Intervention description(s): Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Other intervention name(s): Xeloda (capecitabine); Avastin (bevacizumab); Oxaliplatin
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: locally advanced rectal cancer; preoperative induction chemotherapy chemoradiotherapy
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with
      dofetilide-induced QTc prolongation.
    


Intervention name(s): GS-6615; Placebo to match GS-6615; Placebo to match dofetilide; Dofetilide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GS-6615 tablets administered orally; Placebo to match GS-6615 tablets administered orally; Placebo to match dofetilide capsules administered orally; Dofetilide 500 μg capsules administered orally according to the current prescribing information
Intervention MeSH terms: Dofetilide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug-induced long QT syndrome; DILQTS; prolonged QT
Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Adult; Ventilator-Induced Lung Injury
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Ventilator-Induced Lung Injury; Syndrome
Study type: Observational

Summary: 
      Asynchrony during mechanical ventilation has been poorly described in patients suffering from
      acute respiratory distress syndrome. The purpose of this study is to describe the frequency
      of asynchronies (ineffective efforts and double triggering) in these group and evaluate
      potential risk factors and prognosis implications.
    

Detailed description: 
      Major patient-ventilator asynchronies have been described during assisted mechanical
      ventilation in different settings. Few studies have evaluated double cycling in ARDS patient.
      No clear predictors of this finding beside low tidal volume have been found, and clinical
      outcome implications have not been addressed. This study has 3 main objectives: evaluate the
      frequency of double cycling and ineffective efforts, seek for potential predictors and
      clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical
      ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be
      recorded and automatically analyzed with a custom-made program to detect asynchronies. A
      blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers.
      Clinical and outcome data will be recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation
        for less than 72 hours
      
Biospecimen description: 
      plasma
Treatment of Moderate to Severe Glabellar Lines (BMI2006)
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical
      trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult
      patients in need of moderate or severe glabellar lines
    

Detailed description: 
      Purpose of clinical trial:

      The purpose of this study was to evaluate the efficacy and safety of 20U dose administration
      of 100 units of BMI2006 in adult patients who needed moderate or severe glabellar lines.

      primary purpose Comparing the effectiveness after administration of each 20U dose of 'BMI2006
      100 Units' or 'Botox® Week' for adult patients in need of moderate or severe glabellar lines,
      it was found that the BMI2006 injection group was non-inferior to the Botox® injection group.
      wanted to confirm.

      secondary purpose The purpose of this study was to evaluate the safety and effectiveness of
      'BMI2006 100 Units' 20U compared to 'Botox® Injection' 20U for adult patients who need
      moderate or severe glabellar wrinkles.

      This clinical trial was designed as a multicenter, double-blind, randomized, parallel design,
      active-controlled Phase 3 clinical trial, and was intended for patients with moderate or
      severe glabellar lines.

      Only those subjects who have agreed in writing to voluntarily participate in the clinical
      trial and who are evaluated to meet the selection/exclusion criteria are 1:1 to the test
      group (BMI2006 week administration group) or control group (Botox®) in the order of
      participation in the clinical trial was randomly assigned.

      Subjects assigned with randomization numbers were intramuscularly injected (IM) with a total
      of 20U of clinical trial drugs in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.
      Thereafter, at 4, 8, 12, and 16 weeks at intervals of 4 weeks, the institution was visited to
      evaluate the efficacy and safety for a total of 16 weeks.
    

Intervention name(s): BMI2006; BOTOX®
Intervention type(s): Biological; Biological
Intervention description(s): IM; IM
Other intervention name(s): Clostridium botulinum Type A; Clostridium botulinum Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BMI2006; BMI; Botulinum toxin; Clostridium botulinum Type A; BOTOX; BoNT-A; corrugator supercilii muscle
Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver
      cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal
      antibodies can locate and deliver radioactive cancer-killing substances.

      PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal
      antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not
      responded to high-dose chemotherapy and autologous stem cell transplantation.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when
           administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have
           relapsed after high-dose chemotherapy and autologous hematopoietic stem cell
           transplantation.

        -  Determine the safety and efficacy of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan
      (IDEC-Y2B8).

        -  Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled
           ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive
           rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.

      Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience
      dose-limiting toxicity.

        -  Phase II: Once the MTD is determined, 58 additional patients are treated at that dose
           level as in phase I.

      Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and
      then annually thereafter.

      PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be
      accrued for this study within 2 years.
    

Intervention name(s): rituximab; yttrium Y 90 ibritumomab tiuxetan
Intervention type(s): Biological; Radiation
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma
Study of Danggui Buxue Decoction in Preventing Neutropenia
Condition: Grade 3/4 Neutropenia; Febrile Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with
      EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The
      aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by
      EC/TC regimen during chemotherapy.
    


Intervention name(s): DBD; Epirubicin; Cyclophosphamide; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DBD:one dose of medicine twice per day, orally; Epirubicin:90mg/m2, d1, q3w*4; Cyclophosphamide:600mg/m2, d1, q3w*4; Docetaxel:75mg/m2, d1, q3w*4
Other intervention name(s): Danggui Buxue Decoction
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: incidence of grade 3/4 neutropenia; incidence of febrile neutropenia; time to neutropenia recovery; safety
Lung Ultrasonography in COVID-19 Pneumonia
Condition: Lung Ultrasound; Pneumonia; Covid19
MeSH terms: COVID-19; Pneumonia
Study type: Interventional

Summary: 
      Lung ultrasonography has been used for diagnosis and treatment in many departments including
      intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia
      is still chest tomography. Ultrasonography, which has advantages over tomography, has also
      been tried to be used in covid 19 pneumonia.
    

Detailed description: 
      In this study, it was aimed to investigate the efficiency of lung ultrasonography in
      diagnosis of covid 19 pneumonia.
    

Intervention name(s): lung ultrasonography
Intervention type(s): Device
Intervention description(s): Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Investigating the Effect of Vortioxetine in Adult ADHD Patients
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult
      patients with ADHD in a 12 weeks study.
    

Detailed description: 
      The study employed the Sequential Parallel Comparison Design (SPCD), a clinical study design
      which intend to increase signal detection by using two stages of treatment:

        -  Stage 1 - first 6 weeks of the 12-weeks treatment period (Visit 2/Baseline 1 to Visit
           5/Week 6)

        -  Stage 2 - last 6 weeks of the 12-weeks treatment period (Visit 5/Baseline 2 to Visit
           8/Week 12)

      In Stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. Patients on
      vortioxetine 10 or 20mg/day during Stage 1 remained on the same treatment in Stage 2.
      Responders to placebo in Stage 1 remained on Placebo in Stage 2. Patients who were placebo
      non-responders during Stage 1, defined as patients with a <30% reduction in AISRS total score
      from Baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in Stage 2.
    

Intervention name(s): vortioxetine 10 mg tablet; vortioxetine 20 mg tablet; Placebo tablet
Intervention type(s): Drug; Drug; Other
Intervention description(s): Oral tablets, once daily; Oral tablets, once daily; Oral tablets, once daily
Other intervention name(s): Brintellix®; Lu AA21004; Trintellix®; Brintellix®; Lu AA21004; Trintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Continuous Intrapartum Support to Reduce Primary Cesarean
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      The objective of the study was to evaluate the intervention of intrapartum continuous support
      by a professional nurse with a university degree to reduce the nulliparous, term, singleton,
      vertex (NTSV) cesarean birth rate, in women pregnant less than 40 years in the HGZ No. 4 of
      the Guanajuato delegation of the Mexican Institute of Social Security, Mexico
    

Detailed description: 
      Continuous intrapartum support is a strategy used to decrease the cesarean section rate,
      where multiple factors influence its effectiveness (start and duration of support,
      professional training of support staff, and others.). The objective of the study was to
      decrease the rate of deliveries by cesarean, through continuous intrapartum support during
      the active phase until birth, by a professional nurse with a university degree, the support
      was based on three basic aspects: 1) emotional support, 2) physical support and comfort
      measures and 3) information and counseling, for which a quasi-experimental study was
      conducted, with a study population of 115 women in labour (nulliparous, full-term, single
      product, vertex position) and under 40 years, a group control was formed (n = 55) who
      received routine maternal care and a study group (n = 60) who received continuous intrapartum
      support.
    

Intervention name(s): Continuous Intrapartum Support
Intervention type(s): Procedure
Intervention description(s): Received the usual obstetric care plus continuous intrapartum support that was provided by a Bachelor of Nursing and Obstetrics who received prior training by a professional doula.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The control group was composed of women with labour, who attended the General Hospital of Zone 4 of the Guanajuato Delegation of the IMSS in the period of October-December 2016. The study group was composed of women with labour who presented at the same hospital to receive obstetric care in the period of October - December 2018.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cesarean section; Continuous intrapartum support; nulliparous
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American
      herbal medicine practice. Some of its cardiac uses include the treatment of high and low
      blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used
      as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To
      date, little information is known about the effect of hawthorn when taken with other drugs
      and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is
      to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects
      will be recruited by advertisement. The design of the study will include a 10-day and a
      three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special
      extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover.
      There will be a three-week washout period in between treatment phases. On day 10 (phase I)
      and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic
      analysis. The plasma samples will be measured for digoxin concentration. Additionally, the
      subjects will be assessed for any clinical toxicities or adverse events. The significance of
      this study is to provide the clinician with information regarding the safe use of digoxin in
      combination with the herbal supplement, hawthorn.
    


Intervention name(s): Digoxin; Hawthorn
Intervention type(s): Drug; Drug
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Digoxin; Effect modifiers (Epidemiology); Rosales; Drug Interaction
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
Condition: Respiratory Syncytial Viruses; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of intramuscular
      prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2
      (human adenovirus-vectored vaccine candidate) in healthy participants.
    

Detailed description: 
      This is a single-center, randomized (study vaccine assigned to participants by chance),
      placebo-controlled study (an inactive substance; a pretend treatment [with no vaccine in it]
      that is compared in a clinical trial with a vaccine to test if the vaccine has a real
      effect), double-blind (neither the researchers nor the participants know what treatment the
      participant is receiving) Phase 1 study in healthy participants. The study comprises a 4-week
      screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day
      follow-up period performed after each vaccination and a final visit at Day 337. Approximately
      32 Participants will be randomized in parallel in a 3:3:2 ratio to 3 treatment groups (Group
      1/2/3) to receive either Ad26.RSV.FA2 or Ad35.RSV.FA2 or placebo. The study duration will be
      approximately 52 weeks. Blood samples for immunogenicity will be collected. Participant's
      safety will be evaluated throughout the study.
    

Intervention name(s): Ad26.RSV.FA2; Ad35.RSV.FA2; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.; Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.; Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.
Other intervention name(s): JNJ-61187165-AAA; JNJ-61187191-AAA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ad26.RSV.FA2 (JNJ-61187165-AAA); Ad35.RSV.FA2 (JNJ-61187191-AAA); Healthy participants