bioihbjkbjnl/mcl2 huggingface dataset:
Osimertinib Study in Indian Patients
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of
      osimertinib in Indian adult patients.
    

Detailed description: 
      This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of
      osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M
      mutation-positive NSCLC.

      Prior to data collection, all patients must sign an informed consent form (ICF) allowing data
      collection and source data verification in accordance with local requirements and sponsor
      policy.

      Patients with metastatic EGFR T790M mutation-positive NSCLC, who are eligible to osimertinib
      treatment as per locally approved prescribing information and ratified by an independent
      clinical judgment of treating physician will be evaluated for the inclusion into the current
      phase-IV study based on eligibility criteria. EGFR T790M positivity on plasma or tissue
      biopsy on PCR-based platform will be considered appropriate test. EGFR T790M must be
      performed after progressive disease on last line of therapy (on or after EGFR TKI therapy).
      In order to enroll approximately 60 patients, it is expected that approximately 70 patients
      will be screened.
    

Intervention name(s): Osimertinib
Intervention type(s): Drug
Intervention description(s): Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
Intervention MeSH terms: Osimertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non small cell lung cancer (NSCLC)
Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in
      patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary
      read-out of efficacy is reduction in Aberrant-Behavior Checklist score.
    


Intervention name(s): AF056; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fragile X Syndrome, adults, efficacy
Albuterol Integrated Adherence Monitoring in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators propose to evaluate whether an integrated electronic adherence monitoring
      albuterol rescue inhaler can improve proper use in a mostly minority and inner-city
      population of children treated for asthma at the Children's Hospital of Los Angeles
    

Detailed description: 
      This study is designed to (1) determine whether an integrated EAM albuterol rescue inhaler
      can increase proper use (2) determine if the monitoring capabilities of the device (flow
      rate, warnings) and/or increased proper use from having the device correlate with better
      outcomes. The investigators will also have patients perform at-home gamified spirometry
      (Aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change
      outcomes.
    

Intervention name(s): Digihaler Albuterol Device by TEVA
Intervention type(s): Device
Intervention description(s): Patient with asthma will have their regular albuterol rescue inhaler replaced with Digihaler, they will also be asked to perform gamified spirometry (Aluna) at home
Other intervention name(s): Electronic Adherence Monitor
Intervention MeSH terms: Albuterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
Condition: Tympanic Membrane Perforation
MeSH terms: Tympanic Membrane Perforation
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of the regeneration treatment of tympanic membrane with
      NPC-18 and FBG-18.
    


Intervention name(s): fiblast,gelatin sponge,fibrin glue
Intervention type(s): Drug
Intervention MeSH terms: Fibrin Tissue Adhesive
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EEG Parameters Between Remimazolam- and Propofol-based Anesthesia
Condition: Cholecystitis, Acute; Gallbladder Neoplasms; Acalculous Cholecystitis
MeSH terms: Gallbladder Neoplasms; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This is an observational study comparing perioperative quantitative EEG parameters between
      the conventional propofol/remifentanil and remimazolam/remifentanil. We aim to compare and
      analyze the differences in EEG patterns during the postoperative recovery in a group that
      underwent remimazolam and remifentanil-based total intravenous anesthesia(TIVA), in
      comparison to propofol and remifentanil-based TIVA
    


Intervention name(s): propofol group; remimazolam group
Intervention type(s): Drug; Drug
Intervention description(s): During induction, the propofol group initiates with a target-controlled infusion (TCI) of propofol, starting at an effect site concentration of 4.0 ng/ml. After intubation, it is adjusted to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).; The remimazolam group begins with a continuous infusion of remimazolam at 6 mg/kg/hr, which is then adjusted to 1 mg/kg/hr after loss of consciousness to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys
      (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with
      chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups
      receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two
      doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment
      is 16 or 24 weeks with a 24-week follow-up.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; ribavirin; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 180 mcg sc weekly, 24 weeks; 180 mcg sc weekly, 16 weeks; 800 mg orally daily; 400 mg orally daily
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Condition: Overactive Bladder
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      A pre-market, prospective, non-randomized acute feasibility study for the treatment of
      patients with urinary incontinence (UI) as a consequence of urinary incontinence.
    


Intervention name(s): AHLeveeS System
Intervention type(s): Device
Intervention description(s): AHLeveeS System for treatment of overactive bladder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the long-term safety and tolerability of
      vortioxetine, once daily (QD), in participants with major depressive disorder.
    

Detailed description: 
      Depression has been recognized as a chronic illness that imposes a significant burden on
      individuals, families and society. Major depressive disorder (MDD) is among the most
      important causes of disability worldwide, in both developing and developed countries. Major
      depressive disorder is reported to be the most common mood disorder, with a lifetime
      prevalence of about 15% and as high as 25% in women. Major depressive disorder is
      characterized by the presence of 1 or more major depressive episodes that presents with
      depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy,
      feelings of guilt or low self-worth, and poor concentration.

      This is a multicenter extension study designed to allow eligible patients who have completed
      short-term efficacy and safety studies LuAA21004_315 (NCT01153009), LuAA21004_316
      (NCT01163266) and LuAA21004_317 (NCT01179516) to receive the 52-week treatment with
      vortioxetine in this open-label extension study. Participants are expected to return to the
      site for approximately 13 visits.

      A safety follow-up call will be made 4 weeks after completion of the 52-week treatment
      period.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine tablets
Other intervention name(s): LuAA21004
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Melancholia; Paraphrenia; Drug Therapy
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The aim of this study is to further evaluate this minimally invasive SSLF technique with
      respect to safety, clinical effectiveness, and patient satisfaction. The procedure will be
      performed in women electing to undergo surgical repair of their prolapse who wish to preserve
      their uterus, and will be evaluated using standardized measures and questionnaires.
    

Detailed description: 
      This study will evaluate sacrospinous ligament fixation using an incision-free technique - a
      technique that was developed with the goal of offering a technically simple, safe, and
      effective alternative to surgical prolapse repair procedures. When compared to previously
      reported SSLF methods, this technique has undergone novel modifications with the intent of
      maximizing efficacy and minimizing invasiveness. First, each sacrospinous ligament is
      approached trans-vaginally using a small diameter, low profile needle as the delivery
      platform for the anchoring unit. Secondly, the suspension is bilateral, thus maintaining
      vaginal length and width without deviation or narrowing of the vagina as might occur with a
      traditional (unilateral) sacrospinous repair. And third, using bio-degradable sutures and a
      securing element that stabilizes the fixation as opposed to performing an incision in the
      vaginal wall for suturing enables an incision-free procedure leaving the vagina free of any
      device after a period of several weeks.
    

Intervention name(s): Apyx device
Intervention type(s): Device
Intervention description(s): The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with
      focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and
      safe minimally invasive technique for control of seizures in such patients.
    

Detailed description: 
      In this study, we propose to evaluate a novel, thermal therapy and feedback system
      (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment
      of focal lesional epilepsy in patients that are considered high risk surgical candidates.
      This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which
      allows delivery of laser energy while the patient is being imaged by an MRI unit. The
      Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the
      thermal dose delivered to the target, resulting in a more precise and controlled delivery
      which has heretofore not been possible with previous non-image guided laser technology. We
      hypothesize that the Visualase system can be used in patients refractory to medication
      therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the
      brain.
    

Intervention name(s): Laser ablation
Intervention type(s): Procedure
Intervention description(s): Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this proposal is to investigate the potential benefit of metformin as a
      novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect
      of short-term metformin treatment on the endometrium of obese women with endometrial cancer
      by comparing each patient's endometrial biopsy before treatment with metformin to their
      post-treatment hysterectomy specimen.

      Participants: Obese women who are to undergo surgical staging for endometrial cancer will
      also receive short-term treatment (1-4 weeks) with metformin that will continue until the day
      prior to surgical staging.

      The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be
      compared between pre-treatment endometrial biopsies and post-treatment hysterectomy
      specimens. Tissue microarrays will be constructed and immunohistochemstry performed to
      evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by
      metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh
      tissue will also be obtained, and Western immunoblotting will be used to assess expression of
      the phosphorylated forms of the downstream targets of metformin. The hypothesis is that
      treatment with metformin will result in a decrease in proliferative markers and an increase
      in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition
      of critical downstream targets of the mTOR pathway will be seen in the post-treatment
      hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated
      biofluids (i.e. serum and urine) before and after treatment with metformin to identify
      potential biomarkers of response to this therapy.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin 850 mg once daily
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
Condition: HSV-2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well the vaccine is tolerated at sites where
      administrations are given and any effects it may have on subjects' wellbeing. The study will
      also test the ability of vaccine to cause particular immune responses in the body.
    

Detailed description: 
      Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to
      20% of the US population infected. Following primary infection, HSV-2 establishes a latent
      infection that can lead to recurrent disease when the virus reactivates. Genital lesions are
      often experienced with viral recurrence and these can be uncomfortable and painful, resulting
      in significant anxiety and social distress. There are no commercial vaccines available for
      therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural
      responses by boosting the appropriate cellular immune response to HSV-2 in those latently
      infected individuals who experience frequent and unwanted reactivations. The purpose of this
      study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine
      (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by
      Particle Mediated Epidermal Delivery (PMED)
    

Intervention name(s): pPJV7630 with pPJV2012 administered by PMED
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: DNA vaccine, immunotherapy, HSV-2, PMED
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treatment with low dose cyclosporin and
      methotrexate can inhibit the development of new onset diabetes mellitus
    

Detailed description: 
      Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1
      diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and
      cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo
      and mtx therapy could safely induce remission.

      Research Design and Methods: In an open pilot study, insulin dose and glycemic control will
      be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day
      for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children.
      After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.
    

Intervention name(s): cyclosporin and methotrexate
Intervention type(s): Drug
Intervention description(s): cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year. After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.
Intervention MeSH terms: Cyclosporine; Methotrexate; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes mellitus; cyclosporin; methotrexate; renal function
Autonomic Nervous System and Nitric Oxide Interactions
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators are interested in the role of the autonomic nervous system in the
      regulation of endothelial function among obese hypertensive subjects. In particular, the
      investigators will study how endothelial function (response to intra-arterial acetylcholine)
      changes during autonomic withdrawal.
    


Intervention name(s): Trimethaphan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours); Response to intrabrachial vasodilators during IV saline infusion
Other intervention name(s): Blocked; Intact
Intervention MeSH terms: Trimethaphan; Trimethaphan camsylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Nitric Oxide; Autonomic Nervous System
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Condition: Maintenance Hemodialysis; Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The research is designed as a prospective, randomized, controlled clinical trial without
      blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three
      hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji
      Hospital). All participants will be randomly divided into control group and intervention
      group in a ratio of 1:1. Phosphorus balance status is evaluated in participants of the
      intervention group by the phosphorus balance calculator. Then, these participants will be
      given individualized phosphate-binders, dietary and dialysis intervention according to the
      results of phosphorus balance evaluation. Participants in the control group will not receive
      the phosphorus balance status evaluation but receive phosphate-binder treatment according to
      the KDIGO Guidelines. Dietary phosphorus intake, dialysate calcium concentration and dose of
      active vitamin D, phosphorus-binders of all participants will be recorded during the whole
      research program. After two-week treatment, the phosphorus balance of participants in
      intervention group will be evaluated again and the therapeutic strategies then will be
      adjusted. At the same time, the therapeutic strategies of participants in the control group
      will be adjusted according to the serum phosphorus concentration. All participants will be
      followed up for two weeks again and receive blood test and related examinations at the end of
      study. The results of final examinations will be analyzed to evaluate the efficacy of
      individualized treatment of hyperphosphatemia.
    


Intervention name(s): Phosphate-binder intervention; Phosphorus-restricted dietary intervention
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Use phosphate-binders according to KDIGO Guidelines, Chinese Guidance for Diagnosis and Treatment of Mineral and Bone Disorder in Chronic Kidney Disease and drug specification .; Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary
Other intervention name(s): Additional dialysis intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment