cyrilzakka/clinical-trials huggingface dataset:
Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.

Exclusion Criteria:

* liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.
Overnight Pain Treatment Investigating Opioids vs. Nonopioids

The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking women
* 18 years or older
* Access to cell phone with text-messaging capability/data
* Receiving cervical preparation for induced abortion
* Able to complete baseline survey on smartphone/tablet at screening visit

Exclusion Criteria:

* History of opioid or alcohol abuse
* Contraindications or allergy to ibuprofen
* Contraindications or allergy opioid medications
* Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise
Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood

Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause of death. A previous pilot study from the investigator's group showed that myocardial stunning occurs in AKI patients during continuous renal replacement therapy (CRRT) and may explain the high cardiovascular mortality in this population. In the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. The aim of this study is to find out whether cooling the blood in the CRRT circuit is an effective intervention to prevent myocardial stunning in AKI patients undergoing CRRT and improve patient outcomes.

This is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling CRRT. We will recruit approximately 140 patients (70 in each group) from the Medical Surgical Intensive Care Unit at University Hospital and The Critical Care Trauma Center at Victoria Hospital in London, Ontario.

The study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. All therapy will be delivered using the Baxter PrisMaxTM CRRT machine with TherMaxTM blood warmer.

All participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. Blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at ICU discharge.

Hourly nasopharyngeal and skin temperatures will be collected. Oral temperature will be collected every four hours.

Eligibility Criteria:
Inclusion Criteria:

* AKI as defined by 2012 AKI KDIGO guidelines requiring CRRT.
* Patient's core temperature between 35°C and 40°C at the time of recruitment.
* Age 18 years old and older.

Exclusion Criteria:

* Hypothermia (patient core temperature \<35°C) at the time of recruitment
* Extreme hyperthermia or hyperpyrexia (patient core temperature \>40°C) at the time of recruitment.
* Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
* Patients undergoing targeted temperature management for cardiac arrest.
* Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines \[19\] requiring renal replacement therapy prior to recruitment.
* Receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
* Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Exclusion Criteria:

* Patients with a CD4 count less than 250 cells/mm3.
* Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
* Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.

Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.
2. Aged at least 18 years.
3. Subjects with no history of active TB or symptoms of TB

Exclusion Criteria:

1. Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
2. Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
3. Subjects with history or presence of uveitis
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.

The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year.

Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.

Eligibility Criteria:
Inclusion Criteria:

1. Third or fourth renal graft or
2. Current anti-HLA antibodies above or equal to 30% at the last evaluation or
3. Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
4. A second graft if the first was lost within 2 years because of rejection.
5. Patients who gave their informed consent and are able to understand the scope of the study

Exclusion Criteria:

1. Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
2. Transplantation from a non-heart beating donor
3. Transplantation of two kidneys from the same donor
4. Patients with generalized infection at the time of transplantation
5. Women in child-bearing age who do not plan to use efficient contraception
Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

Fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. But the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing to reveal such tumor remnants. By the time there are published results of randomized control trials comparing these two technics.

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

Participants of the study will be randomly operated using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. Extent of resection will be assessed in postoperative MRI by blinded radiologists.

Eligibility Criteria:
Inclusion Criteria:

* single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
* one or several brain metastases from any cancer
* newly diagnosed
* Karnofsky Performance Status 60-100%
* age 18-79 years
* performed magnetic resonance imaging with contrast enhancement

Exclusion Criteria:

* tumor spreading to corpus callosum or brainstem
* previously performed brain radiotherapy
* planned supratotal tumor resection until neurophysiologically revealed eloquent areas
* known hypersensibility to 5-aminolevulinic or to porphyrin
* hepatic or renal insufficiency
* porphyria
* pregnancy
* breast feeding
PROUD Study - Preventing Opioid Use Disorders

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.

Eligibility Criteria:
Inclusion Criteria Intervention group:

* Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021

Inclusion Criteria Control:

* Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020

Inclusion Criteria Professional Staff:

* All staff that participate in the implementation of the opioid free surgical protocol.

Exclusion Criteria:

* Participants that do not speak English will not be eligible for participation in the study.
* Individuals less than 18 years of age will not be included for participation in the study.
* Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.
Cessation on Internet Addiction in College Students

This study aimed to explore the intervention effect of Tai Chi exercise on internet addiction in college students and its maintenance effect after cessation, providing a scientific basis for the application of Tai Chi in internet addiction intervention among college students. Fifty-one non-sports-major college students with mild or moderate internet addiction were randomly divided into a Tai Chi group (n = 23) and a control group (n = 24). The Tai Chi group underwent 12 weeks of Tai Chi exercise, while the control group maintained their regular study schedule without additional physical exercise. The Chinese Internet Addiction Scale and serum dopamine and β-Endorphin levels were assessed at baseline, week 12, and week 16.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-25;
* CIAS scores of 26-53 (low internet dependence), 54-80 (moderate dependence), or 81-104 (high dependence). Only mild and moderate cases were included;
* non-sports majors; the study followed the Declaration of Helsinki, and all participants understood the purpose and signed consent forms.

Exclusion Criteria:

* Severe IAD (CIAS score \>80);
* Tai Chi practice within 6 months;
* regular exercise habits;
* history of depression/anxiety or undergoing psychological treatment;
* use of medications affecting mental state or neurotransmitter levels.
A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking, age greater than or equal to (\>=) 18 years and less than (\<) 55 years old adult male or female (Cohorts 1 - 6) or age \>=65 years and less than or equal to (\<=) 85 years old elderly male or female (Cohort 7) at the time of informed consent
2. Weight of at least 50 kilogram (kg) and body mass index \>=18 and \<30 kilogram per square meter (kg/m\^2) at Screening

Exclusion Criteria:

1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period plus 90 days after discharge from the study.
2. Females who are breastfeeding or pregnant at Screening or Baseline
3. Females of childbearing potential who:

   * Within 28 days before study entry, did not use a highly effective method of contraception,
   * Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
5. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing
6. Evidence of disease related to chronic headaches, migraines, joint pain or other disorders or disease resulting in chronic or intermittent pain within 4 weeks before dosing
7. Any personal or family history of seizures (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness
8. Any history of neurological or other medical conditions which in the opinion of the investigator has the potential to reduce seizure threshold
9. Any epileptiform discharges in EEG at Screening
10. A prolonged QT/ QT interval corrected for heart rate (QTc) interval \>450 millisecond \[ms\]) A history of risk factors for torsade de pointes
11. History of prolonged QT/QTc interval
12. Left bundle branch block
13. History of myocardial infarction or active ischemic heart disease
14. History of clinically significant arrhythmia or uncontrolled arrhythmia
15. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the C-SSRS
16. Any lifetime history of psychiatric disease
Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094

This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed Visit Week 52 assessments in Study HGT-HIT-094 (NCT02055118).
* The participant's parent(s) or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed. Consent of the participant's parent(s) or legally authorized guardian(s) and the participant's consent/assent, as relevant, must be obtained.
* The participant has continued to receive Elaprase on a regular basis in Study HGT-HIT-094 (NCT02055118).

Exclusion Criteria:

* The participant has experienced, in the opinion of the investigator, a safety or medical issue that contraindicates treatment with idursulfase-IT, including, but not limited to, uncontrolled seizure disorder, bleeding disorder, and clinically relevant hypertension.
* The participant has a known hypersensitivity to any of the components of idursulfase-IT.
* The participant has clinically relevant intracranial hypertension.
* The participant is enrolled in another clinical study, other than HGT-HIT-094 (NCT02055118), that involves clinical investigations or use of any investigational product (drug or \[intrathecal/spinal\] device) within 30 days prior to study enrollment or at any time during the study.
* The participant has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to compromised airways or other conditions.
* The participant has a condition that is contraindicated as described in the SOPH-A-PORT® Mini S, Implantable Access Port, Spinal, Mini Unattached, with Guidewire (SOPH-A-PORT Mini S) intrathecal drug delivery device (IDDD) Instructions for Use, including:

  1. The participant has had, or may have, an allergic reaction to the materials of construction of the SOPH-A-PORT Mini S device.
  2. The participant's body size is too small to support the size of the SOPH-A-PORT Mini S Access Port, as judged by the investigator.
  3. The participant's drug therapy requires substances known to be incompatible with the materials of construction.
  4. The participant has a known or suspected local or general infection.
  5. The participant is at risk of abnormal bleeding due to a medical condition or therapy.
  6. The participant has 1 or more spinal abnormalities that could complicate safe implantation or fixation.
  7. The participant has a functioning CSF shunt device.
  8. The participant has shown an intolerance to an implanted device.
Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy

The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Using validated psychometric tools, including the Brief Illness Perception Questionnaire (Brief-IPQ) and the Oral Health Impact Profile-14 (OHIP-14), the study evaluates patients at baseline and three months after therapy. The study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 80 years
* Diagnosis of peri-implant disease requiring non-surgical therapy
* Presence of at least one dental implant loaded for a minimum of one year
* History of periodontitis
* Good general health
* Ability to provide written informed consen

Exclusion Criteria:

* Pregnant or lactating individuals
* Inability to perform basic oral hygiene procedures
* Inability to understand or complete study questionnaires
Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device

The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.


Eligibility Criteria:
Inclusion Criteria:

* The patients is eligible to undergo WATCHMAN device implant procedure.
* The patient is eligible for short term anticoagulation therapy.
* Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
* Ability to give informed consent for the procedure.
* The patient is able and willing to undergo the procedure under moderate sedation.
* The patient is able and willing to return for required 45-day transesophageal echocardiogram (TEE).

Exclusion Criteria:

* Patient has contraindication for short term anticoagulation.
* The patient has history of a hypercoagulable state per medical record documentation.
* Pregnancy or planning to get pregnant during the investigation.