cyrilzakka/clinical-trials huggingface dataset:
SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia

In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.


Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation
* Age ≥12 months and \<18 years at time of recruitment
* Written informed consent from patients and/or parents

Exclusion Criteria:

* Infants \<1 years old (reason: differences in temperature measurement method)
* Past allogeneic hematopoietic stem cell transplantation
* Denied written informed consent from patients and/or parents
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients

There are currently no published data on the efficacy of the chlorhexidine-impregnated foam dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.

The researchers perfomed a cross-over intervention trial on patients who were dialyzed through central venous catheters at two outpatient dialysis centers were enrolled. The use of a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol during the intervention period. A nested cohort study of all patients who received the foam dressing was also conducted to determine independent risk factors for development of BSI.

The primary outcomes were the catheter-related bloodstream infection rates in the intervention and control groups. Secondary outcomes include the clinical sepsis rates between the two groups and risk factors for development of bloodstream infection despite the use of the foam dressing.


Eligibility Criteria:
Inclusion Criteria:

* All patients who were dialyzed through a central venous catheter during the time period

Exclusion Criteria:

* Patients who were allergic to chlorhexidine
Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.

The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.

Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II
* Age: \>18

Exclusion Criteria:

* patients of severe kidney \& liver dysfunction
* allergy of local anesthetics
Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.

The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value \< .05 or less was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients without systemic diseases
* Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
* Patients who had no spontaneous pre-treatment pain
* Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
* Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

* Patients who had severe periodontal disease
* The teeth with previous endodontic treatment
* The teeth with root canal calcification, root resorption
* The teeth that could not be isolated with rubber dam or were not suitable for further restoration
Comparing Use of Incentive Spirometry With and Without Reminder

This study is designed to determine if patients using an incentive spirometer with visual and auditory signals will increase their use of the incentive spirometer and prevent lung complications.

The purpose of this study is to determine if the frequency of patients' use of physician ordered incentive spirometry increases with visual and auditory electronic encouragement (signals) compared to the no signal cohort.

Secondarily this study will correlate short term outcomes of study patients to known short term outcome data from the study site and published data to determine if there is a relationship between frequency of use and positive or outcomes or complications, as cited by peer reviewed literature.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all the following Inclusion criteria to be eligible for participation in the study:

* Patient has undergone a qualifying surgical procedure.
* Patient is aged 18 years or over.
* Patient has incentive spirometry ordered or incentive spirometry must be part of the study site's standard of care which is implemented by hospital staff.
* Patient is able to comply with all study required incentive spirometry instructions.
* Patient is without severe hearing or impaired visual acuity deficiency such that they cannot hear or see the audible and visual signal for the InSee monitor.

Exclusion Criteria:

* Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:

  * Vulnerable Populations (Pregnant, minors, prisoners, those with significantly reduced mental acuity).
  * Patients where incentive spirometry is inappropriate (patients with Tractotomy, patients who are hemodynamically unstable, patients in reverse isolation due to infection).
  * Patients with a history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
  * Any medical condition that, in the opinion of the investigator, would place the patient at increased risk if they participated.
  * Any Physician determination that the patient should not participate.
Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant

The purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.

Renal failure is a common complication of liver disease. Hepatorenal syndrome is caused by a dysfunctional global circulation in the setting of liver disease: Increased flow to the mesenteric circulation is a contributor to decreased blood flow to the kidneys (1). Renal failure often worsens in the perioperative period of liver transplantation since the kidneys are further stressed by reduced flow due to inferior venacava occlusion, decreased blood flow to the kidneys from anesthetics, as well as hypotension from volume shifts, such as when large volumes of ascites are removed. Renal failure is a cause of major morbidity and mortality in patients undergoing liver transplantation.

Vasopressin is a logical choice of therapy in this context as the effects of the drug work to particularly increase renal blood flow and glomerular filtration rate due to the location of specific vasopressin receptors within the renal vasculature. It has been suggested that the use of splanchnic (and systemic) vasoconstrictors such as terlipressin (a vasopressin analog) or alpha-1-adrenoceptor agonists (midodrine or noradrenaline) may improve renal function in patients with type 1 Hepatorenal Syndrome.

Six studies (with only one randomized study in a small series of patients) have shown that terlipressin improves renal function in these patients (2-7). This drug is available in Europe, but not in the United States. However, while anesthesiologists commonly use vasopressin during liver transplantation in the setting of hepatorenal syndrome or vasodilatory shock, the validity of this practice for its effects on renal function and outcomes has not been rigorously studied (8-10). Therefore, the purpose of this study is to evaluate the effects of low-dose vasopressin on intraoperative and perioperative renal function in liver transplant patients.

This study will be a randomized, double-blind controlled trial performed in adult liver transplant patients coming to surgery for chronic liver disease; the major end-points of analyses are renal function tests in the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* undergoing liver transplant
* ability to provide informed consent. If patient is unable to give informed consent i.e. hepatic encephalopathy, consent may be obtained from the patient's legally authorized representative

Exclusion Criteria:

* \< 18 years of age
* renal failure
Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.

The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, \[18F\]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than or equal to 18 years of age
2. Biopsy-proven cancer or Schwannoma diagnosis
3. No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
4. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

1. Administered a radioisotope within 5 physical half-lives prior to PET imaging
2. In female subjects pregnancy.
ERAS® Guidelines Validation of CRS With or Without HIPEC

Enhanced recovery after surgery (ERAS®) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by standardised application of best evidence-based perioperative care. Recently an international panel of expert have succeeded to elaborate dedicated recommendations for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) in a two-part series of guidelines based on expert consensus (Hübner et al., EJSO, 2020). The aim of this prospective validation study was therefore to study acceptance, feasibility and clinical results of these guidelines in clinical practice.

Hypothesis of the study: Introduction of ERAS® guidelines is feasible and safe. Increasing compliance with ERAS® guidelines (after implementation) will improve recovery and early clinical outcomes of patients undergoing CRS/HIPEC.

The study includes two succesive phases interrupted by a stage to implement ERAS® guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Adults female and male patients (\> 18 year-old)
* Peritoneal cancer from colorectal, ovarian, gastric, appendix origin and primitive peritoneal cancer (peritoneal mesothelioma)
* Multidisciplinary team meeting validation for CRS/HIPEC
* Informed and signed surgical consent

Exclusion Criteria:

* Patients without peritoneal cancer
* Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
* No informed consent signed
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.

The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.

The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .

Eligibility Criteria:
Inclusion Criteria:

* FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
* No prostate cancer specific treatment following FCA
* Consented to undergo reflex MRI and prostate biopsy two years following FCA.

Exclusion Criteria:

* Any contraindication to prostate biopsy
* Prior allergic reaction to 18F-Fluciclovine
* Patient refuses MRI and prostate biopsy two years following FCA.
A New Interdisciplinary Collaboration Structure to Improve Medication Safety in the Elderly

Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥70 years
* Admitted to the geriatric internal medicine ward in the University Hospital of North Norway (UNN) Tromsø or the general internal medicine ward in UNN Harstad.
* Willing to provide written informed consent during hospital stay (patient or next of kin)

Exclusion Criteria:

* Unable to communicate in Norwegian (patient or next of kind)
* Terminally ill, e.g cancer in end-life stage
* Control group patients where the physician request an assessment from a pharmacist
* Time from admittance to the ward to inclusion is more than 72 hours
* Occupying a bed in the study wards but under the care of physicians from a non-study ward.
* Planned discharged on the inclusion day
DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV

This is a pilot study investigating the safety of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.

This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy. The metabolic and neuropsychiatric outcomes among women (and their infants) in a representative African female population of reproductive potential will be investigated.

Approximately 100 women aged between 18 and 49 years old will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.

Eligibility Criteria:
Inclusion Criteria:

* Females, aged 18-49 years and ≥ 40 kg
* On a first-line EFV or DTG-containing regimen for at least six months and not more than 3 years
* Plasma HIV-1 RNA \< 50 copies/mL in last 60 days
* Calculated creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault formula)
* Baseline weight measurement available at ART initiation.

Exclusion Criteria:

* Virological failure on any other regimen
* Women who are pregnant at the time of the screening or enrolment visits or have had a pregnancy gestation ≥ 28 weeks in the preceding 2 years
* Active tuberculosis and/or are on antituberculosis therapy at the time of the screening or enrolment visits
* Taking (and cannot discontinue) prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period (see potential drug interactions section for list).
Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy

EORTC-QLQ-30 questionnaire filled in by participants 6 times

EORTC-QLQ-30 questionnaire filled in by participants 6 times

* 1st before receive radiotherapy
* 2nd after receive radiotherapy
* 3th 1 month after receive radiotherapy
* 4th 3 month after receive radiotherapy
* 5th 6 month after receive radiotherapy
* 6th 1 year after receive radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* good consciousness
* ability to understand and provide information
* no hearing impairment
* Eastern Cooperative Oncology Group performance level of 0 to 2

Exclusion Criteria:

* prior radiotherapy
Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan

From 100 colorectal cancer patients being treated with FOLFIRI regimen or any kind of irinotecan containing regimen, blood samples for irinotecan and its metabolites levels and genotypes related with its metabolism will be collected. The association of their levels and genotypes and treatment effects will be evaluated.

For the genotype-PD association, 50 colorectal cancer patients treated with FOLFIRI will be enrolled and studied. 50 additional colorectal patients treated with any kind of irinotecan containing regimen will be enrolled and including the 50 patients for the genotype-PD association, a total of 100 patients will be evaluated for the genotype-PK association.

Blood samples for PK analysis will be collected from patients with colorectal cancer during 1st treatment cycle of irinotecan and 2nd, 3rd infusion. During the 1st treatment cycle, blood will be drawn 0 h (before irinotecan infusion), 0.75 h, 1.5 h and each at time ranges of 2\~8 h, 8\~16 h, 24\~32h and 48\~52 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 48\~52 hours after the respective 2nd and 3rd infusion.

For 50 colorectal cancer patient treated with FOLFIRI regimen, responses to the treatment will be assessed every 3 cycles. All assessments will be repeated at the end of trial therapy.

The RECIST criteria for measurable disease will be followed and toxicity will be evaluated according to NCI common toxicity criteria version 3.0.

Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed unresectable or metastatic colorectal cancer
* Performance status of 0, 1 and 2 on the ECOG criteria
* Disease status must be that of measurable disease as defined by RECIST criteria (For genotype-PD study only) Only non-target lesions are allowed for PK study
* No previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (For genotype-PD study only) Previously treated patients are allowed for PK study
* Life expectancy of more than 3 months (For genotype-PD study only)
* Adequate major organ functions
* Compliant patient who can be followed-up adequately
* Informed consent

Exclusion Criteria:

* Active or uncontrolled infection
* Pregnant or breast-feeding women
* Patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy
* Patients with brain metastasis (For genotype-PD study only)
* Patients treated with radiotherapy within 2 weeks (For genotype-PD study only)