cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.

Treatment Plan:

Patients undergoing definitive resection for gastric cancer and meeting the eligibility criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents and will be obtained as marketed drugs.

Outcome Measures:

Patients will be followed for 90 days following surgery. All postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.

Schedule for Follow Up:

Trial-related patient assessments will be performed daily while the patient remains in the hospital for postoperative care, and then during postoperative clinic visits. The final postoperative clinic visit for evaluation of study outcomes and complications should occur between postoperative days 90 and 95 to allow for a cumulative assessment of the patient's perioperative complications, if any.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
2. Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
3. ECOG performance status \< 2

Exclusion Criteria:

1. Distant metastases
2. Peritoneal carcinomatosis
3. Synchronous malignancy
4. Tumors at the gastroesophageal junction
5. Recurrent gastric adenocarcinoma
6. Creatinine \>/= 1.5
7. Bilirubin \>/= 2
8. INR \>/= 2
9. Allergy to drugs included in the treatment plan
10. Pregnancy
11. Contraindication to major surgery
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia

The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :

  * With historically documented Ph+ cells
  * ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
  * Currently progressing, resistance to or with a suboptimal response to their most recent therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

Exclusion Criteria:

* Blast phase CML
* Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Nutri-score Labelling in a UK Restaurant Setting: a Randomised Control Trial

An experiment exploring the perceived effectiveness of Nutri-score food labels with calorie labelling compared to calorie labelling only on food choice and consumption in a real-world setting


Eligibility Criteria:
Inclusion Criteria:

* Can visit a restaurant in Liverpool city centre
* Regularly eat food prepared out of the home (from restaurants, cafes, fast food etc., at least once a month)
* Over the age of 18 years
* Fluent English speaker

Exclusion Criteria:

* Pregnant/breastfeeding
* You have been diagnosed with a current or historic eating disorder
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections

The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.

The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)

Exclusion Criteria:

* Palliative colorectal resection where predicted remaining lifespan is likely less than 30 days
* Abdominoperineal resection or pelvic exenteration
* Known allergy/sensitivity to adhesive
* Cases in which there is a suspicion of bowel perforation
* Pregnancy
Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation

This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. The goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. This will also contribute to the evidence-based clinical management of such patients.

With the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. Antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. However, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. Methods: This study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. To evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. In order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients who undergo catheter ablation for arrhythmias.

Exclusion Criteria:

* 1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation;
* 2. Patients \< 18 years or \> 80 years;
* 3. Patients with uncomplete clinical data.
Patterns of Antibiotics Resistance

Antibiotics resistance has become a global health challenge especially in third world countries. The main causes of antibiotics resistance are the improper use or overuse of antibiotics, the lack of skilled public health workers and poor hygiene standards. Resistance to antibiotics reduces the effectiveness of these treatments and has a negative impact on hospital systems especially in intensive care settings.

Medical intensive care unit (MICU) is commonly known as a "hotbed of infections" in high-risk healthcare environments ICU patients are especially prone to infections because of the various invasive procedures they undergo,including vascular access, mechanical ventilation, and intubation.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be admitted at respiratory ICU with respiratory infection who have been treated with antibiotics and patients in whom adequate respiratory specimen is obtained will be included in the study

Exclusion Criteria:

* Patients who are HIV positive, who can't provide adequate respiratory specimen, patients who are not on antibiotics and patients who die within 48 hours after admission
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder

This study will evaluate a treatment program for young children with Obsessive Compulsive Disorder (OCD) and their families.

Childhood onset OCD is a serious condition that may be a predictor of illness in adulthood. To date, no OCD psychotherapy trials have specifically focused on early childhood. Development of interventions for childhood onset OCD that address both developmental considerations and familial relationships is necessary.

Participants are randomly assigned to receive 12 sessions of either Cognitive Behavioral Therapy (CBT) or Relaxation Training (RT) over the course of 14 weeks. The CBT treatment is designed to lessen anxiety by addressing specific OCD symptoms. The relaxation intervention addresses generalized feelings of anxiety with the expectation that OCD symptoms may benefit indirectly. The clarity, completeness, acceptability, and feasibility of both interventions is assessed. A 3-month post-treatment follow-up is also conducted.

Eligibility Criteria:
Inclusion Criteria:

* Obsessive Compulsive Disorder (OCD)
High- Versus Low-calcium Water for Bone Health

The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 18 and \< 30
* Maintenance of diet and physical activity lifestyle throughout the duration of the study
* Acceptance of informed consent

Exclusion Criteria:

* Consumption of water with calcium \> 150 mg/L
* Pregnancy (as established by self-declaration), breastfeeding, menopause
* Inability to follow the study protocol
* Cardiac, vascular, renal, and oncological disease
* Neuropsychiatric disease, developmental disorders
* Disease or past surgery affecting the gastrointestinal tract
* Drugs that interfere with bone (e.g. corticosteroids) or with fluid balance (e.g. diuretics)
Bupivacaine in Tonsillectomy

A placebo-controlled and double-blind study is planned according to current legislation and ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after tonsillectomy, and 50% receive 0.9% sodium chloride.

Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding, fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2, 3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with "mixed models" statistics and the results will be published in a peer-based journal.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years

Exclusion Criteria:

1. Known allergy to local anesthetics.
2. Patients using painkillers in the form of opioids fixed before inclusion in the study. People who have a lot of pain often have more pain after known painful stimuli, such as surgery. This is known as the phenomenon of "central sensitization" and "opioid-induced hyperalgesia" and will probably contribute to great heterogeneity within the groups. Because very few people use opioids regularly from those who have an isolated tonsillectomy performed, it can make it difficult to detect any differences between the groups, and the number is far too low to be able to perform stratified analyzes on only these people.
3. Persons weighing less than 10 kg.
4. Persons over the age of 18 who are not competent to give consent.
5. Patients using class Ib antiarrhythmics (lidocaine, mexiletine) due to increased risk of additive toxicity due to structural similarities. (see SPC)
6. Known partial or total heart block that has not had a pacemaker inserted (see SPC)
7. Severe hepatic failure (spontaneous prothrombin time -international normalized ratio (PT-INR)\> 2.0). These patients are not offered this type of procedure as day surgery due to the high risk of complications for the surgery itself.
8. Severe renal failure (estimated glomerular filtration rate \<15 ml / min / 1.73m2).
HCV Reinfection After DAA Therapy in PWID in Belgium

The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population.

Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.

This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users.

Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18 years or older
* Injecting drug use within 6 months before start of treatment
* Achieved an ETR following at least eight weeks of DAA treatment
* Completed DAA treatment no more than 6 months prior to inclusion
* Blood sample drawn within 6 months pre-treatment stored at -70° C

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria.
Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer

The purpose of this study is to develop an on-line electronic symptom management application that can ultimately be used to improve clinical outcomes in patients with mRCC treated with cabozantinib.

This is a single-site, prospective technology-based, clinical trial. Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria will be enrolled in this study. Subjects will be given an iPOD touch with the symptom monitoring application installed, physical activity and blood pressure monitors. Each patient will be kept on study for the first 12 weeks of therapy with cabozantinib. Subjects on treatment for less than 12 weeks will not be replaced.The symptoms and other data (physical activity, blood pressure) recorded electronically by the patient will be compared to symptoms recorded in the medical record at interval clinic visits.

Eligibility Criteria:
Inclusion Criteria:

Patients \> 18 years of age Patients planning to start treatment with cabozantinib therapy for renal cancer.

Technology requirement: The patient will need to have home wireless internet access for use of the software and technology in this study. The patient will need to already have or be willing to set up a Duke MyChart account.

Exclusion Criteria:

Non-English Speaking. Any patient who is not able to comprehend and operate the technology at the discretion of the enrolling provider.
Blood Collection of Patient Presenting in the ED and Prescribed a BNP

Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.

Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.

Stored specimens for future use in BNP assay development.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>21 years of age
* Able to understand and willing to provide informed consent
* Present in to ED
* BNP test requested

Exclusion Criteria:

* Males and females\< 21 years
* Unable to provide informed consent
* Not presenting to ED
* hemolyzed sample
Radiotherapy or Imiquimod in Complex Lentigo Maligna

The purpose of this study is to investigate the effectiveness of using either radiotherapy (RT) or Imiquimod (ImiQ) to treat the Lentigo Maligna (LM), when surgery is not possible, is refused, or fails.

Surgery is the standard treatment for people diagnosed with LM. However for some people, it may not be possible due to the location of their LM lesion(s).

Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend radiotherapy for the treatment of LM however there is no clinical trial evidence for this and a trial is needed to prove which treatment is safer and more effective. Some clinicians may also recommend the use of a cream called Imiquimod. It is approved and widely used in Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. Although not currently licensed for treatment use in LM, there is some evidence to suggest that it is both safe and effective in treating LM.

This trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.

The primary objective of this trial is to compare the rate of LM treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with ImiQ or RT. For this study, treatment failure includes both the recurrence and persistence of LM, and is defined as the presence of LM cells within the original field of treatment confirmed by histopathology.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older.
2. A biopsy-proven LM. This includes previous treatment failures (not with imiquimod or RT) of LM that are diagnosed as biopsy-proven LM.
3. LM that is in a location amenable to treatment with imiquimod and radiotherapy.
4. Willing and able to comply with study requirements.
5. Written informed consent.

Exclusion Criteria:

1. Invasive melanoma.
2. Medical or psychiatric condition that compromises the ability of the patient to complete protocol treatment or follow-up assessments.
3. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.
4. Life expectancy of less than 2 years.
5. Radiotherapy sensitivity syndrome
Is Levocetirizine Less Sedating Than Cetirizine?

The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.

Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.

Eligibility Criteria:
Inclusion Criteria:

* patients 18 years of age or older
* patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:

  * dust mite
  * cat (if they own an indoor cat)
  * dog (if they own an indoor dog)
* will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
* history of reported sedation/somnolence when taking cetirizine
* patient must have taken cetirizine for at least 1 week prior to discontinuing it
* patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.

Exclusion Criteria:

* chronic urticaria requiring ongoing antihistamine or steroid treatment
* atopic dermatitis requiring ongoing antihistamine or steroid treatment
* URI or sinus infection during the 2 weeks preceding the beginning of the study
* vasomotor (non-allergic) or irritant rhinitis
* afrin use
* elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
* patients who have not tolerated levocetirizine in the past due to sedation.
* taking other prescription or over the counter antihistamines and unwilling to stop them during the study
* the presence of a sleep disorder such as sleep apnea or narcolepsy
* the use of as needed sleeping aid medication
* the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility

The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:

* To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
* To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
* A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
* EEGs performed to ABRET \& IFCN standards using a minimum of 19 electrodes and additional technical requirements.

Exclusion Criteria:

* Subject was not suspected of having had a seizure or epilepsy.
* Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
* Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
* Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
* Sleep deprived EEG recordings in the outpatient setting.
* Encephalopathic subjects.
* Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.
* Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.