cyrilzakka/clinical-trials huggingface dataset:
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus vincristine in treating children and adolescents with low grade glioma.

OBJECTIVES: I. Develop a standardized scheme of therapy for children and adolescents with low grade glioma. II. Determine the effectiveness of carboplatin and vincristine in treating children aged less than 5 years with severe or progressive symptoms or unequivocal imaging evidence of tumor growth.

OUTLINE: A complete resection of tumor is performed on patients with low grade glioma with or without neurofibromatosis type 1. Surgery is reconsidered following tumor relapse, progression, or clinical deterioration. Every effort is made to obtain a biopsy from patients not receiving debulking surgery. Nonoperative patients and postoperative patients who are not candidates for second surgery receive chemotherapy or radiotherapy. Postoperative patients receive radiotherapy following surgical wound healing and within 28 days of resection. Children less than 5 years old receive chemotherapy first, then radiotherapy if the tumor subsequently progresses or recurs. All other patients receive radiotherapy, then chemotherapy. The latter treatment is conducted in the presence of tumor progression. Chemotherapy is given in 2 parts, first an initial intensive phase (phase 1), then a later continuation phase (phase 2). In phase 1, patients receive vincristine IV weekly for 10 weeks and carboplatin IV every 3 weeks. In phase 2, patients receive vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks. Chemotherapy continues until disease progression or unacceptable toxicity. Patients receive radiotherapy daily 5 times a week. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study over 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Patients with or without neurofibromatosis type 1 (NF1) with low grade glioma not previously treated with chemotherapy or radiotherapy Tumor types considered are: Low grade astrocytoma (Kernohan grade 1/2) Oligodendroglioma Mixed oligoastrocytoma Ganglioglioma Patients with NF1 and hypothalamic/visual pathway glioma are eligible without biopsy All CNS sites are eligible, including biopsy proven low grade spinal tumors and intrinsic brain stem tumors No malignant (anaplastic) glioma (Kernohan grade 3/4), glioblastoma multiforme, and ependymal tumors

PATIENT CHARACTERISTICS: Age: Under 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events \[MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke\] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female least 18 years of age
* Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
* No suspicion of acute kidney injury
* Evidence of multivessel coronary artery disease
* Presence of established cardiovascular risk factor(s):

  1. Diabetes mellitus on pharmacotherapy OR
  2. 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease

Exclusion Criteria:

* Ongoing hemodynamic instability
* Evidence of hepatobiliary disease
* Evidence of severe chronic kidney disease
* Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
* Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients, who are at \>=18 years
* Diagnosis of acute DVT and/or PE, objectively confirmed
* Indication for anticoagulation therapy for at least 12 weeks
* Willing to participate in this study and available for follow-up

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy

This study is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* any person undergoing minimally invasive donor nephrectomy surgery at NewYork Hospital/Columbia.

Exclusion Criteria:

* any person undergoing open donor nephrectomy surgery at NewYork Hospital/Columbia.
MAX - SHOCK Clinical Trial

Can Electrical Cardioversion (ECV) for AF be improved. It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued.

Hypothesis:

ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J (® Physio-Control) compared to a biphasic defibrillator with maximum energy of 200J (® Zoll)

Published estimates of ECV success using modern biphasic defibrillators vary considerably but most are limited by small sample sizes. Our pre-intervention ECV success rate of 91.8% was stable over \>2.5 years and is comparable to a previous study from our institute11 and to recent estimates from moderately sized studies using contemporary technology. For instance, the Euro Heart Survey on AF reported an ECV success rate of 91% in 424 patients2 and the Biphasic Energy Selection for Transthoracic cardioversion of Atrial Fibrillation (BEST AF) trial reported 89% success in 380 patients.3 The variability in starting shock energy and shock energy escalation observed at our centre prior to implementing the OAFCP is also consistent with reported practices elsewhere. A recent survey of 57 European centres found that nearly two-thirds of hospitals started with a 100 J biphasic shock for AF whereas the remaining third started with 200 J.1 Considerable differences in electrode placement were also reported in this survey with 58.7% of centres using an anterolateral position and the remainder using an anteroposterior approach.1Our investigators and others have previously shown that physicians seldom apply sufficient force even when prompted to do so and even when using handheld paddles.10,16,17 ECV practices at our institute prior to implementing the OAFCP were therefore likely representative of those at most centres.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 years.
* Persistent atrial fibrillation.
* Scheduled for elective cardioversion at UOHI
* Patient is within the circle of care of UOHI Electrophysiology staff

Exclusion Criteria:

* Known left-atrial appendage thrombus.
* Contraindication to appropriate anticoagulation.
* Patient is included in another randomized clinical trial.
* Patient does not meet all of the above listed inclusion criteria.
Use of ACUPUNCTURE in Emergency Departement

Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED.

In 1998, a United States National Institute of Health Consensus Conference Panel reviewed the status of acupuncture and concluded that: "There is sufficient evidence of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." Similarly, in 2002, the World Health Organisation (WHO) stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness as analgesia has been established in controlled clinical studies.

Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the treatment of chronic pain is comparable to morphine and that its better safety profile and lack of dependence makes it the preferred method of choice for these conditions.

There are very few clinical trials of acupuncture for acute pain to inform clinical practice; that's why we have the idea to do this study in our emergency department.

The objective is to evaluate the efficacy and the tolerance of acupuncture compared to intravenous morphine in the management of acute pain.

The results will also identify the impact that acupuncture treatment may have upon health resource utilization in the ED setting.

It is a randomized, prospective, controlled, conducted into emergency department. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).

In all included we recorded at baseline :

Age, sex, job, comorbidity, hour of beginning of pain. Injury nature and severity assessed by the Injury Severity Score (ISS) Mechanism of the injury and radiologic findings. VAPS : 0-100%

Eligibility Criteria:
Inclusion Criteria:

* Traumatic and non traumatic acute (\<72 hours) musculoskeletal pain with visual analog pain scale ( VAS or NRS ) \> 40 (on a scale 0-100)
* Age ≥18 years
* Presigned consentement to participate in the study.
* no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity); shoulder and elbow tendonitis; upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit; acute abdominal pain with no urgent surgical intervention including renal colic and dysmenorrhea; and acute headache .

Exclusion Criteria:

* Temperature \> 37.7° C,
* Anticoagulation medication use or the presence of a mechanical heart valve,
* Skin infections that would preclude certain acupuncture points being used,
* Refusal, inability to consent or communication difficulties,
* Acute major trauma,
* Any form of analgesia up to 60 minutes prior to study start,
* An initial pain score ≤ 40 on the pain scale (score range 0-100),
* Opiate contraindication,
* Pregnancy,
* Presentation to the ED \> 4 times in the previous 3 months with the same condition.
Biop System's Safety and Performance

Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy

Biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy.

This is a multi-center, prospective, open label, non-randomized study to train the Biop System's algorithm and evaluate the safety and performance of the Biop system in women undergoing cervical colposcopy.

Eligibility Criteria:
Inclusion Criteria:

* Female Age ≥ 22 years and ≤ 65.
* Referred for colposcopy, following abnormal cervical cytology;
* Participant provides signed informed consent

Exclusion Criteria:

* Currently pregnant (through six weeks postpartum) or nursing
* Currently menstruating
* Previous hysterectomy
* Currently has intrauterine device (IUD)
* Cervical biopsy or therapeutic procedure since the referral cervical cytology,
* Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera.
* Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) (Applicable to training stage only)
* A known latex allergy
* Psychological instability, inappropriate attitude or motivation
* Cervical cytology tests within the prior seven days
* Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h
* History of photosensitivity or other diseases affected by UV radiation,
* An observable and untreated gynecological infection.
* Previous history of CIN therapy
Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study

Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.

The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.


Eligibility Criteria:
Inclusion Criteria:

* patient who has given oral consent
* over 18 years
* orally fed
* with a prescription for ONS
* speaks and understands French
* hospital stay longer than 4 days

Exclusion Criteria:

* adult under tutelage
* pregnant or breastfeeding women
* cognitive disorders
* patient does not speak or understand French
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO \& CRUISE trials and subsequently followed in the HORIZON extension trial.

There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age greater than or equal to 18 years
* Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
* Inability to comply with study or follow up procedures
* Participation in another simultaneous medical investigation or trial
Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia

The hyper- or hypo-attribution of risks is deeply related to the core pathological mechanisms of mental disorders and at the same time engaging in risky behaviors influences their course and outcomes. The investigators study risk perception, risk behaviors and underlying brain mechanisms in a longitudinal design in three groups of psychiatric patients who participate in a psychological intervention that is aimed to reduce risk behavior and increase risk perception.

Patients with schizophrenia (SZ), alcohol use disorder (AUD) and both disorders (SZ + AUD) are recruited during psychiatric in-patient treatment and participate in a combined face-to-face and mobile intervention that starts before release and ends four weeks after discharge. The standardized 4-session face-to-face group intervention that is based on motivational interviewing (Miller \& Rollnick, 2013) and relapse prevention (Marlatt \& Donovan, 2005) and addresses the reduction of disorder-specific risk behaviors, i.e. alcohol use for AUD and SZ+AUD and medication non-adherence for SZ. After discharge, a 4-week ecological momentary intervention (EMI) supports participants to maintain abstinence from risk behaviors and to strengthen coping in high-risk situations relying on mental contrasting and implementation intentions (Oettingen \& Gollwitzer, 2011). Participants will be assessed in fMRI and behavioral measurements and by self-report pre and post interventional phase, furthermore they participate in an ecological momentary assessment during the post-discharge phase which assesses risk behaviors, high-risk situations and risk perception in real life contexts.


Eligibility Criteria:
Inclusion Criteria:

* for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both

Exclusion Criteria:

for patient groups and healthy control group:

* no sufficient command of German language
* neurological disorder for patient groups:
* acute psychotic episode
* acute suicidality or not distanced from self-harming behaviors
* other substance use disorder (exception: nicotine and caffeine use disorders) for healthy control group:
* absence of any psychiatric diagnosis (exception: nicotine and caffeine use disorders)
Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer

Brief Summary: This randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. Eligible patients will use the app for perioperative care and be randomized to an intervention group receiving ePRO-based symptom monitoring with clinician feedback or a control group receiving ePRO without feedback. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for perioperative care and periodic PRO measurement. Before discharge, patients will be randomized 1:1 to an intervention group or control group. The intervention group will complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. Secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. If proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old
* Undergoing minimally invasive lung cancer resection
* Able to use smartphones and complete electronic questionnaires
* Signed informed consent

Exclusion Criteria:

* conversions to open thoracotomy during surgery
* ECOG score \> 1
* Received neoadjuvant therapy
* Previous lung resection surgery
* Unable to exercise due to physical limitations
* Continuous systemic corticosteroid use within 1 month before enrollment
* Unresolved toxicity above Grade 1 from previous treatments
* Significant comorbidities or medical history