cyrilzakka/clinical-trials huggingface dataset:
National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.

Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study

Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):

Primary outcome measures:

Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.

Secondary outcome measures:

Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.

Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.

Study start : January 2007. Expected completion 2010.

Women with BRCA gene mutations are more likely than others to develop the disease at a young age when breast density is higher than at older age.The tumours often are more rapidly developing with a short presymptomatic phase. These factors are known to reduce the effectiveness of screening with mammography and mammography seems to have a low sensitivity in women with BRCA gene mutations. Other studies have shown that more than 50% of the cancers appears as interval cancers between two mammography screening examinations and many have positive axillary nodes at the time of diagnosis.

Around 610 women are tested BRCA gene positive in Denmark in year 2006. These women are offered a yearly screening with mammography combined with ultrasound and a clinical examination. The trial will test whether this screening offer should be combined with or replaced by MR mammography.

Eligibility Criteria:
Inclusion Criteria:

* women tested positive of BRCA1 or BRCA2 gene mutations
* referred for screening
* aged 25 - 70 years

Exclusion Criteria:

* general contraindications for MR
* pregnant or lactating
* men
* bilateral mastectomy
* ongoing treatment with chemotherapy
* metastatic breast cancer
* previous breast surgery less than 6 months before MR
* previous radiation therapy of the breast less than 1 year before
* incapable of managing her own affairs
Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy

Patients who have been admitted to Intensive Care Units (ICU) and are intubated and mechanically ventilated for longer than 48 hours have impaired physical, psychological and social health and well-being six to twelve months after discharge. The advocacy of intensive physiotherapy and mobilization early in the course of critical illness has been established. It is of great importance to study the long-term outcomes (physical function and quality of life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as soon as possible during ICU stay because the most effective mode, intensity or frequency of exercise needs to be identified.

The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and upright position in critically ill patients on prolonged invasive ventilation and to develop principles to guide physiotherapists in their clinical decision making in the ICU.

Mobilization is an intervention prescribed by physiotherapists, for critically ill patients in the ICU, to prevent as well as remediate a range of multisystem problems and complications. Mobilization which refers to low levels of exercise and progressive position changes from being supine to being upright and moving, is both a gravitational and an exercise stimulus. Given the hemodynamic status of patients in the ICU can change suddenly, physiotherapists gauge the patient's status moment by moment, and change the parameters of an intervention accordingly, i.e., the type and level of an intervention, its duration and rest periods. The aim of this research is to study the short- and long-term outcomes of enhanced early physiotherapy, with mobilization and upright position, in critically ill patients on prolonged invasive ventilation. This is a prospective, randomized, single blind trial where the intervention permits variation in the physiotherapist's clinical decision making to simulate the general practice. This study started in November 2011, data collection and intervention will continue until November 2014 with 12 months follow up until november 2015.

Eligibility Criteria:
Inclusion Criteria:

* Patient participants will be at least 18 years of age and admitted to the ICU of Landspitali Fossvogur or Landspitali Hringbraut of the The National University Hospital of Iceland.
* Intubated and on mechanical ventilation for \> 48 hours
* Icelandic speaking.
* Upright position and ambulation is not contraindicated or impossible.

Exclusion Criteria:

-Those patients deemed by the medical teams of each unit not to be sufficiently stable. These would include diagnoses such as: Intracranial insults including:Severe head injury, Subarachnoidal hemorrhage, Elevated intracranial pressure, Intraventricular drain, Neurological deterioration, Status epileptics

* Unstable fractures of the vertebral column
* Spinal cord injuries
* Unstable pelvic fractures and/or balanced skeletal traction
* Severe burns
* Mental status precluding being able to follow instructions and cooperate with treatment appropriately
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects

This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects sign the informed consent form (ICF) voluntarily.
* Chinese adult subjects, both male and female.
* 18 to 65 years old (including both ends) at screening.
* BMI≥26.0 kg/m2 at screening.
* Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
* Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods.
* Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.

Exclusion Criteria:

* Lactating women.
* History of fainting with blood and needles.
* Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
* Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
* History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
* Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period.
* Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period.
* Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.
The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury

The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.

Current treatment for Spinal Cord Injury and Traumatic Brain Injury focuses on stabilizing the patient and preventing secondary injury with the aim of maximizing the best chance of recovery. Most patients will show varying amounts of recovery, but, when the injury is severe, that recovery is only partial. Enrollment in the NCTT will allow for classification and characterization of injury, function, co-morbidities, secondary issues/problems, research interests and will serve as a conduit for enrollment into interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* History of spinal cord injury and/or brain injury
* Able to provide HIPAA authorization to share prior medical records/imaging
* Age 18 and older.

Exclusion Criteria:

* Life expectancy less than 6 months, vegetative state or co-existing disease or other characteristic that precludes appropriate diagnosis of spinal cord or brain injury.
* Other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state).
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis

Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.

Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy)or treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic membranous glomerulonephritis on renal biopsy
* Proteinuria - protein/creatinine ratio (PCR) \> 100 units with hypoalbuminaemia or PCR \> 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
* Male or female patients aged 18 to 80 years

Exclusion Criteria:

* Hepatitis B hepatitis C or HIV positive
* Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
* Untreated infection
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
* Any condition judged by the investigator that would cause the study to be detrimental to the patient
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients

The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. This is a single use, sterile dressing that is applied to the patient's skin. It has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. The patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.

Surgical site infection (SSI) in groin wounds after vascular surgery is a significant contributing factor for increased morbidity. Despite the use of prophylactic systemic antibiotics, postoperative groin wound infection still occurs in some circumstances and it continues to be a serious problem after vascular surgical procedures. The incidence of SSI varies from 5 - 40%, and depending upon the depth of infection and type of vascular procedure, the morbidity could range from prolonged hospital stay to limb loss.

Increased incidence of SSIs in patients is related to systemic factors like Diabetes, hypertension (HTN), history of smoking, chronic obstructive pulmonary disease (COPD), and local factors like disruption of lymphatics, groin proximity to the perineum, previous surgery at the same site and the use of prosthetic graft material.

Prophylactic systemic antibiotics have been routinely used in all vascular surgery procedures, and despite of gentle tissue handling, proper hemostasis and other technical points to minimize tissue trauma, SSIs do happen.

The investigators hypothesize that using a closed dressing system with negative pressure will keep the surgical site protected from nearby contaminated field and decrease the risk of infection

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years
2. Subjects are capable of giving informed written consent
3. Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.

Exclusion Criteria:

1. The patient has a history of blood clotting disorders
2. Patient has evidence of infection in the groin area, where surgical procedure is planned
3. Patient body habitus precludes placement of Prevena dressing.
4. Allergy to Silver or acrylic adhesive
Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically indistinguishable and DIP sometimes represents "unmasking of underlying PD. The objective of this study is to determine the relationship of underlying Parkinson's disease (PD) to the incidence and clinical outcome in DIP using non-motor assessments as a marker for nigrostriatal degeneration.

Research Design: This is a nested case-control design to investigate risk factors associated with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.

Methodology: We will examine objective olfactory function (via objective olfactory testing), other non-motor symptoms of PD (via standardized validated questionnaires), and motor findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects) compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed prospectively after a change in AP treatment. Additionally, in patients where it was performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker of nigrostriatal integrity examining the ability of qualitative and semi-quantitative analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and examine their relationship with clinical and radiologic status.


Eligibility Criteria:
Inclusion Criteria:

antipsychotic treated patients with or without parkinsonism

Exclusion Criteria:

parkinson's disease, dementia
MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Participants with Select Advanced Solid Tumors


Eligibility Criteria:
Inclusion Criteria:

* Adult participants; age ≥ 18
* Written and signed informed consent must be obtained
* Have histologic or cytologic documentation of solid tumor including EGFRm NSCLC
* Participants must have at least 1 lesion that is measurable using RECIST guidelines
* Participants must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies.
* Eastern Cooperative Oncology Group performance score of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with tumor necrosis factor receptor superfamily agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, PD-L1, and anti PD-L1.
* Participants who have received prior therapy with regimens containing CTLA-4, PD-L1, or PD-1 antagonists may be permitted to enroll under certain conditions
* Cardiac or peripheral vascular disease meeting any of the following criteria:

  * Past history of myocardial infarction in the prior 12 months
  * Past history of stroke or transient ischemic attack requiring medical therapy
  * Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification
* Grade 3 or greater edema (eg, peripheral, pulmonary)
* History of Grade 3 or greater thromboembolic events in the prior 12 months
* Participants with active tuberculosis are ineligible. In settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out
* Active or prior documented autoimmune or inflammatory disorders
* Untreated central nervous system (CNS) metastatic disease
* Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
* Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas

Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.

OBJECTIVES:

I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416.

II. Determine the safety of SU5416 in these patients.

OUTLINE: This is a multicenter study.

Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 3 months and then every 3 months for 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor
* Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
* Must have received prior chemotherapy with no response or progression after initial response
* Evidence of disease progression in past 3 months
* No CNS metastases or primary brain tumors

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0-1
* Life expectancy: At least 12 weeks
* WBC greater than 2,000/mm3
* Platelet count greater than 100,000/mm3
* Fibrin split products no greater than 0.001 mg
* Fibrinogen greater than 200 mg/dL
* Bilirubin no greater than upper limit of normal (ULN)
* AST/ALT less than 1.5 times ULN
* PT/PTT less than 1.25 times ULN
* Creatinine no greater than 1.5 mg/dL
* At least 1 year since bypass surgery for atherosclerotic coronary artery disease
* No uncompensated coronary artery disease
* No history of myocardial infarction or unstable/severe angina in past 6 months
* No severe peripheral vascular disease
* No history of deep venous or arterial thrombosis in past 3 months
* No history of pulmonary embolism in past 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No diabetes mellitus
* No history of bleeding diathesis
* No known active retroviral disease
* No AIDS-associated Kaposi's sarcoma
* No history of allergic reaction to Cremophor or paclitaxel
* No uncontrolled illness or psychiatric disorder that would preclude study

PRIOR CONCURRENT THERAPY:

* No concurrent immunotherapy
* At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)
* No concurrent chemotherapy
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy
* Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery)
* No concurrent antiinflammatory drugs
Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care

Significant challenges and gaps remain in navigating transitions between acute care and outpatient care for many cancer survivors. This study underscores 1) implementation of Emergency Department (ED) risk-stratified treatments protocols that standardize patient care and would allow for rapid re-assessment and access to specialist care with well-coordinated cancer care plans, and 2) the significant numbers of minority cancer survivors seeking episodic care in the ED that are at increased risk of not receiving recommended post cancer treatment surveillance.

The over-arching goal of this study is to develop a portable model for ED cancer treatment guidelines and management using evidence based protocols in a population at high risk for poor cancer -related outcomes by identifying \& overcoming specific barriers to enhanced survivorship. Based on the demographics of ED population (currently, 70% racial/ethnic minorities), the majority of participants will be underrepresented (African-American and Hispanic) and low-income individuals. The investigators propose a feasibility study of 150 patients in the ED over a 1 year period.

The specific aims are:

Aim 1: Evaluate the effectiveness of ED Risk-Stratified, Evidence-Based Treatment protocols on the primary outcome of ED utilization rates and subsequent acute inpatient admissions at 6 -months post-intervention.

Aim 2: Evaluate the effectiveness of an ED-based Cancer Patient Navigator on the secondary outcomes of patient engagement and primary care engagement at 6 -months post-intervention.

Aim 3: Examine barriers and facilitators to compliance for cancer survivorship recommendations that occur in an ED setting at 6-months post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Cancer survivor (has had cancer in their lifetime, and is currently disease-free)
* Verbal fluency in English or Spanish
* Age 18-75 years

Exclusion Criteria:

* Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
* Plans to move from Chicago area within the next year