cyrilzakka/clinical-trials huggingface dataset:
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.

A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cutaneous melanoma
* ≥ 18 years of age and \< 75 years of age
* Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
* Have a Karnofsky performance status of ≥ 80%
* Negative pregnancy test
* Start of therapy within three months after surgery
* Informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
* Mucous membrane or ocular melanoma
* Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
* Patients who have received chemotherapy or vaccines for melanoma
* Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
* History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
* Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
* ALAT or ASAT \> 2 x ULN
* Bilirubin \> 2 x ULN
* Creatinine \> 2 x ULN
* Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
* Patients with seizure disorders requiring anticonvulsant therapy
* Any of the following abnormal baseline hematologic/laboratory values:

  * Hb \<10g/dl
  * WBC \<3.0 x 109 /l
  * Platelets \<100x109/l
  * Neutrophils \< 1.5 x 109/l
* History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
* Unwilling or unable to comply with the requirements of the protocol for the duration of the study
* Known infection with HBV, HCV, HIV
* Evidence of allergy or hypersensitivity against IFN or pegylated interferon
* Thyroid disease poorly controlled on prescribed medications
* Systemic corticosteroid therapy for any reason (\>1 month)
Effect of AXOS on the Colon Metabolism in Healthy Volunteers

The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* regular dietary pattern (3 meals/day)
* age: 18-45y
* BMI: 18,5-27 kg/m2

Exclusion Criteria:

* intake of antibiotics 1 month prior to the study
* abdominal surgery in the past, with the exception of appendectomy
* intake of medication influencing the gastro-intestinal system 14 days prior to the study
* in treatment at a dietician
* serious liver- or kidney failure
* vegetarians
* intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
* Current episode ≥4 weeks.
* CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria:

* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
* Any other current Axis I disorder other than MDD which is the focus of treatment.
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
* Concomitant psychotropic medication, including herbal preparations and melatonin.
* Psychotherapy of any type.
* Prior exposure to agomelatine.
* Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply
Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

OBJECTIVES:

Primary

* To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.

Secondary

* To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.

OUTLINE: This is a multicenter study.

Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Treated on EST-1490, E-3993, or ECOG-E3999
* Bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available
* No M3 disease

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Outcome of Patients Undergoing Leadless Pacemaker Implantaton

Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.

Observational, multicenter study enrolling consecutive patients undergoing leadless pacemaker implantation. Procedure details, intraprocedural complications, and n-hospital outcomes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.

Exclusion Criteria:

* inability to sign informed consent
Terminal Graft Failure

One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. The problem is that we do not know some of the causes of graft failure thus, it is difficult to diagnose early and treat. Due to graft failure, lots of children are placed back on the transplant list and receive another new heart.

In this study, we plan to perform a retrospective chart review looking to see if we can correlate graft failure with a problem with the vessels called coronary allograft vasculopathy or rejection. In order to do this, we will collect data from patient's charts that have been diagnosed with graft failure and compare their clinical presentation/data to pathology reports of the explanted hearts from these children. Explanted hearts are the old transplanted hearts that are removed in order to put a new heart into the body. Explanted hearts at our institution are always sent to pathology for analysis thus it will be quite easy to perform this review.

The objectives are to describe the pathology findings from the examination of the explanted heart and correlate them with clinical variables such as catheterization data.

Children's Healthcare of Atlanta performs approximately 12-15 heart transplants a year. To date, there have been 19 re-transplantations for late graft failure at Children's. The pathologic and clinical records of these 19 patients will be studied. All data collected will be entered into a database for future analysis.

Data Collection

A retrospective review of standard pathology findings from the examination of the explanted hearts will be conducted in order to determine the following:

1. Evidence of CAV (coronary allograft vasculopathy)
2. Evidence of Endocardial fibroelastosis
3. Evidence of Rejection (acute and chronic)
4. Evidence of Myocardial infarction
5. Evidence of Fibrosis
6. Evidence of Fatty infiltration

A retrospective review of patient charts will also be utilized to compare the pathologic findings to clinical data obtained prior to re-transplantation. The following information will be collected:

1. Type of transplant method
2. Patient age at time of transplant
3. Echocardiographic Data including Tissue Doppler Imaging (if available)
4. Catheterization data

   1. CAV as identified by coronary angiography
   2. Ventricular end-diastolic pressure
   3. Cardiac index
   4. Ventricular ejection fraction
5. Clinical rejection history

Eligibility Criteria:
Inclusion Criteria:

* retransplanted at Children's Healthcare of Atlanta for late graft failure

Exclusion Criteria:

-
Modifying the Home Television Watching Environment

The purpose of this study is to determine if limiting television (TV) and computer time will result in a stabilization or smaller increase in body mass index (BMI), lower energy intake, and increased physical activity in 4-7 year old obese (\>85th BMI percentile) children over two years.

There is a positive correlation between obesity and television watching in adults and children. And, television watching, controlling for current obesity, is a predictor of future obesity. Almost half of all children watch 3 or more hours of television each day. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours each day.

Families will be randomized to one of two conditions. Half the families will be taught to use the TV Allowance to reduce their child's TV and computer use by one-half over a six month period and the other half will use the device to monitor TV watching (control group). This study uses TV Allowance units to monitor home television watching, video game playing, and computer use. The TV Allowance can also be used to limit the amount of TV and computer use by programming it to allow a specific number of hours for each family member. Heights, weights, food intake, and physical activity will be measured at baseline and every six months. The purpose of this study is to determine if limiting television and computer time will result in a stabilization or smaller increase in BMI, lower energy intake, and increased physical activity in 4-7 year old obese (\>85th BMI percentile) children over two years.

Eligibility Criteria:
* Greater than the 85th BMI percentile
* Minimum of 15 hours of TV watching, computer use, and video game playing per week
* No medical conditions that may affect the child's ability to safely participate in physical activity
SYNCHRONISE: LVO Triage Timing and Outcome Study

The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.

This is a multi-center, non-randomized observational study of acute ischemic stroke patients whose CTA scans are analyzed by Viz LVO to support clinicians in making stroke triage decisions,. The study results will be compared to a cohort from enrolling centers prior to Viz LVO implementation that will serve as a historical control. Data will be collected retrospectively from the time of presentation through 90 days post discharge.

The study will include patients undergoing imaging for a suspected LVO acute ischemic stroke. The post-Viz LVO intervention group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, following image analysis by Viz LVO. Data will be collected retrospectively on consecutive patients meeting eligibility criteria from the date of implementation up to 5 years post implementation.

The control group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, for evaluation prior to the implementation of Viz LVO. Data will be collected on consecutive patients from one day prior to implementation, back as far as 2 years prior to implementation

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or greater
* Signs and symptoms consistent with the diagnosis of a large vessel occlusive stroke
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6
* Aspects Score ≥6
* Patient must have a suspected LVO in M1.
* Patient with an intention to treat with mechanical thrombectomy with confirmation of LVO by the CT/CTA radiographic report with the reading diagnosis.

Exclusion Criteria:

* Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)
Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients

After being admitted to and then discharged from a hospital in Cameroon for having experienced an injury, there is no established way for the health system to check in on how the discharged person is doing. The investigators have developed a set of questions with the hope that asking these questions--over the phone--to those who have been discharged from the hospital will allow them to determine which post-discharge patients would benefit from further care. The investigators believe that asking these questions over the phone is a good way of determining which post-discharge trauma patients would benefit from further care.

Broadly, this study aims to answer three questions. (1) Is it feasible to call discharged trauma patients on their mobile phones to check up on them? (2) Can a defined set of questions help determine which discharged trauma patients require further medical care (and which discharged trauma patients do not require further medical care)? (3) Will checking in on discharged trauma patients reduce their experience of disability and economic consequences?

If an individual was a trauma patient who was admitted at and then discharged from one of the study's partner hospitals in Cameroon, the discharged individual (hereafter referred to as "the participant') will be receiving phone calls from one of the study's research assistants at the following post-discharge timepoints: 2 weeks, 1 month, 3 months, and 6 months. Whether the research assistant administers the defined set of questions developed by the study's investigators (see question 2, above) will depend on when the participant was discharged from the hospital. Regardless, all participants will be asked other important questions about the injury and any associated disabilities and economic consequences.

Eligibility Criteria:
Inclusion Criteria:

* All trauma registry patients at participating hospitals who provided cellphone numbers and are alive at hospital discharge are eligible for inclusion regardless of age, injury severity, or hospital disposition status.
Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients

Congestion plays a key role in heart failure (HF) trajectory .Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures. Hemodynamic congestion refers to elevated cardiac filling pressures, which may occur days or weeks before the presentation of symptoms , , .

Serial assessment of congestion is required in each encounter of the HF patients, while in current clinical practice, serial assessment of congestion relies on physical examination, sometimes supported by BNP test. Both physical and BNP test are reported to be unreliable in some cases ， . Echocardiography is good tool, but it requires skilled physician to operation and is more time consuming. In general, there is unmet needs of better tools for serial assessment of congestion in HF patient management.

In this study, we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute heart failure；Stabilized outpatient chronic heart failure patients；Willing to sign the inform consent

Exclusion Criteria:

* 1.Patients under 18 years old 2.Patients with congenital heart diseases (e.g., tetralogy of Fallot, atrial septal defect, Fontan disease, single chamber disease) 3.Patients with implanted artificial mechanical valves, pacemaker or ICD. 4.Patients with significant back issues that prevent them from lying supine on the bed 5.Pregnant patients 6.Patient wight under 35 kg or over 150 kg 7.Patients who are attaching to other medical device that prevent them to receive a test by the study device.
Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health

Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.


Eligibility Criteria:
Inclusion Criteria:

* Women affected by endometriosis with dyspareunia;
* Women in waiting list for surgery

Exclusion Criteria:

* Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
* Psychiatric diseases
* Refusal or inability to sign the informed consent
* Pregnancy
* Previous gynecological surgery
* End of couple relationship
Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

The investigators propose a third hypothesis based on the anatomic observations made in pathological studies. The investigators hypothesize that the anatomic architecture determines the functional properties of the TV-IVC isthmus. As a result,

• Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue.

The muscular bundles form selective targets for ablation and therefore the entire anatomic line need not be ablated. This has direct implications for ablation of the isthmus.

Patients undergoing atrial flutter ablation will have cartosound imaging done during procedure to determine if this will shorten ablation times.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be over 18 years of age provided written informed consent documented atrial flutter by ECG , holter monitor or TTM

Exclusion Criteria:

* previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery
To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD

This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Choroidal neovascularization secondary to AMD
* Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart
* Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD
* Documentation of presence of subretinal fluid and/or cystoid macular edema less than 30 days since last treatment

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.
* Participation in another simultaneous medical investigation or trial
* Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
* Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
* Presence of significant subfoveal fibrosis or atrophy.
* Prior treatment with intravitreal aflibercept injection
* Prior treatment with triamcinolone in the study eye within 6 months of BSL.
* Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Ocular or periocular infection
* Active severe intraocular inflammation
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
* History of allergy to fluorescein, ICG or iodine, not amenable to treatment
* Known hypersensitivity to aflibercept or to any of the excipients