cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
* Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
* Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
* ECOG performance score of 0,1 or 2
* Willing to follow the pregnancy precautions

Exclusion Criteria:

* Any of the following laboratory abnormalities.
* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L).
* Platelet count \< 60,000/mm3 (60 x 109/L).
* Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
* Serum total bilirubin \> 2.0 mg/dL (34 µmol/L).
* Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
* History of active CNS lymphoma within the previous 3 months
* Subjects not willing or unable to take DVT prophylaxis
* History of other malignancies within the past year
* Positive HIV or active Hepatitis B or C
Troponin Elevation in Acute Ischemic Stroke (TRELAS)

The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in acute ischemic stroke. Consecutive patients with acute ischemic stroke admitted to the Department of Neurology Campus Benjamin Franklin of the university hospital Charité will be screened for cTnT elevations suggestive of myocardial infarction (\>0,05 µg/l). Patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will serve as a control. The primary endpoint of the study will be the occurrence of culprit lesions indicating focal cardiac damage on the basis of an acute CAD.

The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in acute ischemic stroke in order to give guidance for clinical practise. All consecutive patients with acute MRI- or CT-confirmed ischemic stroke admitting within 72 hours after symptom onset to the Department of Neurology Campus Benjamin Franklin of the university hospital of the Charité will be screened for cTnT elevations suggestive of myocardial infarction (\>0,05 µg/l) on admission and day 2. Patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will serve as a control. The primary endpoint of the study will be the occurrence of angiographic culprit lesions indicating focal cardiac damage on the basis of an acute CAD. Secondary endpoints will be the localisation of stroke in the cerebral imaging and ventriculographic findings of wall motion abnormalities suggestive of neurally mediated global cardiac dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke, confirmed by cerebral MRI or CT, respectively
2. Inclusion within ≤ 72 hours after symptom onset
3. hsTroponin T \>0,05 µg/l

Exclusion Criteria:

1. Renal insufficiency (creatinine ≥1,2 mg/dl)
2. Limited life expectancy or mRS ≥ 4 prior to stroke event leading to hospital admission
3. Contraindications for the coronary angiography
4. Age \< 18 years
5. Pregnancy
6. Patient unwilling or unable to give informed consent
A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, ≥18 years at screening
* Able to provide written informed consent to participate in the trial
* Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
* Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
* IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
* Adequate liver, pancreatic, renal and bone marrow functions
* Normal ECG

Exclusion Criteria:

For Roll-over Patients from NCT04076462:

* Unresolved, drug-related serious adverse event (SAE) from the preceding trial
* Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation

For New Patients:

* Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\]
* Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
* Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
* Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
* Patients who have undergone pituitary surgery within 6 months prior to screening
* Patients who have received prior pituitary irradiation within 3 years prior to screening
* Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)

The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).

The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects

This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)

Exclusion Criteria:

* History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
* Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
Care Ecosystem: Navigating Patients and Families Through Stages of Care

This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.


Eligibility Criteria:
This study will enroll patients as well as their primary caregivers as research participants.

Inclusion criteria for patient participants:

1. Patient has a diagnosis of dementia with a progressive course
2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
3. Patient is covered by Medicare or Medi-caid or is Medi-pending
4. Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
5. Patient speaks either English, Cantonese, Mandarin, or Spanish
6. Patient lives in California or Nebraska or Iowa
7. Patient is age 45 or older

Inclusion criteria for caregiver participants:

1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish
3. Caregiver is a legal adult

Exclusion Criteria:

1. Patient resides in a nursing home or skilled nursing facility at time of enrollment
2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial
3. Patient is pregnant
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.


Eligibility Criteria:
Inclusion Criteria:

- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.

Exclusion Criteria:

* Are unable to grant informed consent or comply with study procedure.
* Allergy or known sensitivity to magnesium or Renacidin.
* Expected or high risk of bladder extravasation.
* Ongoing atrial fibrillation prior to surgery.
* Are undergoing emergency surgery.
* Are pregnant.
* Known hypermagnesemia.
* Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
* Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
* Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
* Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.
Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness

Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.


Eligibility Criteria:
Inclusion Criteria:

* Elderly individuals able to walk without assistance
* Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).

Exclusion Criteria:

* Contraindication or difficulty to perform evaluation procedures
* Users of medications that interfere with the cardiovascular and / or muscular system
* Smokers
* Neuromuscular or degenerative diseases
* Pulmonary comorbidities
* Heart diseases
* Labyrinthitis.
A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to:

* Is in good health
* Has a body mass index ≥19.0 and ≤26.0 kg/m\^2, inclusive

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* Has a history of gastrointestinal disease
* Has a history of cancer (malignancy)
Video Documentation of Localized Complications

The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must be considered in good health by investigator
* Must be able to read and understand English

Exclusion Criteria

* Less than 18 years of age
* Known allergy to Heparin
* History of HIT (Heparin-induced thrombocytopenia)
* Unable to read and understand English
Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia

RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also help cancer cells become more like normal cells, and grow and spread more slowly.

PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.

OBJECTIVES:

* To determine if valproic acid has a response rate of ≥ 20% in patients with previously treated relapsed or refractory non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.
* To determine if treatment with valproic acid leads to measurable levels of histone acetylation in peripheral blood.

OUTLINE: Patients are stratified according to disease diagnosis (indolent non-Hodgkin lymphoma \[NHL\] vs. aggressive NHL and Hodgkin lymphoma). Valproic acid doses are adjusted until therapeutic level is achieved.

Patients receive oral valproic acid daily for 3 weeks. Treatment repeats every 3 weeks for at least 2 courses and up to 2 years in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically. Samples are analyzed for valproic acid levels; and hyperacetylation (caused by the valproic acid N-terminals of the histones H3 and H4) via western blot.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of relapsed or refractory Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), or chronic lymphocytic leukemia (CLL )
* Patient must have evaluable or measurable disease
* Have failed prior treatment, as evidenced by 1 of the following:

  * Aggressive NHL

    * Failed at least 1 regimen containing rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) (unless anthracyclines are contraindicated) in addition to another salvage regimen (unless it is determined by the treating physician that it is to the patient's best interest to receive valproic acid after the first relapse)
  * Hodgkin lymphoma

    * Failed ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and received salvage chemotherapy with at least 1 salvage combination regimen
  * Indolent or low-grade lymphoma

    * Failed at least 1 combination regimen containing rituximab (patients who are intolerant to the available therapies or have contraindications for them are eligible for the study)
* No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,000/mm\^3
* Platelet count ≥ 50,000/µL
* AST and ALT ≤ 3 times upper limit of normal
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* More than 14 days since prior anticancer treatment
* Prior high-dose chemotherapy with transplant allowed
* No prior valproic acid
* No concurrent corticosteroids
Intralipid for Recurrent Miscarriage

Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.


Eligibility Criteria:
Inclusion Criteria:

* Couples with unexplained secondary infertility
* Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
* Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 \>12%.

Exclusion Criteria:

* Age above forty years old.
* Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
* Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
* Abnormal parental karyotype.
* Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
* Disturbances of normal fat metabolism such as pathologic hyperlipemia
* Allergic to it; or to eggs, soybean oil, or safflower oil.
* Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities.

The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cervical or endometrial cancer
* Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
* Age of 18 years or older
* Written informed consent
* ECOG of 0-2 within 3 months of enrolling

Exclusion Criteria:

* Prior course of pelvic radiation
* Metastatic disease outside of the pelvis
* Active inflammatory bowel disease
* Incapacity to provide informed consent
A Study of Cerebral-circulatory Response to Intravenous Antihypertensive Treatment in Women With Serious Preeclampsia

The purpose of this study is a systematical registration of hemodynamic measurements (cardiac output, blood pressure and systemic vascular resistance) in women with serious preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Women with serious preeclampsia