cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus

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: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.

OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.

OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.

PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent uterine sarcoma Documented disease progression after local therapy Measurable disease consisting of abdominal, pelvic, chest, or other masses that can be defined in at least two dimensions by palpation, x-ray, computed tomography or ultrasound

PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery
Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants

The purpose of this study is to set up a blood bank for infants who have HIV-positive mothers. This blood may be used in the future to treat the child if he/she turns out to be HIV-positive.

Blood from the umbilical cord contains a certain kind of cell called a stem cell. Stem cells eventually turn into one of the many types of blood cells. If HIV infection can be prevented in these stem cells, then, when these stem cells are injected back into the infant, the new cells that develop will also be protected from HIV. This study will provide the blood needed to test whether this type of gene therapy is safe and effective.

Gene therapy may provide a new therapeutic approach to pediatric AIDS. Putting an HIV-resistant gene into umbilical cord blood stem cells and transplanting the cells back into the patient could lead to the production of cells that resist HIV infection. If a patient's cells could be engineered to be resistant to supporting the growth of HIV-1, the cells may have improved survival in the presence of HIV-1. To date, an umbilical cord blood bank for HIV-positive deliveries has not been established in the United States. This protocol establishes a repository of banked umbilical cord blood as a first step toward the potential application of gene therapy for the treatment of HIV-infected infants.

HIV-infected mothers have about 20 ml of blood drawn to test for infectious diseases (e.g., hepatitis). At time of delivery maternal HIV viral load is measured. After delivery, about 60 ml of blood is collected from the umbilical cord; this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant. At birth, infant HIV status and general health are assessed. If the infant is found to be HIV-infected, the mother may be approached about the infant's participation in a future gene therapy study. If the infant is not HIV-infected, the cord blood is stored for up to four years and is then released to the mother, or, with her consent, to the research community.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

* Is not expected to live more than 6 months.
* Weighs less than 3.3 pounds.
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.

Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development compared to DDDR pacing in sinus node disfunction patients.

Several authors have shown that, in patients with intact AV conduction, unnecessary chronic RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and congestive heart failure. These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects.

The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV conduction.

Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent AF, cardiovascular hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Class I/Class II indications for dual chamber pacing
* Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since maximum 2 weeks
* History of atrial arrhythmias (at least one electrocardiogram \[ECG\] or Holter documented episodes in the last 12 months)

Exclusion Criteria:

* Less than 18 years of age
* Pregnancy
* Unwilling or unable to give informed consent or to commit to follow-up schedule
* Medical conditions that preclude protocol required testing or limit study participation
* Enrolled or intend to participate in another clinical trial during the course of this study
* A life expectancy of less than 2 years
* Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implant
* Anticipated major cardiac surgery within the course of this study
* Permanent III degree AV-block or history of AV node ablation
* History of permanent AF (as defined below)
* AF ablation (left pulmonary veins) or other cardiac surgery \< 3 months
* Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted within two weeks)
* Uncontrolled hyperthyroidism
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System

A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.

A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Negative serum pregnancy test
* Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing.
* Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh
* Non-tobacco user
* Adequate venous access in the left or right arm to allow collection of a number of blood samples
* Fluent in the English language
* Provide written informed consent to participate in the study and be willing to comply with the study procedures

Exclusion Criteria:

* History within the previous 2 years of drug or alcohol dependence
* Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
* History of epilepsy or other neurologic disease
* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease
* History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides
* History of scleroderma or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
* Tattoos or birthmarks in the lateral thigh, abdominal area or arm (deltoid) that are large enough to restrict injection site selection and/or evaluation
* Positive screening test for HIV antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
* Positive results on illicit drug test at Screening or at Check-in
* Use of any prescription medication
An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer

This observational study is a follow-up study of protocol ML18280. Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.


Eligibility Criteria:
Inclusion Criteria:

* Patients who took part in and concluded study ML18280 according to protocol

Exclusion Criteria:

* N/A
Predictive Value of pCLE Findings in Pediatric IBD

Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients with established IBD

Exclusion Criteria:

* Any kind of allergy
* Bronchial asthma
* Liver or kidney disease
* Inability to sign informed consent
Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter

In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing middle ear surgery

Exclusion Criteria:

* History of cerebrovascular diseases
* Increased intracranial pressure
* History of ophthalmic surgery or diseases
MEASUREMENT of CIRCULATING MUTATION BURDEN

Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer

This proof-of-concept trial will be conducted with family members being monitored for a predisposition to breast and/or ovarian cancer linked to a BRCA1/2 gene mutation.

The study will be proposed to two sisters from the same sibling:

* one is a carrier of the genetic mutation
* and the other not,

Blood tests will evaluate the Mutation Burden cfMB

Eligibility Criteria:
Inclusion Criteria:

* Female participant
* Participant undergoing oncogenetic follow-up at the Centre François Baclesse
* Participant belonging to a pair of related biological siblings
* Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control).
* Participant between 30 and 50 years of age
* Participant affiliated to a social security scheme
* Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.

Exclusion Criteria:

-
Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus (according to product labelling)

Exclusion Criteria:

* Hypoglycaemia
* Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)
Effect of Extended Cannabis Abstinence on PTSD Symptoms

This will be a 12-week randomized trial. Outpatients and patients from the Mood and Anxiety program at the Centre for Addiction and Mental Health (CAMH) with a current diagnosis of post-traumatic stressed disorder (PTSD) and cannabis-use disorder (CUD) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 55 years (from both sexes \[or genders\]);
2. Diagnosed with CUD (moderate or severe) according to the Structured Clinical Interview for DSM-IV (SCID) (mode of cannabis consumption can be inhalation or ingestion);
3. Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
4. On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
5. Be able to provide written informed consent; and
6. Be able to communicate in English.

Exclusion Criteria:

1. diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
2. diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
3. current suicidality risk as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after the study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes" 34; and
4. have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).
Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia

This phase II trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. After treatment, stem cells are collected from the patient's blood and stored. Higher dose chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PRIMARY OBJECTIVES:

I. Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant.

SECONDARY OBJECTIVES:

I. Estimate the probability of transplant-related mortality (TRM) at 100 days following autologous stem cell transplant (ASCT).

II. Estimate probabilities of overall and disease-free survival. III. Assess if biological and molecular correlative studies can predict better outcome.

OUTLINE:

Patients receive targeted busulfan intravenously (IV) or oral (PO) every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.

After completion of study treatment, patients are followed up yearly for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* AML favorable or intermediate ELN risk
* Achieved true 1st complete response (CR) (absolute neutrophil count \[ANC\] and platelet count \> 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (MRD)
* No measurable residual disease (MRD) as assessed by flow cytometry after initial induction therapy
* Performance score Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
* Creatinine \< 2.0 mg/dl and calculated by Cockcroft-Gault (CG) formula or 24 hour measured creatinine clearance (CRCL) \> 50
* Not pregnant
* Received 1-2 courses of post remission "consolidation" therapy prior to mobilization PBSC
* No MRD by flow, cytogenetics, fluorescence in situ hybridization (FISH) and molecular testing prior to collection of autologous PBSC collection
* Plan is to collect at least 3 x 10\^6 CD34+ PBSC/kg cryopreserved; preference is 4-5 X 10\^6 CD34 cells/kg

Exclusion Criteria:

* Life expectancy is severely limited by diseases other than AML
* Total bilirubin \> 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) \> 2.5 x upper limit of normal (ULN)
* History of Gilbert's disease
* Uncontrolled arrhythmias, left ventricular ejection fraction (LVEF) \< 50% or corrected diffusion capacity of the lung for carbon monoxide (DLCO) \< 50%
* Significant active infection that precludes transplant
* Hepatitis B or C viremia at time of ASCT
* History of central nervous system (CNS) involvement with AML
Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)

To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.

Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Type 2 Diabetes Mellitus,
* random BG \> 200 mg/dL,
* willing and able to provide informed consent and to participate in diabetes self-management education (DSME)
* stable for discharge from the ED once hyperglycemia treatment initiated.

Exclusion Criteria:

* type 1 Diabetes Mellitus,
* diabetic ketoacidosis or hyperosmolar non-ketotic state,
* concomitant treatment with glucocorticoids (other than stable maintenance dose therapy),
* cognitive or physical impairment preventing participation in DSME
* unwillingness or inability to provide consent and/or attend follow-up visits.
Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease


Eligibility Criteria:
Inclusion Criteria:

* Established clinical history of chronic obstructive airways disease.
* Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
* Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values.

Exclusion Criteria:

* Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.

Exclusion Criteria:

-
Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.

Pliaglis is currently approved in the United States for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, and facial laser resurfacing.

This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain associated with postherpetic neuralgia (PHN).

The objectives of the study are 1) to compare the clinical efficacy of lidocaine and tetracaine cream 7%/7% with placebo cream in the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and 2) to monitor the nature and frequency of adverse events following a single, 60-minute application of lidocaine and tetracaine cream 7%/7% and placebo cream.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PHN.
* Painful PHN areas not located on the face, eye, or in the hair.
* At least 3 months post-vesicle crusting.

Exclusion Criteria:

* Has broken skin at the target treatment site.
* Is currently on certain prescription medications.
* Doesn't meet criteria due to physical exam findings or medical history.
* Female that is pregnant, breastfeeding, or of childbearing potential and not practicing adequate birth control.