cyrilzakka/clinical-trials huggingface dataset:
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

To determine feasibility of recruitment and tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.

The current study will test the hypothesis that among adult age survivors of cancer diagnosed at age \< 39 years treatment of Stage B heart failure with sacubitril-valsartan is feasible and safe.

Eligibility Criteria:
Inclusion Criteria:

* Age \</= 39 years old at time of cancer diagnosis
* Clinical records adequate to determine diagnosis and treatment regimen
* Previous anthracycline chemotherapy
* Global longitudinal strain \<18% and/or
* L VEF below the institutional lower limit of normal but \>/=40% on echocardiogram or cardiac MRI
* No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Exclusion Criteria:

* -Age \<18 years
* Inability to obtain consent from patient or legally authorized representative
* Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions
* Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures
* Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
* Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy
* Severe kidney disease (GFR \<30 mL/min/1.73m2)
* Chronic hyperkalemia (\>5mmol/L)
* Evidence of COVID-19 within the last 60 days or recent (21 days) exposure to close personal contact with COVID-19.
* Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy
* Hemodynamically significant congenital heart disease in the opinion of the investigator (not including PFO/small ASD or small VSD)
* Greater than moderate pericardial effusion
* Constrictive cardiomyopathy diagnosed pre-cancer therapy
* Family history of genetic cardiomyopathy
* Evidence of infiltrative cardiomyopathy
* Symptomatic heart disease based on NYHA classification
* Allergy to valsartan or sacubitril
* Inability to complete CMR or 6-minute walk test
* Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting
* Pregnant/lactating
* History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast)
* Concomitant use of other ACE inhibitors or ARBs, aliskiren, NSAIDs or lithium or the inability to stop these medications for the study
Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

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 different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.

OBJECTIVES:

* Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide, doxorubicin, and vincristine.
* Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
* Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age (under 1 month vs over 1 month).

Infants less than 1 month of age are further stratified according to Philadelphia score (less than 1 vs at least 1). Infants over 1 month of age are also further stratified according to Philadelphia score (less than 2 vs at least 2).

Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only. Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy.

* VP-CARBO chemotherapy: Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients with no response receive CADO chemotherapy.
* CADO chemotherapy: Patients receive cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for a maximum of 4 courses.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed stage IV or IVS neuroblastoma or ganglioneuroblastoma

  * Metastases confined to marrow, skin, nodes, or liver

    * No metastases to bone (radiologic bone lesions in skeleton), CNS, pleura, or lung
* No MYCN amplification (i.e., fewer than 10 copies)

PATIENT CHARACTERISTICS:

Age:

* Under 12 months at diagnosis

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

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.

Two arms:

1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)
2. control group (without atorvastatin pre-treatment, chronic statin treatment)

Primary endpoint:

Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)

Secondary endpoint:

Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

Eligibility Criteria:
Inclusion Criteria:

* Indication for percutaneous coronary intervention
* Informed consent
* Chronic statin therapy

Exclusion Criteria:

* Acute coronary syndrome in last 14 days
* Renal insufficiency (creatinine more 150 umol/l)
* Diseases severely limiting prognosis
* Previous participation in this study
* Chronic occlusion of the coronary artery, bypass intervention, left main intervention
* Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.

Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient must comply with follow-up evaluations
* Patient or representative must provide informed consent prior to enrollment
* Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
* Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location

Exclusion Criteria:

* Crohns disease
* Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
* Patients who have not had mechanical bowel preparation
* Patients with known documented sensitivity/allergy to bovine material
* Severe radiation damage to tissue
* Carcinomatosis or stage IV cancer
* BMI is 35 or greater
* Cancer at primary anastomosis site that cannot be excised
* Patients who require an ileo rectal anastomosis
* Surgery anticipated to include jejunostomy pouch
* Anticipated diverting stoma
* No anti adhesive barrier can be used around anastomotic site
* No multiple circular anastomosis
* Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis
* Patient life expectacny less than follow-up timeframe of study
* Pregnancy
* Patients currently enrolled in a study that competes for the same patient population
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

The objective of this study is to explore safety and tolerability of multiple oral doses of ASP015K in healthy volunteers.

Subjects will be confined to the clinical research unit for 19 days. Subjects will receive a follow-up phone call to asses safety 1 to 5 days after being discharged from the study.

Subjects will receive study drug twice per day (BID) on days 1 to 13 of the 14 day treatment period, and will receive a single dose of study drug on the morning of day 14 of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
* Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
* Subject's fasting clinical laboratory values are within normal limits
* Subject is a non-smoker or a light smoker (\< 10 cigarettes/day)
* Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2

Exclusion Criteria:

* Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
* Subject is known positive for human immunodeficiency virus (HIV) antibody
* Subject has a history of severe allergic or anaphylactic reactions
* Subject has a history of chronic diarrhea
* Subject has been vaccinated within the last 60 days prior to study drug administration
* Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
* Subject has had clinically significant illness within 1 month prior to study drug administration
* Subject has a history of hemorrhoids
* Subject has a positive guaiac test
* Subject has a history of drug or alcohol abuse, a positive urine or serum screen for drugs of abuse/illegal drugs, or positive blood or breathalyzer for alcohol
* Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
* Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
* Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)

The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.

Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women.

The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.

Eligibility Criteria:
Inclusion Criteria:

* HIV uninfected
* General good health
* Sexually active
* Agree to use an effective method of contraception
* Normal Pap smear result within 12 months prior to study entry
* Agree to not participate in other drug or device research studies for the duration of study participation
* Agree to not use any intravaginal product for the duration of study participation

Exclusion Criteria:

* History of adverse reaction to silicone, latex, or titanium dioxide
* Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
* Last pregnancy outcome within 30 days or less prior to enrollment
* History of hysterectomy
* Any abnormal pelvic exam finding
* Pregnant
* Condition that, in the opinion of the investigator, would interfere with the study
* Severe pelvic relaxation
Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol

1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma

This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen.

The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.

Eligibility Criteria:
Inclusion Criteria:

* The subject is of age 18\~65, both male and female;
* Newly pathologically diagnosed with classical Hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment;
* Had stage IIB, III or IV disease, as assessed by the Ann Arbor classification;
* ECOG≤2, life expectancy ≥3 month;
* A negative serum pregnancy test required for sexually active women of childbearing potential;
* The subject voluntarily gives written informed consent to participate in the study.

Exclusion Criteria:

* Hematopoietic function:

  * Leukocyte \<3,500/mm3（3.5×109/L）
  * Neutrophils \<1,500/mm3（1.5×109/L）
  * Platelets \<100,000/mm3（100×109/L）
* Intolerance to any of the active ingredients and/or excipients in the study medications;
* Severe central nervous system disorders and mental illness;
* Severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). Echocardiography showed resting left ventricular ejection fraction (LVEF) \< 50%);
* History of severe lung disease;
* AST or ALT\>2.5×ULN，total bilirubin≥1.5×ULN，serum creatinine\>1.5×ULN (for subject with liver metastases: AST or ALT\>5xULN, total bilirubin ≥ 3xULN);
* Uncontrolled, systemic, active infection；
* Positive serology to HIV;
* HBsAg positive subjects can still be enrolled in the study, but researchers should follow "The consensus on the Treatment of Lymphoma with Hepatitis B Infections" to observe closely and/or provide prophylactic anti-HBV therapy (as per investigator's decision);
* Other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ;
* The subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening;
* The subject is pregnant or lactating; or subjects of childbearing potential (both women and man subjects) do not want to take effective contraceptive measures during study period or within 3 months after study completes;
* Investigators believe subjects not suitable to participate in the study for other reasons.
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.


Eligibility Criteria:
Key Inclusion Criteria:

To be eligible, a participant is required to be or have:

* Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.

Key Exclusion Criteria:

Subjects meeting any of the following criteria:

* The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
* Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
N-acetylcysteine and NMDA Antagonist Interactions

This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Ages of 21-45 years from all ethnic backgrounds.
* Male or female.
* Written informed consent.

Exclusion criteria

* DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
* A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test) .
* History of severe allergies or multiple adverse drug reactions.
* Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures.
* Any other conditions which in the opinion of the investigator would preclude participation in the study.
* History of major psychiatric disorder in first degree relatives.
* Current substance abuse/dependency determined by urine toxicology.
* Current treatment with medications with psychotropic effects.
* Treatment with benzodiazepines within one week prior to testing.
* Current pregnancy, unsatisfactory birth control method report for females.
* Education \< 10th grade.
* IQ \< 70, MR as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.
Corneal Protect Used During Cataract Surgery

This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.

This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.Over 100 patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject will accept 5 times assessments:the day before surgery, surgery day , the day after surgery,a week after surgery and a month after surgery.Each time a subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire et.al.The purpose is to evaluate the effect of Cornea Protect to maintain intraoperative clarity and to prevent the postoperative xerophthalmia.

Eligibility Criteria:
Inclusion Criteria:

* with cataracts;
* aged 40 to 85 years old, gender not limited;
* plans to accept PHACO and intraocular lens(IOL)implantation surgery
* the lens nucleus hardness level is less than 3 ;
* signed informed consent.

Exclusion Criteria:

* allergic to any of the drugs or device in this study ；
* existence of other infectious diseases or allergic conjunctivitis.
* the eye had been chemical burned or thermal burned
* diagnosed as Stevens Johnson syndrome or eye-pemphigoid.
* diagnosed with glaucoma or high intraocular pressure;
* existence of eyelid and lacrimal duct disease;
* received any eye surgery in 3 months;
* wearing corneal contact lens;
* history suggests there are serious heart, lung, liver or renal function disorder;
* pregnancy or lactation women;
* Other conditions considered not appropriate by the investigators.