cyrilzakka/clinical-trials huggingface dataset:
Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.

Eligibility Criteria:
Inclusion Criteria:

* Femal patient aged \> 18 years
* Histologically proven breast adenocarcinoma
* HER2 negative receptors
* previously received first or second line chemotherapy for metastatic disease
* previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
* presence of one or several evaluable metastatic lesion(s)
* presence of at least one target lesion not previously irradiated
* previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study)
* ECOG Performance status \< 2
* adequate biological values
* patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
* patient with only local metastatic disease (with the exception of axillary lymph nodes)
* active symptomatic brain metastasis
* patient with an history of significant cardiovascular impairment (congestive heart failure\> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
* peripheric neuropathy grade ≥ 2
* history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin)
* patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
* patient with a known allergy to one or several of the study compounds
* patients who may not be regularly available due to geographical, social or family reasons
* history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
* deficiencies of the upper intestinal tract, malabsorption syndrome
* patient who is pregnant, breast-feeding or using inadequate contraception
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.

Eligibility Criteria:
Inclusion Criteria:

* age from 18-50 yeas old, male or female, course of disease is within one year;
* good heart, liver and kidney function;
* with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
* no significant damage existing in the skin and soft tissue in the operative region
* have signed the informed consent form
* good adherence and willing to return for follow-up visits as required.

Exclusion Criteria:

* with acute or severe infection
* suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
* with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
* with family history of genetic
* allergic to collagen and chitosan
* pregnancy and lactating women
* serious damage existing in the skin and soft tissue in the operative region
* bad adherence and can not return for follow-up visits on time as required
Water Uptake for Health in Amhara Pilot

Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.


Eligibility Criteria:
Inclusion Criteria:

* All residents residing in the state-teams which are randomly selected for this study.

Exclusion Criteria:

* Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
The Effects of Nutritional Supplementation and Drug Abuse on HIV

The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.

Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.

This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* CD4 count greater than 350 cells/mm3
* Identified from the Infectious Disease Care Clinic
* Body mass index greater than 18 for women and greater than 18.5 for men

Exclusion Criteria:

* Current AIDS-defining condition
* Currently participating in another clinical trial
* Pregnant or intends to become pregnant during the study
Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors

This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma associated heart disease compared to a stress echocardiogram. By doing both stress echocardiography and cardiac MRI, we will compare the ability of the two tests to detect heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Classical or nodular lymphocyte predominant HL treated at Memorial Sloan-Kettering Cancer Center.
* Age ≥ 18 years
* Treatment for HL that included mediastinal RT at initial diagnosis or relapse.
* ≥ 5 years from last HL treatment.

Exclusion Criteria:

* Primary HL diagnosis prior to 1980.
* Additional mediastinal RT or subsequent cardiotoxic systemic therapy for secondary malignant neoplasm.
* Known CAD/CHF (defined as documented myocardial infarction, cardiac revascularization, angiographic obstructive CAD, or decreased LV function \[EF \< 55%\] during prior clinical care).
* Contraindication to MRI (i.e. pacemakers, defibrillators, or aneurysm clips, or other implanted ferromagnetic objects), gadolinium (i.e. known hypersensitivity to gadolinium, advanced renal insufficiency as defined by glomerular filtration rate \<30 ml/min/1.73m\^2).
* Contraindication to exercise stress testing other than the above (i.e. unstable angina or severe valvular stenosis).
Use of Fenofibrate for Primary Biliary Cirrhosis

This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
* Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
* Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
* Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
* Signed informed consent after careful review of the information and study details by one of the investigators

Exclusion Criteria

* Hypersensitivity to fenofibrate
* Prisoners and institutionalized subjects
* Pregnant or nursing women
* Anticipated need for liver transplantation in one year (estimated one year survival \< 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
* Recipients of liver transplantation
* Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
* Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
* Acute or chronic renal failure
* Known history of cholecystitis with intact gallbladder
* Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity
Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (CISC) by means of an instructional video and those who do not receive specific preoperative instruction in CISC, other than basic informed consent regarding risks of postoperative urinary retention.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the DIvision of Urogynecology, Department of Obstetrics and Gynecology at Magee Womens Hospital.

Exclusion Criteria:

* Subjects who have performed CISC in the past will be excluded.
* Subjects whose score on the MMSE reflects dementia (\<24) will be excluded.
* Subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded.
* Subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.
Study of Hair Samples From Patients With Cancer

RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at hair samples from patients with cancer.

OBJECTIVES:

* Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer.
* Correlate changes in protein expression with expected changes based on planned therapy in these patients.

OUTLINE: This is a pilot, multicenter study.

Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT.

PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of malignancy
* Undergoing treatment at the National Cancer Institute's Clinical Center
* Must have scalp hair

PATIENT CHARACTERISTICS:

Age

* 18 and over

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
Diet, Exercise and Body Fat in 3-5 Year Olds

To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.


Eligibility Criteria:
Inclusion Criteria:

* 3-5 year old children
* Full term at birth
* English as primary language
* Weighed at least 5.5# at birth
* Parent or guardian is at least 18 years of age

Exclusion Criteria:

* Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD
* Child on any medication thought to interfere with study parameters as determined by the investigator
Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.


Eligibility Criteria:
Inclusion Criteria

* Patients with a Karnofsky (or equivalent) performance status \> 60 and an expected survival of \> 2 months
* Patients agreeing to use a medically effective method of contraception
* Patients able to understand and give written informed consent
* The center of the tumor mass must be \< or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. This is required for optimal retention of MTC-DOX by the magnetic field. If more than one tumor mass is present, all of the treated tumor masses must meet this criterion

Exclusion Criteria

* Women who are pregnant or lactating
* Patient's with metastatic liver cancer, or other primary liver cancer excluding HCC, with diffuse disease that does not have focal area(s) conducive to local regional therapy
* Patients with the following laboratory abnormalities:Hemoglobin \< 10.0 g/dL;Granulocyte count \< 1,500 per mm3;Platelet count \< 50,000 per mm3; Lymphocyte count \< 0.5 x 10 to the 9th per L; Total bilirubin \>/= 3.0 mg/dL;AST or ALT \>/= 5x the upper limit of normal;INR \>/= 1.3; Creatinine \>/= 2.0 mg/dL
* Patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. Patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded.
* Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet
* Patients at the time of study entry with a second invasive cancer other than basal cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
* Patients with documented evidence of hemachromatosis or hemosiderosis
* Patients with CT or ultrasound evidence of portal vein invasion or thrombosis
* Patients who have had prior anthracycline therapy with a left ventricular ejection fraction (LVEF) \<50%, as measured by either multigated radionuclide angiography (MUGA) scan or echocardiogram.
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

This observational study will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed. Data will be collected via an audit of electronic medical charts. The primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. Secondary objectives include subgroup analyses, including by bleed location. Potential differences between patients treated with andexanet alfa versus 4F-PCC, and potential differences in patient characteristics over time, will be assessed. If this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.

Eligibility Criteria:
Inclusion Criteria:

* ICD-10-CM diagnosis code of D68.32 (Hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission
* Taking either an oral FXa inhibitor or enoxaparin at the time of hospitalization for their bleeding event
* Treated with either andexanet alfa or 4F-PCC during the hospitalization for their bleeding event
* Had documented discharge disposition

Exclusion Criteria:

* Less than 18 years old
* Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event
Radiofrequency-assisted Liver Resection in Intractable Liver Cancer

In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors.

The primary clinical treatment of liver cancer is surgical resection, although many integrated applications develop rapidly, surgery is still the best way to remove the tumour lesion. Traditional ways that have curative removed tumours in three methods, which are liver resection, liver transplantation and radiofrequency ablation (RFA).

As for primary liver cancer, surgery, and RFA are both effective and safety, but for the complexity of end-stage liver cancer, surgical resection may not remove the tumours alone. Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient liver tissue, reduce operation damage, reduce the incidence of complications, and improve patients quality of life after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was confirmed to be liver cancer, no pathological results according to China 's 2017 version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line with the standard clinical diagnosis of liver cancer
* According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C (stage C: single tumour\> 5 cm or more than three tumours, and at least one tumour\> 3 cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2 points)

Exclusion Criteria:

* HCC patients with other malignant tumours
* Metastatic liver tumour
* Patients with liver abscess
* Patients with organ dysfunction
SCMC Trial on KHE With KMP (V.2020)

a phase I trial focusing on safety and efficacy of prednison shock plus sirolimus maintenance in treating Kaposiform hemangioendothelioma (KHE) with Kasabach-Merritt phenomenon (KMP)


Eligibility Criteria:
Inclusion Criteria:

* Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon
* 0 - 12 years of age at the time of study entry
* Male or female
* Consent of parents (or the person having parental authority in families)
* Signed and dated written informed consent

Exclusion Criteria:

* with hematological diseases
* with other solid tumors
* with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney
* dysfunction, and cardiopulmonary insufficiency
* with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment