cyrilzakka/clinical-trials huggingface dataset:
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of the age of 18 years or older
* Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
* Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
* Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
* Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study

Exclusion Criteria:

* Patient was treated with vemurafenib as part of a clinical trial or expanded access program
* Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
* Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study
Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer;
2. with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry;
3. breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy;
4. women aged from 18 to 70 years old;
5. required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
6. left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure;
7. Adequate bone marrow, with white blood cell ≥4.0×109 /L，neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L；
8. Serum creatinine ranges from 44 to 133 mol/L;
9. Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value;
10. bilirubin ≤ superior limit of normal value;
11. Expected survival ≥ 12 months;
12. pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year;
13. approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent.

Exclusion Criteria:

1. severe systemic infection;
2. being allergic or intolerant to apatinib, paclitaxel, cisplatin;
3. having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial;
4. uncontrolled hypertension, severe heart function;
5. researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.
Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on response when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls

Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on tumor progression when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls

DNA is constantly subject to damage from exposures including drugs (including chemotherapy), sunlight and aging. Certain genes in the human body help repair this damage (i.e. BRCA1 and other genes). The purpose of this study is to find out if BRCA1 protein expression has a role in response to chemotherapy drugs.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer and have formalin-fixed, paraffin embedded primary tumor available for testing BRCA1 protein expression
* Adults over 18 years of age
* Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1 prior to study registration.
* Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
* Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
* Have a ECOG performance status of 0 - 2
* Measurable disease by CT by RECIST 1.1 to evaluate response
* Adequate bone marrow function defined as platelets 100 X 109 cells/L, neutrophils 1.5 x 109 cells/L, white blood cells (WBC) 3.0 x 109 cells/L and a hemoglobin 90 gm/L
* Creatinine \< 1.5 mg/dl or creatinine clearance \> 40 ml/min
* Liver function tests (AST and or ALT) should be 2 x upper limit of normal (ULN, defined as per laboratory where blood testing is done), total bilirubin 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT 5 times the upper limit of normal is accepted)

Exclusion Criteria:

* Myocardial infarction within 6 months of registration
* Brain metastases unless documented to be controlled post completion of local therapy (surgery and/or radiation therapy) for at least four weeks prior to registration
* Pregnant or breast feeding women. Women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
* Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
* Her2 positive tumors as defined by FDA guidelines(3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by FISH, expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)
Comparison of Mulligan Mobilization Technique and Mckenzie Exercises Among Patient With Sacroilliac Joint Dysfunction

Comparison of Mulligan Mobilization Technique and Mckenzie Exercises Among Patient with Sacroilliac Joint Dysfunction

To determine comparison of mulligan mobilization technique and McKenzie exercises in patient with sacroiliac joint dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 65.(29)
* Both male and female and Pain in low back. (17)
* Pain in sacroiliac joint (PSIS) with or without radiating to buttocks.(30)
* With acute/subacute pain within 4-12 weeks of onset and at least three of four clinical tests positive.(14)

Exclusion Criteria:

* Midline pain in back, Lumber stenosis, Lumber radiculopathy, Spondylolisthesis, Disc related pain, Pregnant females with SIJD(29),Any lower limb pathology or hip fracture, Rheumatoid arthritis(17)
* History of any orthopedic surgery, and conditions such as ankylosing spondylitis.(14)
* Spinal leminectomy
* Arthodesis
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Major patients under the age of 70;
* Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer
* Radiotherapy completed for about 6 months
* Level of study 3 "end of primary studies" minimum (Barbizet scale);
* French mother tongue;
* Menopausal women for at least 1 year before the selection visit
* Absence of primary cancer of the central nervous system or brain metastases;
* Absence of previous neurological damage;
* Absence of personality disorders and progressive psychiatric pathology;
* Having signed the informed consent to participate in the study.

Exclusion Criteria:

* Primary cancer other than breast
* Metastatic cancer
* Treated by chemotherapy
* Cognitive function disorders pre-existing to cancer diagnosis
* Patients with paraneoplastic syndrome;
* Evolutionary psychiatric pathology;
* Refusal of participation;
* Patients unable to respond to cognitive tests;
* Drug use or excessive consumption of alcohol.
Intra-operative Neuromodulation of the Pelvic Plexus

The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).

Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.

The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.

The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for open radical prostatectomy procedure under total anesthesia.
* Age 40 to 75 years old.
* Able to read and understand patient information materials and willing to sign a written informed consent.

Exclusion Criteria:

* Have been diagnosed with severe vasculogenic erectile dysfunction.
* Have a prior history of pelvic surgery, trauma or irradiation therapy.
* Have a penile prosthesis.
* Have been diagnosed with neurologic diseases that may negatively impact erectile functions.
* Currently having an active implantable device (such as a pacemaker).
* Posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study.
* Inability to provide a fully informed consent.
Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease.

Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome.

The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with antisyntheatse syndrome according to Solomon criteria
Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200

RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

OBJECTIVES:

* Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.
* Compare the methylation results to clinicopathologic and molecular findings and survival.

OUTLINE: This is a multicenter study.

Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250.

PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the colon or rectum

  * Advanced disease
* Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin
* Tumor tissue blocks available
* Routine pathology specimens (i.e., blood, urine) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
PCI Imaging System in Pediatric Ophthalmology

The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA).


Eligibility Criteria:
* Exclusion Criteria:

  * Any patient who has a cloudy cornea.
  * Any patient whose RetCam imaging exam easily produces blanching of the optic nerve in the normal course of imaging.
  * Any patient who has consented to the procedure, but whose course of examination has filled the time allotted, leaving no time to evaluate the COSMOS.
* Inclusion Criteria:

  * Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.
Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities

The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.

Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations.

The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Age =\>70 years old
* Angina chest pain
* Troponin elevation
* At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR \<45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold\>2 or ambulatory oxigen therapy). Anemia (Hb =\<11 g/dl)

Exclusion Criteria:

* Dynamic ST changes (=\>1 mm) in the initial ECG
* Prior known non-revascularizable coronay disease
* Concomitant heart disease different to coronary disease
* Life expentancy \< 1 year
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus

This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.

This study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes were measured at baseline, 2 months and 6 months.

The results were that the Lycopene with scaling and root planing group gave:

Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months respectively.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes

* Patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months
* Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines
* Minimum of 15 natural teeth
* At least four teeth with one or more sites with probing depth (PD) greater than or equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and bleeding on probing (BOP).

Exclusion Criteria:

History of antibiotic therapy within the previous 6 months

* History of anti-inflammatory drugs within the previous 3 months
* Pregnancy and lactation
* Use of contraceptives or any other form of hormone
* Usage of tobacco and tobacco related products
* Periodontal treatment within 12 months.
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon.

The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults.

The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 12 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 11%.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. History of pheochromocytoma or insulinoma (glucagon could induce a hormonal response of these tumors)
4. Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
5. Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
6. Chronic acetaminophen treatment (can interfere with glucose sensor measurements)
7. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
8. Anticholinergic drug (risk of interaction)
9. Pregnancy.
10. Severe hypoglycemic episode within two weeks of screening.
11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
12. Known or suspected allergy to the trial products
13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
14. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
15. Treatments that could interfere with glucagon
From Cytotrophoblast to Syncytiotrophoblast

A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.The aim of this study is to compare telomere length, aggregate formation, and senescence markers in placentas from complicated pregnancy with placentas from normal pregnancy.

Protocol summary No. 2 for research 0202-14 of date: 22/11/2014. Rationale for the research A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.

The aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy.

Telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere FISH.

Senescence will be assessed by immunohistochemistry for the markers - SAHF, cyclin dependent kinase inhibitors p16/p21, HLAX, ERVWE1, SA-B-gal.

The study groups

1. A retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies.
2. The prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . Will be compared to placentas of normal pregnancies.
3. A laboratory model based on human placenta cell cultures

Eligibility Criteria:
Inclusion Criteria:

* placentas from normal and complicated pregnancy

Exclusion Criteria:

* women consent