cyrilzakka/clinical-trials huggingface dataset:
GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients


Eligibility Criteria:
Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.
Effect of Rose-colored Glass on Mood

Decades of psychological research has highlighted the impact of visual perception on mood and happiness. The investigators hypothesized that literally seeing the world through rose colored glasses may have an effect on perception, mood, and happiness. After cataract surgery, which classically increases the vividness of perceived colors, patients report significant satisfaction. The investigators therefore sought to explore whether using pink colored lenses leads to a measurable impact on outcomes.

A randomized controlled clinical trial design will be performed. Subjects will be randomized for either pink lenses (treatment group) or clear lenses (placebo group).

Subjects will be asked to wear the assigned glasses throughout the day during the course of the trial. Glasses will not be work while driving at night.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age.

Exclusion Criteria:

* Subjects who wear glasses on a regular basis.
Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)

The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS).

For this study, you will be asked to take part in a personal or mail interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. Treatment information from your medical records at M. D. Anderson will also be collected.

You will be asked to provide a saliva sample or have around 1 tablespoon of blood drawn for special tests. These tests will look for biologic factors associated with treatment-related AML/MDS.

Your participation in this study will be over once the interview has been completed and blood or saliva have been collected.

This is an investigational study. Up to 600 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Willing and able to provide written informed consent and authorization
3. Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
4. A histologically confirmed diagnosis of AML or MDS (cases only)
5. A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
6. Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)
7. Treated for a primary malignancy at MDACC (controls only)
8. Matched to cases (2:1) by cases' prior malignancy(site, treatment (chemo and/or radiation), year of diagnosis (+/- 3 years)), age (+/- 5 years), sex, and ethnicity. (controls only)

Exclusion Criteria:

1. Under 18 years of age
2. History of second primary malignancy (controls only)
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

To assess safety and efficacy of ONYX treatment for cAVM:

The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:

* 12 months post last embolization in case of treatment with embolization only
* 12 months after additional treatment with neurosurgery
* 36 months after additional treatment with radiosurgery

Eligibility Criteria:
Inclusion Criteria:

* The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
* The patient is at least 6 years old.

Exclusion Criteria:

* During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
* The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
* Any condition that could prevent follow-up of the patient.
Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University Hospital in order to reach the optimum technique for our locality

Hysterectomy is the surgical removal of the uterus. It is the commonest major gynecological surgery, next to caesarean section, with millions of procedures performed annually throughout the world.Approximately 90% of hysterectomies are performed for benign conditions.

Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. The optimal route of hysterectomy for a patient will depend on the pathological nature, size and shape of the vagina and uterus, uterine descent, endometriosis and the likelihood of pelvic adhesions, adnexal masses, previous pelvic surgery, available hospital technology, devices and the surgeon's preference.

Approaches to hysterectomy may be broadly categorized into four options: abdominal hysterectomy (AH); vaginal hysterectomy (VH); laparoscopic hysterectomy (LH) where at least some of the operation is conducted laparoscopically and robotic-assisted hysterectomy (RH).Vaginal and laparoscopic procedures are considered "minimally invasive" surgical approaches because they do not require a large abdominal incision and, thus, typically are associated with shortened hospitalization and postoperative recovery times compared with open abdominal hysterectomy.

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy, using bipolar vessel sealer, in cases of abnormal uterine bleeding in order to reach the optimum technique with lower cost to be easily applied to low resource settings.

Eligibility Criteria:
Inclusion Criteria:

* Women assigned for performing hysterectomy for abnormal uterine bleeding due to benign pathology.
* Uterine size by bimanual examination ≤14 weeks gestational size.
* Cases with uterine volumes ≤ 400cm3 will be included in this study.

Exclusion Criteria:

* Patients with BMI \> 30kg/m2
* Uteri \> 14 weeks gestational size by bimanual examination or volume \> 400cm3
* Women with positive pap smear for CIN or endometrial biopsy with atypia or carcinoma.
* Patient with other known body malignancy.
* Patient with other pelvic pathology, endometriosis or pelvic abscesses.
* Patients with abdominal scars.
Dendritic Cell Based Therapy for Breast Cancer Patients

The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Only patients who have tumors \> 5 % positive for p53 by IHC can be referred to this treatment. All patients will receive standard dosage of AI +/- p53-DC vaccination. Patients who express HLA-A2 will also receive DC vaccination. Patients that do not express HLA-A2 will receive only AI and be regarded as controls.

The vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6) with p53 peptide-pulsed dendritic cells, followed by monthly injections until progression; proleukin and Zadaxin are used as vaccine adjuvants.

Defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and loaded with p53 peptides. Frozen preparations of dendritic cells will be prepared using automated cryopreservation.Each patient will receive a minimum of 5x10\^6 dendritic cells per treatment supplemented with interleukin-2 6 MIU/m² sc per vaccine and 1.6 mg Thymosin 1 alpha sc x 2/week.

Toxicity including autoimmunity will be evaluated using the common Toxicity Criteria (CTC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy.
* Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age \>18, PS ≤ 1 and acceptable CBC and blood chemistry results

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)
* Patients with metastatic disease in the central nervous system
* Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure
* Patients with acute or chronic infection including HIV, hepatitis og TB
* Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial
* Patients who received corticosteroids or other immunosuppressive agents
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis
* Severe hypercalcemia
Invasive Left Heart Catheterization Registry

Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure.

Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF develops from a complex interaction of several risk factors such as aging, obesity, hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and, ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea, diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate the role of invasive left heart catheterization with the measurement of left ventricular end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.

Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction \> 50%
* Patients who had a symptom and/or signs of heart failure (dyspnea on exertion, chest discomfort, fatigue, dizziness, or ankle edema)
* Patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Acute coronary syndrome
* More than moderate valvular heart disease
* Primary cardiomyopathies such as dilated cardiomyopathy and hypertrophic cardiomyopathy, amyloidosis
* Pulmonary arterial hypertension
* Heart transplantation
* Constrictive pericarditis
* Stress-induced cardiomyopathy
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
* between 37 and 42 weeks gestational age
* maternal age of 18 years or greater

Exclusion Criteria:

* Parturients with pre-eclampsia
* History of pregnancy induced hypertension
* Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
* Patients with non reassuring fetal heart rate tracings prior to placement of the CSE
SportsPro: Post-Market Clinical Follow Up Study

Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

The purpose of this study is to leverage standard of care data to provide further characterization of clinical outcomes following shoulder, hip and knee joint surgeries.

* Primary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 6 months after surgical intervention.
* Secondary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 3 months after surgical intervention.
* Safety Objective: To describe safety of the Stryker implants in the shoulder, hip, and knee joints 6 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Subject was ≥ 18 years of age at the time of the surgery
2. Subject has undergone joint space repair using one of the study devices

Exclusion Criteria:

1. Subjects who are less than 6 months post-intervention
2. Concurrent participation in an investigational clinical study during the study period
Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.

Primary aim:

To define the maximum tolerated dose of the combination of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first- line treatment in patients with HER2-positive advanced gastro-esophageal cancer.

Secondary aims:

Estimating response-rate, progression free survival and overall survival

Methods:

This dose-finding study is planned to include 15 patients with HER2 positive gastro-esophageal cancer, adenocarcinoma. Patients will be included in cohorts of three at progressively higher dose levels.

Chemotherapy will be repeated day 1 every third week to a maximum of eight cycles. Treatment with trastuzumab will continue until disease progression. Dose-limiting toxicity (DLT) will be evaluated after the first cycle. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continued if 0/3 or 1/6 patients experience DLT.

Patients will be evaluated with a ct- scan at baseline and after every three cycles to exclude progression and evaluate response. Response is assessed by investigators according to RECIST version 1.1.

Blood counts regarding tumour biology will be collected at baseline before 2nd, 4th and 7th cycle and 4 weeks after ended treatment. After completion of treatment patients will be followed every third month until progression or death.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease
2. HER2-positive tumor tissue (IHC 3 + or FISH positive)
3. LVEF \> 50 % (MUGA scan or echocardiography)
4. Age ≥ 18 years
5. No prior chemotherapy
6. WHO performance status 0-1
7. Life expectancy of at least 3 months
8. Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
9. Bilirubin ≤ 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL. In case of liver metastases no UNL for ASAT and ALAT
10. Creatinine clearance ≥ 50 ml/min. Calculated with the Cockroft-Gault formula
11. No neuropathy
12. Planned treatment start within 8 days after inclusion

Exclusion Criteria:

1. Patients who cannot complete treatment or evaluation
2. Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study
3. Known hypersensitivity towards any of the study drugs
4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer
5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)
6. Pregnant women or nursing women
7. Physical or mental conditions which may prevent absorption of oral treatment
Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)

Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom population; it is an autoimmune disease where the body's natural defences (the immune system) attack the body itself resulting, most notably, in joint damage and arthritis. To help prevent this, patients with rheumatoid arthritis need to take disease-modifying anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug treatments are prescribed as long-term medications taken for many years.

With successful drug treatment, many patients are able to achieve an excellent control of their disease and their arthritis can go in to remission. At present, there are no markers which can reliably predict which of these patients can reduce their drug treatment, and hence benefit from a lower risk of side effects and inconvenience, without an increase in their arthritis activity.

We invite patients with stable rheumatoid arthritis to participate in this study conducted by Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle University and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being in remission will be able to stop their DMARD medication and be monitored for a period of 6 months. Patients whose arthritis activity increases during this time will be able to restart their DMARD medication, whereas those patients whose arthritis remains in remission will be able to stay off DMARD medication.

The main aim of this study is to identify clinical, ultrasound and blood markers that can predict which patients will remain in remission after stopping DMARD medication. If identified, these markers could be a useful guide to doctors and patients in the future when deciding whether to stop DMARD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis made by consultant rheumatologist at least 12 months previously
* Current single or combination use of methotrexate, sulphasalazine and/or hydroxychloroquine
* Arthritis currently in remission, as judged clinically by referring healthcare professional
* Willing to consider DMARD withdrawal

Exclusion Criteria:

* Use of biologic therapy within the past 6 months
* Received steroids within past 3 months (enteral, parenteral or intra-articular)
* Use of any DMARD other than methotrexate, sulphasalazine or hydroxychloroquine within the past 6 months (or past 12 months for leflunomide)
* Current pregnancy, or pregnancy planned within next 6 months
* Current participation within another clinical trial
* Inability to provide informed consent