Kornimate/medical-research-clean huggingface dataset:
oncologic safety of sentinel lymph node biopsy in clinically palpable axillary lymph node in breast cancer patients

Conditions: Sentinel Lymph Node Biopsy

Summary: evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.

breast cancer is the most common type of cancer in females and the 3rd leading cause of cancer mortality. one of the important aspects of breast cancer management is axillary staging and the status of axillary lymph nodes is an important prognosticator that affects adjuvant treatment decisions in patients with early breast carcinoma. sentinel lymph node biopsy (slnb), is considered to be the standard of care for node negative breast cancer, as it can save patients from the complications of axillary lymph node dissection (alnd). these complications include lymphedema, arm stiffness, and neuralgia, all of which significantly affect the patient's quality of life and raise healthcare costs. it also allows accurate axillary staging with minimal morbidity. oncologic outcomes in terms of disease-free survival, overall survival, and locoregional recurrence rate were similar in the slnb alone versus the alnd group in patients with clinically node-negative axilla. in doing the slnb, a combination of radioactive technetium-99m and blue bye technique is preferred to increase the sln identification rate than using one technique in isolation. the rationale for performing upfront slnb as routine for patients being treated for breast cancer should be challenged, for this our study aiming for evaluation of the role of sentinel lymph node biopsy in management of breast cancer.

Eligibility criteria:
inclusion criteria: 1. age more than 18 years. 2. fit for surgery. 3. patients with no previous breast surgery. . exclusion criteria: 1. patients less than 18 years. 2. patients unfit for surgery . 3. patients with advanced breast cancer. 4. patients with previous breast surgery.

Keywords: breast cancer
dzd8586 in patients with relapsed or refractory diffuse large b-cell lymphoma (tai-shan9)

Conditions: Diffuse Large B Cell Lymphoma

Summary: this study will treat patients with dlbcl whose disease comes back or is not responding to prior therapy. this study will assess the anti-tumor activity of dzd8586 as monotherapy. it will help to understand what type of side effects may occur with the drug treatment. it will also measure the levels of drug in the body.


Eligibility criteria:
inclusion criteria: participants who meet all the following criteria: 1. male and female ≥ 18 years of age. 2. ecog performance status 0-2. 3. histologically confirmed recurrent or refractory dlbcl. 4. adequate bone marrow reserve and organ system functions. 5. willing to comply with contraceptive restrictions exclusion criteria: participants who meet any of the following criteria: 1. cns involvement 2. stem cell transplantation, cell therapy, or gene therapy within 90 days. approved small molecule therapy within 5 half-lives. monoclonal antibodies and antibody-drug conjugates within 28 days. 3. major surgery or significant traumatic injury within 4 weeks. live attenuated vaccines or viral vector vaccines within 4 weeks. 4. take vitamin k antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. take proton pump inhibitors or strong cyp3a inhibitors or inducers. 5. active infection. 6. clinically significant cardiac disorders. history of thrombotic diseases, stroke or intracranial hemorrhage within 6 months. 7. nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption. 8. another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. 9. women who are breast feeding. 10. history of hypersensitivity to active or inactive excipients of dzd8586 or drugs with a similar chemical structure or class.
feasibility study - neofact

Conditions: Respiratory Distress Syndrome in Premature Infant; Surfactant Deficiency Syndrome Neonatal

Summary: for therapy of respiratory distress syndrome (rds) in premature babies, there are several established options. an important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung. in the recent years, several methods have been developed. the methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. continous positive airway pressure (cpap)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization). in selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via cpap. while this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side. in the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the cpap therapy. in this study, a newly developed and in the european community now certified (ce-mark) application aid (neofact) will be tested for the first time on preterm infants, to verify the feasibility.


Eligibility criteria:
inclusion criteria: * preterm infants with respiratory distress syndrome and the need for surfactant administration (oxygen requirement with fio2 ≥ 30% and/or mod. silverman andersen respiratory severity score (rss) ≥ 5) * respiratory support with non-invasive cpap at the time of surfactant administration exclusion criteria: * preterms with an gestational age \< 26+0 weeks * preterms with malformations of the respiratory tract * clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder * (missing parental consent) * (attending physician is not delegated by the principal investigator)

Keywords: respiratory distress syndrome less invasive surfactant administration neofact preterm babies
evolution and treatments of chronic inflammatory systemic diseases

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; Arthritis, Rheumatoid; Spondyloarthritis; Psoriatic Arthritis; Psoriasis; Verneuil's Disease

Summary: patients with chronic inflammatory diseases (cid) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. the pathologies concerned are inflammatory bowel diseases (ibd - crohn's disease \[mc\] and ulcerative colitis \[rch\]), chronic inflammatory skin diseases (psoriasis or verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis \[ra\] and spondyloarthritis \[spa\] including psoriatic arthritis \[psa\]). presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. an association of extra-articular manifestations is observed in 10 to 30% of patients with spa, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with ibd. no common database for chronic systemic inflammatory diseases currently exists in france.


Eligibility criteria:
inclusion criteria: * patients treated for ibd (mc, uc or indeterminate colitis) in the gastroenterology department of besançon university hospital * subject meeting the clinical, morphological and histological diagnostic criteria for mc, uc or indeterminate colitis or * patients treated for chronic inflammatory rheumatism (ra, spa, psa) in the rheumatology department of the university hospital of besançon subject meeting the acr 2010 classification criteria of ra or modified new york criteria of ankylosing spondylitis or asas criteria of axial or peripheral spa or caspar criteria of psa or * patients treated for chronic inflammatory skin disease (psoriasis, verneuil's disease) in the dermatology department of the university hospital of besançon exclusion criteria: * opposition of the patient * patients in emergency situation, persons deprived of their liberty, protected minors or adults.
a comparative study of the efficacy of transcatheter arterial chemoembolization (tace) and transcatheter arterial pegylated interferon embolization (taie) for liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: primary: to compare the efficacy of tace and taie. secondary: to compare the side effects of tace and taie. the outcome measurements include survival benefit and tumour regression induced by the two therapies.


Eligibility criteria:
inclusion criteria: * confirmed hepatocellular carcinoma not suitable for surgery exclusion criteria: * portal vein thrombosis * severe arteriovenous shunt * bilirubin level \> 50 umol/ml * prothrombin time \> 5 seconds

Keywords: hepatocellular carcinoma
safety study of amg 557 in subjects with lupus arthritis

Conditions: Lupus Arthritis, Systemic Lupus Erythematosus

Summary: this is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.


Eligibility criteria:
inclusion criteria: * diagnosis of sle for at least 6 months as defined by the most recent american college of rheumatology criteria * presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and systemic lupus erythematosus disease activity index (sledai) ≥ 6 at screening; * other inclusion criteria may apply. exclusion criteria: * presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years * any disorder (including psychiatric), condition, clinically significant disease, disease activity related to sle * positive for hiv antibodies, hepatitis b surface antigen or anti-hbc, or hepatitis c antibodies * known residential exposure to an individual with tuberculosis or positive quantiferon test or ppd test at screening * men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study * other exclusion criteria may apply

Keywords: lupus arthritis, systemic lupus erythematosus, amg 557, lupus
effects of dietary protein on musculoskeletal health during calorie deficiency

Conditions: Weight Loss; Muscle Loss; Bone Loss

Summary: military personnel face many physiological challenges, including sustained physical activity and prolonged periods of negative energy balance. chronic energy deficiency often results in a loss of skeletal muscle mass and can reduce overall bone health. recent evidence suggests that dietary interventions that provide protein in excess of the current national dietary recommendation may confer protection against the negative effects of energy deficiency on the musculoskeletal system. the primary objective of this randomized, controlled study is to assess the effects dietary protein intake spanning the current acceptable macronutrient distribution range on musculoskeletal health following prolonged energy deficiency. findings from this investigation will improve current understanding of dietary conditions necessary to reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters. furthermore, given the rise in obesity in military populations, findings may aid in the development of nutritional weight management strategies that promote healthy weight loss without compromising musculoskeletal health.


Eligibility criteria:
inclusion criteria: * weight stable with body mass index 22-29 kg/m2 * physically active * refrain from nsaids and other aspirin containing medications * refrain from alcohol and nicotine exclusion criteria: * metabolic or cardiovascular abnormalities, gastrointestinal disorders * disease or medication that affects metabolism and/or exercise * allergies or intolerance to foods, vegetarian practices, or medications to be used in the study * anemia and sickle cell anemia/trait; abnormal pt/ptt test or problems with blood clotting * present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues * musculoskeletal injuries that compromise the ability to exercise * blood donation within 8 weeks of beginning the study * pregnancy and women not on contraceptives

Keywords: dietary supplement protein metabolism bone turnover
cannabinoid therapy for pediatric epilepsy

Conditions: Epilepsy

Summary: this is a phase 1 trial to determine the tolerability and optimal dose of cbd rich cannabis extract as an adjunct treatment in children with severe drug resistant epilepsy due to dravet syndrome. this is an open label intervention. study duration is 20 weeks to primary analysis with continued follow-up until 64 weeks completed.


Eligibility criteria:
inclusion criteria: * drug resistant epilepsy due to dravet syndrome * must have clinically apparent seizures * must be able to tolerate administration of medication orally or enterally via gastrostomy tube * was never on cannabinoid therapy or have not been treated with cannabinoid products for at least last 60 days (confirmed by negative urine test for tetrahydrocannabidiol (thc), only for those who had been treated with cbd). exclusion criteria: * co-morbid liver or renal disease * without clinically-apparent seizures * currently taking any cannabinoid products.
japanese study with rimonabant in obese type 2 diabetic patients with oral anti-diabetic drug

Conditions: Obesity; Diabetes Mellitus Type 2

Summary: the primary objective of this study is to assess the efficacy of rimonabant (sr141716) compared to placebo on change in hba1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor). the secondary objectives are: * to evaluate the effect of rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, body mass index and metabolic parameters; * to evaluate the safety and tolerability of rimonabant compared to placebo; * to evaluate the pharmacokinetics of rimonabant.

the total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor) * hba1c ≥ 7.0 % and ≤ 10.0 % * body mass index ≥ 25 kg/m² exclusion criteria: * type 1 diabetes * within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction * within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment * secondary obesity * primary hyperlipidemia * positive serum pregnancy test in females of childbearing potential the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: obese diabetes cannabinoid-1 receptor
comparison of safety and efficacy of needle-free injector and insulin pen in patients with t2dm

Conditions: T2DM (Type 2 Diabetes Mellitus); Needle-free Injector; Time in Range

Summary: in this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patients with type 2 diabetes. this trial will enable assessment of the clinically relevant endpoint of a change in time in range (tir), a newly recommended measurement of blood glucose fluctuations.

the objective of the current study is to investigate the efficacy, safety and tolerability of needle-free injector compared to conventional insulin pen given for 2 weeks as the insulin carrier in patients with type 2 diabetes mellitus. the primary endpoint in this study is the change from baseline in tir (after 2 weeks of treatment) in all patients with baseline and at least one post baseline measurement. patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. approximately 200 patients will be enrolled in the study. patients who qualify will be randomized to needle-free injector group or conventional insulin pen group. duration of treatment includes 1-week screening period, 2-week treatment observation period and 2-week follow-up.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 and ≤75 years with type 2 diabetes; * hba1c ≥ 7.5 to ≤11.0%; * receipt of premixed insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study, and insulin dose adjustments ≤ 10% within 4 weeks before enrollment (dose adjustment = (the maximum dose within a month - the minimum dose) / final dose (dose of the day before the visit) × 100%); * bmi ≤ 32kg / m2. exclusion criteria: * patients with any of the following conditions will be excluded: * pregnant or lactating women * severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent * myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent * current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent * severe mental instability, or alcohol abuse, or drug abuse * skin lesions at the insulin injection site * cancer within 5 years prior to informed consent * pancreatitis of severe infectious diseases within 1 months prior to informed consent * known hypersensitivity or allergy to the insulin * renal impairment (ckd-epi egfr\<60ml/min) * impaired hepatic function, defined by serum levels of either alt (sgpt), ast (sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined * participation in another trial within 2 months prior to informed consent * patients that investigators believe may fail to complete the study
clinical efficacy of a cephalic mask for noninvasive ventilation during acute hypercapnic respiratory failure

Conditions: Acute Hypercapnic Respiratory Failure

Summary: noninvasive ventilation (niv) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (ahrf). otherwise, patient-ventilator interfaces are determinant to get an optimal niv efficacy in parallel with ventilatory comfort. facial masks during niv are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. in order to limit these side effects, a cephalic interface has been recently designed. cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. however, this mask has a high volume that may interfere with niv efficacy and may also induce claustrophobic sensations. the aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during ahrf.


Eligibility criteria:
inclusion criteria: * acute hypercapnic respiratory failure * indication to noninvasive ventilation exclusion criteria: * requirement for endotracheal intubation * proven pulmonary embolism * present or previous history of ophthalmologic disease

Keywords: noninvasive ventilation acute hypercapnic respiratory failure cephalic mask facial mask
water-only fasting in the treatment of hypertension patients

Conditions: Hypertension

Summary: this purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.

this is a prospective, open label, single arm, intervention study to examine the safety and feasibility of water-only fasting to treat hypertensive patients. additional aims include describing mean changes in resting blood pressure as well as markers of cardiovascular health and inflammation between baseline and end of fast, end of refeed, 6-weeks post departure, and 12-months after 6-weeks follow-up.

Eligibility criteria:
inclusion criteria: 1. any gender 2. 30-75 years old 3. diagnosis of stage 1 or 2 hypertension 4. fasting plasma glucose \<126mg/dl and/or hemoglobin a1c \<7 percent 5. elect and qualify for a water-only fast of at least 7 consecutive days 6. provide informed consent 7. internet and computer access 8. able to go to labcorp for 6-week follow-up visit 9. willing/able to collect 24-hour urine sample prior to water-only fasting exclusion criteria: 1. systolic blood pressure/diastolic blood pressure \>180/120 mmhg 2. active malignancy 3. active kidney disease (creatinine over 2.0) 4. active inflammatory disorder including classic autoimmune connective tissue (lupus, sjogrens, anca), multiple sclerosis, and inflammatory bowel disorders (ulcerative colitis, crohn's) 5. stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months 6. inability to discontinue medications or supplements 7. abdominal metal implants 8. inability to consume only plant food for at least 48 hours before fast begins. 9. unable to lay still on the back for at least 10 min.

Keywords: fasting water-only fasting whole-plant-food diet
subthalamic nucleus stimulation effect on gait symmetry and freezing of gait

Conditions: Parkinson Disease

Summary: impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in parkinson's disease

unilateral modulation of subthalamic stimulation and its impact on freezing of gait in parkinson's disease will be studied. in a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.

Eligibility criteria:
inclusion criteria: patients affiliated to social security patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year freezing of gait able to give inform consent exclusion criteria: patient under guardianship, legal guardianship psychosis severe depression severe cognitive troubles (mattis \< 130) other neurologic or medical pathology interfering with gait

Keywords: parkinson disease deep brain stimulation freezing of gait