Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of bavituximab plus paclitaxel and carboplatin to treat breast cancer

Conditions: Carcinoma Breast Stage IV

Summary: this is a phase ii, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * living in india for the duration of the study * adult females over age 18 years of age with a life expectancy of at least 3 months * confirmed breast cancer with evidence of locally advanced or metastatic disease * disease that is measurable by radiology imaging * ambulatory and capable of all selfcare but unable to carry out any work activities. * adequate laboratory results (hematologic, renal, hepatic) * negative pregnancy test exclusion criteria: * history of or susceptibility to bleeding or coagulopathy (e.g., von willebrand disease or hemophilia) * any history of thromboembolic events (clots within blood vessels) * ongoing treatment with high doses of anticoagulants * use of hormone therapy * advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) * prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy * radiotherapy within 2 weeks entering the study * chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study * allergies to polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine) * diagnosed and active cns disease or metastatic lesions * major surgery within 4 weeks of starting the study * pregnant or nursing * uncontrolled disease (e.g., diabetes, hypertension, thyroid disease) * history of heart disease * history of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids * diagnosed with hiv or hepatitis

Keywords: locally advanced or metastatic breast cancer
nasal expiratory positive airway pressure for the treatment of pediatric obstructive sleep apnea syndrome

Conditions: Organic Pediatric Obstructive Sleep Apnea

Summary: this study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (nepap) device as an an alternate therapy for children with obstructive sleep apnea syndrome (osas). nepap is currently approved for use only in adults.

the nasal expiratory positive airway pressure (nepap) device has been used to treat osas in adults. a disposable device is placed in each nostril at night and attached with adhesive. the device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. during expiration, the valve closes and airflow is directed through small air channels, increasing resistance. the increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. in contrast to continuous positive airway pressure (cpap) which provides positive pressure during both inspiration and expiration, nepap creates pressure during expiration. nepap is a potential alternative therapy which is less cumbersome than cpap and may increase adherence.

Eligibility criteria:
inclusion criteria: 1. subjects age 5-16 years (note: due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. subjects will be evaluated in clinic to fit for size and habituate to the device) 2. osas (ahi \> 5/hr) 3. subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy 4. subject is non-adherent to cpap or is seeking an alternative therapy 5. tolerance of nepap device during a daytime session 6. parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: 1. severe developmental delay thought to involve a high risk of aspiration 2. family does not understand english well enough to perform the standardized, validated questionnaires. 3. age \>16 years since results may be similar to adult studies in these older patients. 4. severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum) 5. severe heart disease (including heart failure) 6. an acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection or perforation of the ear drum subjects that do not meet all of the enrollment criteria will not be enrolled. any violations of these criteria will be reported in accordance with institutional review board (irb) policies and procedures. study members will not recruit females who are known to be pregnant. however, if a subject becomes pregnant during the study, we will continue to use the device. pregnancy is not an exclusion criterion as positive airway pressure therapy does not harm the pregnant woman or fetus.

Keywords: nepap cpap alternative osas
marcaine use in laparoscopic gynecological surgery

Conditions: Post-operative Pain

Summary: the purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative marcaine injection.

post-operative pain control is a key component of a patient's experience with surgery. in laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. the advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. in many cases, the patient will go home within 24 hours of surgery. many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. the best method for administration of the local anesthetic for optimal pain relief remains unclear. some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

Eligibility criteria:
inclusion criteria: * • ages 18-50 * bmi 20-35 * gynecologic ambulatory cases only * total of 3 incisions, with left and right incisions both being 5mm-10mm in size * not taking pain medications prior to surgery * length of surgery up to 3 hours * pacu stay up to 6 hours * willing and able to sign informed consent exclusion criteria: * • age or bmi out of range * surgery longer than 3 hours or pacu stay longer than 6 hours * patients with chronic pelvic pain * oncologic cases * pregnant patients
theralux extracorporeal photochemotherapy (ecp) in patients with extensive chronic graft versus host disease (gvhd)

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to assess the tolerability and safety of two intensity levels of theralux extracorporeal photochemotherapy in the treatment of subjects with steroid refractory or intolerant gvhd. the current hypothesis is that apoptotic cells re-injected into patients induce an immunomodulation effect alleviating the gvhd symptoms. using the theralux procedure, the dose of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in the treated patients. the intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood mononuclear cells (pbmc) with a rhodamine-derivative th9402 (drug) and theralux (device).

graft versus host disease (gvhd) remains a major cause of morbidity and mortality related to allogeneic stem cell transplantation. while improvements in immuno-suppressive regimens have reduced the frequency and severity of acute gvhd, the incidence of chronic gvhd (cgvhd) remains unchanged ranging from 30% after sibling matched related donor transplants to over 70% after unrelated donor bone marrow or peripheral blood stem cell transplant. factors associated with cgvhd include increased donor and recipient age, prior acute gvhd, and the use of alloimmune female donors. conventional therapeutic approaches for cgvhd, including corticosteroids and immunosuppressive agents, have demonstrated limited efficacy in patients with extensive disease and are associated with high toxicity. iterative extracorporeal photopheresis has demonstrated clinical and immunomodulatory activity in subjects with acute and chronic gvhd. the currently available process of ecp has not been controlled for cell number, exposure time, or specific cell populations targeted due to the nature of the procedure. using the theralux procedure, defined populations of cells may be targeted, and the intensity of photoactivating agent and exposure can be modulated to achieve the maximal immunomodulatory effects in the treated subjects. this study will attempt to explore the effects of the theralux procedure under two defined conditions. response and toxicity will be determined at each intensity level and the dose associated with clinical response and immunomodulatory effects on dc and nk cell populations will be defined as the optimal intensity level for subsequent larger trials.

Eligibility criteria:
inclusion criteria: * clinical features compatible with extensive chronic gvhd * refractory or intolerant to standard therapy exclusion criteria: * pregnant or lactating women * underlying concurrent medical condition which would hinder the ability to safely administer the treatment * known hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * participation to another investigational trial within 30 days of study entry

Keywords: chronic gvhd extensive chronic gvhd resistant chronic gvhd
comparison of the pharmacokinetics of tiotropium delivered from test inhaler products with reference

Conditions: Healthy

Summary: the purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.

Eligibility criteria:
inclusion criteria: * healthy volunteer * willing and able to give informed consent * willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration exclusion criteria: * evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders * any presence or history of a clinically significant allergy including any adverse reaction to study drug * history of drug or alcohol abuse within the past 2 years * smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) * donation or loss of greater than 400 ml of blood within the previous 3 months * have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) * have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) * upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months * if female, nursing, lactating or pregnant * regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)

Keywords: inhalation anticholinergic
multicenter prospective study on the changes of sexual function following treatment with alfuzosin (xatral xl®) in patients with benign prostate hypertrophy

Conditions: BPH/LUTS/Sexual Functions

Summary: to collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(xatral xl® )is administered once daily in patients with lower urinary tract symptoms(luts) suggestive of prostatic hypertrophy


Eligibility criteria:
inclusion criteria: * male patients suffering from luts lasting 6months and over * male patients aged 50 years old and over who has a continuous active partner exclusion criteria: * primary hypogonadism and neuropathy patients * history of prostate surgery * patients with prostate cancer * history of organ surgery or organ damage in pelvis * history of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months * patients with haematuria caused by other reasons except bph * patients with uncontrolled hypertension in spite of treatment with antihypertensive agents * history of a malignant tumor within last 5 years * patients who are currently controlled with other medication for erectile dysfunction * patients who have been administered with androgen or antiandrogen * patients who is treated for psychiatric disorder or depression * combination with other alpha1-blockers * patients previously not improved by an alpha1-blocker treatment * known hypersensitivity to the alfuzosin * history of postural hypotension or syncope * hepatic insufficiency * unstable angina pectoris the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
kv-cbct and ultrasound imaging in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer

Conditions: Adult Liver Carcinoma; Malignant Pancreatic Neoplasm; Prostate Carcinoma

Summary: this clinical trial studies if kilo-voltage cone beam computed tomography (kv-cbct) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. computer systems, such as kv-cbct and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed.

primary objectives: i. to investigate the feasibility of combining on-board cone beam computed tomography (cbct) with ultrasound imaging to overcome the shortcomings of cbct or ultrasound imaging alone for imaging guided radiotherapy delivery. outline: patients undergo ultrasound imaging prior to and during radiation therapy. patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy. update (2021/02/04): removed secondary outcome "incidence of adverse events related to the ultrasound probe". per pi: study initially intended to involve a non-fda approved probe for use with liver patients but removed this section.

Eligibility criteria:
inclusion criteria: * the patient must have either 1) cancer involving the liver by biopsy or radiographic criteria, or 2) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the liver, or prostate. patients with prostatectomy receiving post-operative radiotherapy are also eligible. * karnofsky performance status (ps) ≥ 70 * subjects must have the ability to understand and the willingness to sign a written informational form exclusion criteria: * patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements
oral findings in chronic kidney disease

Conditions: Oral Disease; Chronic Kidney Diseases

Summary: the patients with chronic kidney disease suffer from many oral problems affecting the quality of life. the aim of our study is to assess their oral health to provide the proper management and increase their awareness

the study will be held in the nephrology units at the kasr al-ainy cairo university hospital. the data collected through the questionnaire will be obtained through an interview between the investigator and the patient. clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. for patients undergoing dialysis, examination will be performed before dialysis therapy selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic. non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study. incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record. using a precision of 5, a design effect set at 1 with 90% ci (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. the sample size was calculated by epi info software.the sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect

Eligibility criteria:
inclusion criteria: 1. adult patients \>18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4. 2. adult patients \>18 years old with a diagnosis of end stage renal disease "stage 5". 3. recorded data of glomerular filtration rate for every patient. 4. recorded data for dialysis patients (hcv, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time). exclusion criteria: 1. adult patients \<18 years. 2. end stage renal disease undergoing peritoneal dialysis. 3. patients not physically able to participate in oral examination. 4. patients with kidney transplantation. 5. patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning

Keywords: oral findings or oral manifestations pre-dialysis or end stage renal disease
comparison of olopatadine 0.6% and fluticasone proprionate 50mcg nasal sprays in a two week seasonal allergic rhinitis trial

Conditions: Seasonal Allergic Rhinitis

Summary: comparison of two nasal sprays for the treatment of seasonal allergic rhinitis


Eligibility criteria:
inclusion: * a history of spring/summer seasonal allergies. * positive skin prick test for the currently prevalent allergen of the area. * confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article. * for pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study. exclusion: * history of chronic sinusitis. * asthma, with the exception of intermittent asthma. * smokers. * known non-responders to antihistamines. * chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids. * chronic use of long acting antihistamines. * upper or lower respiratory infection within 14 days of visit 1. diagnosis of acute sinusitis within 30 days of visit 1. * relatives of study site staff or other individuals who had access to the clinical study protocol. * participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.

Keywords: rhinitis seasonal allergic rhinitis allergies
the effect of liraglutide adjunct to insulin on glucagon response to hypoglycaemia in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo. subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation * body mass index (bmi) between 20.0 and 28.0 kg/m\^2 (both inclusive) exclusion criteria: * use of liraglutide or exenatide within 3 months of randomisation * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: interferon alfa may interfere with the growth of cancer cells. purpose: phase ii trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.

objectives: * evaluate the efficacy of recombinant interferon alpha (ifn alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas. * determine the nature and extent of central nervous system (cns) toxicities associated with the use of alpha interferon in current doses and schedules. outline: this is a two arm, randomized study. the first arm includes all histologically benign meningiomas. the second arm includes all other pathologies. all patients receive inf alpha as a subcutaneous injection monday through friday for 8 weeks. treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable. treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade iii or greater. dosage for subsequent courses is one dose level below the dose that produced toxicity of grade iii or greater. projected accrual: 20 patients will be entered per year into each arm.

Eligibility criteria:
disease characteristics: * histologically proven tumors: * unresectable meningioma * atypical meningioma * malignant meningioma * angioblastic meningioma * hemangiopericytoma * recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries patient characteristics: age: * 16 and over performance status: * karnofsky at least 60% life expectancy: * at least 3 months hematopoietic: * agc at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * sgpt less than 2.0 times normal * alkaline phosphatase less than 2.0 times normal * bilirubin less than 1.5 mg/dl renal: * bun less than 1.5 times normal or * creatinine less than 1.5 times normal other: * no active infection * no diseases that obscure toxicity or dangerously alter drug metabolism * no serious intercurrent medical illness * not pregnant * fertile patients must use adequate contraception prior concurrent therapy: biologic therapy: * no concurrent biologic therapy chemotherapy: * prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy endocrine therapy: * prior hormonal therapy allowed * no concurrent hormonal therapy radiotherapy: * prior radiotherapy allowed surgery: * not specified

Keywords: recurrent adult brain tumor