Kornimate/medical-research-clean huggingface dataset:
study evaluating awbat-d versus the standard of care of split-thickness skin graft donor sites

Conditions: Healing of Donor Site; Pain Level

Summary: use of awbat-d on split thickness skin graft sites will reduce healing time and pain level.

the study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using awbat-d compared to current standard of care: tegaderm. this will involve randomizing subjects to treatment with the awbat-d dressing or tegaderm and monitoring outcomes. the awbat-d device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. the purpose of this study is to evaluate if there are differences in outcomes between awbat-d and tegaderm in healing split thickness skin graft donor sites.

Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older 2. subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um. 3. ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. exclusion criteria: 1. subjects \< 18 years of age 2. subjects with an allergy to porcine products. 3. subjects undergoing stsg with a wound size less than 5 cm2 or greater than 50cm2. 4. subjects undergoing stsg with a wound depth of less than 12um or greater than 18um. 5. subjects undergoing repeat skin graft harvesting at the same donor site. 6. has active malignant disease of any kind. a subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. 7. subjects participating in any other trials involving the split-thickness skin graft donor site.
dna analysis of blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial mrc-re05-sorce

Conditions: Kidney Cancer

Summary: rationale: studying samples of blood and/or tissue in the laboratory from patients with kidney cancer receiving sorafenib may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how well patients will respond to sorafenib. purpose: this research study is looking at the dna in blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial mrc-re05-sorce.

objectives: * examine the relationship between tumor genotype, expression, and patient outcome. * examine the relationship between constitutional genotype and patient outcome. outline: this is a multicenter study. patients undergo blood and/or tissue sample collection for laboratory studies. laboratory studies include generation of tissue microarrays; analysis of protein expression by immunohistochemistry; tumor dna extraction and whole genome amplification; detection of vhl or other relevant gene mutations by direct sequencing; and constitutional (lymphocyte dna) genotyping by single nucleotide polymorphism analysis.

Eligibility criteria:
disease characteristics: * histologically confirmed resected renal cell carcinoma * clear cell or non-clear cell tumor * receiving sorafenib tosylate on clinical trial mrc-re05-sorce patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: clear cell renal cell carcinoma stage i renal cell cancer stage ii renal cell cancer stage iii renal cell cancer stage iv renal cell cancer papillary renal cell carcinoma
use of biotene moisturizing mouth spray for xerostomia associated with oral oxybutynin use

Conditions: Overactive Bladder; Xerostomia; Compliance

Summary: this is a randomized placebo controlled trial of the use of biotene versus no treatment in women receiving oral oxybutynin for overactive bladder. the primary outcome will be rate of discontinuation of oxybutynin at 6 month.

overactive bladder (oab) is a common condition affecting roughly 20% of women. anticholinergic medications are the main treatment modality for women with oab; however, treatment is hampered by high rates of dry mouth which limit tolerability. discontinuation rates for anticholinergic medications for dry mouth have been reported to be as high as 71% at 6 months. biotène(tm) moisturizing mouth spray is used for xerostomia due to various etiologies in adults. the purpose of our study is to determine the rate of discontinuation of oral oxybutynin therapy for overactive bladder in women using biotène(tm) moisturizing mouth spray versus no additional treatment. this is a randomized open label trial. participants will be randomized to moisturizing mouth spray versus no additional treatment. urinary symptoms, xerostomia symptoms, and compliance with oral oxybutynin will be compared between groups. our primary outcome is rate of discontinuation of oral oxybutynin at 6 months. assuming a baseline discontinuation rate of 70% at 6 months, and assuming 80% power and α = 0.05 for a two-sided test, we will require 42 subjects in each group to detect a difference of 30% in cure rate between the two groups. assuming followup of 75%, 60 subjects in each group will be recruited. participants within groups will be compared with respect to differences in baseline demographics, questionnaire scores and compliance with oxybutynin using a chi square test for categorical variable, a t test for normally distributed continuous variables or a mann whitney u test for non-normally distributed or ordinal variables.

Eligibility criteria:
inclusion criteria: * age \>18 * able to give informed consent * women diagnosed with overactive bladder or urgency incontinence who are being started on oral oxybutynin. exclusion criteria: * any allergy to biotène® moisturizing mouth spray or its components * any contraindication to oxybutynin, including urinary retention (pvr \> 100ml), gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions, and patients who have demonstrated hypersensitivity to the drug substance or other components of the product. * using ocular anti-cholinergic agents, treatment for dry mouth or oral anti-muscarinics in the preceding 3 months. * prior history of head/neck surgery or radiation (excluding thyroid surgery).
vitamin c for the prevention of uti in women who undergo elective gynecological surgeries

Conditions: Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Summary: this open-label randomized trial aims at assessing the role of vitamin c pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.


Eligibility criteria:
inclusion criteria: * non pregnant women at least 18 years of age visiting the preadmission unit (pau) or the obgyn floor (7n), presenting for elective gyn surgery at the american university of beirut medical center (aubmc). exclusion criteria: * any women with the following: 1. nephrolithiasis 2. congenital anomaly or neurogenic bladder 3. allergy to ascorbic acid 4. who require therapeutic anticoagulant medicine during the 6 weeks after surgery 5. surgery did involve a fistula repair or a vaginal mesh removal 6. positive urinalysis in the pau 7. recurrent uti's 8. diabetes 9. g6pd 10. hemochromatosis 11. renal disorders patients already taking vitamin c supplementation will also be excluded from the study.

Keywords: vitamin c cauti ascorbic acid
the safety and efficacy of low and high carbohydrate diets

Conditions: Obesity

Summary: this study will compare the safety and effectiveness of a low carbohydrate diet (atkins diet) with a high carbohydrate diet (conventional usda diet).

despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. despite its widespread use for more than 30 years, the atkins diet has never been evaluated in a large, randomized, controlled trial. this study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women. participants in this study will be randomly assigned to the atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional usda diet (high-carbohydrate, low fat). the study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition, 2) metabolic and organ function, 3) exercise tolerance. each participant will be enrolled in the study for 2 years.

Eligibility criteria:
inclusion criteria: * body mass index between 30 and 40 * live and work within 1 hour of the study site * stable psychological status exclusion criteria: * history of heart disease, heart attack, or stroke * blood pressure \> 140/90 mmhg * abnormal cholesterol levels * significant psychiatric illness * any medication that affects weight or metabolic rate * presence or history of a chronic disease that is known to affect appettite, food intake, or metabolism (i.e. diabetes, thyroid disease or cancer). * currently using antidepressants, steroids, tobacco or illegal drugs * pregnant, breastfeeding, or planning pregnancy * 10 lb change in weight within 6 months of study entry * history of malignant arrhythmias or cerebrovascular, renal, or hepatic disease * history of protein wasting diseases or gout * severe arthritis * osteoperosis * certain types of hormone replacement therapy * currently following a vegetarian diet

Keywords: weight loss
efficacy and safety of olanzapine in patients with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with borderline personality disorder (bpd).


Eligibility criteria:
inclusion criteria: * patients must be of outpatient status at visit 1 and through visit 2 * patients must be 18 through 65 years of age at visit 1 * patients must meet all of the dsm-iv-tr general diagnostic criteria for a personality disorder and patients must meet dsm-iv-tr diagnostic criteria for bpd as determined by the dipd-iv, confirmed by a psychiatrist with training in the evaluation and assessment of bpd. * the symptom severity as assessed by the total score of the zan-bpd, confirmed by a psychiatrist with training in the evaluation and assessment of bpd, must be greater than or equal to 9 at visit 2. * female patients of childbearing potential must test negative for pregnancy and must be using medically accepted means of contraception throughout the study. use of any oral or injectable contraception must be initiated prior to visit 2. exclusion criteria: * investigators, study site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * persons employed by lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). immediate family of lilly employees may participate in lilly-sponsored clinical trials, but are not permitted to participate at a lilly facility. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted * have previously participated (have been randomized) or withdrawn from this study or any other lilly sponsored study investigating olanzapine. * have had previous treatment with olanzapine unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of olanzapine was confounded by concomitant medication. * female patients who are either pregnant or nursing.
impact of a health intervention on some indicators in the care of chronic complex patient (ccp).

Conditions: Preventive Care

Summary: the aim of this study is to assess the effectiveness of proactive and integrated healthcare program for chronic complex patients (ccp). this program are based in coordination the primary level of attention with and speciality level. the objective is reducing hospital readmissions and know the benefit in total cost of care in 4 month before and 4 after intervention.

quasi-experimental study with single-arm (pre-post study design without control group). the investigators checking pre and post intervention the effectiveness of a healthcare program for ccp. the interventions consist: 1. - help the nurse in the hospital to carry out the care plans and the continuity care report. 2. - refer patients to the social workers. 3. - collaborate with the social worker to refer to centers of media, long stay and reference hospital. 4. - ensure the follow-up appointments for the ccp. 5. - make proactive calls to the ccp and/or their caregiver after discharge 6. - plan the hospital discharge 48 hours in advance, so that the family and the patient can be organized. the investigator analysed if with this program, the ccp reducing hospital readmission and reducing the hospital expenditure.

Eligibility criteria:
inclusion criteria: * patient ≥ 75 years. * having attended 5 or more emergency visits or having had more than 3 hospital admissions in the last 12 months. * identified with social risk alert. exclusion criteria: * participate in other health programs (aht, diabetes mellitus,...). * terminal patient.

Keywords: chronic complex
monopolar dielectric diathermy and therapeutic exercise on chronic neck pain and therapeutic exercise on pain, functionality, movement phobia on pain, functionality, movement phobia and quality of life of patients of patients with chronic neck pain. randomized clinical trial

Conditions: Chronic Pain; Neck Pain

Summary: the aim of this study is to compare the effects of applying monopolar dielectric radiofrequency diathermy plus therapeutic neck yoga with performing only therapeutic neck yoga in patients with non-specific chronic neck pain.

chronic non-specific neck pain (cnnp) is a widespread public health problem in the modern world. cnnp is considered persistent neck pain or severe neck discomfort for more than 3 months, which is caused by poor posture and mechanical and degenerative changes, excluding pain due to neck cancer, infections, hernias or other neck disorders or pathologies. in the general population, 71% of adults have neck pain at some time in their lives, and its annual prevalence in the general and working population varies between 30% and 50%. in addition, cnnp is an important cause of work absenteeism and disability. the research of effective techniques and therapies in the approach of this ailment is a current need within the field of physiotherapy and would mean a reduction of the direct and indirect costs in the health systems generated by patients diagnosed with non-specific chronic neck pain. one of the therapies that is achieving positive results in the symptomatology of different musculoskeletal pathologies such as fibromyalgia syndrome , multiple sclerosis or femoropatellar pain syndrome, is the technique of applying monopolar electric diathermy by radiofrequency emission (mdr), using the physicalm® device which produces an increase in local temperature due to the action of electromagnetic waves that stimulate tissue metabolism and reduce pain. due to all the structural and functional alterations that occur in cnnp, within clinical practice guidelines exercise is one of the most important components in rehabilitation programs for patients with neck pain. recently, supervised therapeutic exercise has been included as a common intervention in clinical practice worldwide.

Eligibility criteria:
inclusion criteria: * men and women between 30 and 65 years of age. * diagnosed by a specialist physician of chronic cervical pain of non-specific origin. * acceptance and signature of informed consent for voluntary participation in the research study. * not to be undergoing any type of physical therapy or pharmacological treatment. * acceptance to attend the treatment sessions of the present research study. exclusion criteria: * being under rehabilitation or pharmacological treatment of lumbar pathology. * alterations of sensitivity or coagulation. * thermal sensitivity problems. * present osteosynthesis material at lumbar level. * present cardiac, epilepsy or tumor complications. * non-acceptance of the informed consent or non-attendance to all the sessions that make up the treatment.

Keywords: monopolar electrical diathermy therapeutic exercise
study of metanx® in subjects with type 2 diabetic peripheral neuropathy (dpn)

Conditions: Type 2 Diabetic Peripheral Neuropathy (DPN)

Summary: the purpose of this research study is to determine if metanx improves sensory neuropathy in persons with type 2 diabetes. metanx is a medical food available with a prescription from a physician. it consists of l-methylfolate, pyridoxal 5'-phosphate, and methylcobalamin, which are the active forms of folate, vitamin b6, and vitamin b12, respectively. subjects will be randomly assigned to receive either metanx or placebo for 6 months.


Eligibility criteria:
inclusion criteria: 1. male or female between 25 and 80 years of age (inclusive); 2. documented diabetes mellitus type 2 (based upon ada criteria); 3. peripheral polyneuropathy: vibration perception threshold (vpt) 25-45 volts at hallux on either leg. 4. adequate lower extremity vascular status: * palpable pedal pulse in both feet; * no intermittent claudication; * no history of lower extremity vascular bypass surgery or angioplasty 5. the subject is able to understand the information in the informed consent form and is willing and able to sign the consent. exclusion criteria: 1. amputation of any kind or an ulceration within the last two (2) years including at screen; 2. history or active charcot neuroarthropathy on either foot; 3. previous surgery to spine or lower extremity with residual symptoms of pain or difficulty with movement; 4. severe rheumatoid arthritis or osteoarthritis that would cause discomfort during causal walking or stair climbing; 5. current treatment with systemic steroids, immunosuppressives, or radiotherapy; 6. peripheral vascular disease defined as any nonpalpable foot pulse, history of claudication, or a history of lower extremity vascular bypass surgery or angioplasty; 7. glycated hemoglobin (hba1c) \>9 at screen. 8. uncontrolled heart (hypertension: bp \> 160/90), or lung disease (uncontrolled asthma or shortness of breath) in the last 2 months prior to screen; 9. end stage kidney disorder requiring hemodialysis or serum creatinine \> 2.5x (normal upper limit); 10. the following supplements within 2 months prior to screen: alpha lipoic acid; b12 injection; \>10mg of b6; or, \> 800mcg of folate; 11. taking either an opiate at any dose or on the maximum dose of any anticonvulsant; 12. pregnant or nursing; 13. life expectancy \< 12 months; 14. initiated therapies for painful diabetic neuropathy (pregabalin, gabapentin, duloxetine etc.) in the last 2 months prior to screen; 15. initiated new hyperglycemic, insulin, statin or hypertensive therapies within 2 months prior to screen (dose modifications of current therapies are allowed at the discretion of the investigator); 16. current alcohol or drug abuse (or history of such abuse within the past 3 years); and, 17. not willing or able to follow procedures specified by the protocol and/or the instructions of the study personnel.

Keywords: metanx diabetes neuropathy folic acid folate l-methylfolate vitamin b6 pyridoxal 5'-phosphate vitamin b12 methylcobalamin
study of incb040093 in subjects with previously treated b-cell malignancies

Conditions: B-cell Malignancies

Summary: the study will be conducted in three parts. part 1 is a dose escalation phase to determine the maximum tolerated dose (mtd) of incb040093, a pi3kδ inhibitor, or a tolerated, pharmacologically active dose; part 2 will evaluate the combination of incb040093 and itacitinib (incb039110), a jak1 inhibitor, to determine the mtd of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; part 3 will further evaluate the chosen doses of incb040093 alone and in combination with itacitinib (incb039110) in subjects with relapsed/refractory b-cell malignancies.


Eligibility criteria:
inclusion criteria: • aged 18 years or older, with lymphoid malignancies of b-cell origin as follows: \*indolent / aggressive b-cell (nhl) non- hodgkin's lymphoma: excluding: burkitt lymphoma and precursor b-lymphoblastic leukemia/lymphoma including: any non-hodgkin's b-cell malignancy such as cll and rare non-hodgkin's b-cell subtypes such as hairy cell leukemia, waldenstrom macroglobulinemia, mantle cell lymphoma, transformed nhl histologies, etc. \*hodgkin's lymphoma * life expectancy of 12 weeks or longer. * subject must have received ≥ 1 prior treatment regimen. * the subject must not be a candidate for potentially curative therapy, including stem cell transplant. exclusion criteria: * received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug. * received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) except steroids at ≤ 10 mg prednisone daily (or equivalent). * has any unresolved toxicity ≥ grade 2 from previous anticancer therapy. * has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system. * has an eastern cooperative oncology group (ecog) performance status of ≥ 3. * received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (gvhd) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant. * received autologous hematopoietic stem cell transplant within the last 3 months. * laboratory parameters not within the protocol-defined range. * current or recent history (\<30 days prior to screening and/or \<45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection. * current clinically active viral infection. * known history of infection with the human immunodeficiency virus (hiv). * history of active hepatitis or positive serology for hepatitis.