Kornimate/medical-research-clean huggingface dataset:
pilot study assessing breast temperature in breast cancer patients

Conditions: Breast Reconstruction

Summary: our investigators plan to measure the skin on the breast six months after breast reconstruction. the non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. for those who have bilateral reconstruction, a core temperature will be obtained from the ear.

many factors influence outcomes following mastectomy and breast reconstruction. cutaneous sensation, degree of scar formation, nipple projection and overall appearance are well correlated with patient satisfaction. however, very little data exists on the importance of skin temperature after mastectomy and reconstruction. our investigators have noted that a number of patients report their reconstructed breast is cold and relate this as a source of dis-satisfaction. in these patients, it is unclear if 1) the reconstructed breast skin is cold and if so 2) can something can be done to improve this. our investigators hypothesize that cutaneous breast temperature may be altered after mastectomy and reconstruction. this may be dependent on the reconstruction technique and other patient factors. in this pilot study, our investigators aim to establish techniques for evaluating cutaneous breast temperature following mastectomy and reconstruction. our investigators hope to establish baseline data to develop an understanding of breast skin temperature after mastectomy and reconstruction. our long-term goals are to evaluate how cutaneous breast temperature may contribute to patient satisfaction. our investigators also hope to determine which patients are at risk for developing a cold breast after surgery. finally, our investigators will setup a prospective trial evaluating techniques to correct this problem and improve patient satisfaction.

Eligibility criteria:
inclusion criteria: * for post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction. exclusion criteria: * metastatic malignancy of any kind. * subjects with a history of breast implant augmentation prior to mastectomy and reconstruction. * subjects who cannot give an informed consent.
deciphering rheumatoid arthritis-associated interstitial lung disease pathogenesis 2

Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

Summary: the overall goal of this study is to identify risk and prognosis factors of interstitial lung disease (ild) in patients with rheumatoid arthritis (ra).

this is not an interventional study. this is a study designed to recruit individuals affected by ra and investigate associated ild to better understand the clinical phenotypes and genetic/molecular endotypes of raild, including the prognosis of the disease.

Eligibility criteria:
selection of cases : inclusion criteria: * age ≥18 years * ra diagnosis according to acr (classification of rheumatoid arthritis) 1987 and/or acr/eular 2010 criteria, validated by a senior rheumatologist * ild diagnosis based on typical high-resolution computed-tomography (hcrt) patterns and pulmonary function tests (pft), validated by a senior pulmonologist exclusion criteria: - lack of signed informed consent selection of controls: inclusion criteria: * age ≥18 years * ra diagnosis according to acr 1987 and/or acr/eular 2010 criteria, validated by a senior rheumatologist exclusion criteria: - lack of signed informed consent

Keywords: rheumatoid arthritis interstitial lung disease
evaluation of walk with ease in arthritis

Conditions: Arthritis

Summary: the overall goal of this study is to determine the whether the walk with ease (wwe) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. participants will be approximately 657 subjects from 20-24 rural and urban communities across north carolina. it is expected that participants in the wwe program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.


Eligibility criteria:
inclusion criteria: * self-reported, doctor-diagnosed arthritis * ages 18+ exclusion criteria: * non-english speaking * severe impairment of physical or mental function * co-existing condition for which exercise is contraindicated

Keywords: arthritis osteoarthritis rheumatoid arthritis fibromyalgia lupus
erythrocyte and adipocyte g6pd activity levels in obesity

Conditions: Diabetes; Obesity

Summary: this study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, hdl, and ldl) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (g6pd).

same as brief summary

Eligibility criteria:
inclusion criteria: * age \> 19 years of age and \<70 years of age * hga1c\<6.0% * fasting blood sugar less than 100mg/dl exclusion criteria: * taking antidiabetic medications for other indications
an evaluation of iv gamma globulin as a method to improve kidney transplant survival in patients with end-stage renal disease who are highly sensitized to transplant antigens

Conditions: End-Stage Renal Disease; Kidney Transplantation

Summary: this study is designed to test the clinical and laboratory observations that suggest ivig given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transplant antigens could result in reduced sensitization and reduced rates of kidney rejection. some esrd patients are highly sensitive to certain transplant antigens (foreign substances that activate the immune system) and must wait for a long time before a well-matched kidney becomes available. transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized. there is no proven method to improve a highly-sensitized patient's chances of receiving and keeping a transplanted kidney.

kidney transplantation is the treatment of choice for patients with end-stage renal disease (esrd). however, many patients do not receive this treatment due to immune sensitization to hla antigens. ivig has been shown to somewhat reduce anti-hla antibody activity. by blocking this activity, ivig may make transplants more feasible and increase graft survival in transplant recipients. patients are randomized to receive iv infusion of either 2 g/kg (maximum dose 180 g) ivig 10% s/d (gamimune-n, 10%, manufactured by bayer) or placebo (0.1% human albumin, manufactured by bayer) at time of dialysis at study entry and monthly for 3 months. if patients have not received a transplant at 1 year, they receive a "booster" dose of ivig or placebo; patients receive another booster at 24 months if transplant still has not occurred. if transplant occurs, patients receive 2 g/kg (up to 180 g) ivig or placebo monthly for 4 months, beginning at time of transplant. before and after initiation of ivig/albumin placebo treatment, specific immune parameters, including panel reactive antibodies (pra) levels, mlr, serum inhibition of mlr, and cytokine gene transcription in the mlr, and aeca levels are measured. outcomes studied include time on dialysis and graft survival rates.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are 12 years of age or older. * have end-stage renal disease. * currently receive either hemo- or peritoneal dialysis. * have an elevated (\> 50%) level of panel reactive antibodies (pra level) on 3 consecutive monthly tests. * agree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after. exclusion criteria you will not be eligible for this study if you: * have received ivig for any reason within 6 months prior to enrollment. * are hiv positive. * are hepatitis b e-antigen/hepatitis b viral dna-positive. * have selective iga deficiency or have known antibodies to iga. * are allergic to human immune globulin. * are pregnant or breast-feeding.
evaluation of efficacity and safety of deep brain stimulation (dbs) in chronic and treatment-resistant cluster headache(ch)

Conditions: Cluster Headache

Summary: the aim of this study is to evaluate the efficacy and safety of deep brain stimulation (dbs) in chronic and treatment-resistant ch. inclusion criteria are: patients with chronic ch (\>3years), with daily attack and non response to adequate treatment. electrodes are implanted stereotactically in the postero-inferior hypothalamus. in this crossover, randomized, placebo-controlled double-blinded study, the efficacy of dbs is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (placebo sequence). efficacy is defined as ≥50% decrease of weekly frequency of ch attacks. after the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.

over the past 7 years, deep brain stimulation (dbs) has been used in various centres to treat patients with intractable chronic cluster headache (ch). results in these non-controlled studies were encouraging but need to be confirmed in controlled conditions. the aim of this study is to evaluate the efficacy and safety of dbs in chronic and treatment-resistant ch, in randomized placebo-controlled conditions. inclusion criteria are: patients with chronic ch (\>3years), with daily attack and non response to adequate treatment (verapamil up 960 mg/d, lithium with plasmatic level 0.6-1 meq/ ml, and association of both drugs). after induction of local anaesthesia, electrodes are implanted stereotactically in the postero-inferior hypothalamus according to the previously described coordinates, and connected to a sub-cutaneous generator. in this crossover, randomized, placebo-controlled double-blinded study, the efficacy of dbs is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (considered as the placebo sequence). primary efficacy is defined as ≥50% decrease of weekly frequency of ch attacks, compared to a prospective run-in pre-implantation period. safety and tolerability are clinically and biologically assessed. after the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.

Eligibility criteria:
inclusion criteria: * between 18 and 65 year old * suffering from cluster headache since 3 years at least * not responding to others treatments such as : verapamil, lithium or both of them exclusion criteria: * patient with addiction * pregnancy or feeding women * contraindication to general anesthetic * contraindication to mri

Keywords: deep brain stimulation cluster headache hypothalamus
priapism in boys and men with sickle cell disease - demographics, characteristics and prevalence

Conditions: Priapism; Anemia, Sickle Cell

Summary: priapism, a prolonged erection of the penis, is a medical issue that often affects men with sickle cell disease. the purpose of this study is to collect demographic and clinical information on priapism by interviewing men with sickle cell disease.

priapism is a prolonged, painful erection of the penis that lasts for more than four hours and occurs without sexual stimulation. it occurs when blood in the penis becomes trapped and is unable to drain properly. if it is not treated immediately, it can lead to scarring and permanent erectile dysfunction. many cases of priapism are the result of sickle cell disease; approximately 42% of all adults with sickle cell disease will eventually develop priapism. current treatments include medication, ice packs, or surgery. more research is needed to better understand the demographic and clinical characteristics of priapism. the purpose of this study is to collect information and further characterize priapism by conducting interviews with men with sickle cell disease. in turn, these findings may guide future priapism clinical trials. this study will consist of two standardized questionnaires that will be administered to 1,650 men with sickle cell disease. participants will complete an initial five-item questionnaire about priapism. if a participant indicates past experience with priapism on this initial questionnaire, he will be asked to complete a second questionnaire. this questionnaire will ask in-depth questions to further characterize the participant's episodes of priapism. if health issues such as drug use, harmful sexual behaviors, or impotence are identified upon reviewing the questionnaire, clinic staff will suggest care options and provide appropriate referrals to the participants. all participants will receive an educational brochure about priapism and compensation for completing the questionnaires.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over or * diagnosis of sickle beta plus thalassemia or sickle hemoglobin c disease, if 15 years of age or over * participant and/or parent or guardian must be able to communicate adequately with the interviewer * may participate if currently taking hydroxyurea, undergoing chronic transfusion, or participating in other research studies, including those involving treatments such as arginine, if all other inclusion criteria are met exclusion criteria subjects who meet any of the following criteria are disqualified from enrollment in the study: 1. patient or parent/guardian declines participation. 2. female. 3. subject or parent/guardian unable to communicate adequately with the interviewer.

Keywords: sickle cell anemia
meditation strategies, attention, and mobility in older adults

Conditions: Mobility Limitation

Summary: approximately 30% of community-dwelling older adults experience one or more falls per year, resulting in injuries, loss of independence, and reduced quality of life. while there are known physiological risk factors for falls, including poor balance and altered gait patterns, it is now recognized that impaired cognitive functioning is also a risk factor for falls. within the broad construct of cognition, one specific domain that has been focused on in the falls literature is attention. the literature suggests that improving attention in those at-risk for falls may reduce older adult's risk of falling.

the current study aims to investigate the impact of meditation strategies on measures of attention and electrical signals in the brain in older adults. investigators will recruit older adults who are living in the community. participants will be assigned to one of two groups: 1) guided focused attention group, or 2) music group (control group). all participants will complete three in-person sessions per week and then be encouraged to practice independently on the other days in the week, for a total of four weeks.the current study focuses on focused attention meditation strategies, as it is recommended for beginner-level meditators. this will include training to be able to focus on one's breathing for 20 minute sessions. focused attention meditation has been found to increase levels of executive functioning and attention. participants will complete mobility and cognitive assessments at both the beginning and end of the intervention. these will be completed in the retirement homes for convenience. participants will also attend an in-lab session to complete electroencephalogram (eeg) testing at both timepoints.

Eligibility criteria:
inclusion criteria: 1. minimum 60 years of age, 2. minimum completed high school, 3. must be comfortable writing and reading english, 4. be able to walk independently, 5. must be right-handed (for eeg analysis), 6. score 6+/8 on the instrumental activities of daily living scale, 7. score \>24/30 on the mini-mental status examination. exclusion criteria: to be included, participants must not: 1. have a diagnosis of neurodegenerative disease, 2. have a diagnosis of cognitive impairment (e.g., mci), 3. have a diagnosis of a psychiatric condition, 4. have had a concussion in the last 12 months, 5. have had a stroke, 6. have musculoskeletal or joint disease, 7. experience dizziness or loss of balance, 8. have visual, auditory, or somatosensory impairment, or 9. a recent history (past 2 years) of regular meditation practice (1 or more times per week) or include a meditation component in their religious practice.

Keywords: meditation cognitive assessment executive function older adults randomized control trial mobility
efficacy, safety and tolerability of neramexane in patients with subjective tinnitus

Conditions: Subjective Tinnitus

Summary: the purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 years with a clinical diagnosis of first onset, * persistent (i.e. tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months exclusion criteria: * clinical diagnosis of intermittent or pulsatile tinnitus * patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, menière's disease, otosclerosis, etc)
comparison between sutureless devices for picc and a new system kt fix plus

Conditions: Catheter Complications; Thrombosis; Displacement of Infusion Catheter; Quality of Life

Summary: picc (peripherally inserted central catheter) are commun used. just one paper report morbidity with suture as fixation system for picc (dislodgement, infection) in the guidelines it's recommended to use sutureless device. the devices actually used are unsatisfactory because of the high risk of migration, accidental removal. a new device, called ktfix plus, seem to be more secure for picc fixation and offer the possibility to simplify the after care. this device may stay on patient for 4 weeks. others devices may be changed 1/week. the investigators aimed to compare morbidity between this new device and the old one. the investigators also want to perform an economic evaluation of this device and compare patient quality of life.


Eligibility criteria:
inclusion criteria: * patient with indication for picc according guidelines * hospitalized in a departement of your hospital * with the possibility to use a sutureless device exclusion criteria: * infection * thrombosis * pediatric patient * emergency context

Keywords: central venous catheter catheter bloodstream related infection economic evaluation
safety and efficacy study of qr-333 in patient's with symptomatic diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: the purpose of this study is to determine whether qr-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.

diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. the pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. the pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution. to date there is no fully effective treatment for diabetic neuropathy. therapy is tailored individually according to subject complaints and may be selected from categories including non-steroidal anti-inflammatory drugs (nsaids) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants). the clinical trial is being conducted to determine the safety and efficacy of qr-333 in the treatment of diabetic neuropathy as compared to placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetic neuropathy * must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment * must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed exclusion criteria: * uncontrolled pain that has persisted for \> 12 months.

Keywords: diabetic peripheral neuropathy
parecoxib for treatment of catheter related bladder discomfort

Conditions: Postoperative Pain

Summary: catheter-related bladder discomfort (crbd) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. in the present study, the investigators evaluated parecoxib (p) for preventing crbd in patients undergoing catheterization after transurethral resection of bladder tumor (turbt).

participants will be randomized into one of two study groups: group p: 40 mg of intravenous parecoxib 30 min before surgery and control group c: an equal volume of saline. lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg sufentanyl. intra-operatively, urinary catherization was performed with a 16 fr foley's catheter, and the balloon was inflated with 10 ml distilled water. the crbd was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. severity of crbd was graded as none, mild, moderate and severe.

Eligibility criteria:
inclusion criteria: 1. adult (\>/=18) 2. male or female 3. undergoing catheterization after transurethral resection of bladder tumor (turbt) 4. under spinal anesthesia 5. subject is american society of anesthesiologists (asa) physical status 1 or 2. exclusion criteria: 1. patient who disagrees to participate this investigation 2. patient with severe cardiovascular disease 3. patient with small-sized foley catheter (less than 18 fr.) 4. patinets with bladder outflow obstruction 5. patient with overactive bladder (frequency \>3 times,in the night or \>8 times in 24 h) 6. patients with chronic renal failure 7. patient with morbid obesity 8. patient with medications for chronic pain 9. patient with disturbance of the central nervous system

Keywords: parecoxib bladder discomfort