Kornimate/medical-research-clean huggingface dataset:
subcutaneous nerve stimulation for failed back surgery syndrome (fbss) patients

Conditions: Failed Back Surgery Syndrome; Post-laminectomy Syndrome

Summary: the purpose of this study is to assess the safety and efficacy of subcutaneous nerve stimulation (sqs) (also known as peripheral nerve stimulation \[pns\]) in the reduction of chronic, intractable post-surgical back pain in adults.

this study is a multi-center, prospective, randomized (1:1) parallel-group design.

Eligibility criteria:
key inclusion criteria: * have persistent back pain for at least 6 months * had back surgery at least 6 months ago * have tried pain medications and physical therapy * read and understand written english or spanish * male or non-pregnant female. if female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation * willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements * have an expected lifespan greater than 12 months key exclusion criteria: * have leg pain in addition to back pain. * currently enrolled in or plan to enroll in another drug and/or device study * have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia * have an active systemic infection or are immunocompromised * will be exposed to diathermy or anticipate needing a full-body mri scan * currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator * treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery
biologic effects of dehydroepiandrosterone (dhea) in humans

Conditions: Aging; Obesity; Insulin Resistance

Summary: the purpose of this study is to determine whether dhea replacement therapy decreases abdominal fat and improves insulin sensitivity.

studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (dhea) reduces abdominal visceral fat and protects against insulin resistance. this study was done to learn if dhea replacement therapy decreases abdominal obesity and improves insulin action in humans. participants were randomly assigned to receive 50 mg per day of dhea or a placebo at bedtime for 6 months. participants underwent magnetic resonance imaging (mri) and oral glucose tolerance tests at the beginning and conclusion of the study. other tests included measurements of hormones and lipids.

Eligibility criteria:
inclusion criteria: * 65 to 78 years old * physically healthy * non-smoker * on stable medications for at least 6 months * stable body weight for the past year exclusion criteria: * serious active medical problems * hormone therapy * abnormal psa (prostate specific antigen) in men

Keywords: abdominal fat dehydroepiandrosterone insulin sensitivity
evaluation and timing in an eras-like structured rehabilitation program after lumbar spine surgery

Conditions: Lumbar Pain Syndrome

Summary: the goal of this clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery. participants are assigned to therapy groups c (low) - a (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. groups are compared in terms of safety, disability impairment as well as pain. timing of rehabilitation is considered.

purpose literature on early rehabilitation after lumbar spine surgery trends towards a structurized program beginning in the post-acute phase, but publications are rare. therefore, this study was conducted to investigate the safety of early rehabilitation according to eras® principles after different lumbar spine surgeries with regard to training intensity and timing of rehabilitation. methods study design was prospective, non-randomized, and multicentric (3 inpatient rehabilitation facilities in germany). based on the senior rehabilitation physician's assessment for patient's physical capacity, patients were assigned to therapy groups c - a (low - high intensity). for statistical analysis patients were also grouped in 3 different time intervals depending on days past surgery until rehabilitation start and. safety (recurrence rates), disability (oswestry disability index (odi)), and pain (visual analogue scale (vas)), were measured at the beginning and at the end of rehabilitation stay. scores were compared between 3 therapy groups and 3 time intervals for within- and between-group differences. analgesics and back orthesis use was assessed and analysed as well.

Eligibility criteria:
inclusion criteria: * all patients admitted to inpatient rehabilitation facility after lumbar spine surgery exclusion criteria: * non-german speakers

Keywords: enhanced recovery after surgery spinal injuries rehabilitation recurrence low back pain
long term safety of cooling anesthesia for intravitreal injection

Conditions: Anesthesia, Local; Intravitreal Injection; Macular Edema; Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema

Summary: the purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema. there is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia. recens medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye this device cools to a temperature around -5 to -15 degrees celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. the value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections. this device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care. the purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Eligibility criteria:
inclusion criteria: * men and women \> 18 years old at screening visit. * men and women who are undergoing intravitreal injections in either one eye or both eyes with either lucentis or eylea as part of their normal standard of care with a 30 gauge needle. * subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit. * subject is willing and able to sign the study written informed consent form (icf). exclusion criteria: * history of presence of scleromalacia * preexisting conjunctival, episcleral or scleral defects * less than 18 years of age * unable to provide informed consent * has received less than 3 injections in the study eye * active severe eye disease not controlled with artificial tears and requiring restasis or other prescription drugs for dry eye. * history of endophthalmitis with intravitreal injection * history of uveitis * history of retinal detachment in either eye * history of vitrectomy * subjects who received administration of cooling anesthesia as part of the cool-1 study will not be excluded and are eligible to participate in this study.

Keywords: intravitreal injection anesthesia macular degeneration diabetic macular edema
establishment of biomarkers for fabry disease

Conditions: Fabry Disease

Summary: fabry disease, an x-linked recessive lysosomal storage disease (lsd) is commonly recognized as a cause of renal failure in involved men and more recently recognized in women too. women are involved in significant numbers and with complications, as are men, of vascular disease. this manifests as unexpected strokes in young adults. we have morphologic evidence that storage-endotheliopathy induced microvascular disease is the cause of cardiopathy and of cryptogenic strokes, and that storage endotheliopathy starts in early life, probably before birth. based on our earlier work with other endotheliopathies such as diabetes mellitus, susac syndrome, and hypertension, we will find and study patients using unique methods, neuro-retinal fluorescein angiography (nrfa), that we have developed for this purpose. these methods include nrfa to demonstrate capillary perfusion in the optic nerve head and retinal quadrants. we anticipate, based on our earlier experience with other endotheliopathies, that we will show more vascular pathology earlier than previously reported. using epidemiologic and genetic tools we will find more patients than previously known or expected. it will offer opportunity for earlier diagnosis, prognosis, and response to enzyme replacement therapy. we hypothesize that fabry disease is a poorly recognized and poorly characterized cause of microvascular disease and cryptogenic strokes in young women and men. neuroretinal capillary perfusion abnormalities in fabry disease will be predictive of equivalent vascular disease in kidney, heart, brain and other organs, and further that it will be responsive to change induced by enzyme replacement therapy treatment.

specific aims specific aim 1. to demonstrate the specificity and sensitivity of the diagnostic capabilities of a neuroretinal examination which includes slit lamp and fundoscopy, and nrfa for the diagnosis of fabry disease on a subject population of identified fd patients. specific aim 2. to show capillary perfusion abnormalities in optic nerve and retina using neuroretinal fluorescein angiography in patients with fabry disease and compare these to renal (measured by gfr). specific aim 3. to show that the change in capillary perfusion studies when compared to baseline in response to enzyme replacement therapy treatment over time, as a manifestation of tissue burden and prognosis is a more sensitive biomarker of the extent of patient disease than corneal keratopathy.

Eligibility criteria:
inclusion criteria: * fabry patient * evidence of angiopathy (renal, cardiac, or ocular) * patients above the age of 18 exclusion criteria: * patients unable or unwilling to provide written informed consent will not be recruited * patients who are below the age of 18 * patients who have not or will not be undergoing fluorescein angiography * allergy to fluorescein * pregnant women and fetuses are exclude from the study due to risks related to fluorescein and no direct benefit to the pregnant woman and fetus

Keywords: fabry disease vascular disease storage endotheliopathy
do preoperative carbohydrate drinks prevent preoperative catabolism in mothers undergoing elective caesarean section? a randomised controlled study

Conditions: Starvation; Caesarean Section

Summary: the primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.

patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. this is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents). however, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. fasting increases anxiety levels and leads to poor patient satisfaction with the care received. recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation. carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed enhanced recovery after surgery (eras). the benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. however, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. we hope to address this gap in the knowledge with our proposed study. all mothers undergoing a planned caesarean section in the princess royal maternity (prm) will be invited to participate. mothers will be divided into two groups. one group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. information collected from the groups will be compared to evaluate the expected benefits and risks. the study will continue until the target sample size of 100 mothers in each of the two study groups is reached.

Eligibility criteria:
inclusion criteria: * mother scheduled for elective caesarean delivery at the princess royal maternity unit, glasgow. exclusion criteria: * patient refusal * severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. barrett's oesophagus.) * diabetes mellitus requiring treatment beyond dietary modulation * unable to consent * patients undergoing general anaesthetic should be excluded from the study. * anticipated complex caesarean section patients.

Keywords: sequela ketosis
the effect of bovine colostrum supplementation in older adults

Conditions: Sarcopenia; Osteoporosis

Summary: bovine colostrum is the initial milk secreted by cows during the first day after calving. colostrum is high in protein and contains a number of substances that have potential to be beneficial for the immune system. preliminary studies about effects of colostrum supplementation show its potential for increasing human exercise performance; however, more evidence across the lifespan is required to confirm effects and to understand mechanisms of action. the objectives are to determine the effect of 8 weeks of bovine colostrum supplementation, compared to whey protein supplementation on the following dependent variables in men and women 50 years and older while participating in a resistance-training program: * muscle mass * strength * blood levels of growth factors and markers of inflammation * urine levels of muscle and bone catabolic markers * tests of cognitive ability it is hypothesized that bovine colostrum supplementation will result in greater increases in muscle mass, strength, blood igf-1 levels (an anabolic hormone), and cognitive ability, and greater reductions in inflammation, and markers of muscle and bone catabolism, compared to placebo.


Eligibility criteria:
inclusion criteria: * men or women 50 y or older exclusion criteria: * milk allergies * contraindications to exercise as indicated by the physical activity readiness questionnaire

Keywords: sarcopenia osteoporosis cognition inflammation
a study of talquetamab with other anticancer therapies in participants with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.


Eligibility criteria:
inclusion criteria: * have documented initial diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria * have measurable disease at screening as defined by at least 1 of the following: a. serum monoclonal protein (m-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dl); or b. urine m-protein level \>= 200 milligrams (mg)/24 hours; or c. light chain multiple myeloma: serum immunoglobulin (ig) free light chain (flc) \>=10 milligrams per deciliter (mg/dl) and abnormal serum ig kappa lambda flc ratio * have an eastern cooperative oncology group (ecog) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration * a woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hcg) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration * be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (imid) global pregnancy prevention plan (ppp) or local ppp/risk evaluation and mitigation strategy (rems) program exclusion criteria: * live, attenuated vaccine within 4 weeks before the first dose of study treatment * received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the start of study treatment administration * active central nervous system (cns) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. if either is suspected, brain magnetic resonance imaging (mri) and lumbar cytology are required * known to be seropositive for human immunodeficiency virus * history of stroke or seizure within 6 months prior to the first dose of study treatment
physiologic approach to sodium supplementation in premature infants

Conditions: Postnatal Growth Disorder

Summary: postnatal growth failure occurs in up to 50% of very low birth weight (vlbw, \<1500 grams at birth) infants as assessed by discharge weight. this study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.

postnatal growth failure is a significant morbidity in very low birth weight (vlbw, \<1500 grams at birth) infants. efforts to promote growth and optimize nutritional support have included earlier initiation of parenteral nutrition and increased caloric and protein administration. while these advances in nutritional practices have resulted in improved growth, up to 50% of vlbw infants continue to experience postnatal growth failure (defined as discharge weight \<10th percentile by fenton growth charts) and over 25% experience severe postnatal growth failure (\<3rd percentile). current nutritional recommendations for sodium provision to preterm infants is 3-5 meq/kg/d and fails to take into account the degree of renal immaturity present in extremely preterm infants. the investigators hypothesize that the sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over current sodium replacement practices. the algorithm will be evaluated in a prospective, pragmatic, randomized trial. infants in the sodium supplementation algorithm group will have a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal day and continuing until 36 weeks postmenstrual age with sodium supplementation provided according to the algorithm.

Eligibility criteria:
inclusion criteria: 1. infants with gestational age 25 0/7 - 29 6/7 at birth 2. birth weight ≥ 500 grams 3. admitted within the 1st week of life 4. \< 17 days of age at time of enrollment exclusion criteria: 1. infants admitted after the 1st week of life 2. major congenital anomalies 3. structural genitourinary abnormality 4. renal dysfunction (serum creatinine \> 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures. 5. diuretic use less than 48 hours prior to initiation of study procedures 6. infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn) 7. infant with a diagnosis or suspicion of diabetes insipidus

Keywords: postnatal growth disorder growth and development
somatic disease among alcohol abusers in an out-day patients' clinic

Conditions: HEART DISEASE; Liver Failure; DEPRESSIVE DISORDER; Alcoholic Neuropathy

Summary: alcohol abuse is associated with a variety of clinical diseases, but studies on prevalence of different somatic diseases among alcohol abusers are lacking. studies on populations in an out-day patients' clinic are also lacking. the investigators aim to study somatic health standard in an out-day patients' clinic population of alcohol abusers, with regard to prevalence of different kinds of somatic diseases, and how the interaction of somatic and psychiatric treatment can influence on patients quality of life. clinical examination including blood samples and echocardiographic examinations in all participants, other additional examinations (as x-ray, ct or mri if indicated by clinical findings).

retrospective methods will be used to study former somatic disease, cross-section design to study present somatic disease and prospective design to study quality of life, psychiatric and somatic health after combination of psychiatric and somatic examinations and treatment.

Eligibility criteria:
inclusion criteria: * alcohol abusers reffered to the out-day patients' clinic at dep. of psychiatry, levanger hospital, norway exclusion criteria: * not consenting to participate * not able to consent

Keywords: heart failure liver depression neuropathy
assessment of hearts deemed unsuitable for transplant with the aim of expanding the donor heart pool.

Conditions: Heart Failure

Summary: the main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. ultimately this may lead to an increase the number of hearts available for transplantation.

year on year with improvement in road safety and improvement in neurosurgery the number of ideal young brain dead donors have been declining whilst the number of more marginal donors have been increasing. the consequence of this is the number of heart transplants being performed have steadily declined. at present there are 600 hearts from brain dead donors offered for transplant every year in the united kingdom (uk). of these 200 have anatomical reasons why they cannot be used for transplant such as ischaemic heart disease. 100 are transplanted and the remaining 300 hearts are judged to have inferior function which probably occurs as a direct result of brain death (dark). ex vivo 'rig' testing has been developed for lungs that were judged unsuitable for transplantation. as a result several donor lungs have been 'improved' by warm perfusion on the rig to the extent that they became suitable for transplantation and so national lung transplant rates are increasing (dark). the aim would be to develop a similar approach for the heart.

Eligibility criteria:
inclusion criteria: * participant is brain dead and their relative is willing to give informed consent * male or female, aged between 18 and 75 years * heart is not eligible for transplantation exclusion criteria: * participant's relative refuses consent * brain dead donor whose heart is eligible for transplantation

Keywords: heart transplantation ev vivo perfusion cardiac function