Kornimate/medical-research-clean huggingface dataset:
18f-clofarabine pet/ct in imaging cancer patients before and after interventions

Conditions: Malignant Neoplasm

Summary: this clinical trial studies 18f-clofarabine positron emission tomography (pet)/computed tomography (ct) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). pet/ct scans give detailed pictures of areas inside the body. 18f-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dck), which is highly expressed in activated immune cells, making them light up during pet/ct scans. doctors also want to know how 18f-clofarabine is distributed throughout the body before and after treatment with immunotherapies.

primary objectives: i. to determine whether positron emission tomography (pet) using the new imaging agent 18f-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18f-clofarabine. outline: patients receive 18f-clofarabine intravenously (iv) and undergo pet/ct scan at baseline and 2-4 weeks after completion of immunotherapy.

Eligibility criteria:
inclusion criteria: * must be able to tolerate pet/ct (i.e. not claustrophobic and able to remain supine) * no restrictions based on gender or racial/ethnic background exclusion criteria: * women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
a non-interventional, epidemiological, registry-based evaluation of anaemia in swedish patients with chronic kidney disease

Conditions: Chronic Kidney Disease Associated Anemia

Summary: the primary purpose of this study is to describe renal anemia treatment patterns in non-dialysis dependent (nd) and dialysis dependent (dd) populations, with a particular focus on iron use in erythropoiesis stimulating agent (esa) treated patients. this study will also provide an epidemiological description of chronic kidney disease (ckd) associated anemia in relation to ckd stage, dialysis modality and underlying morbidity, as well as describe the relationship between inflammation and esa treatment and describe the associated cardiovascular illness in esa treated patients.

data from year 2015 will be used for the prevalence analysis.the prevalent population of ckd patients \> 18 years in the swedish renal registry in 2015 both dependent on dialysis (dd) and not on dialysis (nd).

Eligibility criteria:
inclusion criteria: * for nd-ckd population: * all prevalent patients with a ckd with estimated glomerular filtration rate (egfr) \< 45ml/min/1.73m2 with a recorded visit pre-dialysis in swedish renal registry (srr) in 2015 * not on dialysis * for dd-ckd population * all prevalent patients taking part in the yearly cross-sectional dialysis investigation in srr in 2015 * dialysis dependent exclusion criteria: * not applicable

Keywords: erythropoiesis stimulating agent chronic kidney disease associated anemia asp1517
neuro- and biofeedback in nonsuicidal self-injury

Conditions: Nonsuicidal Self Injury; Emotion Regulation

Summary: nonsuicidal self-injury (nssi) is defined as the direct, deliberate destruction of one's own body tissue without suicidal intent, typically including behaviors such as cutting, burning, or hitting oneself. the risk of engaging in nssi is particularly high during adolescence. nssi is associated with impairments in emotion regulation and nssi behavior serves as an attempt to regulate emotion. we propose to examine whether training adolescents with nssi to self-regulate using emotion regulation skills to down-regulate hemodynamic activity of the salience network, involved in emotional processing. moreover, we propose to examine whether limbic-prefrontal cortex connectivity can be increased following neurofeedback, thereby helping adolescents find an optimal way to emotionally regulate with the help of neurofeedback, instead of engaging in nssi to regulate emotions. we also aim to examine effects of real-time biofeedback by investigating if adolescents can regulate their psychophysiological activity during emotional reactivity with biofeedback. sixty participants with nssi will be recruited and offered either real-time functional magnetic resonance imaging (rt-fmri-nf) (n = 30) or real-time biofeedback (n = 30) training. participants each each condition will then be randomized to either an active or a control condition (n = 15/group). participants will take part in three runs of feedback training. changes in emotional reactivity as measured with facial electromyography (emg) before and after feedback training will be the proximal outcome measure together with changes of the blood oxygenation level dependent (bold) response during real-time fmri-neurofeedback for the neurofeedback training. proximal outcome measures for the biofeedback will include psychophysiological measures of emotional reactivity (facialemg). more distal outcome measures for both neuro- and biofeedback will be measures of nssi: frequency, methods and severity as well as self-report measures of difficulties with regulating emotions, emotional reactivity and psychiatric symptoms.


Eligibility criteria:
inclusion criteria: * ongoing contact at the child- and adolescent psychiatric clinics in both linköping and norrköping, sweden * ongoing contact at the primary care facilities in linköping and norrköping (ungdomshälsan, råd, stöd \& hälsa) * nssi, independent of psychiatric diagnosis * between 15 and 19 years of age * having engaged in five or more instances of nssi during the last six months * the patient is cognitively capable to decide for him- or herself exclusion criteria: * anorexia in starvation with bmi 16 or under * substance abuse disorder * psychosis * needing interpreter * intellectual disability * and for those who do the neurofeedback, severe claustrophobia, pregnancy and braces

Keywords: nonsuicidal self-injury emotion regulation adolescents neurofeedback biofeedback
safety and efficacy of cryoablation for metastatic lung tumors

Conditions: Metastatic Lung Cancer

Summary: eclipse will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.

eclipse is a treatment, phase 1 multicenter, prospective, single-arm study with participants serving as their own control. this study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. participants will be followed for 5 years post their cryoablation procedure. cryoablation is the process of destroying tissue by the application of extremely cold temperatures. galil medical cryoablation systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), ears-nose-throat (ent), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).

Eligibility criteria:
inclusion criteria: * participant must be at least 18 years old. * participant has signed a written informed consent. * participant presents with stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease. * participant has up to 3 local metastases unilaterally targeted by cryoablation. maximum of 5 total pulmonary tumors bilaterally. * targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm. * the target tumor is determined (by ct/mri) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures. * eastern cooperative oncology group (ecog) score of 0-2. * karnofsky performance scale (kps) score ≥60. * platelet count \>50,000/cubed millimeters (mm\^3) within 60 days prior to study treatment. * international normalized ratio (inr) less than 1.5 within 60 days prior to study treatment. * participant has a life expectancy of \>3 months. * participant is clinically suitable for cryoablation procedure. exclusion criteria: * participant's primary cancer is lung cancer. * participant is unable to lie flat or has respiratory distress at rest. * participant has uncontrolled coagulopathy or bleeding disorders. * participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (anc) of less than 1000 that produce increase risk for the cryoablation procedure. * participant has a history of an allergic reaction to iodine injections or to shellfish. * participant has evidence of active systemic, pulmonary, or pericardial infection. * participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up. * participant is currently participating in other experimental studies that could affect the primary endpoint.

Keywords: cryoablation cryotherapy cryosurgery metastatic lung pleura tumors
acute effects of gabapentin in sleep parameters and hormonal release during sleep in older men

Conditions: Sleep

Summary: the primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (hpa), hypothalamic-pituitary-gonadal (hpg) and somatotropic axes hormones and basal igf-1 in older men.

the influence of sleep variables on muscle protein anabolism is little studied, but data on the effects of slow-wave sleep and the syndrome of obstructive sleep apnea on the hypothalamic-pituitary axis indicate that interventions in the sleep structure and disorders impact on the age-related muscle loss. thus, we propose to assess the acute effects of a drug potentially capable of increasing slow wave sleep, and consequently growth hormone release during sleep, on the physiological release of growth hormone, testosterone and igf-1 during the night in older healthy men.

Eligibility criteria:
inclusion criteria: * 60 years old or more, * healthy men exclusion criteria: * basal apnea-hypopnea index (ahi)\>=15 * restless legs syndrome symptons * bmi less than 18.5 kg/m2 or greater than 30 kg/m2 * less than 30 min. of regular physical activity (at least walking inside home, etc.) * plasma albumin below 3.5 mg/dl * psychoactive drugs use * drugs with muscle anabolic potential * current treatment for obesity or weight gain * enteral or parenteral feeding * inability to walk without assistance, * loss of independence in any activity of daily living * nocturia above 2 episodes * smoking more than 2 cigarettes per day * alcoholism (more than 2 doses a day) * prior epilepsy diagnosis * clinically evident atherosclerotic disease * dementia * depression * rheumatic diseases * cancer * diabetes (poorly controlled, hba1c \> 7,0, requirement of insulin) * thyroid dysfunction without treatment * advanced stages in copd, hf, liver or renal failure

Keywords: delta sleep growth hormone igf-1
efficacy and safety of novomix® 30 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (novomix®30) to that of biphasic human insulin (mixtard® 30) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 24 months * insulin treatment for the pase 3 months * hba1c (glycosylated haemoglobin) below 13% * bmi (body mass index) below 40 kg/m\^2 * ability and willingness to perform self-blood glucose monitoring exclusion criteria: * receipt of any investigational drug within 4 weeks prior to this trial * treatment of ohas (oral hypoglycaemic agents) within 4 weeks prior to this trial * total daily insulin dosage less than or equal to 1.8 iu/kg
periosteal electrical dry needling in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: to determine the effect of periosteal electrical dry needling as an adjuvant to mwm in knee osteoarthritis for pain management, for improvement in functional activities and for rom (range of motion)

periosteal stimulation therapy (pst) or periosteal electroacupuncture applies direct electrical stimulation of the periosteum and its associated nerves using parsimoniously applied acupuncture needles over bony prominences. it is an aggressive local treatment for deep pain problems such as oa (osteoarthritis ) . mobilization with movement (mwm) is a manual therapy technique that is used most frequently for the management of musculoskeletal conditions. in this technique, the physiological movement is performed in a pain-free manner with accessory glides being applied in the direction towards the opposite of the previously painful movement to have the greatest improvement mwms has shown promising various therapeutic benefits such as reduction of pain and improved range of motion. previous evidence has shown the effectiveness of mwm on pain reduction and functional improvement in patients with knee oa. the rationale for the use of pst in comparison with mwm techniques is to determine the effectiveness of periosteal electrical dry needling for the common use intervention for knee osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. age group \>40, 2. patient who met american college of rheumatology criteria of osteoarthritis, 3. chronic knee pain \> 3 months, 4. morning stiffness \<30 mins, 5. crepitation 6. bony tenderness exclusion criteria: 1. diagnosed meniscal injury or ligamentous injury, 2. history of intraarticular injection in last 3 months, 3. generalized low back related leg pain, 4. patients with fear of needles, 5. patients administered with corticosteroids or receiving any other invasive treatment such as prp, stem cell therapy, ozone therapy 6. history of any surgery of lower extremity in last 6 months 7. malignancy

Keywords: dry needling acupuncture mobilization with movement
a clinical data collection study of verily patch

Conditions: Febrile; Afebrile

Summary: this is a single center, prospective, non-randomized prospective observational data collection study of the verily patch. the verily patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the verily patch.


Eligibility criteria:
inclusion criteria: * at least 18 years old * able to read and speak english * able to read and understand the informed consent form * willing to wear verily patch in the axillary region * willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings * have a working smartphone device and willing to use it for study activities * willing to install study apps on their personal smartphone * willing to comply with all study-related procedures exclusion criteria: * pregnant or breastfeeding during study participation * have known allergies to medical grade adhesives * have known cutaneous hypersensitivity * have infection in both axilla * have open injury or rash where the study device will be worn * have a cardiac pacemaker or other implanted electronic medical device(s) * have any additional condition or situation that, in the opinion of the investigator, makes the subject inappropriate for participation in the study
mri assessment of rv function: patients with tof or aortic coarctation

Conditions: Congenital Disorders

Summary: at children's healthcare of atlanta at egleston, it is standard of care to do a cardiac mri on patients with the diagnosis of tetralogy of fallot and aortic coarctation to evaluate heart function. we propose to do a retrospective chart review of patient data along with their mri data to analyze ventricular function and cavity volumes pre-tetralogy of fallot repair, post-tetralogy of fallot repair (pre-valve repair/replacement) and post-valve repair/replacement in order to assess the efficacy and optimal timing of valve replacement.

patients with tetralogy of fallot have various degrees and levels of right ventricular outflow tract obstruction. they undergo surgical removal of the obstructing structures, which includes the pulmonary valve. the repair of the outflow tract is done utilizing a transannular patch. this approach, which is considered the standard of care, results in free pulmonary insufficiency, which may become severe and lead to right heart overloading and subsequent dilatation and dysfunction. this chronic overloading results in progressive tricuspid insufficiency and a suspected decline in effective pulmonary blood flow, cardiac output and right ventricle functional capabilities. many patients develop progressive exercise intolerance, arrhythmias and severe cardiomegaly leading to dilated cardiomyopathy. the progressive decline in patient clinical status results in recommendations of pulmonary valve replacement to interrupt further dysfunction of the ventricles. clinical improvement is generally seen among the patients and cardiac function is measurably improved in many cases, however the timing of surgery remains undefined and its impact on function improvement and recovery post -valve replacement is under serious debate and continuous discussion. preliminary work suggests that magnetic resonance imaging (mri) determined right to left ventricular volume ratio's of greater than 2:1 with associated tricuspid regurgitation, right ventricular regurgitant volumes of greater than 50%, and right ventricular ejection fractions less than 45% are common among patients with severe right ventricular failure and dysfunction. these patients are in need of pulmonary valve replacement and have routinely been referred for surgical intervention. patients with aortic coarctation have a localized malformation characterized by deformity of the aortic media, causing narrowing, usually severe, of the lumen of the vessel. surgical repair or removal of this malformation is the treatment of choice however; the use of mri to better determine the extent of damage or malformation would allow the surgeon to plan an operative strategy prior to opening the chest.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of tetralogy of fallot or aortic coarctation being treated at children's healthcare of atlanta at egleston. exclusion criteria: * those patients who do not meet the inclusion criteria

Keywords: cardiac pediatric mri tetralogy of fallot tof aortic coarctation
compartmental overpressures associated to reamed intramedullary nails

Conditions: Tibial Fractures

Summary: the purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. when reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. in fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-p value, which is the result of the mean arterial pressure minus compartmental pressure. if this one is less than 30 mm hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.

Eligibility criteria:
inclusion criteria: * tibial shaft fractures treated with intramedullary reamed nails exclusion criteria: * tibial fractures treated with other types of fixation or nails not reamed.

Keywords: intramedullary nails compartmental syndrome fractures
comparing analgesic efficacy of systemic lidocaine against placebo in general anesthesia in bariatric surgery

Conditions: Pain, Postoperative

Summary: the investigators plan to evaluate the analgesic effect of systemic lidocaine in addition to general anesthesia during bariatric surgery. patients will be subdivided into a "lidocaine group" and a "control group". the primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery. secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.

postoperative pain is a common problem in today's surgery, although pain management techniques have improved in the last years. systemic application of lidocaine has gained interest since several studies have shown its analgesic, anti-inflammatory and antihyperalgesic properties. in this clinical trial the analgesic effect of intravenously administrated lidocaine is compared with placebo. despite longstanding use as an antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not licensed for this indication and application. current studies, setting the focus on abdominal surgery, indicated that the systemic application of lidocaine was associated with fewer intensity of pain at rest and during mobilization and resulted in a decrease of patients'opiate consumption. the intervention to be studied will either be the additional application of systemic lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo. patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of ponv, time to first defecation and length of hospitalization will be monitored. the population to be studied will include 140 patients listed for bariatric surgery at the kantonsspital st. gallen. patients, medical practitioner, nurses and investigators will be blinded. each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

Eligibility criteria:
inclusion criteria: * elective laparoscopic bariatric surgery * asa classification i - iii * age 18 - 80 * given informed consent exclusion criteria: * no written consent * allergy to the investigational product * cardiac arrhythmia (pacemaker) * liver dysfunction (child-pugh classification a, b or c) * pregnancy * central nervous disease * chronic pain and pre-existing opiate prescription * expected non-compliance * drug/alcohol abuse

Keywords: systemic lidocain