Kornimate/medical-research-clean huggingface dataset:
mt2014-14 it-msc for advanced cerebral adrenoleukodystrophy (cald)

Conditions: Cerebral Adrenoleukodystrophy

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of mesenchymal stem cells (it-msc) in patients with active, advanced cerebral adrenoleukodystrophy (cald).

this is a single-institution dose escalation study to determine the maximum tolerated dose (mtd) of intrathecally administered allogeneic, 3rd party mesenchymal stem cells (it-msc) in patients with active, advanced cerebral adrenoleukodystrophy (cald).

Eligibility criteria:
inclusion criteria: * age ≥ 4 years at time of study enrollment * diagnosis of ald - the diagnosis of ald can be made by either biochemical or molecular/genetic evidence (plasma vlcfa or abcd1 mutation analysis) supportive of ald as the cause of cerebral demyelination * evidence of active cerebral disease - defined as the presence of gadolinium enhancement on a single brain mri study - mri used for eligibility determination may be performed at an outside institution; the most recent mri used to determine eligibility must be within 2 calendar months of the date of enrollment on this study * ald mri (loes) score ≥ 10 * off of n-acetylcysteine, systemic immunosuppressive drugs or any other therapeutic intervention (except hydrocortisone and/or fludracortisone for the treatment of adrenal insufficiency) for ≥ 10 days prior to the first it-msc dose * life expectancy of \>6 months as determined by the enrolling researcher and documented in the medical record * voluntary written consent provided by parent(s)/guardian(s) exclusion criteria: * a candidate for allogeneic hematopoietic stem cell transplantation as determined by the university of minnesota inherited metabolic and storage disease group * inability to undergo sedation, lumbar puncture or mri studies for any reason * inability to stay in minnesota for therapy through the day 28 evaluation

Keywords: cerebral adrenoleukodystrophy cald
evaluating sexual function after vaginal repair with perineorrhaphy

Conditions: Sexual Function

Summary: this is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. we hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.


Eligibility criteria:
inclusion criteria: * sexually active * genital hiatus measured between 4 and 6 centimeters * desires sexual function * undergoing vaginal repair with native tissues * agrees to use vaginal estrogen for 12 months after surgery exclusion criteria: * genital hiatus \> 6 cm * planned obliterative procedure * perineal body length \<0.5cm * disrupted external anal sphincter

Keywords: vaginal prolapse sexual function sexual dysfunction prolapse surgery
behavioral exercise therapy and multidisciplinary rehabilitation for chronic non-specific low back pain

Conditions: Chronic Low Back Pain

Summary: multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. exercise therapy plays a major role in such a combination of treatments. there is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. it is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. the role of exercise therapy has yet to be investigated. aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. the main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.


Eligibility criteria:
inclusion criteria (icd-10): * f45.4 persistent somatoform pain disorder * f45.41 chronic pain disorder with somatic and psychological factors * f54 psychological and behavioural factors associated with disorders or diseases classified elsewhere * m51.2 other specified intervertebral disc displacement * m51.3 other specified intervertebral disc degeneration * m51.4 schmorl's nodes * m51.8 other specified intervertebral disc disorders * m51.9 intervertebral disc disorder, unspecified * m53.8 other specified dorsopathies * m53.9 dorsophathy, unspecified * m54.4 lumbago with sciatica * m54.5 low back pain * m54.6 pain in thoracic spine * m54.8 other dorsalgia * m54.9 dorsalgia, unspecified * r52.2 other chronic pain exclusion criteria: * distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy) * severely limited health status (comorbidity) * serious impairment of vision and hearing (not corrected) * serious psychiatric codiagnosis (exkl. see inclusion criteria) * inability to speak german * pension claim (§51 sgb v - german law)
intraretinal cystoid changes after vitrectomy with membrane peeling

Conditions: Macular Edema, Cystoid

Summary: aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

epiretinal membranes (erm) are disorders leading to vision loss and metamorphopsia. vitrectomy with membrane peeling has developed to be the gold-standard in treatment of erm. nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. the aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Eligibility criteria:
inclusion criteria: * presence of an erm * indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the erm * application of periocular triamcinolone acetonide at the end of surgery * at least one follow-up examination present in the patient's history exclusion criteria: * macular edema caused by conditions other than erm (such as choroidal neovascularization, diabetic macular edema, etc.)
snif (sniff nasal inspiratory force) reference values of mediterranean population

Conditions: Healthy People Programs

Summary: snif test has been described as a method to explore the diaphragmatic function. but there are no defined the reference values of this test in healthy population. the investigators' hypothesis is that there is a variation on snif values in mediterranean population depending on gender, age and anthropometric variables such as height and weight. the investigators will analyze 1000 snif test of healthy people. the investigators will divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the investigators will study 100 men and 100 women. all the subjects will perform a forced spirometry, maximal inspiratory pressure (mip) and snif. if spirometry and mip are correct the investigators will consider that person has a correct diaphragmatic function and strength. then the investigators will measure the snif test. with all of these snif values the investigators will try to achieve the reference values of this test in the different groups of age in mediterranean population. and the investigators will compare snif with mip. cross multicentric study. hospitals involved: hospital de bellvitge, hospital del mar, hospital parc taulí, hospital de la santa creu i sant pau (coordinator center) and hospital de la vall d'hebrón.


Eligibility criteria:
inclusion criteria: * healthy people with spirometry and mip values in the reference range * age between 20 and 70 years old * caucasian race exclusion criteria: * rhinitis * nasal obstruction * frequent episodes of epistaxis * ongoing cold
dexamethasone for peng block in total hip arthroplasty

Conditions: Hip Osteoarthritis; Hip Arthropathy; Hip Pain Chronic

Summary: effect of adding dexamethasone to periarticular nerve group block in patients undergoing total hip arthroplasty

hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. patients may complain of severe pain due to surgical trauma and prostheses. regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Eligibility criteria:
inclusion criteria: * patients scheduled for total hip arthroplasty * patients aged \>65 and \<100 years * patients able to provide informed consent * patients able to reliably report symptoms to the research team exclusion criteria: * inability to provide first-party consent due to cognitive impairment or a language barrier
management of obstructive colon tumors in istanbul

Conditions: Colon Cancer; Tumor Obstruction; Emergencies; Quality of Life

Summary: the aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.


Eligibility criteria:
inclusion criteria: * acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected * clinical findings of obstruction (abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or ct exclusion criteria: * benign diseases * emergency surgery due to bleeding, perforation and other non-obstructive situations * recurrent colon tumors * rectal cancer
increasing the removal of protein-bound solutes during extended hours hemodialysis

Conditions: End Stage Renal Failure on Dialysis

Summary: hemodialysis keeps patients with renal failure alive but does not restore normal health. retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. this proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. the effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.


Eligibility criteria:
inclusion criteria: * stable on nocturnal in-center dialysis located close to stanford university and va palo alto exclusion criteria: * recent use of antibiotics * gastrointestinal disease
impact of the covid-19 pandemic in gynecological oncology

Conditions: Gynecologic Cancer; Breast Neoplasm Female; Uterine Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms

Summary: the current infection with the coronavirus sars-cov-2 (covid-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. data from the literature suggest that infection with coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. in addition, the risk of infection would be 3 times greater in case of cancer. faced with the covid-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (cpr, teleconsultation, adaptation of treatment or even postponement of treatment). the objective of the high council of public health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). this must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. the hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.


Eligibility criteria:
inclusion criteria: * women over 18 * gynecological cancer (breast cancer, uterus, ovary, cervix, vagina or vulva cancer) * therapeutic management planned during quarantine * person having expressed his non-opposition inclusion criteria of control group : * women over 18 * gynecological cancer (breast, uterus, ovary, cervix, vagina or vulva cancer) * therapeutic management planned on the end of the year 2019 * person having expressed his non-opposition exclusion criteria: * inability to understand the information given * person deprived of liberty, * person under guardianship.

Keywords: gynecologic cancer covid-19
intermittent fasting versus carbohydrate drinks before surgery

Conditions: Perioperative Care; Intermittent Fasting; Carbohydrate Loading; Preoperative Fasting; Orthopedic Surgery; Insulin Resistance

Summary: the purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.

patients in the time-restricted feeding (trf) group will follow a daily trf regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery. patients in the carbohydrate loading (chl) group will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia.

Eligibility criteria:
inclusion criteria: * undergoing elective orthopaedic surgery; * intermediate, major or complex surgery according to the surgical outcome risk tool (sort; http://www.sortsurgery.com/) severity of surgery classification; * scheduled for surgery at least 17 days from the date of screening; * motivated to follow a time restricted feeding regimen. * willing and able to provide written informed consent. exclusion criteria: * history of diabetes mellitus; * history of feeding or eating disorders; * history of delayed gastric emptying or gastro-oesophageal reflux * active malignancy * patients classified as asa iv by the attending anaesthetist; * bmi \< 18.5 or ≥ 35; * outpatient or day case surgery; * palliative surgery; * participation in another clinical trial that is interfering with the procedures or outcomes of the princess trial; * patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in dutch).

Keywords: perioperative care carbohydrate loading orthopedic surgery insulin resistance homa-ir time restricted feeding
rtms and botulinum toxin in primary cervical dystonia

Conditions: Primary Cervical Dystonia; Dystonia

Summary: primary cervical dystonia (pcd) is the most common form of focal dystonia. pcd is frequently reported as a source of disability, decreased quality of life, and social stigma. botulinum toxin (bont) is the gold standard treatment for pcd. the average duration of benefits from bont injections was about 9.5 weeks and bont treatment is known to provide only pure symptomatic benefits and does not seem to modify the disease pathophysiology. the investigator plans to use repetitive transcranial magnetic stimulation (rtms) therapy as an adjunctive therapy in combination with bont injections as a novel approach to treat pcd. the primary goal of this study is to compare standard treatment with bont versus bont combined with a two week course of rtms.

rtms refers to the application of transcranial magnetic stimulation (tms) pulses to a specific target at predefined stimulation parameters. repeated sessions of rtms therapy have been demonstrated to induce cumulative persistent benefits that can last weeks after the conclusion of the rtms sessions the central hypothesis of this study is that rtms therapy in pcd can potentiate the effects of bont injections. with the current standard treatment, the peak-dose benefits seen with bont are seen at about 4-6 weeks after the administration of injections. the investigator will introduce a 1 week course of rtms around 2-8 weeks before or after bont or t1). the investigator will examine the effects of combined therapy at 10 weeks after bont and 12 weeks after bont injections follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of pcd in accordance with the consensus statement of the movement disorder society * subjects who report botulinum toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care) exclusion criteria: * pregnancy * active seizure disorder * presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.

Keywords: botulinum toxin transcranial magnetic stimulation
which analgesia is better for proximal femoral fractures?

Conditions: Proximal Femur Fracture

Summary: this patient population is typically elderly and frail. they are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but the analgesia from these blocks is only moderate and literature suggests that the obturator nerve (on) is not covered.

the aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery. fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control. a recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the aon and fn play a greater role in the anterior hip innervation than previously reported the high articular branches from fn and aon are consistently found between the anterior inferior iliac spine (aiis) and the iliopubic eminence (ipe), whereas the on is located close to the inferomedial acetabulum. the ultrasound-guided technique for blockade of these articular branches to the hip, the peng (pericapsular nerve group) block reported significantly reduced pain scores compared with baseline. roy et al 2019 recommended the use of peng block together with lfcn block as adjunctive to cover the lateral surgical incision.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i, ii and iii. exclusion criteria: * patient refusal. * neuromuscular diseases * hematological diseases * bleeding abnormality * coagulation abnormality. * psychiatric diseases. * local skin infection at the site of the block. * local skin sepsis at the site of the block * known intolerance to the study drugs. * body mass index \> 40 kg/m2. * multiple trauma patients.
microarchitecture, bone strength and fracture risk in long-term type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: this single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration\>/= 25 years) and healthy controls.

based on a cross-sectional approach the investigators aim to assess microstructural, biomechanical and densitometric bone characteristics in patients with longstanding type 1 diabetes and age- and sex-matches controls. the investigators examine whether the presence of microvascular disease and/or poor diabetic control is associated with an altered bone microarchitecture and whether any such effect is independent of bone mineral density. furthermore, the investigators aim to look into the relationship between an altered bone microarchitecture and advanced glycation end product (age) formation as well as biochemical markers of bone formation and bone turnover. the study aims to identify type 1 diabetic patients with high fracture risk by assessing the discriminatory power of parameters of cortical and trabecular microstructure measured via high resolution peripheral quantitative computed tomography (hr-pqct) of the distal radius and tibia and high resolution quantitative computed tomography (hr-qct) of the proximal femur and tibia with and without adjustment for bone density.

Eligibility criteria:
inclusion criteria: * women and men with longstanding type 1 diabetes (age 40-80 years, bmi 18-37 kg/m2 and age- and sex matched non-diabetic controls * presence of type 1 diabetes for at least 25 years (defined by history of insulin treatment) exclusion criteria: * patients unable to give written informed consent, e.g. with severe dementia or patients not understanding german (or other local language) * any medical or psychiatric condition which would preclude the participant from adhering to the protocol * idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. paget´s disease, primary hyperparathyroidism) * previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment * patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage iv and v (kdigo), liver dysfunction (serum aspartate amino transferase (asat) \>3 times the upper limit of normal) * inability to keep the extremities still for a few minutes of an hr-pqct examination (e.g. parkinson disease, spastic syndrome) * pregnant or breastfeeding women