Kornimate/medical-research-clean huggingface dataset:
electroacupuncture vs. sham electroacupuncture for treatment of fatigue in patients with inflammatory bowel disease

Conditions: Fatigue; Inflammatory Bowel Disease

Summary: fatigue is a common symptom in inflammatory bowel diseasei and persists despite clinical remission. fatigue in patients with chronic diseases can be objectified by the facit-f scale. acupuncture has been shown useful in the treatment of fatigue in various chronic diseases. this study evaluates the effect of electroacupuncture in the treatment of fatigue in patients with quiescent inflammatory bowel disease. patients with inflammatory bowel disease and severe fatigue (facit-f score \<38) who agree to participate in the study will be randomized to three different treatments: electroacupuncture vs. sham electroacupuncture vs. control group.

fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. fatigue in patients with chronic diseases can be objectified by the facit-f scale. acupuncture has been shown useful in the treatment of fatigue in various chronic diseases. this study evaluates the effect of electroacupuncture in the treatment of fatigue in patients with quiescent inflammatory bowel disease. patients with inflammatory bowel disease and severe fatigue (facit-f score \< 38) who agree to participate in the study will be randomized to three different treatments: electroacupuncture vs. sham electroacupuncture vs. group control. treatment consists of a total of 9 sessions / patient (2 sessions / week the first week and then one session / week for two months). during and after treatment, patients fill in questionnaires to assess fatigue, anxiety, depression, quality of life in inflammatory bowel disease and sleepiness. those patients who do not improve with the initial treatment or present a recurrence of fatigue (defined as a decrease of at least 4 points in the facit-f score) then receive crossover treatment for 8 more weeks (total of 9 new sessions). the control group fill in questionnaires in the same periods as patients who receive active treatment. these patients (control group) receive electroacupuncture sessions(total of 9 sessions) in a second period.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease and fatigue in patients over 18 years * presence of continued fatigue determined in two consecutive scores and stability of the symptoms of fatigue according to the patient's opinion . * inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) . * written informed consent exclusion criteria: * patients who are participating in other clinical studies. * associated tumor disease . * pregnant or breast feeding women . * anemia hemoglobin determined under 12 in women and 14 in men. * patients who have suffered minor adverse reactions to acupuncture. * prior acupuncture.
benchmarks in acute laparoscopic cholecystectomy

Conditions: Gallbladder; Gall Stones (&Amp; [Calculus - Gall Bladder]); Gall Stone; Gallbladder Inflammation

Summary: the aim of this observational cohort study is to define peri- and postoperative reference values for acute laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (abc™). another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. the goal is to spur quality improvement initiatives.

the data source is the swedish patient registry gallriks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ercp). the time frame will be 2015-2023. register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. the study will analyze data for the time of surgery and up to 30 days afterwards. as the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age * laparoscopic acute cholecystectomy exclusion criteria: * other indications than acute cholecystitis will be excluded * cholecystectomy due to malignancy * other organ surgery performed at the same occasion * previous upper gastrointestinal surgery * single port access * robotic surgery * no data concerning surgical intervention

Keywords: laparoscopic cholecystectomy benchmarking surgical outcomes reference values quality improvement
parathyroid vascularization during total thyroidectomy using indocyanine green angiography

Conditions: Thyroid; Thyroid Cancer; Hypoparathyroidism; Vascularization

Summary: prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy. the main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism. it is planned to enroll 66 patients.

postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. the incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia. although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands. the general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal. in particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. during standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. this technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Eligibility criteria:
inclusion criteria: * able to sign informed consent * indication to total thyroidectomy * no contraindication to indocyanine green administration exclusion criteria: * evidence of parathyroid disease * allergy to iodinated contrast * chronic kidney failure * pregnancy or lactation

Keywords: parathyroid thyroid surgery indocyanine green angiography
efficacy of transcranial direct current stimulation in acute ischemic stroke

Conditions: Ischemic Stroke

Summary: non-invasive brain stimulation (tdcs) such as transcranial direct current stimulation (tdcs) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. however, few studies have been done in participants with acute cerebral infarction. in this study, the investigators want to see the effect of tdcs in acute cerebral infarction. the investigators perform tdcs in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.

cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind. in participants with cerebral infarction, non-invasive brain stimulation (tdcs) such as transcranial direct current stimulation (tdcs) has been reported to be effective in improving motor performance and safe. however, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. so in this study, the investigators want to see the effect of stimulating tdcs to both hemispheres in acute cerebral infarction against this backdrop. study objective: to see if tdcs is effective in improving motor paralysis in participants with acute cerebral infarction. expected effectiveness: stability of tdcs has already been demonstrated in many studies. since tdcs itself is a non-invasive treatment, if the efficacy of the tdcs prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients. intervention : in this randomized controlled trial, the investigators perform tdcs in patients with acute ischemic stroke within 48 hours after stroke onset with sham control. outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.

Eligibility criteria:
inclusion criteria: * ischemic stroke patients within 2 days stroke onset * 18-85 of age * corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla) exclusion criteria: * pre-stroke disability (defined as modified rankin scale (mrs) \>=2) * intravenous r-tpa thrombolysis or evt (endovascular thrombectomy) * history of epilepsy * advanced systemic disease or coexisting neurological/psychiatric disease * severe contact dermatitis or skin lesions interfering with the applying the electrode of tdcs
poetry: study of estrogen replacement therapy in postmenopausal women with parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary objectives of the poetry study are to assess the safety and tolerability of estrogen replacement therapy (ert) in postmenopausal women with parkinson's disease (pd) and to assess recruitment for a study of ert in postmenopausal women with pd.

poetry is an 8-week study of 30 post-menopausal women with parkinson's disease (pd) who will be enrolled at six clinical sites in the united states. the study is designed to measure the safety and tolerability of estrogen replacement therapy (ert). the study will also measure how ert affects thinking and behavior, movement and activities of daily living, as well as motor fluctuations and dyskinesias. although we know there are gender differences in pd, no studies have assessed their impact on symptom management. women with pd usually require less levodopa, are more likely to experience drug-related dyskinesia, and commonly report changes of their symptoms with menstruation, menopause and use of hormones, implying that hormonal changes may impact pd symptoms. all perimenopausal women face the decision whether or not to use estrogen replacement therapy (ert) and for women with pd, information about estrogen's effects in pd may facilitate decision-making.

Eligibility criteria:
inclusion criteria: * post-menopausal women with parkinson's disease who experience levodopa-related motor fluctuations averaging at least 2 hours daily in the "off" state confirmed by home diaries * must be on a stable dose of carbidopa/levodopa, immediate or controlled release therapy, antidepressants, or anxiolytics (for the last 30 days) exclusion criteria: * insulin dependent diabetes * thyroid disease

Keywords: parkinson disease women postmenopause estrogen replacement therapy clinical trials
occipital nerve stimulation in fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. the study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.


Eligibility criteria:
inclusion criteria: * diagnosed according to the criteria of the american college of rheumatology (acr-90) * minimally treated with adequate trials during 3 months * insight of the patient in her disease and capable of understanding and signing an informed consent exclusion criteria: * history of severe illness or suffering from severe chronic disease * history of substance abuse, unless treated and in remission during 6 months * cardiac disease * history of epileptic insults * psychiatric disorders with psychotic symptoms * pace maker / defibrillator * pregnancy
a randomised double-blind trial of targeted repetitive transcranial magnetic stimulation in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the study will involve a 3-week (15 session) randomized double-blind clinical trial of two repetitive transcranial magnetic stimulation (rtms) conditions in patients with treatment resistant depression. rtms site selection will be localized from structural mri scans. the patients will be randomized to one of two conditions 1. rtms targeted to the border of brodmann area 46 and brodmann area 9, 2. rtms targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).

the outcome measure used is the madrs (montgomery-asberg depression rating scale). this is administered at baseline and on a fortnightly basis. at study end response criteria is defined as a 50% reduction in total madrs score and remission defined as a madrs score of less than or equal to 10. other outcome measures administered fortnightly are: bprs (brief psychiatric rating scale), core (measure of melancholic symptoms), bdi (beck depression inventory), cgi (clinical global impression scale), gaf (global assessment of functioning scale). a cognitive battery is also administered. inclusion criteria: * moderate to severe depressive symptoms as indicated as madrs \>20 * failure to respond to a minimum of two antidepressant medications * no increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial exclusion criteria * have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating * previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker * in the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy * have a current dsmiv diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Eligibility criteria:
inclusion criteria: * moderate to severe depressive symptoms as indicated as madrs \>20 * failure to respond to a minimum of two antidepressant medications * no increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial exclusion criteria: * have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating * previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker * in the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy * have a current dsmiv diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Keywords: transcranial magnetic stimulation depression
mr, histologic and em imaging of intravenous ferumoxytol in central nervous system (cns) inflammation

Conditions: Nervous System Diseases; Diagnostic Imaging

Summary: this exploratory study utilizes ferumoxytol, an iron oxide nanoparticle mr contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. the protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal cns lesions, multiple sclerosis, tia or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. the main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical mr imaging.


Eligibility criteria:
inclusion criteria: * subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (cns) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular cns lesions such as ischemic stroke, tia with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. * subjects must be 18 years or older * subjects will be followed for at least 1 month after the infusion of ferumoxytol. * all subjects or their authorized representative must sign a written informed consent and give hipaa authorization in accordance with institutional guidelines. * female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. these criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient. * karnofsky must be 30% or greater exclusion criteria: * subjects with clinically significant signs of uncal herniation * subjects who have a contraindication for mri: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gd contrast material. * subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations * subjects with known hepatic insufficiency or cirrhosis * subjects with known or suspected iron overload * hiv-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol * pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.

Keywords: ferumoxytol
the effect of trauma informed care in childbirth

Conditions: Psychological Well-being; Childbirth; Care Pattern, Maternal

Summary: the aim of this study is to determine the effect of supportive care based on trauma informed care during childbirth on perinatal mental health outcomes.

this is a randomized control experimental study. data were collected from 100 women who attended supportive care based on trauma informed care or standart care from turkey between july 2022 and september 2022. participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. block randomization could not be performed because of the different and long delivery processes. data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. the consort directive was followed in the planning, implementation and writing of the research.

Eligibility criteria:
inclusion criteria: * the ages of 18-40 women, * at least primary school graduate, * mother tongue turkish, * single fetus, * term, * spontaneous birth, * cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery. * primiparous women * not have any disease or complication and agreed to participate in the study were included. exclusion criteria: * women who developed a complication with the fetus or themselves during delivery, * not be reached during follow-ups by telephone, * wanted to withdraw from the study

Keywords: intrapartum supportive care trauma informed care birth trauma fear of childbirth perinatal well-being
gluten immunity and islet autoimmunity in type-1 diabetes

Conditions: Type 1 Diabetes; Celiac Disease

Summary: the purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.

participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. this blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.

Eligibility criteria:
inclusion criteria: * diagnosis of celiac disease by histology and serology * for those with type-1 diabetes, at least one anti-islet antibody * hla-dq2.5 genotype exclusion criteria: * not following a gluten free diet for at least 12 months * known gluten exposure within the prior 2 months * treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months * treatment with systemic immunomodulatory agents in prior 30 days * human immunodeficiency virus infection, untreated hepatitis b virus, or hepatitis c virus infection * nut allergy * hemoglobin level below normal range * history of angina * pregnant or lactating * severe symptoms to gluten challenge in the past * elevation in transglutaminase-iga or deamidated gliadin peptide iga or igg greater than or equal to 50% above upper limit of normal * uncontrolled complications of type-1 diabetes or celiac disease which pose a risk to participation