Kornimate/medical-research-clean huggingface dataset:
research study of greater occipital nerve block as a treatment for prolonged migraine attacks

Conditions: Migraine

Summary: greater occipital nerve blocks (gonb) are a common procedure used for the treatment of headache. the gonb procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). the purpose of this study is to determine whether gonb is effective for the treatment of prolonged migraine attacks. this study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). the study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. the study remains blinded only for the first 30 minutes, at which point additional treatments (including gonb) can be administered at the discretion of your treating physician. 40 patients are expected to participate in this research study. this study is being conducted at thomas jefferson university only.


Eligibility criteria:
inclusion criteria: * subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling ihs criteria for episodic migraine * presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months. * pain must be reported as at least moderate pain level at time of injections exclusion criteria: a subject is ineligible to participate in this study if he/she satisfies any of the following criteria: * subjects who have received greater occipital nerve blocks in the past * subjects who in their own or the investigator's opinion are unable to describe their symptoms * subjects who are pregnant or lactating
phospholipids as nutritional support for reduction of anxiety

Conditions: Anxiety

Summary: the goal of this clinical trial is to learn about the effects of a milk-based dietary supplement in adults that report regular and frequent episodes of intermittent anxiety. the main question it aims to answer is: can this extract be used to reduced symptoms of intermittent anxiety? participants will consume the milk-based dietary supplement every morning for 4 weeks and each week they will fill out 3 different questionnaires.

clinical study evaluating the effects of a dietary milk-based supplement to help reduce symptoms of anxiety. the milk-based supplement is a fat-rich fraction of whey, rich in phospholipids. 24 subjects who report frequent and regular episodes of intermittent anxiety will participate in a questionnaire based clinical trial, wherein they will be consuming the milk-based dietary supplement each morning for 4 weeks. each week subjects will fill out 2 questionnaires evaluating their anxiety and 1 questionnaire evaluating their sleep. changes in stress will be measured relative to baseline scores, collected during the first week before supplement consumption.

Eligibility criteria:
inclusion criteria: * adult people of any gender * age 18-75 years (inclusive) * bmi between 18.0 and 34.0 (inclusive) * experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations. * specific situations that occur regularly that cause anxiety, for example: * performing specific tasks at work or at home * inter-personal conflicts at work or at home * driving or commuting * fearful and worrying about one's own situation (such as paying bills) * worrying about ongoing problems experienced by others exclusion criteria: * cancer during the past 12 months * chemotherapy during the past 12 months * currently taking anxiolytic, hypnotic, or anti-depressant prescription medication * currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product * food allergies or insensitivity related to lactose or other ingredients in test product * people who are pregnant, nursing, or trying to become pregnant
effects of supplementation with tocotrienol on chronic kidney disease patients

Conditions: Chronic Kidney Diseases; Hemodialysis; Microbiota; Oxidative Stress; Inflammation

Summary: the objective of this study is to evaluate the supplementation with tocotrienol, a vitamin e compound on inflammation, oxidative stress, and microbiota on chronic kidney disease patients.

in chronic kidney disease (ckd), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. in this regard, strategies in the management of this framework are necessary. it has been observed that vitamin e plays an important role in the modulation of transcription factors involved in inflammation such as nf-kb and nrf2, acting on cell membrane protection and tissue recovery. its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin e supplementation in the modulation of intestinal microbiota with consequent effect on ckd and its reflexes are scarce. thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin e supplementation on the modulation of the expression of nuclear cytokine (nf-kb e nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients ckd.

Eligibility criteria:
inclusion criteria: * chronic kidney disease * aged from 18 to 60 years * must be able to swallow capsules exclusion criteria: * pregnant patients * smokers * using antibiotics in the last 3 months * using antioxidant supplements in the last 3 months * usual intake autoimmune * hemodialysis started less than 6 months for hemodialysis patients
a general anesthesia regimen for dbs surgery in patients with pd

Conditions: Parkinson&#39;s Disease (PD)

Summary: patients who meet the enrollment criteria and voluntarily join this study will be admitted to the operating room on the day of surgery, and will receive endotracheal intubation under general anesthesia. induction will be conducted with sufentanil 0.2\~0.3ug/kg, rocuronium bromide 0.6mg/kg and propofol 1\~2 mg/kg. after successful intubation, mechanical ventilation will be provided with a fresh air flow of 2.0 l/min, a tidal volume of 6\~8ml/kg and a respiratory rate of 10\~12 times/min to control the end-tidal carbon dioxide between 35\~45mmhg. following that, 20 ml of 0.5% ropivacaine will be applied for bilateral scalp nerve block. the surgeon will then install the stereotactic head frame and take the patients out for ct examination. after returning to the operating room after ct examination, the surgeons will install driving electrodes. during this period, ga will be maintained with sevoflurane, propofol, remifentanil and rocuronium bromide. the depth of anesthesia is monitored using bis, with a target of 40-65. during electrode implantation stage: sevoflurane, propofol and rocuronium bromide will be stopped, and esketamine 0.2\~0.5mg/kg/h combined with remifentanil 0.5\~1ug/kg/min will be used to maintain anesthesia with a target bis value of 60-70. patients' blood pressure and heart rate will be controlled to change within less than 30% of the basal value with necessary medication. if the patient moves during the electrode implantation stage, the rescue plan is to quickly inhale sevoflurane to 0.3 mac, and the number of rescues will be recorded. the vital signs of the patient, mer signal strength, stn discharge frequency, length of stn localization nucleus, and whether the stn boundary is successfully located will be recorded. during the implantation stage of the pulser, the ga regimen will return to before electrode implantation stage. in other words, sevoflurane + remifentanil + propofol + rocuronium bromide will be used to maintain the depth of anesthesia till the end of the operation.


Eligibility criteria:
inclusion criteria: * bilateral stn-dbs surgery is planned for primary pd (meeting the international movement disorder society (mds) diagnostic criteria for pd); * asa classes i-iii; * age 50-75 years; * informed consent from patients or their families exclusion criteria: * bmi≥28.0kg/m2； * comorbid other conditions causing parkinson-like motor symptoms; * previous history of severe head trauma, deformity, or craniocerebral surgery; * previous history of psychiatric and neurological diseases, such as history of overt stroke (ischemic lesion near stn), depression, severe central nervous system depression, basal gangliopathy, schizophrenia, epilepsy, alzheimer's disease, myasthenia gravis, etc.; * preoperative moca scale showed that the patient had dementia; * severe heart, liver, lung, kidney, and immune system diseases; * allergy or contraindication to the trial drug

Keywords: deep brain electrical stimulation a general anesthesia regimen esketamine remifentanil parkinson&#39;s disease
impact of unapproved drug initiative on colchicine use

Conditions: Gout

Summary: measure if fda regulation of colchicne in 2009 has resulted in safer use in clinical settings. our study will assess the impact of this initiative on colchicine use and will provide data that supports its continuation and expansion.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gout * current use of colchicine/colcrys to treat gout * ablility to provide informed consent exclusion criteria: -inability to provide informed consent

Keywords: gout colchicine
high clopidogrel dose versus prasugrel and ticagrelor in high reactive stable patients

Conditions: Coronary Artery Disease

Summary: dual antiplatelet therapy with aspirin and clopidogrel for at least one year is essential in patients following an acute coronary syndrome (acs) or percutaneous coronary intervention (pci) with drug eluting stent(s) implantation. interindividual variability in platelet response to clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity \[pr\], variability of the drug metabolism, and various drug interactions) being implicated for high post-clopidogrel treatment pr. the investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by prasugrel 10 mg/day, ticagrelor (90 mg twice daily) and high-dose 150 mg/day clopidogrel in patients with high on-treatment platelet reactivity (htpr) with standard dose of clopidogrel. patients with htpr (defined as area under curve-auc ≥ 450 or \> 45 unit) and with loss-of-function allele cyp2c19\*2 will be enrolled in the study and will be randomized (day 0) in a 1:1:1 ratio, to either clopidogrel 150 mg a day or prasugrel 10 mg a day or ticagrelor (90 mg twice daily) until day-15 and-30 post randomization.


Eligibility criteria:
inclusion criteria: * patients underwent to percutaneous coronary intervention (pci) * clopidogrel resistance after platelet reactivity blood test exclusion criteria: * history of bleeding diathesis * chronic oral anticoagulation treatment * contraindications to antiplatelet therapy * pci or coronary artery bypass grafting (cabg) \< 3 months * hemodynamic instability * platelet count \< 100,000/μl * hematocrit \< 30% * creatinine clearance \< 25 ml/min * patients with a history of stroke * contraindication for prasugrel administration * patients weighing \< 60 kg * \> 75 years of age.

Keywords: antiplatelet effect prasugrel clopidogrel stable angina
analgesic effect of trigger point injection and emla for shoulder pain in laparoscopic hysterectomy

Conditions: Myoma of Uterus

Summary: laparoscopic operative procedures have revolutionized gynecological surgery. these have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. however, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. trigger point injection removes the pain developing point and block the pain signal. emla cream shows analgesic effect when being spread on the skin. an literature showed that patch of local anesthetics showed the effect of trigger point inject. the purpose of this study is to investigate the alleviation of shoulder pain, headache, abdominal pain, and back pain after trigger point injection or emla cream applying on shoulder in patients undergoing total laparoscopic hysterectomy.


Eligibility criteria:
inclusion criteria: * asa class i or ii * age 20\~70 * patients undergoing total laparoscopic hysterectomy exclusion criteria: * history of shoulder surgery * coagulopathy * infection or trauma of shoulder * general inflammation * allergy to local anesthetics
motor cortex stimulation for chronic neuropathic pain

Conditions: Neuropathic Pain; Facial Pain; Post-stroke Pain; Brachial Plexus Avulsion; Phantom Limb Pain of the Upper Extremities

Summary: the purpose of this study is to evaluate the efficacy of cortical stimulation (cs) as an adjunctive treatment for chronic neuropathic pain.

prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period. an interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.

Eligibility criteria:
inclusion criteria: * men and women (non-pregnant) age 21-70 years; * able to give informed consent in accordance with institutional policies; * diagnosis of chronic neuropathic pain according to the dn4 neuropathic pain diagnosis scale (score ≥ 4). * documented pain for at least 12 months; * documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids; * vas scores of at least 6 during baselines #1 and 2. * documented clinical diagnosis of neuropathic pain associated with one of the following conditions: facial pain, post-stroke pain, brachial plexus avulsion, or phantom limb pain of the upper extremities. * in the group with post-stroke pain, only patients with predominant face and upper extremity pain will be included. this will be defined as a difference of ≥ 30% or ≥ 2 points in vas scores between these regions and lower extremity (in patients who also have pain in the leg). * no change in current neuropathic pain medication regimen for at least 4 weeks prior to study enrollment. * able to comply with all testing and follow-up requirements as defined by the study protocol. * must be determined medically stable by surgeon to undergo cortical stimulation surgical procedure. exclusion criteria: * alcohol, medication, or illegal substance dependence or abuse within last 12 months; * trigeminal neuralgia or atypical facial pain. * post-stroke pain predominantly in the lower extremity. * advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon; * clinically relevant abnormality (e.g. tumor) on study mri; * has cardiac pacemaker/defibrillator or other implanted active stimulator; * has a medical condition requiring a repetitive mri body scan; * requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous, immunosuppressive, or steroid therapy; * is unable to comply with study visit schedule and timeline; * past ablative or relevant intracranial surgery; * a female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception; * other medical conditions likely to require hospitalization within the next year.

Keywords: motor cortex stimulation neuropathic pain
inflammatory marker in ibd and peripheral arthritis

Conditions: IBD-Inflammatory Bowel Disease

Summary: the objective of this study is to estimate the correlation between disease activity in ibd, inflammatory markers and peripheral arthritis after exclusion of other causes arthritis

inflammatory bowel diseases (ibd) are chronic relapsing inflammatory disorder of the gastrointestinal tract (git) , which represented mainly by ulcerative colitis (uc) and crohn's disease . ibd is to be considered systemic disease since they are often associated with extra intestinal manifestation, especially during activity, which reflect a pathogenic mechanism as arthritis ,erythema nodosum ,pyoderma gangrenosum , apthous ulceration ,iritis and uveitis. peripheral arthritis (pa) is observed rather than frequently, the arthritis involves predominantly the joint of the lower limb ,and in most cases it accompanies the activity of the intestinal disease pauciarticular, asymmetric, migratory and non deforming. predicting relapse by measuring non invasive biomarkers could allow early treatment adaptation .several studies have shown a correlation between intestinal inflammation and serum c-reactive protein or fecal calprotectin levels .

Eligibility criteria:
inclusion criteria: * 1-pt above 18 yrs. 2- ibd pt. confirmed by colonoscopy 3- ibd patient with arthritis during activity exclusion criteria: * 1-age below 18 yrs. old 2-arthritis of other causes than ibd pt
1.2% atorvastatin and 1.2% simvastatin in treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: background: statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. atorvastatin (atv) and simvastatin (smv) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme a reductase. the present study was designed to evaluate and compare the effectiveness of 1.2% atv, and 1.2% smv as an adjunct to scaling and root planing (srp) in the treatment subjects with chronic periodontitis. methods: ninety six subjects were categorized into three treatment groups: srp plus 1.2% atv, srp plus 1.2% smv and srp plus placebo. clinical parameters; full mouth plaque index (pi), modified sulcus bleeding index (msbi), probing depth (pd), and relative attachment level (ral) were recorded at baseline before srp and at 3, 6 and 9 months. percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.


Eligibility criteria:
inclusion criteria: * moderate to severe cp subjects with pd ≥ 5 mm or clinical attachment level (cal) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months exclusion criteria: * individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the smv/atv/statin group, those on systemic smv/atv/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Keywords: chronic periodontitis, local drug delivery,
safety and efficacy of octreotide long acting release (lar) in treatment naïve acromegalic patients

Conditions: Acromegaly

Summary: currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. octreotide lar is approved for treatment of acromegaly after surgery if the disease is not controlled. this study was aimed to test the safety and efficacy of octreotide lar in acromegalic patients who did not have any previous treatment for acromegaly.


Eligibility criteria:
inclusion criteria: * newly diagnosed or previously untreated acromegalic patients * lack of suppression of growth hormone (gh) nadir to \<1.0 µg/l, after oral administration of 75g of glucose (oral glucose tolerance test \[ogtt\]) * insulin-like growth factor-i (igf-i) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) exclusion criteria: * requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass * no evidence of pituitary adenoma on magnetic resonance imaging (mri) * symptomatic cholelithiasis

Keywords: acromegaly untreated newly diagnosed octreotide lar
bi836826 dose escalation in relapsed chronic lymphocytic leukaemia (cll)

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. the trial will examine whether monotherapy with bi 836826 is safe and tolerable at escalating dose levels.


Eligibility criteria:
inclusion criteria: 1. diagnosis of relapsed or refractory chronic lymphocytic leukaemia. 2. at least two prior treatment regimens for chronic lymphocytic leukaemia. 3. at least one criterion for active disease as defined by the international workshop on cll. 4. absolute lymphocyte count lower than 200 x 10\^9/l . 5. eastern cooperative oncology group (ecog) performance status 0, 1 or 2. 6. age 18 years or older. 7. written informed consent which is consistent with international conference on harmonisation - good clinical practice (ich-gcp) guidelines and local legislation. exclusion criteria: 1. treatment with anti cluster of differentiation (cd) 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, ibrutinib or idelalisib within 1 week prior to the first administration of the trial drug. 2. prior allogeneic stem cell transplantation. 3. active autoimmune haemolytic anemia. 4. active autoimmune thrombocytopenia. 5. known transformation to an aggressive b-cell malignancy. 6. concurrent treatment with relevant doses of systemic glucocorticosteroids. 7. prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol). 8. aspartate aminotransferase or alanine aminotransferase \> 2.5 x upper limit of normal. 9. total bilirubin \> 1.5 x upper limit of normal. 10. absolute neutrophil count \< 1.000/µl. 11. platelets \< 25.000/µl. 12. estimated glomerular filtration rate \<45 ml/min. 13. proteinuria common terminology criteria for adverse events (ctcae) grade 2 or higher. 14. significant concurrent disease. 15. any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks. 16. hepatitis b or c. 17. human immunodeficiency virus (hiv) infection. 18. cytomegalovirus (cmv) viremia. 19. women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose. 20. pregnancy or breast feeding. 21. known or suspected active alcohol or drug abuse. 22. treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial. 23. prior treatment with bi 836826. 24. patients unable to comply with the protocol
evaluation of the gore® c3 delivery system module

Conditions: Aortic Aneurysm, Abdominal

Summary: this is an observational registry designed to obtain early data on the use of the gore® excluder® aaa endoprosthesis with c3 delivery system.

this is a retrospective and prospective observational cohort registry designed to obtain data on the use of the gore® excluder® aaa endoprosthesis with c3 delivery system. patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.

Eligibility criteria:
inclusion criteria: 1. minimum age required by local regulations (as applicable) 2. indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current instructions for use of the gore® excluder® aaa endoprosthesis with c3 delivery system)