Kornimate/medical-research-clean huggingface dataset:
the effectiveness of auricular point compared to body point acupuncture theraphy on tension-type headache

Conditions: Tension-Type Headache

Summary: the purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in dr.cipto mangunkusumo hospital

the purpose of this study is to compare the effectiveness of manual acupuncture therapy between auricular points and body points in improving tension-type headache symptoms based on a headache diary which is consisting of intensity and frequency of headache days, a short form-36 questionnaire, and an examination of the press pressure threshold on eight pericranial muscles. if the use of auricular points is proven to be superior, then this method will benefit the patient more because it is more efficient and can be used as a protocol for providing therapy to patients with tension-type headache.

Eligibility criteria:
inclusion criteria: * healthcare workers who work in dr. cipto mangunkusumo hospital * age 18-60 years * has an episodic or chronic tth classification and is in accordance with the diagnostic criteria in the international classification of headache disorders 3rd edition beta version (ichd-3beta) * headache with vas score of 10-70 mm * willing to participate in research and sign an informed consent * willing to follow the research process to completion. exclusion criteria: * migraine headaches or secondary headaches * long-term (\>10 days per month) uninterrupted use of nsaids and other analgesia drugs 24 hours before starting acupuncture therapy * has contraindications to acupuncture, namely: medical emergencies, pregnancy, history of bleeding disorders (including the use of anticoagulant drugs) obtained from anamnesis history, tumor, or infection at the acupuncture site. * ear deformities and earlobe infections * fever 38°c * have had acupuncture therapy in the last 7 days.

Keywords: acupuncture auricular acupuncture tension-type headache healthcare worker
therapeutic exercise through exergames on mobile devices for cervical rehabilitation

Conditions: Neck Pain

Summary: the objective of this study is to determine whether performing cervical therapeutic exercises using a serious game through a mobile application enhances treatment adherence compared to performing the same exercises at home following standard practice.

participants in the study will be adults with non-specific neck pain (cervicalgia) who own a smartphone or tablet, and that give informed consent. individuals with acute or severe conditions, such as recent surgeries or trauma, will be excluded. before participation, they will be informed about the study and potential risks. the study is designed as a randomized clinical trial with two groups. the control group will follow a traditional home exercise program with written instructions, while the intervention group will use a personalized mobile app to guide their exercises. all participants will be asked to log their progress and any incidents in a compliance journal.

Eligibility criteria:
inclusion criteria: * persons of legal age with cervicalgia. * have a smart mobile device (smartphone or tablet) on which to download the app. exclusion criteria: * acute musculoskeletal pathological processes or exacerbation (less than 15 days of evolution). includes presentation of symptoms such as paraesthesia, radiating pain, loss of strength in the upper limb. * episodes of severe pain more than 15 days of evolution. * accident with cervical or dorsal injury within the last month. * refusing to sign the informed consent. * not having a device suitable for installation or lack of experience in the use of smart mobile devices. * baseline ndi score of less than 5. * presence of red flags: * suspicion of fracture: advanced age, previous trauma, osteoporosis. * suspicion of neurological involvement: loss of sensation in extremities, loss of strength or muscle mass. * suspicion of infection: fever, night sweats. * suspicion of cancer: previous history of cancer, no improvement in one month of treatment, weight loss, headache, vomiting. * suspicion of systemic disease: headache, fever, malaise, general headache, fever, malaise, unilateral skin rash (herpes).
study for optimizing anti-inflammatory prophylaxis

Conditions: Postoperative Cystoid Macular Edema; Irvine-Gass Syndrome

Summary: the purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. we want to compare topical prophylaxis with nsaid eye drops to topical prophylaxis with a combination of nsaid and prednisolone. we also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. in addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. the primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.


Eligibility criteria:
inclusion criteria: * patients with age-related cataracts * older than 18 years * women must be postmenopausal. women are asked if they have menstruated within the preceding 12 months. * capacity to consent * scheduled to undergo cataract surgery at the ophthalmic department at rigshospitalet-glostrup, denmark * the surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed * only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. if both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study * informed consent to participation exclusion criteria: * known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study * medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (amd) or amd with geographical atrophy * significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material * pregnancy * fertile women, i.e. women who are not menopausal. * women who breastfeed

Keywords: cataract cataract surgery
marathon and enduron polyethylene at long-term follow-up

Conditions: Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Summary: the purpose of the study is to determine whether crosslinked marathon and standard enduron polyethylene liners show differences in survivorship due to wear-related revisions at minimum 14-year follow-up and every 5 years after.

several institutions have reported very low wear rates with crosslinked polyethylene based on early and midterm clinical data. however, since revisions associated with osteolysis typically occur after 10-year follow-up, the greatest benefits of the reduced wear associated with crosslinked polyethylene are expected to be reflected in lower revision rates for wear-related complications at long-term follow-up. while crosslinking has proven to substantially reduce polyethylene wear during the first decade in vivo, characterizing the long-term clinical performance of marathon polyethylene remains important because crosslinking is accompanied by a reduction in the ultimate tensile strength, fatigue strength, and elongation to failure of ultra high molecular weight polyethylene. as a consequence, concerns have been expressed about the potential for the liner fracture, in vivo polyethylene oxidation or accelerated wear at long-term follow-up, the effects of femoral head roughening over time and the bioreactivity of crosslinked polyethylene debris particles. ultimately, the best way to address these concerns is in the context of well-controlled, long-term clinical outcome studies. this study will evaluate outcome at a minimum of 14-years after surgery among the same group of patients whose outcome was previously reported at 10-year follow-up. as part of our efforts to follow patients throughout their lives to obtain long-term outcome data, we will continue to obtain routine follow-up every 5 years from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years). because we anticipate that the reduced incidence of wear and osteolysis will result in a lower incidence of revision surgery among the patients randomized to marathon liners, implant revision for reasons related to wear will be our primary outcome measure at long-term follow-up.

Eligibility criteria:
inclusion criteria: (from original study) * elective total hip replacement patient (from 10-year follow-up) * consented to the original study. * received a duraloc 100 cup with either a crosslinked marathon or standard enduron liner. * received an aml/solution or a prodigy stem with 28mm cobalt chrome femoral head. exclusion criteria: (from original study) * none (from 10-year follow-up) * patient did not receive device as specified in inclusion criteria. * patient refused to consent to continued follow-up.

Keywords: osteolysis polyethylene crosslinked polyethylene total hip replacement marathon
vitamin d in minorities with prediabetes

Conditions: Pre-diabetes

Summary: vitamin d supplementation in minority subjects with both pre-diabetes and low vitamin d levels will delay the development of diabetes.

low vitamin d levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. minority populations (african-americans and latinos) are more likely to have both low levels of vitamin d and diabetes. this study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin d. those that have both will be randomized to either high doses of vitamin d or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. this study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin d and whether supplementing this vitamin may delay the development of diabetes.

Eligibility criteria:
inclusion criteria: 1. age greater than 40. 2. impaired fasting glucose (fpg level greater than 100 and less than 126 mg/dl); and/or 3. impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl) 4. serum 25-ohd less than 30 ng/ml 5. able and willing to provide informed consent exclusion criteria: 1. fpg greater than 126 mg/dl or 2-hour-ogtt plasma glucose greater than 200 mg/dl 2. major psychiatric disorder on medication (excluding successfully treated depression) 3. diagnosed diabetes mellitus 4. hiv/aids 5. major hematological, hepatic (ast/alt levels greater than or equal to 2 times normal) or renal egfr less than 60 ml/min) disorder 6. history of carcinoma, except skin basal cell or squamous cell skin carcinomas 7. heart failure, unstable angina or history of a myocardial infarction 8. alcohol or substance abuse 9. current treatment with glucocorticoids 10. current treatment with diabetes medications, including metformin 11. cushing's syndrome 12. primary hyperparathyroidism 13. nephrolithiasis 14. pregnancy or breast-feeding 15. regular visits to a tanning salon (unlikely in this minority population)

Keywords: pre-diabetes minorities oral glucose tolerance test disposition index insulin secretion insulin sensitivity diabetes
systematically assessing effects of colored light on humans with a multi-modal approach (substudy 4 of 7)

Conditions: Exposure to Man-made Visible Light

Summary: note: this is the fourth of in total 7 sub-studies related to the ethics committee of the canton of bern ref. no. kek-be 2016-00674. this sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies. general study information: this is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. the participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. the risk for the participants is negligible and comparable to the risk during daily life.


Eligibility criteria:
inclusion criteria: * normal color vision * right handed * written informed consent exclusion criteria: * smoking * any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months * acute severe traumas * chronic diseases with the necessity for medication * use of recreational drugs * regular intake of medication that would affect the outcome measures * regular excessive alcohol use (\> 18 standard units / week) * transmeridian travel in the last month (crossed \> 1 time zone border) * night shift word during the last month

Keywords: cerebral oxygen metabolism functional near-infrared spectroscopy partial pressure of carbon dioxide heart rate variability blood pressure affect mood respiration systematic randomized cross-over study systemic physiology electro-dermal activity pulse-respiratory quotient
t-cell vaccination in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the safety of t-cell vaccination in ms patients.

immunization of ms patients with irradiated autologous encephalitogenic myelin peptides (emp) specific t-cell lines or clones. clinical immunologic and neuroradiologic evaluation.

Eligibility criteria:
inclusion criteria: * definite ms (post criteria) * relapsing remitting or primary progressive clinical course. at least one relapse in the last two years. * disease duration \> 1 year * expanded disability status scale (edss) between 0-6 * brain magnetic resonance imaging (mri) compatible with ms * not involved in any other clinical trials * no other systemic disease exclusion criteria: * does not comply with the above

Keywords: t cell
a study of faldaprevir, td-6450 and other antivirals in participants with genotype 1b hepatitis c virus infection

Conditions: Hepatitis C Viral Infection; Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1

Summary: phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of faldaprevir and td-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis c virus (hcv) infection.

a study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis c infection. the study will test the safety and anti-viral activity of two regimens administered for a duration of 12 weeks. secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate hcv rna kinetics during treatment.

Eligibility criteria:
inclusion criteria: * chronic genotype 1b hepatitis c infection and hcv rna ≥ 10\^4 iu/ml at screening * hepatitis c virus treatment naive, defined as defined as having never received a direct acting anti-viral (daa), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening * absence of cirrhosis as defined by one of the following: * a liver biopsy performed within 24 calendar months of day 1 showing absence of cirrhosis * transient elastography (fibroscan®) performed within 12 calendar months of day 1 with a result of ≤ 12.5 kpa (kilopascals) * a non-invasive test measuring liver scarring (fibrosure®) score ≤ 0.48 and ast (aspartate aminotransferase):platelet ratio (apri) ≤ 1 performed during screening exclusion criteria: * infection with hepatitis b virus (hbv) or human immunodeficiency virus, hiv-1 or hiv-2
network medicine approaches to classify heart failure with preserved ejection fraction by signatures of dna methylation and point-of-care risk calculators (presmet)

Conditions: Heart Failure, Diastolic; Heart Failure, Systolic; Pulmonary Hypertension; Atrial Fibrillation

Summary: heart failure (hf) is a syndrome, resulting from structural or functional impairment of ventricular filling or ejection of blood. effective hf management depends on accurate and rapid diagnosis requiring assessment of symptoms and physical signs in combination with advanced and expensive imaging tools. however, several challenges arise from the traditional symptom-based diagnosis because co-morbidities of hf have similar presentations. this implies the need for a deeper knowledge of mechanistic links among genetic and epigenetic events governing the pathophysiology of hf leading to a novel molecular-based system to differentiate hf phenotypes. now, it is emerging that the pathophysiology of hfpef and hfref is different, it provides an opportunity to identify biomarker candidates that could aid in hf diagnosis and stratification between these two forms of the disease. the aim of presmet project is to perform liquid biopsy strategies to identify novel putative non-invasive epigenetic-sensitive biomarkers that could be used either alone or in combination with established diagnostic tests, such as natriuretic peptide, to help differentiate hfpef from hfref. the investigators will perform dna methylation analysis on cd4+ t cells isolated from patients versus controls. remarkably, big data generated from ngs tools will be analyzed by advanced network-oriented algorithms. our results may provide a useful clinical roadmap in order to improve precision medicine and personalized therapy of hf.

the investigators will perform the first network medicine approach to integrate the dna methylome of circulating cd4+t cells and clinical parameters in patients with hfpef and hfref. liquid biopsy strategies will be performed to isolate pbmcs and purificate cd4+ t cells. successivelly, genomic dna will be extracted on columns and will be send out for rrbs. network-oriented algorithms will be used to analyze dna methylation signatures and to identify specific epigenetic changes in relation to left ventricle ejection fraction. network-oriented dna methylation signatures will be integrated to the h2fpef point-of-care calculator and, then, will be validated by the use of q-rt-pcr, wb, and elisa.

Eligibility criteria:
inclusion criteria: * hfref (lvef \< 40%) * hfpef (lvef \> 50%) exclusion criteria: * patients with hf with a history of a reduced lvef ≤ 40% (hfref) who recover lv function (lvef ≥ 50%) * chronic inflammatory diseases * cancer

Keywords: hfpef interactome cd4+ t cells hfref liquid biopsy network medicine
needle-free dental anesthesia

Conditions: Anesthesia, Local; Needle Phobia

Summary: many patients experience pain and anxiety from traditional needle anesthesia and may avoid necessary dental treatments. the needle-free liquid jet injection(nflji) could solve these problems. nflji delivers drug solutions by creating a micro-thin pressure liquid jet to penetrate the skin and disperse in the soft tissue. it has many advantages like eliminating injection pain, needle phobia and needle disposal. however, anesthesia techniques in dentistry were all developed for needle injection, and they are not very effective for nflji. moreover, clinical trials of dental anesthesia using nflji have shown inconsistent efficacy. in this study, we aim to compare the clinical efficacy between nflji and needle dental anesthesia in pilot split-mouth cross-over randomized clinical trials, assess the feasibility to conduct such trial on a larger scale. participants will be assigned to one of the following four groups: 1. infiltration on a maxillary lateral incisor,2. inferior alveolar nerve block, 3.mental nerve block, 4. infraorbital nerve block. each participant will receive one injection with a needle and another one with nflji randomly at the same appointment. a washout period of 1 hour between two procedures for participants' to forget the previous experience. needle injection will be performed according to clinical standards. nflji will be performed according to a guideline developed in our research group. participants will stay in the clinic until the anesthesia effect disappear and be followed for one week. the primary outcome is the efficacy and effect of two anesthesia interventions. the secondary outcome is the pain and anxiety visual analogue scale before and during injection, taste preference, and complications. additionally, patients' overall feelings for two interventions as well as any barriers to conducting such a trial will be recorded.


Eligibility criteria:
inclusion criteria: * age between 18-35 years-old * fluent in english * cooperate exclusion criteria: * has a history of chronic pain, * has a systematic disease, * has root canal therapy at the upper lateral incisor/lower posterior teeth region.

Keywords: needle-free injection dental anesthesia infiltration nerve block
a randomised trial with irinotecan, cetuximab and everolimus (ice)compared to capecitabine and oxaliplatin (capox) for patients with gemcitabin resistant pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is an open multicenter randomized phase i/ii study. the main purpose with this study is to investigate dose and efficacy of a combination of irinotecan, cetuximab and everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer after progression from 1. line treatment with gemcitabine.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to study entry? 2. patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas? 3. progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy? 4. former treatment with chemotherapeutic agent containing gemcitabine? 5. is the age of the patient ≥ 18 years? 6. is the ecog performance status 0-1? 7. is the absolute neutrophil count (anc) ≥ 1.5 x 109/l? 8. is the platelet count ≥ 75 x 109/l? 9. is the total bilirubin ≤1.5 x unl (upper normal limit)? 10. patient has normal liver function? (if liver metastases are present, there is no upper limit for alat/spgt/alk phosph)? 11. creatinine clearance ≥ 30 ml/min 12. is the patient capable of following the treatment and the plan of evaluation? exclusion criteria: 1. ctc grade 3 hyperlipidaemia (\>10.34 mmol/l) in spite of treatment 2. active former or concurrent history of malignant neoplasm, in the last 2 years? 3. any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial? 4. pregnant or breast feeding patient (fertile patients must use contraceptives)? 5. infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease) 6. known hypersensitivity toward one or more of the parts in the treatment?

Keywords: pancreas cancer everolimus irinotecan cetuximab capecitabine oxaliplatin gemcitabine resistant pancreascancer