Kornimate/medical-research-clean huggingface dataset:
maternal autoimmune disease research alliance (madra) registry

Conditions: Autoimmune Diseases; Pregnancy Related; Systemic Lupus Erythematosus; Cutaneous Lupus; Rheumatoid Arthritis; Sjogren's Syndrome; Scleroderma

Summary: this multi-site registry, centered at duke university, will enroll pregnant women with autoimmune and rheumatologic diseases. the main goal of madra is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy. prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. the future research will seek to better define these risk factors and to identify ways to may improve them.

at each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. this is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care. management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. enrollment in the registry will not dictate specific therapy. the registry will include data from each office visit during pregnancy and up to 12 months after delivery. the registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved. enrollment in the registry does not significantly increase risks for a patient.

Eligibility criteria:
inclusion criteria: * desire for pregnancy within 6 months or currently pregnant * women with systemic autoimmune disease, including: * lupus (systemic lupus erythematosus or cutaneous lupus) * antiphospholipid syndrome or positive antiphospholipid antibodies * rheumatoid arthritis * scleroderma (systemic sclerosis) * sjogren's syndrome * inflammatory arthritis (including psoriatic arthritis and ankylosing spondylitis) * undifferentiated connective tissue disease (uctd) * vasculitis * myositis (polymyositis or dermatomyositis) * positive ro/ssa or la/ssb antibodies exclusion criteria: * unable to speak english * unable to provide informed consent * unable to travel to duke university for follow-up visits
comparison between intraligamentary piroxicam and articaine

Conditions: Pulpitis - Irreversible

Summary: comparing the efficacy of intra-ligamentary piroxicam and intra-ligamentary articaine on pain during and after endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

owing to the painful nature of endodontic treatment in teeth with symptomatic irreversible pulpitis and difficulty in achieving effective anesthesia particularly in mandibular molars due to various factors such as different bony landmarks, anatomical variations, needle deflection, accessory innervation, so local anesthesia isn't enough in such cases. piroxicam is a long-acting potent analgesic non selective oxicams derivative, has a half-life of 50 hrs in the plasma.the onset of action of oral piroxicam is 2-4 hrs, but it is anticipated that injectable piroxicam could produce more rapid onset of action. it could favourably overcome the intense pain up to 48 hrs following the treatment. it is also postulated that the intraligamentary injection enables the application of anti-inflammatory agents in the periapical intraosseous region. moreover, intra-ligamentary injection of local anesthesia was reported to be an effective and easy way to control severe pain during endodontic treatment mainly in mandibular teeth which are more difficult than maxillary teeth , thus piroxicam may be effective as an adjuvant drug to support the action of local anesthetics.

Eligibility criteria:
inclusion criteria: * healthy and medically free patients. * acute symptomatic irreversible pulpitis of the mandibular first or second molar teeth. * vital teeth with no history of previous root canal treatment. * teeth that could be treated endodontically in single visit. * teeth with normal periodontium, not sensitive to percussion with no periapical radiolucency. * patients able to understand numerical rating scale and sign the informed consent. exclusion criteria: * known hypersensitivity to piroxicam. * pregnancy or lactation. * asthma or allergy to other anti-inflammatory drugs. * history of peptic ulceration. * teeth associated with swelling or fistulous tract, acute or chronic periapical abscess.
comparison of strategies based on rt-pcr or antigenic test for the screening of sars-cov-2 infection (covid-19).

Conditions: SARS-CoV Infection

Summary: the virological diagnosis of sars-cov-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. despite nasopharyngeal swabbing tested by rt-pcr is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. the aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by rt-pcr. the comparison will be performed during a mass screening of the population of the city of saint-etienne (170000 inhabitants), france. the sensitivity of the rapid antigenic test will be evaluated in comparison to that of rt-pcr considered as gold standard.

the main objective is to evaluate the performance of a strategy for screening for cov-2-sars infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary rt-pcr technique recently validated by national authority for health (has).

Eligibility criteria:
inclusion criteria: * adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing * subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research exclusion criteria: * inability to understand the protocol (language barrier notably) * deny to participate to the proposed research * patients under tutorship

Keywords: covid19 rt-pcr rapid antigenic test sars-cov-2 self-sampling diagnosis mass screening isolation measures health education
a retrospective chart review of ozurdex® in patients with macular edema

Conditions: Macular Edema

Summary: this retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom ozurdex® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. ozurdex® was previously administered according to general clinical practice.


Eligibility criteria:
inclusion criteria: * retinal disease involving macular edema * received at least one ozurdex® injection exclusion criteria: * none
carvedilol as an adjunct to endoscopic cyanoacrylate injection for secondary prophylaxis of gastric variceal bleeding

Conditions: Esophageal and Gastric Varices

Summary: gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. carvedilol is a potent non-selective β-blocker. the role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. this study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

gastric variceal bleeding is a lethal complication of portal hypertension. the rebleeding rate ranged between 30% to 50% in patients after initial hemostasis. endoscopic cyanoacrylate injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding and prevention of recurrent bleeding. however, the rebleeding rate is still high in the patients undergoing repeated endoscopic cyanoacrylate injection. non-selective β-blockers are frequently used for the secondary prophylaxis of variceal bleeding. in the case of esophageal varices, combination of non-selective β-blockers and endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy alone. however, propranolol failed to decrease the rebleeding rate as an adjunct to endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse effects in gastric variceal bleeding patients. a more potent non-selective β-blocker than propranolol might further decrease portal pressure and decrease the rebleeding rate. carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. it significantly lowers portal pressure even in propranolol non-responders. however, it is unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal bleeding. the investigators conducted a randomized controlled trial to compare the efficacy of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate injection alone in secondary prophylaxis of gastric variceal bleeding.

Eligibility criteria:
inclusion criteria: * age of 20 to 80 years * cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding * stable hemodynamic condition for at least 3 days after cyanoacrylate injection exclusion criteria: * previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery * contraindications to non-selective beta-blockers or cyanoacrylate injection * serum total bilirubin \>10 mg/dl * grade iii/iv hepatic encephalopathy * hepato-renal syndrome * severe heart failure (nyha fc iii/iv) * chronic kidney disease under renal replacement therapy * refractory ascites * malignancy other than hepatocellular carcinoma * pregnancy * pacemaker use * refusal to participate

Keywords: gastric varices cyanoacrylate carvedilol
rise - reduce sitting time among breast cancer survivors

Conditions: Sedentary Behavior; Sedentary Time; Breast Cancer

Summary: this 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. this is known as accelerated aging. one way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. long periods of sitting are related to many physical and health problems. cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. this study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.

Eligibility criteria:
inclusion criteria: * breast cancer survivors (stages i-iv) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy) * breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy * self-report difficulties with physical function * self-report low levels of moderate to vigorous physical activity * self-report high levels of sitting time exclusion criteria: * medical condition that interferes with ability to safely stand or stay balanced * other cancer diagnoses that occurred after their breast cancer diagnosis * stage iv breast cancer with brain metastases or less than 12 months life-expectancy * unable to commit to a 3-month study

Keywords: physical function cognitive function quality of life
chronic pain self-management for older adults with cognitive impairment: a randomized pilot trial

Conditions: Chronic Pain; Cognitive Impairment

Summary: the goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. the main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. a control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.


Eligibility criteria:
inclusion criteria: * age \> 50 years; * have a cell or landline phone and internet access; * self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>1 day/previous 30 when pain made it difficult to do usual activities. * self-reported mild cognitive impairment (mci)/memory difficulties that at least sometimes interfere with usual daily activities * willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program * able to converse comfortably in english. exclusion criteria: * serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement) * other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder). * current or prior participation in the parent steps study or the reset (re-engaging in self-care and enjoying today) study.
the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted globally. the aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. the total trial duration per subject is approximately 58 weeks.


Eligibility criteria:
inclusion criteria: * - informed consent obtained * - type 1 diabetes mellitus for 12 months or longer * - basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment for 6 months or longer * - stable insulin treatment for the last 3 months prior to screening, as judged and documented by the investigator * - hba1c 7.0-10% (diabetes control and complications trial (dcct)), both inclusive, (corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc)) * - ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits exclusion criteria: * - prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dpp-4) inhibitors * - use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.premix insulin is not allowed * - known proliferative retinopathy or maculopathy requiring acute treatment * - severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator * - uncontrolled/ untreated blood pressure at screening above 160 mmhg for systolic or above 100 mmhg for diastolic * - history of acute or chronic pancreatitis * - screening calcitonin value equal to or above 50 ng/l * - personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men2) * - diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
antiphospholipid syndrome low-molecular-weight heparin pregnancy loss evaluation: the pilot study

Conditions: Antiphospholipid Syndrome in Pregnancy; Pregnancy Loss

Summary: the apple pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. pregnant women with antiphospholipid syndrome (aps) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited. eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (lmwh) prophylaxis until 37 weeks gestation and low-dose aspirin (asa) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.

the purpose of this pilot trial is to determine the feasibility of conducting a multicenter randomized full trial evaluating antepartum prophylaxis with asa versus lmwh/asa in women with confirmed aps and a history of late or recurrent early pregnancy loss. given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of asa alone versus lmwh/asa, the investigators first need to determine if it is possible to meet minimum recruitment rates needed for a full multicenter trial. if the pilot feasibility trial is successful, then the secondary outcomes collected will be used in the analysis of the full multicenter trial.

Eligibility criteria:
inclusion criteria: * confirmed pregnancy; * 18 years or older; * two or more unexplained pregnancy loss before the 10th week of gestation, and/or one or more unexplained pregnancy loss at or beyond the 10th week of gestation; * one or more aps laboratory criteria present, according to the revised sapporo criteria; exclusion criteria: * greater than 11 weeks +6 days gestational age at time of randomization; * indication(s) for prophylactic or therapeutic-dose anticoagulation; * contraindication to heparin or aspirin; * received 7 or more doses of lmwh; * previous participation in the trial; * geographic inaccessibility; * refused consent.
l-carnitine in the palliative treatment of advanced pancreatic cancer (carpan)

Conditions: Pancreatic Carcinoma

Summary: the study investigated the role of l-carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, uicc stage iv .

pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether l-carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer. study drug: l-carnitine 4g per day (vers) placebo study design: a multi-centre, double blind, and placebo-controlled, randomised, parallel group study patient population: patients with advanced pancreatic carcinoma number of patients: total of 90 patients in two equal groups number of centres: 4 (greifswald, magdeburg, berlin,heidelberg,all germany) duration of dosing: 12 weeks

Eligibility criteria:
inclusion criteria: * advanced pancreatic cancer (uicc stage iv) * karnofsky index larger than 60 * compliance * consent to participate to the study exclusion criteria: * child-pugh classification of liver failure greater than child b, * a known second malignant tumor * oral or parenteral supplementation with omega-3-fatty acids * treatment with thalidomide or infliximab * mental or physical disorders

Keywords: pancreatic carcinoma l-carnitine quality of life survival malnutrition cancer cachexia fatigue
one-piece le fort i osteotomy versus segmental le fort i osteotomy

Conditions: Cleft Lip and Palate; Le Fort

Summary: le fort i osteotomy is often used in orthognathic surgery for patients to solve midface retrusion. it is known that post-surgical stability of le fort i osteotomy can be influenced by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. in patients with cleft lip and palate, the postoperative instability of le fort i osteotomy can be even worse due to scar tissue resulted from palate surgery. segmental lefort i osteotomy is another useful surgical modifications that can be easily done through the alveolar cleft. it is performed to allow the correction of differences in the occlusal planes, correction of transverse discrepancy or to facilitate an optimal occlusion. the most important benefits is that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to have successful result can be narrow down or even closed by approximation of two separating alveolar segments. however, there are limited previous studies comparing the stability of segmental versus one-piece le fort i osteotomy especially in patients with cleft. it is our aim to investigate whether one-piece le fort i osteotomy or segmental le fort i osteotomy can provide a better stability after surgery.

measurements skeletal movement 1. skeletal surgical movement from t2 to t1 * positional change of landmarks in vertical from constructed frankfurt plane * positional change of landmarks in horizontal plane in relative to constructed coronal plane through sella point 2. post-surgical skeletal movement (stability) from t3 to t2 * positional change of landmarks in vertical from constructed frankfurt plane * positional change of landmarks in horizontal plane in relative to constructed coronal plane through sella point 3. skeletal angular measurement change on mid-sagittal plane from (t2 to t1) and (t3 to t2) 4. dental change measured from digital maxillary cast in transverse direction from (t2 to t1) and (t3 to t2) 5. facial height / facial proportion changes from (t2 to t1) and (t3 to t2) 6. alveolar cleft width changes from (t2 to t1) and (t3 to t2)

Eligibility criteria:
inclusion criteria: 1. cleft lip/palate patients 2. non growing taiwanese adults, at least 18 years old for men and 16 years old for women 3. patients with midface retrusion and malocclusion that will need le fort i osteotomy 4. rigid fixation with bone plates 5. patients who signs the informed consent form exclusion criteria: 1. association with craniofacial anomalies 2. patient without complete 3d imaging records including cbct scans and digital dental models

Keywords: cleft lip and palate cone-beam computed tomography le fort i osteotomy segmental osteotomy stability