Kornimate/medical-research-clean huggingface dataset:
twenty-four hour intraocular pressure patterns in patients with uncontrolled thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: patients with thyroid eye disease (ted) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. the confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (iop). many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. to date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in ted. it is not know if the pattern of iop is more consistent with normal iop patterns, glaucomatous patterns, or perhaps completely different then either. the goal of this project is to investigate patterns of iop in patients requiring orbital decompression because of orbital congestion. changes in iop during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. this device has previously been investigated and shown to be safe and well-tolerated. monitoring the pattern in these patients will allow us to compare thyroid ted patterns of iop with those of normal and glaucomatous patients. also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved.


Eligibility criteria:
inclusion criteria: * subject is able to comply with the study procedures * 18-80 years old * subjects diagnosed with thyroid eye disease based on both endocrinology studies showing autoimmune dysfunction consistent with graves' disease as well as orbital imaging studies manifesting characteristics consistent with thyroid eye disease. * ability to understand the character and individual consequences of the study * subject has consented to be in the trial exclusion criteria: * subjects with contraindications for wearing contact lenses * severe ocular surface disease * keratoconus or other corneal abnormality * severe ocular inflammation * full frame metal glasses during sensimed triggerfish® monitoring * known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) * simultaneous participation in other clinical studies * diagnosis of glaucoma
characterisation of biofilm of the chronic wounds

Conditions: Chronic Wounds

Summary: in this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.


Eligibility criteria:
inclusion criteria: * patients with chronic wounds (period \> 6 weeks) \> 10 cm2 * patient age \>18 for the 3 french centres * patient participation in a follow-up program for treatment of their wound \> 1 month * availability of patient information and written informed consent from them or their legal representative exclusion criteria: * patients unable to submit to medical follow-up in the trial due to geographical constraints etc * patients deprived of freedom or under guardianship
study safety and efficacy of bone marrow derived autologous cells for the treatment of muscular dystrophy.

Conditions: Muscular Dystrophy; Duchenne Muscular Dystrophy,

Summary: this study is single arm, single centre trial to check the safety and efficacy of bone marrow derived autologous cell(100 million per dose) for the patient with duchenne muscular dystrophy.

muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). however, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes muscle weaknesses, difficulty with motor skills ,progressive difficulty walking.breathing difficulties and heart disease,frequent falls,weak limbs,lose motor function.begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.trouble getting up from a lying position or climbing stairs.

Eligibility criteria:
inclusion criteria: * patient with diagnose of duchenne muscular dystrophy. * aged in between 6 to 25 years. * willingness to undergo bone marrow derived autologous cell therapy. * ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required informed consent form(icf) for the study. * ability and willingness to regular visit to hospital for protocol procedures and follow up exclusion criteria: * patient who is not diagnose of duchenne muscular dystrophy. * patient with history of immunodeficiency hiv+,hepatitis b ,hbv and tppa+,tumor markers+ * history of life threatening allergic or immune -mediated reaction. * the site of bone marrow aspiration potentially limiting procedure. * alcohol and drug abuse / dependence. * patients with history of hypertension and hypersensitive.

Keywords: muscular dystrophy stem cell
a study to learn about the study medicine called rimegepant in women when used for intermittent prevention of menstrual migraine

Conditions: Menstrual Migraine

Summary: the purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (pmp) for intermittent prevention of migraine in women who experience menstrual migraine attacks.


Eligibility criteria:
inclusion criteria: 1. participant has regular menstrual cycles ≥24 days and ≤34 days 2. a minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the international classification of headache disorders, 3rd edition 3. a history of menstrual migraine attacks of at least 3 months 4. participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening. 5. if the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the screening visit and, the dose is not expected to change during the course of the study exclusion criteria: 1. greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to screening 2. a diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to screening 3. history of retinal migraine, basilar migraine or hemiplegic migraine 4. current diagnosis of schizophrenia, bipolar, or borderline personality disorder 5. other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea
identification of cetp as a marker of atherosclerosis

Conditions: Cardiovascular Disease

Summary: the reverse cholesterol transport (rct) pathway, which involves the centripetal movement of free cholesterol from peripheral tissues, including the vessel wall, to the liver represent the primary mechanism by which hdl protects against atherosclerosis and by which it may induce plaque regression. recent data reveal that the capacity of hdl to efflux cholesterol from macrophages, a metric of hdl function reflecting the initial step of the rct, is clinically relevant, displaying a strong inverse association with both carotid intima-media thickness and the severity of angiographic cad; such observations were independent of hdl-c levels. in human, the cholesteryl ester transfer protein (cetp), represents a key protein of the rct pathway and mediates redistribution of neutral lipids between lipoproteins, has been identified as a potential therapeutic target against atherosclerosis. it is known that cetp activity correlates with hdl-c levels and represents a key modulator of the ability of whole plasma to mediate free cholesterol efflux from human macrophages. recent studies showed that 23% of endogenous plasma cetp activity variability is explained by plasma ldl-c (12.0%), hdl-c (6.4%) and tg (4.4%) whereas sex and bmi accounted together for only 0.7% of its variability. scoring patients for cardiovascular risk on the basis of their plasma lipid levels (tc, tg, ldl-c and hdl-c), revealed that patients with high cardiovascular risk (score ≥3) displayed a mean endogenous plasma cetp activity above 34%. therefore plasma cetp activity represents a potent indicator of cardiovascular risk in patients with metabolic disorders since it integrates major independent risk factors. the objective of this study is to decipher the relationship between cetp, hdl efflux capacity and the development of atherosclerosis in humans in order to identify cetp as a potent biomarker of atherosclerosis distribution.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of the study * men and women aged 18 or more years * patients displaying at least one abnormal plasma lipid parameter and/or receiving a lipid-lowering therapy unchanged for at least 3 months. exclusion criteria: * current significant renal disease, including: nephrotic syndrome; chronic renal failure and/or serum creatinine \>1.7 x upper limit of the reference range (ulrr) * uncontrolled hypothyroidism defined as tsh \>2 x ulrr * active hepatobiliary disease, including chronic hepatitis b or hepatitis c infection (confirmed by serology); or an aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) \>3.0 x ulrr * any prior history of malignancy or current cancer * current chronic or acute inflammatory syndrome defined as crp\>10 mg/l
comparaison between mri alone or combined with positron emission tomography for brain metastasis diagnosis

Conditions: Brain Metastases, Adult

Summary: during gamma scalpel treatment of brain tumors and metastases, a follow-up magnetic resonance imaging (mri) scan is performed. the radiologist who reviews the mri assesses whether there is an increase in signal at the tumor site. this increase potentially indicates that the treatment was not effective. however, in 25% of cases (one in four people), this signal enhancement is not due to ineffective treatment, but to inflammation (swelling/damage) and tissue death around the tumor. this is why when an increase in signal is detected, additional follow-up is essential. the standard additional follow-up has an accuracy of about 83%. this is an observational study on patients with brain metastatis comparing mri alone or combined to pet-fet to improve accuracy of diagnosis of metastasis recurrence.


Eligibility criteria:
inclusion criteria: * male or female over 18 years of age; * having undergone gamma knife radiosurgery for brain metastasis; * presenting for a first mri follow-up (cohort c1); * presence of one or more brain metastases with increased enhancement on follow-up mri (cohort c2.1 and c2.2); a participant recruited for cohort c1 could be recruited for follow-up in cohort c2.1 or c2.2 if the mri result is ambiguous. exclusion criteria: * pregnancy or breastfeeding; * other condition that may influence the imaging result; * renal impairment (\<30 ml/min/1.73 m2). this threshold is consistent with recent rac recommendations; note: for participants with intermediate renal clearance (30-60 ml/min/1.73 m2), the total gadobutrol dose injected is set at the manufacturer's recommended clinical dose. for patients with renal clearance greater than 60 ml/min/1.73 m2, a dose of 1.5x the normal dose is used. these dose values have been approved by dr. chénard and are consistent with the rac recommendations. * inability to maintain supine position for the required duration (variable, depending on the sequence); * patients who have previously received full brain irradiation; * patients who are claustrophobic and cannot tolerate insertion into the mri scanner;

Keywords: magnetic resonance imaging radiofrequency radionecrosis tumor recurrence post-stereotactic surgery positron emission tomography ct scan 18f-fluoroethyl-tyrosine perfusion mri
study evaluating safety of 13-valent pneumococcal conjugate vaccine in healthy elderly subjects

Conditions: Pneumococcal Infections

Summary: to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vpnc) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vps) at least 3 years before study enrollment.


Eligibility criteria:
main inclusion criteria: * male or female aged 68 years or older * determined by medical history, physical examination, and clinical judgment to be eligible for the study * documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment main exclusion criteria: * known history of severe reaction to a vaccine * documented s pneumoniae infection within the past 5 years. * known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids * serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.

Keywords: pneumococcal conjugate vaccine vaccine
exploring the feasibility of a digital service to improve nutrition and hydration status of older adults

Conditions: Malnutrition; Healthy Aging; Dehydration

Summary: trial design: this is a feasibility randomised controlled trial. aim: the study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (keep-on-keep-up nutrition, koku-nut) to improve dietary intake in community-dwelling older adults. objectives: 1. is it feasible and practical to run koku-nut study as a powered randomised controlled trial. 2. adherence to the intervention, motivations, barriers and facilitators of engaging with koku-nut study population: community-dwelling adults aged 65 and older intervention: participants in the intervention group will be asked to engage with koku-nut at least 3 times a week throughout the 12-week period. a crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues. control: participants will continue with usual care and receive a leaflet developed by age uk about the importance of a healthy lifestyle. timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period

background: dietary patterns can play an important role in health in older age. apps that encourage dietary change are available and commonly used in younger populations, however; few are designed for the nutritional and technical requirements of older adults. keep-on-keep-up nutrition (koku-nut) is the latest development of the digital tool and includes nutritional games based on the eatwell guide to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid. the innovation process has brought together researchers, clinicians, software designers and older users to co-develop the digital tool. in this study, researchers will test the practicality of koku-nut as an intervention before further larger studies are conducted to assess it's effectiveness. the aim of this study is to assess the feasibility of conducting a randomised controlled trial using this digital health tool (koku-nut) to improve dietary intake in community-dwelling older adults. participants will be randomised to receive usual care and an information booklet about living a healthy lifestyle or to the intervention group and asked to engage with koku-nut 3 times a week for 12 weeks.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * living independently in the community * have access to the internet (to complete online dietary assessment) * willing to use an ipad or tablet (their own or one provided) for the duration of the study exclusion criteria: * unable to communicate in english * have a known cognitive impairment

Keywords: feasibility malnutrition dehydration digital health
short pulse and q-switched nd-yag laser with topical carbon versus fractional co2 laser for enlarged facial pores

Conditions: Skin Lesion

Summary: facial pores are visible topographic features of the skin that reflect openings of pilosebaceous follicles, that may be enlarged causing distress to some individuals. many patients desire treatment for this condition, which can be an early sign of skin aging. therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and topical retinoids, as well as chemical peeling. lasers, as fractional co2, short pulse and q-switched nd-yag, can potentially be used in treatment of wide pores. this study aims at the assessment and comparison of therapy with short pulsed and q-switched nd-yag laser plus topical carbon with fractional co2 laser in the management of wide facial pores.

topical carbon cream will be applied to one side of the face in patients with wide facial pores, followed by 2 passes of short pulse 1064 nd:yag laser, then one pass of q-switched nd-yag laser. fractional co2 laser will be performed to the other half of the face. the patients will receive 2 treatment sessions

Eligibility criteria:
inclusion criteria: * participants who are more than 18 years old with the large facial pores and are aware of their problem and seeking treatment exclusion criteria: * • previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure for the face. * patients with any contraindication to laser therapy such as photosensitive diseases, skin malignancies, patients on oral retinoids. * keloid-forming tendency. * local or systemic treatment for skin pores in the previous 3 months * connective tissue disease or the use of immunosuppressive medications. * pregnancy. * present or past history of herpes labialis.
efficacy, safety and tolerability of dnk333 (25 and 100 mg bid) in women with diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Irritable Bowel Syndrome

Summary: this study will evaluate the tolerability, safety and efficacy of dnk333 against diarrhea caused by irritable bowel syndrome in women.


Eligibility criteria:
inclusion criteria: women of 18 - 65 years of age with ibs-d as defined by the rome ii criteria. the rome ii criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. it involves completing of a questionnaire about gastrointestinal symptoms. note: patients who are 50 years of age and older must have had a colonoscopy or a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings. clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis. patients must report ≥ 3 days with ibs-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period: 1. ≥ 3 bowel movements/day 2. bowel urgency 3. loose or watery stool - exclusion criteria: * patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. the questions are: (1) over the past week did you have satisfactory relief of your ibs-related abdominal pain/discomfort? (2) over the last week did you have satisfactory relief of your overall ibs-d symptoms? * patients with hard or lumpy stools for more than one day during the baseline period * lactose intolerant patients relieved on a lactose free diet * use of antidepressants (tricyclic, ssri etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial. * women of child-bearing potential who do not use an acceptable methods of contraception * pregnant or nursing (lactating) women

Keywords: ibs diarrhea gastrointestinal functional disorder ibs-d
open-label expanded access for ebola-infected patients to receive human mab ansuvimab as therapeutic or for hr pep

Conditions: Ebola Virus Disease

Summary: the human monoclonal antibody (mab), ansuvimab (mab114), will be provided to ebola-infected patients as either a treatment or as pep under an expanded access protocol. ansuvimab is administered at 50 mg/kg as a single intravenous (iv) infusion

this is an open-label, intermediate-size patient population, expanded access protocol (eap) of ansuvimab administered once by iv infusion at a dose of about 50 mg/kg (weight-based dosing). participants will be monitored and assessed daily for safety, including clinical observation, laboratory monitoring, the incidence of adverse events (aes) and serious adverse events (saes) as defined by protocol, including aes that by clinical judgement are atypical for orthoebolavirus zairense (ebov) in infected patients, and any aes that occur during product infusions. pep participants will be followed to determine outcome following ansuvimab administrations through the study period for ebov status (positive/negative). blood will be collected for protocol-specific assessments and rt-pcr evaluation of viral load by available assay. a blood sample for ebolavirus viral load measurement will be collected before mab114 administration and at subsequent study time points per the schedule of evaluations. participants will be followed for a period as defined by protocol after the product administration. survival status for infected patients and follow up for pep participants for signs/symptoms of ebov will be recorded as applicable. ansuvimab will be provided for expanded access in any ebov outbreak location as authorized by the applicable regulatory authorities and/or ethics committee(s).

Eligibility criteria:
inclusion criteria: * male or female with laboratory confirmed (based on local standard of care) ebov infection or with recent high-risk ebov exposure as determined by a treating physician or designee. * able to provide proof of identity to the satisfaction of the clinical team * able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations. exclusion criteria: - any medical condition that, in the opinion of the treating physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol.

Keywords: ebanga orthoebolavirus zairense, ebov ansuvimab zaire ebolavirus, evd compassionate use ebola
phase ii study of bevacizumab, capecitabine and oxaliplatin in colon cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent korean colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented colorectal adenocarcinoma * ecog performance status of 2 or lower * adequate bone marrow function * adequate kidney function * adequate liver function * informed consent exclusion criteria: * major surgical procedure or significant traumatic injury within 28 days prior to study treatment start * known allergy to study drugs