Kornimate/medical-research-clean huggingface dataset:
differences in dry eye symptoms related to geographic location in spain and impact of artificial tears use

Conditions: Dry Eye Syndromes; Hyaluronic Acid; OSDI

Summary: this study assessed the differences in ded symptomatology measured with the osdi questionnaire regarding climate data of the geographic location in a large population in spain, with a special focus on the relative humidity (rh) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education

this was a multicentre study enrolling patients to attend primary eye care centres of the emo research group across 12 different spanish locations. a comprehensive eye examination was performed in all participants. dryness symptomatology was assessed with osdi questionnaire. in subjects with dryness symptomatology (osdi questionnaire score between 13 and 32) were prescribed to use high molecular weight ha-based artificial tears (disop inc, spain) along three months), instilled 3 times per day. additionally, the daily mean, minimum, and maximum values of the climate data for five different variables \[skin temperature (°c), wind gusts (m/s), air temperature (°c), atmospheric pressure (pa) and rh (%)\] corresponding to the visit date were collected from the eu-funded copernicus climate change service and the 5-year average rh values published by the spanish meteorological agency.

Eligibility criteria:
inclusion criteria: • volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center exclusion criteria: * hyperthyroidis * rheumatism * lupus * autoimmune disease * previous diagnosis of dye eye disease * cicatricial conjunctivitis * pterygium * eyelid trichiasis * history of any eye medication use in the last 3 months to treat any eye condition (glaucoma, etc.) * active anterior eye inflammation (such as blepharitis, conjunctivitis, keratitis, scleritis, uveitis, etc.) * use of contact lenses in the last 3 months * previous ocular trauma or surgery in the last 6 months.
neuromodulation of cardiovascular risks associated with cardiotoxic chemotherapy

Conditions: Breast Cancer; Lymphoma

Summary: this study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.

patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.

Eligibility criteria:
inclusion criteria: * patients (\>50 years) who have received anthracycline-based therapy (a cumulative dose of ≥ 200 mg/m2 doxorubicin or bioequivalent dose of other anthracyclines) for breast cancer or lymphoma within the last 15-30 days * a least 1 of following additional criteria: * previous chest radiation * type 2 diabetes mellitus * hypertension * current smoking * obesity (bmi ≥ 30) * previous myocardial infarction * established atherosclerotic heart disease. exclusion criteria: * atrial paced rhythm * history of seizure currently on treatment * history of vasovagal syncope * end stage liver or kidney disease

Keywords: stimulation device vagus nerve stimulator
clinical pilot study for personalized risk-based breast cancer screening

Conditions: Breast Cancer

Summary: the study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (mpv) testing in the norwegian healthcare setting.

the study will recruit women age 40-50 referred for clinical mammography at the vestre viken breast center, with mammographic density bi-rads a or d. after informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (prs) for breast cancer. the participants will be recommended future mammographic screening based on the prs (standard screening, or more frequent/start at earlier age). the participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. the study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.

Eligibility criteria:
inclusion criteria: * women referred for clinical mammography in the vestre viken breast centre * breast density bi-rads a or d * 40-50 y.o. exclusion criteria: * prior history of breast cancer or premalignant breast disease * prior genetic counselling/testing

Keywords: risk based screening
heterodyned whole-body vibration in treatment of opioid withdrawal-induced anxiety

Conditions: Opioid-use Disorder

Summary: in this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of oud and being treated at local substance abuse clinics. the study visits will include screening, baseline, weeks 1, 2, 3, and 4, with both safety and efficacy assessments.

approximate time commitment is 30 minutes / day, for 5 days / week, in testing effects of specialized 'massage' chair for a period of 4 weeks (up to total 20 treatment periods). only about 20 minutes time is in the test chair, and the rest is setup time and completing questionnaires. * upon arrival to the clinic for treatment, some short questions are asked. * participant is seated in a hwbv chair device. * a clip is attached to one finger to track heart rate and skin response to the treatment. * after relaxing for about 5 minutes, the hwbv chair actuated for 10 minutes. * the finger attachment is disconnected. * post-treatment, some more survey questions conclude the session.

Eligibility criteria:
inclusion criteria: * minimum age of 18 (female and male) * confirmed diagnosis of opioid use disorder and deemed appropriate to participate in this study as referred by the medial director of a local outpatient treatment clinic for oud * concurrent craving for drug * in otherwise good physical health * access to a phone (communication device) and willingness to communicate with study staff * ability to understand and provide informed consent in english exclusion criteria: * inability to provide verifiable contact information or unwillingness to assist with follow-up * unwilling to allow potential access to medical, drug treatment records or criminal history or criminal activity records that in the opinion of the site investigator would interfere with the conduct of the study * history of violence or violent, erratic behavior that would indicate a risk to other participants, study staff or to the participant her/himself * psychoses, major depression, bipolar disorder, or other mental disorder that in the opinion of the site investigator, would interfere with the participant's ability to participate in the study * a score of \> 2 on the beck depression inventory-ii (bdi-ii) \[suicidality\] * a score of \< 6 on the clinical opiate withdrawal scale, which indicates mild opiate withdrawal symptoms * prior history of severe brain injury or seizures * prone to fainting * suffering from a recent injury from which they are still recovering or needing medications for recovery * not have used opiates within the last 24 hours or longer than the past 60 days

Keywords: opioid-use disorder addiction, opioid
assessment of the safety and performance of a patellofemoral brace

Conditions: Patellofemoral Pain Syndrome; Patellar Instability

Summary: decathlon has developed kneesoft500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon kneesoft500 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility criteria:
inclusion criteria: * subject is aged ≥18 years old * subject has patellofemoral syndrome * the current condition of his/her knee allows the subject to keep a regular physical activity * subject has been informed and is willing to sign an informed consent form * subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks) * subject is affiliated to the french social security regime non-inclusion criteria: * subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * subject has worn a support (knee brace or articulated orthosis) in the last month during his/her sport practice * subject has any medical condition that could impact the study at investigator's discretion * subject has a known hypersensitivity or allergy to the components of the device (polyamide, cotton, elastane, elastodiene, polyester) * adult subject to a legal protection measure
safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy

Conditions: Tonsillectomy

Summary: the hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.


Eligibility criteria:
inclusion criteria: 1. patients between 6 and 17 years of age scheduled to undergo tonsillectomy. exclusion criteria: 1. have inadequate intravenous access 2. patients with significant cognitive impairment 3. active, clinically significant asthma 4. history of allergy or hypersensitivity to any component of intravenous ibuprofen, nsaids, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl. 5. have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding 6. any child with obstructive sleep apnea, defined as an apnea-hypopnea index of greater than or equal to 5.0 7. have taken investigational drugs within 30 days before clinical trial material administration. 8. inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]) and agree to abide by the study restrictions. surrogates will be needed for most patients. 9. refusal to provide written authorization for use and disclosure of protected health information. 10. be otherwise unsuitable for the study, in the opinion of the investigator.

Keywords: tonsillectomy, pediatric
measuring eating, activity and strength: understanding the response -using protein

Conditions: Weight Loss

Summary: the purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (\>/= 60) who participate in a 6 month weight reduction intervention. participants will be randomized into one of two study arms: weight loss control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or weight loss-high protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef. subject criteria will include obese (\>30 kg/m2) older adults (\>60 yrs.) with mild to moderate functional impairment (by short physical performance battery; sppb score \>/= 4)


Eligibility criteria:
inclusion criteria: * age 60+ yrs. * bmi of \>30 kg/m2 * body weight \<495 lbs. * normal blood chemistries * normal renal function * primary care physician acknowledgement * non-vegetarian * mild to moderate movement impairment exclusion criteria: * body weight \>495 pounds. * current smoker. * presence of unstable, acutely symptomatic, or life-limiting illness. * positive screen for dementia using mini-cog evaluation tool. * neurological conditions causing functional or cognitive impairments. * history of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation). * unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months. * inability to walk independently. * bilateral hip replacements. * unable to give consent. * unable to complete written recording forms including journals of eating and exercise behaviors. * current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications. * primary care physician advises against participation.

Keywords: function muscle mass
metformin and core temperature in obese and lean males

Conditions: Obesity

Summary: metformin is known to increase 18f-fdg uptake in subjects using metformin in retrospective trials. in this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (bmi \ 28kg/m2). the investigators will measure 18f-fdg uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

obesity and diabetes mellitus type 2 (dm2) are health problems with a tremendous impact. many attempts have been made to combat obesity and dm2, however, a breakthrough therapy is still lacking. obesity is the result of an imbalance between energy intake and energy expenditure. 18f-fluorodeoxy-d-glucose (18f-fdg) positron emission tomography computed tomography (pet-ct) pinpoint areas with high glucose turnover. physiological 18f-fdg accumulation is frequently observed in the colon. therefore, the colon might play an important role in increasing energy expenditure by consuming calories. however, the possibility of the colon as an energy dissipating tissue has not yet been explored. the colon could become an interesting new target of research to find a method to combat obesity. metformin is one of the few drugs in the treatment of dm2 that is associated with moderate weight loss. interestingly, patients using metformin show an increased 18f-fdg-uptake in the colon. whether this higher uptake of glucose also cause an increase in core temperature and/or an increase in energy expenditure is not known. the cause for this increase in glucose uptake in the colon by metformin use is unknown. also, it is unknown whether this increase in glucose uptake results in an increased energy expenditure and/or an increase in core body temperature. objective: in this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (bmi \ 28kg/m2). the investigators will measure 18f-fdg uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

Eligibility criteria:
inclusion criteria: * male * caucasian origin * subjects should be able and willing to give informed consent * \> 50 years old * bmi\ 28 kg/m2 exclusion criteria: * renal failure (gfr\< 60ml/min) * liver insufficiency (ast or alanine aminotransferase 3 times upper value) * chronic use of drugs or medication * diabetes mellitus * lactate acidosis or precoma diabeticum in medical history * acute or chronic diseases such as: dehydration, severe infection, shock, heartfailure, pulmonary insufficiency, recent heart attack * alcoholism
fluorescence for sentinel lymph node identification in cancer surgery

Conditions: Breast Carcinoma; Head and Neck Cancer; Melanoma (Skin); Squamous Cell Carcinoma, Skin; Cervix Cancer; Endometrium Cancer; Ovary Cancer; Vulva Cancer; Anus Cancer; Rectum Cancer

Summary: this is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery. the diagnostic performance and the tolerance of indocyanine green (icg) to the radio-isotope (techniciun99) in the detection of sentinel lymph nodes will be assess using an "optonuclear" probe (eurorad s.a.) and quest camera


Eligibility criteria:
inclusion criteria: * age \>18 years * cancer histologically proved * patient eligible for sentinel node detection * contraceptive methods for men and women of childbearing age * signed informed consent form * patient affiliated to the social security system exclusion criteria: * neoadjuvant chemotherapy or hormone therapy * adenopathy (s) clinically suspicious or positively cytopenic * women who are pregnant or breast-feeding * associated pathology that may prevent patient of receive indocyanine green * ongoing participation in another clinical trial with an investigational drug * patients deprived of liberty or under supervision * impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons

Keywords: indocyanine green (icg) sentinel lymph node biopsy technetium99 tumors optonuclear probe surgery
automated versus standard physiotherapy for upper limb rehabilitation in patients with acquired brain lesions

Conditions: Vascular Accident, Brain; Traumatic Brain Injury

Summary: the armeo spring has proven its effectiveness in the rehabilitation of acute stroke patients. it neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. the armeo spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns. aim of the study is to compare the armeo device with standard physiotherapy in chronic patients with acquired brain lesions. the result of the trial should show which treatment is more effective in the clinical practice. a significant better outcome of one arm should suggest to follow one treatment strategy more than the other.


Eligibility criteria:
inclusion criteria: * 6 month after the onset of disease * acquired brain lesions in adults with upper limb hemiparesis * modified ashworth \<= 3 * muscular strength mrc =\>1 mano; mrc =\>2 elbow e shoulder * fugl meyer =\> 18 exclusion criteria: * nyha \>iii * mmse (mini mental status examination test) \< 24 * muscular strength (mrc) \< 1 * dystonia, spasticity (ashworth =\> 3) * articular contractions in the upper limb * previous upper limb lesions * cognitive/language impairment likely to influence assessments * any diagnosis likely to interfere with rehabilitation

Keywords: stroke tbi rehabilitation upper limb
clinical comparison of silicone hydrogel monthly lenses

Conditions: Refractive Error

Summary: the purpose of this study is to compare air optix® plus hydraglyde (aohg) contact lenses to acuvue® vita® (vita) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.


Eligibility criteria:
inclusion criteria: * sign informed consent; * best corrected visual acuity (bcva) of at least 0.1 logarithm of the minimum angle of resolution (logmar) in each eye at visit 1; * manifest cylinder less than or equal to 0.75 diopter (d) in each eye at visit 1; * successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses; * screening lenses worn 10 hours exhibiting high lipid uptake. exclusion criteria: * habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months; * habitually wearing air optix aqua, air optix plus hydraglyde, acuvue oasys®, or acuvue vita as contact lenses during the past 2 months; * any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current) * history of herpetic keratitis, corneal surgery, or irregular cornea; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * abnormal ocular conditions or findings, as specified in the protocol; * known pregnancy and lactation.

Keywords: contact lenses lipids deposits
celecoxib, irinotecan and concurrent radiotherapy in preoperative pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purposes of this study are to examine the effects of a new combination of drugs, celecoxib (celebrex®) and irinotecan (cpt-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. while not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

the purposes of this study are to examine the effects of a new combination of drugs, celecoxib (celebrex®) and irinotecan (cpt-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. while not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

Eligibility criteria:
inclusion criteria: * locally advanced carcinoma of the pancreas * arterial invasion or encasement * invasion/encasement of the portomesenteric veins * patients who have been previously denied operation * obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment. * white blood cell count \> 3500 per ml and platelet count \> 100,000 per ml * serum creatinine ≤ 1.5 mg/dl * bilirubin ≤ 1.5 * ecog performance status \< 2 exclusion criteria: * prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer * evidence of distant metastasis or malignant lymphadenopathy * concurrent malignancies * history of allergic reactions to celecoxib or to sulfa drugs * no non-steroidal anti-inflammatory drugs (nsaids), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments. * pregnant women and lactating women * uncontrolled or serious intercurrent illness * hiv-positive patients receiving combination antiretroviral therapy

Keywords: locally advanced pancreatic cancer invasion of major arteries and veins around pancreas no prior radiation or chemo