Kornimate/medical-research-clean huggingface dataset:
feasability and clinical impact study of non pharmacological interventions in management of chronic pain

Conditions: Chronic Pain; Slackline; Mindfulness; Adapted Physical Activity; Self-hypnosis; Qi Gong

Summary: this feasability study aims to compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and qi gong versus usual care in the management of chronic pain.

chronic pain management is complex. 27.2 to 43.5 % of general population suffers from it. opoid crisis has shown the limit of the who 3 step analgesic ladder. multidisciplinary pain management programs, shared decision making and non pharmacological interventions targeting subject's empowerment are needed. among these non pharmacological interventions, patients are increasingly turning to traditional and complementary medicines. evidence about their safety and efficacy is hard to build. thus our study aims to assess the feasibility of a systematic proposal for non pharmacological interventions targeting the subject's empowerment.

Eligibility criteria:
inclusion criteria: * patient with stable chronic pain defined by the presence of pain for more than 3 months and without substantial change in management in the month prior to inclusion * patient with a mean eva maximum daily pain over 7 days greater than or equal to 4/10 * patient aged 18 and over * informed and written consent signed by the patient (or his / her legal representative). * person affiliated with social security or beneficiary of such a scheme exclusion criteria: * patient with a cluster headache * patient followed for 7 years or more by a pain center * patient treated with adjuvant or neo-adjuvant chemotherapy or radiotherapy for the primary tumor * patient with a decompensated psychiatric condition * patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study; this impact is left to the investigator's discretion * protected persons

Keywords: non pharmacological interventions chronic pain slackline mindfulness adapted physical activity self-hypnosis qi gong shared decision making
comprehensive oral intervention in patients with ami

Conditions: Acute Myocardial Infarction; Dental Diseases

Summary: the investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction. the purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.

subjects were divided into a treatment group and a control group. both sides receive basic periodontal examinations, but the treatment group receives active dental procedure such as scaling and root planing. both groups also receive post-myocardial infarction management. as part of a pilot study, this study used the primary outcome measure for changes in surrogate markers rather than clinical outcomes.

Eligibility criteria:
inclusion criteria: * adults over 18 * patients diagnosed with type 1 or 2 mi according to the fourth universal definition of myocardial infarction (2018) criteria * patients with baseline hscrp (high-sensitivity c-reactive protein) elevated above 1.0 mg / dl exclusion criteria: 1. clinical exclusion criteria * inability to provide informed consent * patients who are predicted to have low compliance * those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons * those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding * those who need active dental treatment such as extraction * patients suspected of having active infection * those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment 2. periodontal exclusion criteria * fully edentulous (except for fixed implant restorations) * if more than 15 teeth and implants do not exist * if the last dental visit experience is less than 6 months * if periodontal treatment is not possible by the researcher
ics/laba adherence and copd exacerbation

Conditions: Pulmonary Disease; Chronic Obstructive

Summary: the purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ics/laba combination therapy in the reduction of copd exacerbations during the 12 months after initiation of therapy between copd patients who are adherent to the index medication and those who are non-adherent.

this retrospective, observational study will assess the effectiveness of ics/laba combination therapies among copd patients new to the ics/laba combination therapies in the us, comparing those who are adherent to the index medication and those who are non-adherent. adherence will be measured using the proportion of days covered with the index medication. medical and pharmacy claims data will be used as the data source.

Eligibility criteria:
inclusion criteria: * at least one prescription fill for ics/laba combination during identification period. * copd diagnosis * 40 years or older at index date * \> or = 12 months of continuous health plan enrollment prior to and following index date * 1 or more prescription for saba, sama or saba/sama during the pre-index period. exclusion criteria: * patients with prescription claim for ics/laba combination therapy during the 12 month pre-index period * patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period * patients with cancer diagnosis in 12 month pre-index period

Keywords: copd chronic bronchitis pulmonary emphysema
endoscopic stenting versus surgical bypass for low bile duct obstruction by cancer of the pancreatic head

Conditions: Pancreatic Cancer

Summary: the prognosis of patients with unresectable pancreatic cancer is dismal. hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. endoscopic stenting and surgical bypass are currently the two competing treatment options. there is currently no randomized trial comparing the recently developed metal stents to surgical bypass. furthermore, there is very limited data on quality of life of these patients receiving either therapy. while endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.


Eligibility criteria:
inclusion criteria: * age equal or greater than 18 years * diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. in unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively * operability certified by anesthesiologist * written informed consent exclusion criteria: * intervention technically/medically not feasible * expected lack of compliance * one treatment option considered to be clearly in favor of the patient

Keywords: pancreatic cancer bile duct obstruction stent bypass
leucine-enriched formulas in patients with tumor-induced sarcopenia

Conditions: Sarcopenia; Cancer

Summary: currently there is a lack of evidence for recommending specific oral supplements (os) for nutritional support in patients with cancer, including leucine-enriched supplements.

appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

Eligibility criteria:
inclusion criteria: * patients of both sexes, age \> 18 y-old * cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t * weight loss \>5% during the previous three months or \>10% during the previous six months exclusion criteria: * end-stage kidney disease * life expectancy \< 2 weeks

Keywords: sarcopenia cancer
a randomized control trial of enhanced cognitive behavioural group therapy for older adults with depression: efficacy across older age-groups

Conditions: Major Depression

Summary: this study is on a type of psychotherapy to treat depression in older adults called cognitive behavioural therapy (cbt-oa). cbt is based on the idea that changing thoughts and behaviours can improve mood. cbt has been shown to treat depression in many types of people. cbt-oa changes the usual approaches used for older adults and offers the therapy in a group settings for 8 weeks, for 2 hours a week. participants will be randomly (by chance) placed into one of two study groups. one group will receive cbt-oa treatment right away. the other group (treatment as usual) will receive standard care from their doctor during the 12-week study period. both groups will be closely monitored during the study period. the standard care group will be offered cbt-oa in a future session outside of the study.


Eligibility criteria:
inclusion criteria: * ambulatory patients 65+ years of age and diagnosed with mde per dsm-v criteria by a geriatric psychiatrist using a standard clinical biopsychosocial assessment and a beck depression inventory (bdi) of \>12. exclusion criteria: * patients with psychosis, those undergoing acute inpatient care or electroconvulsive therapy (ect), those with dementia (mini-mental status examination (mmse) score of \< 26), and those with chronic personality disorders

Keywords: cbt cbt-oa depression major depression major depressive disorder cognitive behavior therapy older adults
evaluation of exercise treadmill test (ett) indices in participants with cardiovascular disease

Conditions: Atherosclerotic Coronary Vascular Disease

Summary: the study was designed to evaluate the use of ett electrocardiogram (ecg) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ascvd).


Eligibility criteria:
inclusion criteria: * history of stable coronary artery disease exclusion criteria: * inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the investigator. * history of chronic atrial fibrillation. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cardiovascular disease exercise treadmill test ranolazine angina myocardial ischemia
safety study of bile acid to treat hypercholesteremia

Conditions: Hypercholesterolemia

Summary: preclinical data support the hypothesis that the administration of ahro-001 reduces ldl cholesterol levels, improves hdl function, and finally, decreases atheromatous plaque burden.

4 sequential dosing cohorts, each cohort beginning with single dose (sdd), single day exposure, followed by one week of multiple daily dosing (mdd) with bid exposure, a 4 day drug honeymoon, then one week of mdd utilizing tid exposure. each subsequent cohort utilizes the same sdd/mdd design, starting with sdd higher than prior sdd but a sdd significantly lower than prior tid mdd cohort just completed, the overall goal being to provide gradually increasing dose exposure contingent on satisfactory safety and tolerability of lower doses in the previous groups. cohort 4 (mdd) utilizes best dose determined by cohorts 1, 2 \& 3 for 21 days. estimated duration of subject participation: 8-9 weeks under protocol amendment version 5.0, an additional cohort, cohort 5, will concomitantly enroll 48 volunteers randomized to receive either ahro-001 or placebo. volunteers included in the study may be either currently receiving or not receiving a statin treatment. the 48 volunteers in cohort 5 will thus be allocated to 3 treatment groups with 16 volunteers enrolled per group: group a: ahro-001 alone group b: statin + ahro-001 group c: placebo subject population: healthy volunteers, both males \& infertile females, with asymptomatic mild to moderate hypercholesterolemia

Eligibility criteria:
key inclusion criteria: * males or infertile females * 18-70 years of age, inclusive * asymptomatic mild to moderate hypercholesterolemia, (ldl =110-220 mg/dl) * cohort 5: on no statin or on a stable statin dose not meeting ldl \>110 mg% key exclusion criteria * fasting triglycerides \ 250 mg/dl (\ 2.8 mmol/l) * body mass index (bmi) \ 34 kg/m2 * diabetes mellitus (fbs \> 125 mg% (\>6.94 mmol/l) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>uln * serum creatinine \>uln for gender * hemoglobin \<11.5 g/dl * female volunteers of childbearing potential * history of cancer in past 5 years * any disease requiring medication * use of investigational medication in past 3 months * positive results for illegal drugs, hbsag, hbsab, hcv or hiv * cohort 5:prescription lipid lowering medications other than a statin in past 4 wks * cohort 5: history of gastrointestinal tract surgical resection

Keywords: atherosclerosis atherosclerotic heart disease hypercholesteremia atherosclerotic plaque hyperlipidemia
impact of minimally non-surgical periodontal treatment on residual pockets

Conditions: Pocket, Periodontal; Periodontitis

Summary: a double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach minst or q-si (quadrantwise) approach in subjects with periodontitis on residual pockets after active periodontal treatment

a double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment in subjects with periodontitis. 60 patients: 30 with periodontitis and 30 healthy controls who underwent active periodontal treatment. all the patients are assessed for clinical, periodontal, blood following of minimally invasive approach minst or q-si (quadrantwise). measurements are taken before and after initial periodontal treatment in the periodontal subjects in order to evaluate the best treatment for residual pockets.

Eligibility criteria:
inclusion criteria: * diagnosis of periodontitis * presence of residula periodontal pockets exclusion criteria: * periodontal treatment * use of antibiotics, nsaids, and immunosuppressants during the last 6 months * pregnancy
pl_gnt01_isr_grant 53234273

Conditions: Transthyretin Cardiomyopathy (TTR-CM); Transthyretin (TTR) Amyloid Cardiomyopathy; Transthyretin Amyloidosis

Summary: we carry out a prospective non-interventional, longitudinal, observational multicentre registry designed to improve our understanding of the epidemiology of ttr amyloidosis in our country. the main objective of the proposed study is to determine the occurrence of ttr amyloidosis and describe clinical profile of patients in the population of our country.

demographic information, ttr genotype, medical history, family history of the disease, and transplant history are assessed at baseline. on return visits, signs and symptoms of the disease are evaluated, general examinations are conducted, and laboratory data, measures of neurologic and cardiovascular function, and quality of life are assessed according to the standard of care for patients. specific aims and hypotheses our working hypotheses are: 1. ttr amyloidosis affects patients in the population of our country; 2. there are specific ttr mutations in the population of our country; 3. there is genotype-phenotype relationship in hereditary ttr amyloidosis; 4. there are risk factors for ttr amyloidosis in the population of our country. these hypotheses will be tested in our specific aims. in aim 1. we will describe the occurrence of ttr amyloidosis in the population of our country, including the hereditary and acquired forms of the disease. in aim 2. we will determine and characterize high frequency ttr mutations in the population of our country. in aim 3. we will determine a clinical profile of patients and we will try to enhance understanding of the natural history of ttr amyloidosis, including the variability, progression of the disease, and predisposing factors. we will evaluate patients' quality of life. in aim 4. we will search for genotype-phenotype relationship in hereditary ttr amyloidosis. in aim 5. we will evaluate effects of liver transplantation and other treatments on disease progression in our patients. we will advance knowledge of the disease to optimize the assessment, treatment and monitoring of patients. in aim 6. we will formulate novel hypotheses for further prospective studies. we will form a community of medical experts on amyloidosis (cardiologists, neurologist, internal medicine physicians, as well as other specialists) to create in the future national centre of amyloidosis in our country that would offer the highest standard of care and gather clinical data on this rare disease.

Eligibility criteria:
inclusion criteria: * adults over 18 years old with confirmed diagnosis of ttr amyloidosis exclusion criteria: * refusal to participate in the study. light-chain amyloidosis.

Keywords: transthyretin transthyretin amyloidosis attr transthyretin amyloid cardiomyopathy
tixel treatment for dry eye symptoms

Conditions: Peri-orbital Wrinkles; Dry Eye

Summary: dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. consequences of dry eyes range from subtle but constant eye irritation to significant inflammation and even scarring of the front surface of the eye. meibomian gland dysfunction (mgd) refers to the condition where the glands are not secreting enough oil or when the oil they secrete is of poor quality. tixel is a fractional skin rejuvenation system, which relies on direct thermal energy delivery, free of any radiation type such as laser, rf, etc. the energy is transferred via a continuously sterile, thermal titanium element (the "tip"), located on the applicator (the "handpiece"). in this study, the principal investigator will undertake standard treatment of periorbital wrinkles with tixel and observe the effect on dry eye disease symptoms and signs.

tixel® (novoxel®, israel) is a thermomechanical system developed for fractional treatment. the system is designed for the treatment of soft tissue by direct conduction of heat, enabling fast water evaporation with low thermal damage to the surrounding tissue (such as charring or ablation). the system consists of a handpiece connected to a console. the handpiece applies a therapeutic element, the "tip", fixated on the distal section. the tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. while treating patients for wrinkles, it has been observed that in several cases, treatment had an effect on subjects who have been suffering from a pre-condition of dry eye disease. the effect was expressed mainly by increased tearing. in this study, the principal investigator will undertake standard treatment of periorbital wrinkles with tixel and observe the effect on dry eye disease symptoms and signs.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years 2. mild to moderate periorbital wrinkles 3. osdi score of at least 23 4. noninvasive tear film break up time (nikbut) ≤ 10 seconds 5. willing and able to provide written informed consent. 6. willing to participate in all study activities and instructions. exclusion criteria: 1. pregnancy and breastfeeding 2. lesions in the periorbital area 3. acute severe blepharitis 4. acute conjunctivitis 5. other concomitant anterior eye disease
biomarkers in the brain oxygen optimization in severe traumatic brain injury trial

Conditions: TBI (Traumatic Brain Injury)

Summary: bioboost is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.

this study is a prospective observational, multi-center study of subjects enrolled in the brain oxygen optimization in severe traumatic brain injury-phase 3 (boost-3) trial. boost-3 is a multicenter, randomized, blinded-endpoint, comparative effectiveness study of goal-directed critical care based upon monitoring of brain tissue oxygen and intracranial pressure versus monitoring of intracranial pressure alone in patients with severe traumatic brain injury. the investigators will obtain an initial set of biospecimens (serum, plasma, cerebrospinal fluid (csf), dna and rna) shortly after randomization into boost-3 and within 24 hours of injury. subsequent biospecimens will be obtained every 8 hours for the first 24 hours post-enrollment. this will allow the characterization of acute changes in biomarker levels. on study days 2 through 5, biospecimens will be obtained twice a day to allow characterization of sub-acute changes in biomarker levels, without overburdening study teams or taking too much blood from individual subjects. on study days 7 and 14 and at 6-months post-enrollment, one set of biospecimen will be obtained, preferably in the morning. biospecimens collected at each time point will consist of 6 ml of whole blood for serum extraction, 6 ml of whole blood for plasma extraction, 2.5 ml of whole blood for rna extraction (a total of 14.5 ml \[one tablespoon\] of blood) and 5 ml of cerebrospinal fluid (csf). bioboost will utilize data collected in the boost-3 trial. this data includes: demographic data and clinical data such as injury characteristics, vital signs, head ct findings, laboratory data and data on physiologic parameters such as intracranial pressure (icp), partial pressure of brain tissue oxygen (pbto2), mean arterial pressure (map), and cerebral perfusion pressure (cpp), among others. bioboost will also utilize outcome assessment data collected from boost-3 participants at 6 months after injury (180 days ± 30 days). trained study personnel who are blinded to the treatment arm will administer the outcome assessments, which will include the measures listed below. the battery includes measures of functional status (gose), cognition, and emotional health. the 6-month follow-up interview will be done in person whenever possible. it may be done by telephone or video conference with participants where an in-person interview is not possible.

Eligibility criteria:
inclusion criteria: * enrolled in boost-3 (this is an ancillary study to the boost-3 trial) * boost-3 participant is enrolled at a bioboost site * able to maintain initial blood sample within 24 hours of injury * provide proxy informed consent exclusion criteria: * profoundly anemic (subjects who are profoundly anemic require blood transfusion) * age less than 18 years

Keywords: biomarkers
a study to evaluate the effects of laropiprant on the antiplatelet effects of clopidogrel and aspirin in combination (mk-0524a-114)(completed)

Conditions: Primary Hypercholesterolemia; Mixed Hyperlipidemia

Summary: this is a 3-period study. periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of tredaptive.


Eligibility criteria:
inclusion criteria: * participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol) * participant is a non-smoker exclusion criteria: * participant has a history of chronic seizures * participant has a history of cancer * participant has a history of stomach or intestinal ulcers or any history of gi bleeding * participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks