Kornimate/medical-research-clean huggingface dataset:
serial fes pet/ct to measure hormone expression in patients undergoing endocrine targeted therapy

Conditions: Estrogen Receptor Positive; Primary or Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7

Summary: this clinical trial studies use of f-18 16 alpha-fluoroestradiol (\[f-18\] fes) positron emission tomography (pet)/computed tomography (ct) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

outline: patients undergo f-18 fes pet/ct scan at baseline. patients also undergo f-18 fes pet/ct and fdg pet/ct between 1-12 weeks after starting therapy, and then 1-12 weeks after the second fes pet/ct scan. repeat fdg pet may be omitted in patients on selective estrogen receptor degrader. after completion of study, patients are followed up for up to 20 years.

Eligibility criteria:
inclusion criteria: * adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer * breast cancer from er+ primary that is seen on other imaging tests. tumor er expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease. * at least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of pet imaging. * patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline fes. * patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. selected treatments may be part of experimental treatment protocols for which the patient would be separately consented. * patients must be willing to undergo serial imaging procedures. * patients must agree to allow access to clinical records regarding response to treatment and long term follow up. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * an inability to lie still for the tests * individuals weighing more than 300 lb. (this is the weight limit of the scanner table) * pregnant or lactating. women of childbearing potential with either a positive or no pregnancy test at baseline are excluded. * any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication). * use of tamoxifen, faslodex, des or any other er blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan. * uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dl) * adult patients who require monitored anesthesia for pet scanning.
novel approach to surveillance of gastric lesions

Conditions: Intestinal Metaplasia of Gastric Mucosa; Gastric Dysplasia; Gastric Cancer; Atrophic Gastritis

Summary: this will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

gastric cancer is an important public health concern, accounting for 26,240 new cases in the united states (us) annually. outcomes are poor, with 5-year survival of 31%, but improve when lesions are detected at early stages amenable to curative therapy. research has shown that lesions such as atrophic gastritis and gastric intestinal metaplasia are precursors to more advanced lesions such as dysplasia and adenocarcinoma, thus providing a potential target for early intervention. gastric cancer screening programs have decreased mortality in high-prevalence countries like japan. however, providers in low-prevalence settings are less experienced at detecting precursor lesions endoscopically on visual inspection. this pilot study will investigate a novel approach to screening for precursor lesions and early detection of gastric cancer by utilizing pressurized irrigation of the gastric mucosa. the study will target patients with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy. following routine endoscopic evaluation, the investigators will utilize the erbejet 2 device (erbe usa inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. the aspirate will be collected for cytologic/pathologic assessment. the goal is that this technique will simplify testing for precursor lesions of gastric cancer, making screening more effective in regions of lower prevalence where providers are less experienced with visual identification of such lesions.

Eligibility criteria:
inclusion criteria: * individuals with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy exclusion criteria: * personal history of gastric cancer * personal history of irritable bowel disease
observational study to evaluate statins patterns of use in spain

Conditions: Dyslipidemia

Summary: the present project is aimed at describing the statins prescription pattern in spanish patients. it will also look into how adequate these prescriptions are accordingly to the recommendations given in treatment guidelines and in the summary product information.


Eligibility criteria:
inclusion criteria: * patients receiving a new statin prescription (naïve patients) * patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug) exclusion criteria: * patients without enough information in the medical records to complete the fields required in the ecrf

Keywords: statins dyslipidemia spain rosuvastatin naive switching new statins prescriptions in spain (naive patients and switching)
safety and efficacy of treatment with azzalure, restylane/emervel filler and restylane skinbooster

Conditions: Facial Aesthetic Treatment

Summary: the efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with azzalure alone or restylane/emervel filler alone followed by repeated combined treatment with azzalure, restylane/emervel filler and restylane skinbooster. subjects will be followed for up to 18 months after initial treatment.


Eligibility criteria:
inclusion criteria * subjects aged 35 to 50 years old * subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction. * subjects with nasolabial folds assessed as mild or moderate. * subjects with glabellar lines assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject. * subjects with signed informed consent. exclusion criteria: * subjects requiring treatment of forehead lines or crow´s feet. * obvious facial sagging (major loss of facial fat/volume). * signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity. * heavily scarred or sun-damaged facial skin. * active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated. * cancerous or pre-cancerous lesions in the areas to be treated. * facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (ha) or collagen, or botulinum toxin treatment during the last 12 months. * procedures or treatments inducing an active dermal response such as laser, intense pulsed light, chemical peeling, microdermabrasion, retinoids within the last 6 months. * any aesthetic surgery of the face. * permanent implant or aesthetic treatment with non-ha or non-collagen products in the face. * history of severe keloids and/or hypertrophic scars. * neuromuscular junctional disorders (e.g. myasthenia gravis, eaton lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration. * known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics. * history of autoimmune diseases. * any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment). * concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \[nsaids\]), omega-3 or vitamin e within 10 days before study treatment, or a history of bleeding disorders. * immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit. * female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.
predicting postoperative chemotherapy efficacy in patients with esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; DNA Methylation

Summary: esophageal cancer remains a disease with a poor prognosis. chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. the investigators aim to develop a model to predict the response to chemotherapy by dna methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

esophageal cancer remains a disease with a poor prognosis. in the treatment of esophageal squamous cell carcinoma (escc), multidisciplinary treatment including surgery, chemotherapy, and radiation therapy is important. chemotherapy is an effective treatment for esophageal cancer, but some patients do not respond to it. non-response to chemotherapy can result in disease progression, loss of patient fitness, and even the opportunity to receive other treatments that might have originally had a therapeutic effect. if there are biomarkers that could indicate the efficacy of chemotherapy before treatment, ineffective patients would be able to change their treatment plan. patients on preoperative chemotherapy would be able to avoid unnecessary chemotherapy and undergo surgery without the effects of physical weakness and side effects. on the other hand, patients on definitive chemotherapy may choose to intensify their treatment with additional radiation therapy or immunotherapy. the investigators aim to develop a model to predict the response to chemotherapy by dna methylation of preoperative biopsy specimens to identify the chemotherapy ineffective

Eligibility criteria:
inclusion criteria: 1. patients who had histologically confirmed esophageal squamous cell carcinoma. 2. patients who had undergone chemotherapy. 3. patients receiving initial chemotherapy 4. written informed consent following full study information is provided to the patient. exclusion criteria: 1. patients for whom a preoperative biopsy sample cannot be obtained 2. patients who cannot assess at 2 months later after chemotherapy. 3. patients with multiple cancers.
criteria associated with patient willingness to participate in biomedical research

Conditions: Consulting in Pneumology Department, But Not for Oncology or Tobacology

Summary: the primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).

the secondary objectives of this study are: * to compare patient acceptance rates for participation in a clinical research protocol before and after january 15, 2016. * to determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before january 15, 2016. * to determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after january 15, 2016. * to describe the patient population seen during pneumology consultations. * to determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory. * to determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution. * construct clusters (homogeneous groups) of patients seen during the pneumology consultations.

Eligibility criteria:
inclusion criteria: * the patient was informed about the study. * the patient is scheduled for a consult in the pneumology department exclusion criteria: * the patient is under judicial protection or is an adult under any kind of guardianship * the patient expresses opposition to the study * it is impossible to correctly inform the patient about the study * the patient cannot fluently read french * the patient is pregnant * the patient is breastfeeding * the patient has cancer * the patient is consulting in tabaccology
a randomised controlled trial comparing the impact of virtual reality, paper and pencil and conventional methods on stroke rehabilitation

Conditions: Stroke

Summary: virtual reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. the purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.

cognitive impairments after stroke are not always given sufficient attention despite its limitations in activities-of-daily- living (adl's). current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday-life. besides limited ecological-validity, paper-and-pencil tasks are not accessible for most stroke patients whose dominant arm is paretic. virtual reality (vr) has shown to be a solution for the development of accessible and ecologically valid systems, but, does it have more impact than a paper and pencil personalised intervention? through a participatory design approach, with health professionals, the investigators have developed: * a motor-accessible and cognitive-personalized vr-based system, where conventional cognitive tasks were operationalized in meaningful simulations of adl's (reh@city) and; * a web tool which generates personalised paper and pencil tasks( task generator). the investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the vr training with reh@city; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the task generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy).

Eligibility criteria:
inclusion criteria: * ischemic stroke with more than 6 months post-stroke * cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the token test (6-item version, portuguese population) * able to read and write exclusion criteria: * neglect * severe depressive symptoms as assessed by the beck depression inventory

Keywords: virtual reality cognitive rehabilitation motor rehabilitation ecological validity personalisation
effect of tok-sen massage for non-specific low back pain

Conditions: Non-specific Chronic Low Back Pain

Summary: the purpose of this clinical trial was to find out whether tok sen massage (a massage method with wooden instruments from northern thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. the main questions it aims to answer are: can tok sen massage relieve chronic lower back pain? can tok sen massage improve the quality of life of patients with chronic low back pain? researchers compared tok sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain. participants will: receive tok sen massage or pressure massage every week for 1 month. questionnaires and flexion measurements before and after each massage. after the massage session, fill out the online questionnaire once a month for three months.

low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (ylds), with a high prevalence of 28%-42% among those aged 40 to 69 years. the prevalence of different occupations in taiwan ranges from 35% to 90%; according to the summary of the national health insurance database results report: "the annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime suffering from low back pain. "most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. tok-sen massage is a kind of folk therapy in northern thailand, specializing in musculoskeletal system diseases. this trial selected pressure massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain. this is an open-label and randomized controlled trial. patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the tok-sen massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the pressure massage group received a 40-minute intervention once a week for a total of 4 times. massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs. the evaluation methods are: 1. oswestry disability index (odi) (baseline and after three interventions), 2. visual analogue scale (vas)before and after each massage, 3. trunk flexibility test. before and after each massage.

Eligibility criteria:
inclusion criteria: * chronic low back pain for more than 3 months * diagnosis of non-specific low back pain exclusion criteria: - * spinal surgery history * joint disease * pregnancy * cancer * systemic disease * mental disease * bone mass measurement less than

Keywords: tok-sne massage pressure massage low back pain
efficacy study of cilostazol and aspirin on cerebral small vessel disease

Conditions: Cerebral Small Vessel Disease

Summary: there may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.

the primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease. the secondary objectives are to compare the impact of aspirin and cilostazol on dti parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living. we also investigate risk factors associated with progression of cerebral small vessel disease.

Eligibility criteria:
inclusion criteria: * 50 to 85 years of age * he/she can walk to the hospital (walker or cane is permissible). * cerebral small vessel disease is observed on brain mri. 1) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified fazekas scale): periventricular wmcs with cap or rims lager than 5mm and deep subcortical wmcs \>10 mm in maximum diameter * written informed consent exclusion criteria: * any patient with contraindication of antiplatelets * any patient with cardioembolic source * carotid bruit or large cerebral artery stenosis \>50% * cortical infarction or subcortical infarction lager than 1.5 cm * bleeding tendency * chronic liver disease (ast or alt \>100 il/l) * chronic renal disease (creatinine \>3.0mg/dl) * active gastrointestinal ulcer * any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma) * anemia (hb \<10g/dl) or thrombocytopenia * cardiac pacemaker or contraindication to mri * pregnancy or breast-feeding * drug or alcohol addiction * any other white matte disease (i.e., multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor * parkinson's disease, alzheimer's disease or any other neurodegenerative disease * any hearing or visual impairment that can disturb the efficient evaluation of the patient * recent cerebral infarction with 3 months

Keywords: cerebral small vessel disease leukoaraiosis magnetic resonance imaging diffusion tensor imaging
the role of fibrocytes in acute lung injury

Conditions: Acute Lung Injury(ALI)

Summary: the important character of acute lung injury (ali) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. one of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. it has been proved that cxcl12/sdf-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. study indicated that inhibition of tlr4 receptor signaling pathway improves fibrosis progression induced by ali, however, the role of fibrocyte in ali is still unclear. the fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased ctgf expression. therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. the central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. the overall objective of this project is to study the role of fibrocytes in acute lung injury.


Eligibility criteria:
inclusion criteria: * acute lung injury patients * above 20 years old * bilateral lung infiltrates * pao2/fio2\<300mmhg * pcwp\<18mmhg exclusion criteria: * pregnant women * under 20 years old * hb\<8.0mg/dl

Keywords: acute lung injury(ali)