Kornimate/medical-research-clean huggingface dataset:
biomarkers in native american women with breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from native american women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. it may also help doctors learn more about the prognosis of these patients. purpose: this laboratory study is looking at biomarkers in native american women with breast cancer.

objectives: * evaluate a selected panel of molecular markers in tissue specimens from native american women with breast cancer. * determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients. * compare and contrast the prevalence of positivity in native american women with breast cancer with an age- and stage-matched cohort of caucasian women with breast cancer enrolled on clinical trial ncctg-77-30-51 or the mayo breast cancer registry. outline: immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbb2, p53, ki-67, bcl-2, bax, cyclin d-1, and insulin-like growth factor-1r.

Eligibility criteria:
disease characteristics: * diagnosis of primary adenocarcinoma of the breast in native american women * prior surgical treatment for breast cancer within the aberdeen or phoenix areas of the indian health service or the alaska area of the native health service between 1990-2000 * paraffin-embedded tissue available * paraffin-embedded tissue available from caucasian women with breast cancer enrolled on ncctg-77-30-51 or the mayo breast cancer registry patient characteristics: age * 18 and over sex * female

Keywords: stage i breast cancer stage ii breast cancer stage iv breast cancer stage iiia breast cancer breast cancer in situ recurrent breast cancer stage iiib breast cancer inflammatory breast cancer stage iiic breast cancer
written genetic counseling and mutation analysis of brca1 and brca2 to patients with breast cancer

Conditions: Hereditary Breast Cancer

Summary: the overall purpose of the study is to evaluate a method for offering mutation analysis of brca1 and brca2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosis and family history. information about the study as well as pre-test genetic counseling will primarily be given in a written way. in addition to that, if a study participant wishes to, she can also receive pre-test telephone genetic counseling.

study population: all patients with newly diagnosed breast cancer in southern sweden are offered inclusion in the scan-b study at the time of diagnosis pre-surgery. if they consent to that, a part of the tumor is sent to a lab in lund, sweden, for research purposes (rna sequencing etc.). patients that are included in the scan-b study are eligible for inclusion in brcasearch, see inclusion and exclusion criteria. study procedure (summary): 1. an envelope with written information is given to the patient at the visit to the surgeon the week after surgery. this envelope contains a written genetic counseling, information about the study, an informed consent form, psychosocial questionnaires and our contact information (telephone, e-mail). the patient can contact a genetic counselor for pre-test telephone genetic counseling if she wishes to. 2. brca1 and brca2 are analyzed by full sequencing. 3. non-carriers are informed about the test result with a letter. mutation carriers and vus (variants of uncertain significance) are telephoned and given a time for an appointment at the department of clinical genetics within a week. 4. psychosocial self-reported questionnaires (had scale, eortc qlq-c30, eortc qlq-br23) are delivered at 3 times: at invitation to the study, one month after information about test result, and one year after information about test result.

Eligibility criteria:
inclusion criteria: 1. the patient is included in the scan-b study. 2. the patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ. 3. the patient has signed an informed consent form. exclusion criteria: 1. the patient is unable to understand the written information in swedish. 2. the patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.

Keywords: brca1 brca2 hereditary breast cancer genetic counseling
weight loss maintenance of a new bioactive compound (metobes-long)

Conditions: Obesity

Summary: the objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. furthermore, if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss.

it has previously been shown that a combination of tyrosine, capsaicin, catechines, and caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and thermogenesis. in addition, dietary calcium may increase fecal fat excretion. method: 80 healthy danish overweight to obese (bmi between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. all subjects was be weight stable (within 3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds. all subjects gave their written consent after verbal and written information about the study. the study protocol was approved by the municipal ethical committee of copenhagen and frederiksberg as being in accordance with the helsinki ii declaration. the total study period was 12 weeks. the intervention design was an 8-weeks randomized, 3-arm parallel, placebo-controlled and double-blind intervention. prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 3.4 mj/d low caloric diet (lcd). only subject who lost more than 4% of their initial body weight after 4 weeks lcd treatment was randomized and continued in the study. the subjects were randomized into 3 balanced groups i.e. placebo, simple or enterocoated release. all subjects received dietary instruction to a slightly hypo caloric diet of -300 kcal/day after the isoenergetic educational system. the dietary advice was reinforced by dietetic consultations every fortnight. body weight and composition were assessed by dexa before and after the lcd period, four weeks into the randomized period and at completion i.e. the last day of the study. all participants underwent assessment of energy expenditure by indirect calorimetry in a ventilated hood. the first respiratory measurement was on the first day of the intervention and will last for 5 hours. all subjects collected all feces excreted three days prior to respiratory measurement and one day of urine excreted.

Eligibility criteria:
inclusion criteria: * healthy danish overweight to obese (bmi between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. all subjects must be weight stable (within 3-kg) 2 months prior to study inclusion. exclusion criteria: * smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmhg

Keywords: body fat loss energy expenditure capsaicin caffeine green tea calcium fecal fat fecal energy
tele-ultrasound: virtual hands-on education for novice users

Conditions: Ultrasound; Education; Virtual

Summary: this study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. this study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning ultrasound in a traditional, in-person format. utilizing a butterfly ultrasound machine, a hand held personal ultrasound device, students wil be guided through a fast (focused assessment with sonography in trauma) examination and imaging of the carpal tunnel using modules and instructor aid. the fast (focused assessment with sonography in trauma) exam images the heart and abdomen for free flowing blood. the carpal tunnel is a region in the wrist that houses the tendons for finger movement. participants will be assessed on the ability to identify key regions, anatomical landmarks and confidence in utilize the ultrasound machine.

this project intends to adapt previous research ("innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners") to assess the effectiveness of tele-education using the butterfly handheld ultrasound device when compared to in person education imaging devices, learning modules and assessments will be kept constant across experimental groups. this experiment aims to adapt the current ultrasound modules used by the university of colorado anschutz school of medicine and modern human anatomy program to formulate in depth modules that outline the following: carpal tunnel (wrist), brachial plexus (shoulder), and fast "focused assessment with sonography in trauma". additionally, participants will be provided an orientation module that will be completed prior to the live session. participants will be divided into either the in-person group or virtual group and participate in a live session where participants go through each module with a trained instructor. participants will be asked to complete a pre/post assessment to determine prior knowledge and the level of learning that took place during the session as well as participant satisfaction and confidence levels.

Eligibility criteria:
inclusion criteria: * first year medical students enrolled at the university of colorado, anschutz medical campus with minimal previous ultrasound experience. * first year graduate students enrolled in the modern human anatomy program (mha) at the university of colorado, anschutz medical campus with minimal previous ultrasound experience. exclusion criteria: * individuals younger than the age of 18. * individuals not enrolled in the medical school or modern human anatomy program (mha) programs at anschutz medical campus * individuals with greater than minimal ultrasound experience.

Keywords: tele-education ultrasound fast carpal tunnel
patient research cohort: rapidly evolving multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Summary: the primary goal of the research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions, or access to second- line treatments. secondary objectives of the research cohort study are to obtain detailed clinical phenotyping and immunological analysis of blood samples, aiming to identify and validate biomarkers of disease activity and response to treatment and prognostic markers.


Eligibility criteria:
* male or female, aged 18-65 * able to give informed consent * diagnosis of ms according to to the revised mcdonald's criteria (polman et al. ann neurol 2005) * relapsing-remitting or secondary progressive ms form * disease duration ≤15 years from diagnosis * expanded disability status scale (edss) score 2.0 to 6.0 at screening evaluation * highly active and/or treatment-refractory ms activity defined as: 1. two or more clinical exacerbations in the previous 12 months, regardless of treatment; or: 2. one clinical exacerbation and sustained increase in edss of at least 1 point in the previous 12 months after receiving immune-modifying treatment, or: 3. evidence of gadolinium (contrast)-enhancement or increase of t2 lesion load at mri after receiving immune-modifying treatment. or 4. not tolerating or not wishing to receive any of the available immune-modifying treatments and meeting one of the stated criteria (b or c) for ms activity in treated subjects (1 relapse and increase in edss of at least 1 point in the previous 12 months; or evidence of contrast-enhancement or increase of t2 lesion load at mri). exclusion criteria: * contraindication to mri including but not limited to intracranial aneurism clips (except sugita), history of intra-orbital metal fragments that have not been removed by an md (as confirmed by orbital x-ray), pacemaker and non-mr compatible heart valves, inner ear implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1.5 hours in the mri scanner. * if female, positive urine pregnancy test * history or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min) * inability to give informed consent/comply with study procedures

Keywords: multiple sclerosis
multiple sclerosis and heavy progressive resistance training

Conditions: Multiple Sclerosis

Summary: the purpose of the present investigation is to determine whether ms patients can tolerate and benefit from heavy progressive resistance training. a second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.

multiple sclerosis (ms) patients are characterized by reduced muscle strength and functional capacity. for ms patients, improvements in muscle strength and thereby functional capacity, would have the potential to make both the daily living easier and to extend the time living independently. attempts to improve muscle strength and function include the application of physical training, although the general advice to ms patients for many years has been to avoid participation in physical training. it has now been demonstrated that endurance training at low to moderate intensity is well tolerated by ms patients, but it only induces modest improvements in both muscle strength and functional capacity. heavy progressive resistance training (hprt) has proven to be the most effective means to improve muscle strength and functional capacity during daily activities in healthy older people. however, the effects of hprt have not been investigated in randomised control trials in ms patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of relapsing remitting multiple sclerosis according to the mcdonald criteria * expanded disability status scale score between 3,0-5,5 * be able to walk at least 100m * be able to train twice a week at the university exclusion criteria: * alcohol abuse, alzheimer's and pacemaker * comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases * having had an attack in a period of 8 weeks prior to the start of the intervention period * having an attack during the intervention period * pregnancy * systematic resistance training in a period of 3 months prior to the start of the intervention period. * training adherence of less than 85%.

Keywords: resistance training strength training training adaptations cns
dietetic efficacy of mare's milk for patients with chronic inflammatory bowel diseases

Conditions: Ulcerative Colitis; Crohns Disease

Summary: mare's milk consumption could improve the well-being in patients with crohn's disease and ulcerative colitis, respectively.

background: dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk. objective: dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated. design: in a randomized, placebo-controlled, double-blind, cross-over intervention study, eight crohn's disease patients and nine ulcerative colitis patients received daily 250 ml mare's milk or placebo drink.

Eligibility criteria:
inclusion criteria: clear and definite diagnosis of ulcerative colitis and crohn's disease resp. exclusion criteria: lactose intolerance and pregnancy

Keywords: mare's milk, crohn's disease, ulcerative colitis, clinical
natural history of asphyxiating thoracic dystrophy (dtj)

Conditions: Asphyxiating Thoracic Dystrophy

Summary: the aim of the project is to prospectively analyze at a clinical and molecular level a series of 50 asphyxiating thoracic dysplasia (atd) patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

asphyxiating thoracic dysplasia (atd, mim 208500) belongs to the short rib polydactyly group and is characterized by short ribs often responsible for an early death due to respiratory distress, trident acetabular roof and short long bones. in the course of the disease, renal, liver and eye complications may occur. however, their frequencies are unknown. atd is transmitted with an autosomal mode of inheritance and up till now only one gene has been identified, namely ift80, which accounts only for a small part of atd. the aim of our project is to prospectively analyze at a clinical and molecular level a series of 50 atd patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

Eligibility criteria:
inclusion criteria: * short ribs with narrow thorax * trident acetabular roof * short hands * all ages * informed consent signed exclusion criteria: * other disease * ellis van creveld syndrome * no social security

Keywords: natural history ift80 short ribs multivisceral involvement
examining health-related physical fitness in individuals with diabetic dyslipidemia.

Conditions: Diabetic Dyslipidemia

Summary: to compare health-related physical fitness parameters in type 2dm patients with and without dyslipidemia.cardiometabolic biomarkers glucose and lipid profile will be noted from medical records. body composition, functional capacity will be assessed with a six-minute walk test, peripheral muscle strength with a dynamometer, and physical activity level with a pedometer.


Eligibility criteria:
inclusion criteria: * having been diagnosed with type 2 dm for at least 1 year, * having an hba1c value between 6.5-11%, * being between the ages of 35-65, * knowing how to read and write turkish, * having signed the informed consent form exclusion criteria: * lack of cooperation * patients with peripheral or central serious neurological disorders * patients with uncontrolled hypertension and uncontrolled arrhythmia * pregnant or lactating patients * patients with diabetic ulcers or neuropathy * chronic renal failure (egfr\<30 ml/min) * chronic liver disease (alt/ast\<3x upper limit of normal) * patients with serious respiratory system disease * patients with cardiac pacemakers * history of previous stroke or myocardial infarction * presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests
measurement of physical activity in the first days after thoracic surgery

Conditions: Pulmonary Disease

Summary: objective measurement of physical activity has several advantages compared to declarative measures: exemption from memory bias and desirability bias, more precise evaluation, taken into account activities of low intensity, measurement of physical activity and sedentariness profiles (number and duration of periods of activity, number of breaks in sedentary lifestyles). the aim of this study is to assess the early postoperative mobility of patients who have undergone pulmonary excision by thoracoscopy or robot surgery using actigraph gt3x accelerometer. this assessment will serve as a reference element for further studies.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * having to undergo pulmonary excision by thoracoscopy or robotic surgery * accepting to wear a belt fitted with an actigraph gt3x accelerometer for a maximum of 5 days post surgery * affiliated to a health insurance plan * having given an oral non-opposition exclusion criteria: * pregnant or breastfeeding woman * patient unable to move independently (paraplegic, etc.) * patient deprived of liberty or under guardianship.

Keywords: actigraph gt3x physical activity
to demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg

Conditions: Depression

Summary: to demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antidepressant
fasenra pediatric japan post-marketing study(pms)

Conditions: Bronchial Asthma

Summary: the purpose of the investigation is to confirm the followings under the post-marketing actual use of fasenra® subcutaneous injection 30 mg / 10mg syringe (hereinafter referred to as fasenra). 1. development of unexpected related aes\* 2. to grasp development of related aes\* in the real-world post-marketing setting. 3. effectiveness (pulmonary function and asthma control) \* aes investigator or mah considers that there is a reasonable possibility that the experience may have been caused by the drug

this investigation will be conducted to support the application for re-examination specified in article 14-4 of the act on securing quality, effectiveness and safety of products including pharmaceuticals and medical devices. the purpose of the investigation is to confirm the followings under the post-marketing actual use of fasenra® subcutaneous injection 30 mg / 10mg syringe (hereinafter referred to as fasenra). 1. development of unexpected related aes\* 2. to grasp development of related aes\* in the real-world post-marketing setting. 3. effectiveness (pulmonary function and asthma control) \* aes investigator or mah considers that there is a reasonable possibility that the experience may have been caused by the drug

Eligibility criteria:
inclusion criteria: the evaluable patients in children aged ≥6 years to \<15 years are those treated with fasenra for the first time due to "bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy) exclusion criteria: none