Kornimate/medical-research-clean huggingface dataset:
glucose kinetics after wheat and rye breads

Conditions: Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics

Summary: certain functional properties of cereal products, e.g. their postprandial glucose and insulin responses, have been characterized as steps towards obtaining a greater understanding of their beneficial health effects. a low-glycemic index diet results in decreased postprandial insulin and glucose responses, which is thought to be beneficial for insulin and glucose metabolism. in healthy subjects, it has been shown that rye breads (rbs) produce a lower postprandial insulin response compared with refined wheat breads (rwb) despite similar glucose responses. juntunen et al. (2003) suggested that the difference in the structural characteristics between rye and wheat breads is a possible explanatory mechanism. however, the underlying mechanism of this discrepancy between insulin and glucose responses to rye bread, the so-called "rye factor" (rf), is still largely unknown. faster starch digestibility and higher postprandial insulin responses for rwb compared with rbs may indicate faster intestinal glucose absorption and faster glucose disappearance respectively. therefore our hypothesis is that despite having similar glucose responses, rwb has faster turn over (kinetics) compared with rbs. the present study is aiming to apply an experimental set up which can comprehend the hypothetical differences in rwb and rbs kinetics.

the human subjects after an overnight fasting 10-12 hours are coming to the clinic. on arrival, catheters are inserted into a forearm vein of each arm for blood sampling and isotope infusion, respectively. a primed followed by a constant-rate infusion of \[6,6-2h2\] glucose are administered. the enrichment of \[6,6-2h2\] glucose in the blood is then measured at different time points after the breakfast. the glucose kinetics can be calculated from this.

Eligibility criteria:
inclusion criteria: * males 18-40 years with bmi 22-25.5 kg/m2 exclusion criteria: * a family history of diabetes mellitus, regular use of nicotine, recurrent extensive exercise, regular intake of medication or food intolerances. the subjects had to be free from illnesses for one month prior to the study.

Keywords: rye wheat rye factor glucose kinetics
quality of life in patients undergoing parathyroidectomy

Conditions: Parathyroidectomy; Hyperparathyroidism

Summary: there are three specific aims in the present study: 1. to validate the investigators' translated version of parathyroidectomy assessment of symptoms (pas) questionnaire. 2. to evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism. 3. to analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.

either primary or secondary hyperparathyroidism may necessitate parathyroidectomy in some patients to improve the related biochemical abnormalities or symptoms, or both. many patients diagnosed with hyperparathyroidism today do not have the classic or historical severe manifestations such as osteitis fibrosa cystica or nephrocalcinosis. the well-known pentad of symptoms - painful bones, kidney stones, abdominal groans, psychic moans, and fatigue overtones - is more common, although most patients have few dramatic symptoms. the multifactorial causes for many of the symptoms that patients have make it difficult to know to what extent surgical intervention will alleviate the symptoms. several endocrine surgeons from the western countries have used a standardized health status assessment tool such as the sf-36 (the medical outcomes study short-form health survey) to assess symptoms and health state in patients with hyperparathyroidism. results of the studies confirmed that these patients are indeed impaired in several domains and even seemingly "asymptomatic" patients benefit from parathyroidectomy. more recently, canadian surgeon pasieka designed and validated a disease-specific surgical outcome tool, the parathyroidectomy assessment of symptoms (pas) score, for patients with hyperparathyroidism. using this tool, several studies from different countries showed that the study group of patients with hyperparathyroidism had significantly more symptoms than controls, and some of the symptoms are remarkably ameliorated after surgery. in taiwan, only a small number of studies have evaluated neuropsychiatric function and neuromuscular abnormalities in these patients. none of the studies has used a patient-based measure of health status or quality of life intended to capture patient-reported perceptions of health and function.

Eligibility criteria:
inclusion criteria: * aged 18 and older exclusion criteria: * subjects who are illiterate or unable to complete questionnaire * excluded by patient's clinician prior to recruitment

Keywords: quality of life hyperparathyroidism
an extension trial to evaluate long-term safety of saber™-bupivacaine for pain following shoulder surgery

Conditions: Pain

Summary: this is an extension to a previous research trial testing saber™-bupivacaine (an experimental pain-relieving medication). the purpose of this extension trial is to assess whether treatment with saber™-bupivacaine or saber™-placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. this trial will also assess safety (side effects).

this research trial will involve all available subjects who received treatment in durect protocol c803-017. all subjects will have the same follow-up safety assessments performed. no experimental treatment will be given in this trial. subjects, investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.

Eligibility criteria:
inclusion criteria: * participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time. * participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff. * participants must have participated in durect protocol c803-017 and received saber™-bupivacaine or saber™-placebo approximately 18 months before enrolling in this trial. exclusion criteria: * participants who participated in any other trial with an investigational drug or device since their participation in durect protocol c803-017.

Keywords: long-term safety shoulder surgery bupivacaine
efficacy and safety of ivabradine on top of atenolol in stable angina pectoris

Conditions: Angina Pectoris

Summary: to test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris


Eligibility criteria:
inclusion criteria: * chronic stable angina pectoris * documented coronary artery disease * previous treatment with atenolol or other beta-blocker agent * exercise tolerance test positivity and stability exclusion criteria: * heart rate \< 60 bpm * congestive heart failure
study of an internet-delivered treatment based on experiential dynamic psychotherapy for social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. the study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control.


Eligibility criteria:
inclusion criteria: * 18 years old or older * fulfill the dsm-5 criteria for social anxiety disorder (score \> 60 on the self-assessment instrument lsas-sr) * have access to a computer/smartphone/tablet with internet connection * be able to read and write swedish. exclusion criteria: * suicidal (within the previous month, assessed with the self-assessment instrument c-ssrs) * partaking in psychological treatment * ongoing treatment with psychopharmacological drugs with dose adjustments within the nearest month or planned dose adjustments. the following self-reported diagnoses are excluded: * autism spectrum disorder * serious depression (score ≥ 20 on the phq9) * indications of psychosis or bipolar disorder (type 1 or 2).
validation of 70-gene mammaprint profile in japanese population

Conditions: Breast Cancer

Summary: by using gene-expression profiling, van't veer and colleagues developed a 70-gene prognosis profile, mammaprint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. the aim of this study is to evaluate the prognostic value of the 70-gene mammaprint profile in japanese women with node-negative breast cancer.

frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on mammaprint array. patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between december 1998 and august 2001 at osaka medical center for cancer and cardiovascular diseases. samples are evaluated by gene expression profiling for the 70-gene mammaprint profile and classified as genomic high risk or genomic low risk.

Eligibility criteria:
inclusion criteria: * breast cancer patients * node-negative * treated with breast conserving therapy or mastectomy with axillary lymph node dissection at osaka medical center for cancer and cardiovascular diseases

Keywords: microarray gene expression profiling mammaprint breast cancer
impact of preoperative sarcopenia on morbidity and mortality in patients operated on from digestive cancers

Conditions: Sarcopenia; Malnutrition; Pancreatic Cancer; Liver Cancer

Summary: sarcopenia (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). it deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. sarcopenia appears like an independent factor decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing mortality for gastrointestinal cancer. however, few studies have demonstrated his impact on postoperative course in digestive oncology. the search for sarcopenia, complementary nutritional status, is now a source of great interest with 62 ongoing projects in the united states. the first objective of this study is to evaluate the impact of preoperative sarcopenia on 30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal cancer (liver and pancreas). the second objective is to evaluate the impact of preoperative sarcopenia on the long term outcomes (12 months) on the same patients.

in this interventional, intent-to-treat, single-center cohort, prospective study, sarcopenia will be evaluated by the decrease in muscle surface (assessed by ct-scan) associated with a decrease in muscle strength (assessed by hand gauge). preoperative evaluation will also include nutritional status by physical examination and laboratory tests, and many nutritional questionnaires. the same data (including sarcopenia, laboratory tests and nutritional evaluation) will be collected at 7 days, 30 days and 12 months, as well as the morbidity and mortality. statistical tests might evaluate if sarcopenia may be an independent factor of morbidity and mortality among these patients.

Eligibility criteria:
inclusion criteria: * patients treated in the our digestive surgery department during the inclusion phase for the surgical curative treatment of liver (primary or secondary) and pancreatic cancer * patients over 18 years * patients who agreed to participate in the study * the patients insured by french health care exclusion criteria: * patients treated by radio-frequency * patients operated for extrahepatic cholangiocarcinoma , cancer of the papilla of vater or the gall-bladder * patients with primary peritoneal cancer * patients with palliative surgery without resection * patients protected by law * minor patients
ibsr intervention for adults who stutter

Conditions: Stuttering

Summary: stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. it is often accompanied not only by verbal difficulties but also by negative impact on several psycho-social aspects in the life of the people who stutter. recently, clinical evidences have shown the effectiveness of inquiry based stress reduction (ibsr) technique to improve psychosocial symptoms and enhance well-being in clinical and non-clinical samples. ibsr, the clinical application of byron katie's "the work", enables individuals to mindfully spot and investigate in a systematic and comprehensive manner thoughts that lead to stress and suffering by a series of questions and turnarounds. ibsr was found to have significantly positive influence on the quality of life, mental well-being and stress management in a variety of populations which suffer from elevated levels of stress, suffering, tension and anxiety, and to enhance resilience of non-clinical general population. in our research we hypothesized that: 1. adults who stutter will have high levels of anxiety, and low levels of psychological flexibility and satisfaction with life. 2. ibsr intervention will improve experience of stuttering in adults who stutter. 3. ibsr will decrease anxiety levels and enhance psychological flexibility and satisfaction with life.


Eligibility criteria:
inclusion criteria: * diagnosis of either developmental or acquired stuttering. * age of 18 years or above. * capability to understand and fill out the study outcome instruments and informed consent form. exclusion criteria: * diagnosis of severe mental illness. * inability to understand or read hebrew. * subjects who declare they can not take a part in the trial throughout its whole duration.

Keywords: inquiry based stress reduction ibsr stuttering adults who stutter overall assessment of the speaker's experience of stuttering "the work" meditation well-being
a study to assess the efficacy and safety of hmi-115 in male subjects with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: to investigate the efficacy of hmi-115 compared to placebo in treating androgenic alopecia patients for 24 weeks


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent. 3. clinical diagnosis of androgenetic alopecia. male subjects who meet norwood-hamilton scales iii vertex, iv and v . 4. be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area. 5. subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified imp) during the study. 6. subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of imp or complete whole study period whichever is longer. exclusion criteria: 1. subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery). 2. subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc. 3. subject with history of hair weaves within 3 months prior screening. 4. subject has a current history of hyperthyroidism or uncontrolled hypothyroidism. 5. subject has, in the investigator's opinion, uncontrolled hypertension (systolic blood pressure \[sbp\] \> 159 mmhg, diastolic blood pressure \[dbp\] \> 99 mmhg). 6. subject has any of the following conditions within 6 weeks prior to screening: 1. myocardial infarction, stroke, unstable angina, or transient ischemic attack. 2. heart failure with classified as being in new york heart association class iii or iv. 7. subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening. 8. subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp). 9. subject plans to schedule elective surgery during the study.
thoratec's reduce driveline trauma through stabilization and exit site management study

Conditions: Left Ventricular Assist Device; Percutaneous Lead Management

Summary: the purpose of this study is to evaluate the feasibility of a percutaneous lead management kit for heartmate ii driveline stabilization and exit site management.

the percutaneous lead management kit is a combination of commercially available components that are packaged together in a kit to be used for heartmate ii driveline exit site cleaning, dressing and stabilization. the resist study is a prospective, non-randomized study to evaluate the wearability and usability of the percutaneous lead management kit. evaluation of the percutaneous lead management kit for wearability and usability will be performed for 30 days from enrollment. study patients will also be followed for up to 6 months for any evidence of driveline infection.

Eligibility criteria:
inclusion criteria: * signed informed consent form * 16 years of age or older * supported by heartmate ii lvad continuously for at least 6 months and not currently hospitalized * will continue on lvad support for at least another 30 days * no driveline or systemic infection * willing and able to perform kit dressing changes at least once every 7 days for 30 days * can fill out study forms * can use a digital camera * willing to return to clinic for final study visit in 30 days exclusion criteria: * high risk for non-compliance * ongoing mechanical circulatory support other than heartmate ii lvad * sensitivity to kit components * skin condition that may react to kit component adhesives * already using all components of percutaneous lead management kit

Keywords: thoratec heartmate ii heart-assist devices driveline or percutaneous lead management heartmate ii percutaneous lead management
omega-3 supplementation after surgical treatment of obesity

Conditions: Obesity

Summary: the study evaluates diet supplementation of omega-3 fatty acids after surgical treatment of obesity in adults. half participants will receive diet supplementation of omega-3 fatty acids, while the other half will receive placebo.

omega-3 fatty acids has been related to immunomodulation and antioxidant action. diet supplementation of omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.

Eligibility criteria:
inclusion criteria: * bmi \> 30kg/m2 * candidate to bariatric and metabolic surgery exclusion criteria: * use of omega-3 * contraindication to bioimpedance analysis * uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics * refusal to participate

Keywords: sarcopenia lipid profile bariatric surgery metabolic surgery
endoscopic ultrasound-guided needle-based confocal laser endomicroscopy for evaluation of malignant lymph nodes - a pilot study

Conditions: Malignancy or Benign of Enlarged Lymph Nodes

Summary: current modalities for lymph node staging in cancer can be limited. needle-based confocal laser endomicroscopy (ncle) is a novel endoscopic technique, which is compatible with the 19-gauge fna needle. under endoscopic ultrasonography (eus) guidance, ncle enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.this study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (ncle) at the time of endoscopic ultrasound (eus) and to describe the ncle features that distinguish between benign and malignant lymph nodes.


Eligibility criteria:
inclusion criteria: * patients undergoing eus for staging of malignancy or assessment of enlarged lymph nodes exclusion criteria: * patients aged \ 80 years * known allergy to fluorescein dye * previous eus-fna performed within the past 3 months, and usualcontraindications to eus-fna * pregnancy or breastfeeding * inability to provide informed consent
irinotecan liposomes combined with epirubicin in recurrent non-muscle invasive bladder urothelium carcinoma after anthracyclines treatment

Conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma

Summary: the goal of this clinical trial is to learn the dose-limiting toxicity of the new combined treatment with irinotecan liposomes (intravenous injection) and epirubicin (intravesical instillation) in anthracyclines treatment-failed non-muscle invasive bladder cancer adults. it will also learn if the combined treatment works to treat these patients. additionally, the safety and biological mechanisms of the combined treatment will also be explored. the main questions it aims to answer are: * does the combined treatment of irinotecan liposomes and epirubicin reverse anthracyclines resistance of participants? * what medical problems do participants have after taking the combined treatment of irinotecan liposomes and epirubicin? * what biological mechanisms underlie the effect of irinotecan liposomes on anthracyclines resistance? participants will be classified into arm a and arm b. * arm a: participants will receive an intravenous injection of irinotecan liposomes once every two weeks for one month, along with intravesical instillation of epirubicin once a week for one month. patients will be evaluated by two professional urologists; those with a complete response or partial response will undergo transurethral resection of bladder tumor (turbt) and intravesical therapy. patients with stable or progressive disease will receive subsequent treatment at the investigator's discretion. participants are required to visit the hospital for physical examination every two weeks. * arm b: in the first month after turbt surgery, participants will receive intravenous injection of irinotecan liposomes once every two weeks for one month, and intravesical instillation of epirubicin once a week for one month, followed by once a month for six months. participants are required to visit the clinic for physical examination once every two weeks in the first month, and once every three months after that. * keep a diary of their symptoms during the study period.


Eligibility criteria:
inclusion criteria: * cta-ct1n0m0 patients with non-muscle invasive urothelial carcinoma * tumor recurrence occurred after anthracyclines treatment * systemic chemotherapy had not been used * tumor is measurable according to new response evaluation criteria in solid tumours: revised recist guideline * ecog (zps, 5-point scale) 0-1 exclusion criteria: * age less than 18 years * patients with severe cardiac, cerebral, hepatic, or renal disease * severely malnourished patients * patients with mental illness and those without insight and unable to express exactly * combined with malignant tumors of other organs * systemic infectious diseases
safety and maintenance of effect of ziprasidone plus a mood stabilizer in bipolar i disorder (manic or mixed)

Conditions: Bipolar Mania; Bipolar Disorder

Summary: the purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with bipolar i disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.


Eligibility criteria:
inclusion criteria: adults meeting dsm-iv (diagnostic and statistical manual of mental disorders, fourth edition) criteria for bipolar i disorder (currently with manic or mixed symptoms) exclusion criteria: ultra rapid cyclers and subjects with significant cardiovascular disease including history of qt prolongation and/or congenital long qt syndrome