Kornimate/medical-research-clean huggingface dataset:
metabolic effects of a pre-meal protein drink with or without added amino acids at a subsequent composite meal

Conditions: Diabetes Mellitus, Type 2; Satiety Response

Summary: the purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.

hyperglycaemia in type 2 diabetes (t2d) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in t2d. observational studies indicate that milk consumption reduces the risk of developing t2d, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. it has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in t2d patients. the effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (aa) pattern in postprandial blood after ingestion of whey proteins. in the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic aa might be useful to optimize an insulinogenic effect. additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. the possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest. a randomized, single blind, within-subject trial was performed. the test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. the test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. altogether, the protein drink and the sandwich meal were to be consumed within 12 min.

Eligibility criteria:
inclusion criteria: * normal fasting blood glucose * normal bmi exclusion criteria: * smokers * vegetarians * subjects who receives any drug treatment * lactose malabsorption

Keywords: whey protein soy protein insulinogenic amino acids incretins glycaemia insulinaemia
kinesiological taping and aerobic exercise in women with primary dysmenorrhea:

Conditions: Primary Dysmenorrhea; Kinesics; Aerobic Exercise

Summary: dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. kinesiological taping (kt) and aerobic exercise (ae) are effective methods for dysmenorrhea. the purpose of this study is to investigate the effects of kt and ae on pain, attitude, depression, and quality of life in women with dysmenorrhoea. forty-five women with dysmenorrhea wıll randomly be divided into three groups as kt group (n=15), ae group (n=15) and control group (n=15). in kt group, 6 sessions of kt will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. in the ae group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. no application will be applied to the control group. all groups will be evaluated with beck depression scale (bds), mcgill pain questionnaire (mpq), menstrual attitude scale (mas), and short form- 36 (sf-36) before and after the intervention.


Eligibility criteria:
inclusion criteria: * being in the age range of 15-30 * not being married * women with abdominal pain during menstruation 5 and above according to the visual analogue scale. * women whose menstrual cycle has started and those whose cycle continues. exclusion criteria: * endometriosis and adenomyosis * myoma * endometrial polyp * previous pelvic infections * intrauterine device use * venous congestion in the internal genital organs

Keywords: primary dysmenorrhea kinesiological taping aerobic exercise
stroke complications after traumatic experiences and stress

Conditions: Stroke

Summary: the primary aim of this retrospective cohort study is to test the hypothesis that previous traumatization (long) before an ischemic stroke increases the degree of stroke-induced ptsd symptoms at 9-13 months after the stroke event. secondary outcome parameters include quality of life and depression.

neuropsychiatric consequences of brain ischemia play a critical role in shaping long-term stroke outcome. unfortunately, however, as of now, clinical research and clinical practice have not adequately addressed this growing challenge. a good case in point is posttraumatic stress disorder (ptsd). previous trauma exposure and posttraumatic stress symptoms may increase the risk of cardiovascular events (sumner et al., 2015). moreover, unbeknownst to most clinical neurologists, a significant portion (approximately 25%) of their stroke patients develop symptoms of post-traumatic stress disorder (ptsd) within the first year post-event. ptsd-related symptoms after an acute coronary syndrome increase the risk of recurrent cardiac events and mortality (edmondson et al., 2012). similarly, stroke-induced ptsd has been linked with worse long term stroke outcome, in particular, recurrent stroke, greater disability, non-adherence to medications, and comorbidities (goldfinger et al., 2014; kronish et al., 2012). for a period of 22 months, all stroke patients treated at the charité medical center will be screened retrospectively 9-13 months after a first-ever ischemic stroke (\~2000). all eligible patients will be contacted by mail 9-13 months after their hospital stay with the request that they complete the questionnaires. the mailing will also include an information statement, the consent form, as well as a stamped return envelope.

Eligibility criteria:
inclusion criteria: 1. patients treated at the charité medical center for acute ischemic stroke 2. confirmation of diagnosis by ct or mri 3. age \> 18 years 4. ability to give informed consent exclusion criteria: 1. stroke secondary to complications from an intracranial aneurysm, arterial-venous malformation, intracranial tumor or neoplastic process 2. major diseases at the time of the hospital stay that would be expected to obviate meaningful follow-up assessments such as life-threatening heart or respiratory failure, renal or hepatic failure, cancer 2. severe comprehension deficits, e.g. severe aphasia, dementia 3. substantial pre-stroke disability (e.g. from a previous stroke)

Keywords: ptsd stress traumatization
sleep disturbance in lung cancer patients.

Conditions: Lung Cancer

Summary: the aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, performans status and lung cancer staging at diagnosis.


Eligibility criteria:
inclusion criteria: newly diagnosed lung cancer age \> 18 yrs performans status \ 5 months exclusion criteria: psychiatric disease performans status \> 2 known sleep disorder
a study to evaluate ibi112 in the treatment of moderate to severe active ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: to evaluate the efficacy of ibi112 induction therapy in patients with moderate and severe active ulcerative colitis (uc) to achieve clinical remission.

this is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of ibi112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis

Eligibility criteria:
inclusion criteria: 1. diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting uc and histopathological evidence supporting uc diagnosis; 2. patients with moderate to severe ulcerative colitis, defined as modified mayo score ≥4 and endoscopic score ≥2; 3. subject must have received at least one prior treatment or first use of a biological agent: exclusion criteria: 1. diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease; 2. uc lesions were limited to rectum or involved colon \< 15cm; 3. evidence of toxic hirschsprung's disease was found during screening; 4. history or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
laparoscopic surgery vs rfa for recurrent hcc

Conditions: Hepatocellular Carcinoma

Summary: management of recurrent hcc is urgent and several treatments have been developed .repeat hepatectomy is considered to be the first choice for recurrent hcc. unfortunately, repeated open hepatectomy can be performed only in a small proportion of patients due to inadequate liver function reserve, widespread recurrence or high invasiveness. given that recurrent tumors are usually detected at small size during follow-up after initial surgery, radiofreqency ablation (rfa), which is less invasive, may be locally curative and causes minimal damage to liver function reserve,has been widely used. however, the re-recurrence rate after rfa is more than 50%,and the recurrence-free survival is less than 20%. recently, satisfactory short- and long-term oncological outcomes have been reported for laparoscopic surgery (ls) for the treatment for primary hcc with cirrhosis. some single center pilot studies reported that ls may, compared with open surgery, improve the prognosis of hcc with less blood loss and shorter hospital stay. ls was initially considered not suitable for recurrent hcc due to postoperative adhesions that might make laparoscopic surgical procedure more difficult and less safe. with improvement in technique and experience, recent studies showed that ls for recurrent hcc in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. however, thus far, no study has been performed to evaluate the long-term oncological outcomes of ls for recurrent hcc, and compare those results to that for rfa. to clarify these issues, a multicenter retrospective comparative study by using propensity score matching method that included a large consecutive series of patients with recurrent hcc within milan criteria, who underwent ls or rfa, was performed.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. first recurrent hcc after curative hepatectomy; 3. a solitary recurrent hcc ≤ 3.0 cm in diameter, or multiple recurrent hcc ≤ 3 lesions, each ≤ 3.0 cm in diameter; 4. tumor located in left lateral lobe (segment ii or iii) or subcapsule of liver(subcapsular nodule was defined as a lesion located less than 1 cm from the liver edge and could be treated by either ls or rfa. 5. no radiologic evidence of invasion into major portal/ hepatic vein branches; 6. no extrahepatic metastases; 7. child-turcotte-pugh class a or b; exclusion criteria: 1. coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3); 2. history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding; 3. history of a secondary malignancy; 4. severe dysfunction of the heart, kidney, or other organs
mindfulness therapy for individuals with lung cancer

Conditions: Lung Cancer

Summary: managing psychological and physical symptoms to improve quality of life in patients with lung cancer are a major public health concern. mindfulness-based therapies are showing promise in modifying psychological distress and improving quality of life in some cancer groups, but little testing has included lung cancer samples. mindfulness-based therapies integrate meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental acceptance and awareness of bodily states. such strategies may promote well being, self-regulation, and symptom management. the study purpose was to test the acceptability, feasibility, and symptom / health-related quality of life (hrqol) outcomes of a home-based mindfulness intervention for individuals with advanced lung cancer during non-curative treatment (radiation and/or chemotherapy). acceptability and feasibility were measured via patient consent and retention rates, therapy expectancy, study adherence, attrition reasons, and quality assurance indicators. efficacy was determined via symptom and hrqol (health perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions (n=20) or an attention control condition (n=20). outcome data was obtained at baseline (time 1), post-intervention (time 2, week 8), and four weeks after completion (time 3, week 11). in addition, both groups received weekly symptom assessment interviews. the hypothesis was that the mindfulness group would report better symptom management and hrqol (lower worry, dyspnea, insomnia, depression; higher physical and social function; more positive health perceptions) than the attention control group at the protocol end and that these differences will be sustained at time 3.

the final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).

Eligibility criteria:
inclusion criteria: 1. able to understand and speak english 2. at least 21 years old 3. active treatment for a diagnosis of non-small cell lung cancer 4. karnofsky score \> 80 5. have a telephone by which they can be reached exclusion criteria: 1. current substance abuse other than tobacco 2. active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation. 3. cognitive impairment 4. active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses 5. diagnosis of small cell lung cancer

Keywords: lung cancer mindfulness therapy active treatment (radiation and/or chemotherapy)
efficacy of ea on depression related insomnia: study protocol for a multicenter rct

Conditions: Insomnia Due to Mental Disorder

Summary: the investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.

sleep difficulties are among the main symptoms presented by depressed patients, and they can profoundly impact course of illness. acupuncture is a widely recognized therapy to treat depressive disorders and sleep disturbances in clinical practice. this multicenter randomized placebo-controlled trial is aimed to investigate the efficacy and safety of electroacupuncture, sham acupuncture and standard medical care, administrated by professional acupuncturists and psychiatrists, in depression patients with insomnia. the investigators describe a protocol for a multicenter randomized controlled trial. two hundred seventy eligible patients in 3 different health-care centers in shanghai will be randomly assigned to one of 3 treatment groups: ea group (electroacupuncture+standard medical care), control a group (sham acupuncture+standard medical care) and control b group (standard medical care). treatment will be given 3 times per week for 8 weeks. the primary outcomes is the pittsburgh sleep quality index (psqi). the secondary outcomes are sleep parameters recorded in the actigraphy, hamilton rating scale for depression (hamd) score and self-rating anxiety scale (sas) score. daily dose of patients' antidepressant and sedative-hypnotic medication will be recorded in the dairy. all adverse effects will be assessed by the treatment emergent symptom scale (tess). outcomes will be evaluated at baseline, 4 weeks post-treatment and 8 weeks post-treatment, as well as at 1 month, 3 months and 6 months follow-up. the findings from this trial will help further about the efficacy and safety of acupuncture for depression related insomnia, as well as determine the differences between electroacupuncture, sham acupuncture and standard medical care for treating insomnia and depression.

Eligibility criteria:
inclusion criteria: 1. male or female participants aged 18-70; 2. participants who meet the diagnostic criteria of depression according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv); 3. participants whose hamd score is 20-35; 4. participants who have complaint about insomnia at the first visit to the doctor; 5. participants whose psqi score is more than 7; 6. participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial. exclusion criteria: 1. participants with secondary depressive disorders caused by organic diseases, medicine, or psychotic disorders including schizophrenia, etc; 2. participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases; 3. participants with alcohol abuse or drug dependence; 4. participants who refuse to wear the actigraphy during the trial; 5. pregnant or lactating women.

Keywords: acupuncture insomnia depression antidepressants
glioblastoma radiotherapy using imrt or proton beams

Conditions: Glioblastoma

Summary: radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. as the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. by using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. an initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. the aim of the grips study is to prospectively test this clinical benefit in a randomized, open-label phase iii study. patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). the primary endpoint is the cumulative toxicity ctc grade 2 and higher in the first 4 months. secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.


Eligibility criteria:
inclusion criteria: * histologically confirmed gliomblastoma who iv (operated or after biopsy) * indication for radiotherapy / radiochemotherapy * informed consent * ki ≥ 60% or ecog 0/1 * age ≥ 18 years * sufficient effective contraception exclusion criteria: * patient is not able to consent * previous radiotherapy in the brain or skull base * active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...) * contraindication to mri imaging * simultaneous participation in another clinical trial that could influence the outcome of this study or other study
oea and lipisperse metabolic study

Conditions: Healthy Volunteers - Male and Female; Pharmacokinetic Study in Healthy Volunteers

Summary: a placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (oea) with lipisperse supplementation on metabolic pathways in healthy participants.

this study aims to compare the metabolic effects of two different doses of oea with lipisperse to a placebo in healthy participants over an 8-hour period. there are three trial arms in this study. each participant will complete all 3 arms of the study, for a 3-way cross-over.

Eligibility criteria:
inclusion criteria: * adults aged 30 years and older * generally healthy * bmi 25.0-34.9 kg/m2 * able to provide informed consent * agree to not participate in another clinical trial while enrolled in this trial * agree not to change current diet and/or exercise frequency or intensity during entire study period * females using a prescribed form of birth control (e.g. oral contraceptive) * participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points exclusion criteria: * have a serious illness e.g. neurological disorders such as ms, kidney disease, liver disease or heart conditions * history of any glucose or insulin regulation problem, including diabetes. * have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar). * diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, nafld, hyperinsulinemia, hypoglycaemia. * use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., glp-1, gip, glucagon), glucose or insulin. * current malignancy (excluding basal cell carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction) * active smokers, nicotine use or drug (prescription or illegal substances) abuse * chronic past and/or current alcohol use (\>21 alcoholic drinks week) * pregnant or lactating women * allergic to any of the ingredients in active or placebo formula * participants who are or who have participated in any other clinical trial during the past 1 month (excludes rdc clinical trials which are to be assessed on a case-by-case basis). * any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * regular use within the past 4 weeks of supplements containing oea and/or lipisperse

Keywords: healthy volunteer oea oleoylethanolamide