Kornimate/medical-research-clean huggingface dataset:
rw efficacy of sotorasib in kras g12c-mutated metastatic nsclc

Conditions: Nsclc; KRAS P.G12C

Summary: the purpose of the ifct2102 lung kg12ci study is to closely monitor cohort atu applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (amg 510) as well as the demographic and molecular characteristics of patients.

the purpose of the ifct2102 lung kg12ci study is to closely monitor cohort atu applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (amg 510) as well as the demographic and molecular characteristics of patients. the objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of nsclc patients with a kras g12c mutation, treated with sotorasib in the framework of the cohort atu in france.

Eligibility criteria:
inclusion criteria: * patients with stage iv nsclc at time of initiation of treatment with sotorasib * presence of kras g12c mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed) * patients who received at least one dose of the treatment with sotorasib as part of the french early access program (atu program) * patients who were informed about the study and do not object for their data to be collected * age \> 18 years exclusion criteria: * patients enrolled in a sotorasib clinical trial * patients with a psychiatric history that hinders the comprehension of the information leaflet * patients under curatorship or guardianship * unable to obtain data collection

Keywords: sotorasib real-world study kras p.g12c nsclc ifct
modalities and safety of cardiac rehabilitation in a population managed for spontaneous hematoma or coronary disruption

Conditions: Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD

Summary: spontaneous coronary artery dissection (scad) is a rare and often misdiagnosed cause of acute coronary syndrome (acs) affecting predominantly young women without cardiovascular risk factors. there is no definitive evidence on the optimal management of scad, but the general approach is conservative. unlike established evidence-based rehabilitation programs for acs and heart failure, no cardiac rehabilitation protocol exists for scad. the aim of the study is to report and detail the cardiac rehabilitation program which was proposed to patients previously included in the study of the prevalence fibromuscular dysplasia in patient with haematoma or spontaneous coronary artery dissection. (disco trial - nct02799186).

the cardiac rehabilitation program was proposed to the patients presenting with scad in each interventional cardiology department, according physician's in charge of the patient decision. the patient who has undergone a cardiac rehabilitation program following the acs is included in a retrospective way. the patients are informed about this study by the investigator. after a reflection period, the patient is included. details regarding the entrance psychosocial evaluation, the entrance exercise treadmill test, the medications changes during rehabilitation, the training program modalities, the exit exercise treadmill test, and the left ventricular ejection fraction evolution (evaluated by echocardiography) were recorded. the safety for each cardiac rehabilitation program was also assessed.

Eligibility criteria:
inclusion criteria: * patient previously recruited in the study of the prevalence fibromuscular dysplasia in patient with haematoma or spontaneous coronary artery dissection. (disco trial - nct02799186) : * patient over 18 years old * patient with a possible diagnosis of spontaneous coronary dissection defined by: * acs presentation * angiographic signs compatible with a scad * more or less confirmed by intracoronary imaging (oct/ivus) or remote angiographic control (upper to 1 month). * patient with signed informed consent to participate in the disco study * subject agreeing to the use of his or her personal data in the form of anonymous coding, including in scientific publications. * patient who has undergone cardiac rehabilitation following the management of acute coronary syndrome. exclusion criteria: o exclusion criteria for the disco study : * minor patient * patients of legal age under protective supervision (guardianship, trusteeship) * non affiliation to the french social security system * coronary dissection of iatrogenic or traumatic origin.

Keywords: cardiac rehabilitation spontaneous coronary artery dissection
a study of maraviroc in hiv co-infected subjects with hepatitis c and/or hepatitis b

Conditions: HIV Coinfection

Summary: to describe liver enzyme elevations in patients who are coinfected with hiv and either hepatitis c (hcv) and/or hepatitis b (hbv) receiving maraviroc or placebo in combination with their current suppressive anti-hiv drug therapy.


Eligibility criteria:
inclusion criteria: * hiv coinfected with hcv and/or hbv. * undetectable hiv-1 rna for at least 3 months prior to the screening visit * treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months. exclusion criteria: * currently receiving maraviroc. * active opportunistic infections. * alt and/or ast \>5x upper limit of normal. * direct bilirubin \>1.5x upper limit of normal. * severe or decompensated liver disease. * liver disease unrelated to viral hepatitis infection.

Keywords: hiv coinfection maraviroc ccr5 blocker entry inhibitor liver disease viral hepatitis
conjugated linoleic acid (1:1 isomer mixture) intake in overweight people

Conditions: Overweight; Obesity

Summary: the aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.


Eligibility criteria:
inclusion criteria: * aged 30-55 years * grade ii overweight (bmi≥27 but \<30 kg/m2) * not to be adhered to any calorie restriction diet * not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study exclusion criteria: * suffering of serious concomitant disease such as diabetes mellitus type ii, metabolic syndrome (according to the criteria of the adult treatment panel iii), cancer, kidney disease, hiv, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders. * having undergone bariatric surgery and/or intestinal resection * breastfeeding and pregnancy. * not to give their signed, informed consent to be included in the study.
growth hormone treatment in men with high risk of developing type 2 diabetes mellitus

Conditions: Abdominal Obesity; Metabolic Syndrome; Obesity

Summary: the overall aim of this study is to investigate the effects of gh treatment in men with the metabolic syndrome and a high risk of developing type 2 dm. forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with gh and placebo for 12 months. the subjects will receive treatment with recombinant human gh (genotropin®) or placebo administered by a daily s.c. injection before bedtime. the initial dose of gh will be 0.4 iu per day increased to 0.8 iu after 2 weeks and to 1.2 iu after 4 weeks of treatment. thus, the target dose is 1.2 iu per day which resembles approximately 0.015 iu/kg/day. the gh dose will be reduced by half in the event of side-effects. oral and written instructions in terms of administration and dosage will be given. the treatment can be discontinued by the patient. the treatment should be discontinued if malignancy is discovered, dm developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious. the treatment code for each subject included in the trial will be kept at the sahlgrenska university hospital pharmacy. this code can be broken on the request of the investigator. compliance will be assessed by collecting empty vials from the study subjects. the treatment is discontinued at the end of the study.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/l (ifg) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/l (igt). * bmi \> 25 kg/m2. * waist/hip ratio \> 0.95 exclusion criteria: * proliferative diabetic retinopathy. * macro-albuminuri and/or serum creatinine \>150mmol/l * known ischemic heart disease, previous stroke or claudicatio intermittence. * known malignancy. * other hormonal therapy.

Keywords: growth hormone obesity abdominal obesity
administration of kisspeptin in patients with hyperprolactinemia

Conditions: Hyperprolactinemia; Hypogonadism

Summary: the goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (iv) kisspeptin administration). subjects in the second group will receive subcutaneous (sc) kisspeptin every 90 minutes for eight days.


Eligibility criteria:
inclusion/exclusion criteria: * confirmed diagnosis of elevated levels of prolactin measured via blood test, * no pituitary adenoma or a microprolactinoma (\<10 mm). patients with a macroprolactinoma confirmed on mri imaging will be excluded, * no history of a medication reaction requiring emergency medical care, * no illicit drug use or excessive alcohol consumption (\>10 drinks/week), * not currently seeking fertility, breastfeeding or pregnant, * no history of bilateral oophorectomy, * willing to complete a dopamine agonist washout and/or oral contraceptive washout, * normal physical exam and laboratory studies within protocol reference range.

Keywords: kisspeptin hyperprolactinemia gnrh hypogonadism
practice structure on motor learning in post-stroke patients

Conditions: Stroke

Summary: background: the literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. however, this effect is not well known in post-stroke patients. objective: the goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. methods: participants included an experimental group (eg) of post-stroke patients: 17 males and females; and a control group (cg) of healthy individuals: 17 males and females. at the acquisition phase, all participants performed 30 trials of a coincident timing task. nine individuals from each group practiced constantly (c) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (r) at speeds of 2, 3, and 5 mph. subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).

utilized was bassin's anticipation timer (lafayette instruments #50575), which is comprised of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response button. the screen has a digital display, with commands that permit the operator to control the stimulus propagation speed and the preparatory interval speed. once activated, the screen exhibits an alert signal, and, after the preparatory interval, it initiates the propagation of a luminous stimulus, lighting the 32 diodes successively. the task required participants to press the response button simultaneously with the illumination of the last diode. the digital display showed the error measure (em): that is, the difference between the illumination of the last diode and the response.

Eligibility criteria:
inclusion criteria: 1. first cerebrovascular accident 2. lesion covering the middle and the anterior cerebral artery territories 3. presence of hemiplegia or hemiparesis 4. mini-mental state examination (mmse) score above 24 (19) 5. sufficient attention and comprehension to perform the task 6. absence of other associated neurological diseases. exclusion criteria: 1. acute medical problems 2. uncorrected vision loss 3. previous history of psychiatric admission 4. history of multiple strokes, transient ischemic attacks 5. pathology of the less affected, ipsilateral to stroke upper extremity that would affect ability to perform the task 6. score of 23 or less on the mmse 7. difficulty in comprehension of verbal command and simple instructions 8. aphasia of comprehension.

Keywords: motor learning hemiplegia stroke practice physiotherapy
boosting cpap use in adults with severe sleep apnea: role of motivation and psychological factors

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the goal of this randomized prospective clinical trial is to examine whether phenotypic traits, psychological characteristics, assessed by stai (engl. the state-trait anxiety inventory) and ipip50s (engl. international personality item pool) questionnaires, and patients' self-efficacy, assessed by semsa (engl. self-eficacy measure for sleep apnea) questionnaire, are associated with cpap adherence after three months of use. the study also evaluates whether a motivational phone call one month after therapy initiation improves cpap adherence at the three-month follow-up. the main questions it aims to answer are: * are phenotypic and psychological traits associated with adherence to cpap therapy after 3 months of treatment? * can a single motivational telephone intervention, one month after initiating cpap therapy, significantly improve cpap adherence at the three-month follow-up compared to no intervention? researchers will compare patients who receive a phone call to those who do not, to see if this simple intervention leads to better cpap adherence after three months of use. participants will: * undergo polysomnography before starting cpap therapy, * complete three questionnaires (ipip50s, stai, semsa) before starting cpap therapy, * be randomly assigned to either receive a motivational phone call one month after starting cpap therapy or to a control group without any phone call, * be invited for a follow-up after three months of cpap use to download and analyze cpap adherence data from their cpap devices.


Eligibility criteria:
inclusion criteria: * participants aged 18 years or older * diagnosis of severe obstructive sleep apnea (osa), defined as ahi ≥30 * signed informed consent for participation in the study * adequate physical and psychological capacity to participate in the intervention and complete questionnaires * patients who are initiating cpap therapy at the sleep medicine center, university of split school of medicine * availability for follow-up over a three-month period exclusion criteria: * presence of central sleep apnea or other primary sleep disorders * cognitive impairment or psychiatric conditions that may hinder the ability to follow instructions or complete questionnaires * previous experience with cpap therapy prior to study enrollment * significant comorbidities (e.g. unstable cardiovascular disease, advanced pulmonary disease) that may interfere with study outcomes * pregnancy * inability to participate in follow-up assessments or be contacted by telephone
a study to evaluate the safety and efficacy of ccx140-b in subjects with diabetic nephropathy

Conditions: Diabetic Nephropathy; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of treatment with ccx140-b in subjects with diabetic nephropathy.

the primary objective of this study is to evaluate the safety and tolerability of ccx140-b in subjects with diabetic nephropathy based on subject incidence of adverse events. the secondary objectives of this study include evaluation of the effect of ccx140-b on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications. study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
key inclusion criteria: * aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per american diabetes association \[ada\] criteria) * residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ace) inhibitor or an angiotensin receptor blocker (arb) for at least 8 weeks prior to screening (albumin:creatinine ratio \[acr\] of 100 to 3000 mg/g creatinine, inclusive) * estimated glomerular filtration rate based on serum creatinine (egfr, determined by modification of diet in renal disease \[mdrd\] equation) of ≥ 25 ml/min/1.73 m(2) * must be on a stable dose of an ace inhibitor or arb for at least 8 weeks prior to screening, but subjects must not be on both an ace inhibitor and an arb * hemoglobin a1c (hba1c) \> 6.0% but not \> 10.0% and fasting plasma glucose less than 270 mg/dl at screening key exclusion criteria: * type 1 diabetes mellitus or history of diabetic ketoacidosis * previous renal transplant or known non-diabetic renal disease, except related to hypertension * undergone renal dialysis at any time in the past * received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening * use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening * received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (nsaid) treatment within 2 weeks of screening * cardiac failure (class iii or iv), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening * poorly-controlled blood pressure (systolic blood pressure \>155 or diastolic blood pressure \>95, with blood pressure measured in the seated position after at least 5 minutes of rest)
a study on building a voice cohort for the development of a non-face-to-face machine learning diagnostic and monitoring platform using voice analysis and various sensors in patients with dysphagia.

Conditions: Deglutition Disorders

Summary: collection of basic data for real-time analysis and monitoring by measuring what changes in voice occur according to the state of dysphagia using voice analysis and various sensors.

* design : prospective cohort study * setting : hospital rehabilitation department * inclusion criteria of the patient group : patients scheduled for vfss examination * intervention * this study will be conducted after collecting basic information such as age, gender, and disease of patients who met the inclusion criteria among patients scheduled to undergo a video fluoroscopic swallowing test (vfss test) for the diagnosis of dysphagia, and after obtaining guidance and consent through the study description will do. * before the subject's vfss test, "ah for 5 seconds", after clearing the throat, "ah for 5 seconds", and briefly cut with a slightly high sound, "ah. oh ah.", shut lips lightly and read "ummm\~\~\~\~", read a short sentence. * while the subject makes the above sound, voice is recorded, video is taken, and integrated sensors such as a microphone (sound detection) sensor and surface electromyography sensor are attached to measure changes in each sensor. * after the vfss test, participants will repeat the above sound and record the same twice. (as before the test, imaging of the patient's swallowing is also performed.) * using voice analysis, various sensor values, and image information, a voice indicator that can predict the amount of suction and residue on the vfss test is found.

Eligibility criteria:
inclusion criteria: * those who are 19 years of age or older and do not fall under the exclusion criteria * patients scheduled for vfss test * patients who can record voices such as "ah.", "ummm\~\~\~", short sentences * patients who can attach sensor on their throat * those who voluntarily consent to the clinical trial exclusion criteria: * those who do not agree to participate in this study * patients who can not follow step 1 instructions * patients who can not vocalize or follow to speak * patients who cannot apply the sensor due to skin allergy or hypersensitivity to sensor attachment * other who have comorbidities (e.g., maligant tumors, blood clotting abnormalities, etc.) that are inappropriate for clinical trial participation by the judgment of the researcher 6) other who are judged by the researcher to be unsuitable for this clinical trial.
observational study of quality of live in patients with metastatic pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: this is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy this study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. patients will be enrolled in 7 spanish sites. in all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study. given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically * patients with karnofsky index ≥ 70 previously untreated with chemotherapy. * patients with life expectancy ≥ 6 months. * patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.\* * informed consent in writing or orally before witnesses. * the decision to prescribe any treatment will be clearly dissociated from the patient's inclusion in the study. therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it exclusion criteria: * pregnant or breastfeeding. * patients who are participating in an interventional clinical trial. * patients who refuse to participate in this study. * patients who have no ability to understand and respond to questions related to their health.
special investigation of comirnaty in the population with underlying diseases

Conditions: COVID-19

Summary: post-marketing study, cohort study of comirnaty vaccines. to collect information on adverse events and covid-19 observed after vaccination with comirnaty and to assess safety in patients with underlying disease considered to be at high risk of aggravation of covid-19 who have received vaccination with this product under actual use conditions.

this is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be at high risk of aggravation of covid-19 who are vaccinated with this product, and the investigator will enter the information required in this study in the case report forms (crfs) based on the information obtained through preliminary examination sheet or medical interview, etc. and records such as medical records. a health observation diary will be distributed to the subjects participating in this study and they will be requested to record information on local reactions and systemic reactions after vaccination with this product.

Eligibility criteria:
inclusion criteria: -subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors) exclusion criteria: * there are no exclusion criteria for this study.

Keywords: covid-19, post-marketing study comirnaty underlying disease