Kornimate/medical-research-clean huggingface dataset:
from acute to chronic postoperative pain in patients for elective cholecystectomy. immunological tests

Conditions: Pain

Summary: chronic pain after cholecystectomy is a well known problem. one theory is that it is due to persisting inflammation. the purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation. dna-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility criteria:
group 1: inclusion criteria: * unexplained abdominal pain 12 months after elective cholecystectomy exclusion criteria: * immunosuppressive treatment (nsaid excepted) * anticoagulant treatment group 2: inclusion criteria: * no pain 12 months after elective cholecystectomy exclusion criteria: * immunosuppressive treatment (nsaid excepted) * anticoagulant treatment group 3: inclusion criteria: * elective operation in spinal anesthesia or * or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected exclusion criteria: * acute or chronic pain condition * immunosuppressive treatment (nsaid excepted) * previous abdominal operation

Keywords: chronic postoperative pain postcholecystectomy pain inflammation interleukines
sleevediab to explore the early and late metabolic effects of sleeve gastrectomy in obese patients

Conditions: Severe Obesity; Type 2 Diabetes

Summary: sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. according to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. the mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. an increase in post- absorptive levels of glucagon-like peptide 1(glp-1), peptide yy(pyy) and insulin has been reported, but in non-diabetic subjects mostly. the important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. specific metabolic and hormonal effects of this surgical procedure cannot be excluded.the aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. we will also evaluate insulin sensitivity, insulin secretion and incretin effect. we will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to has criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. they will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. test meals with dosages of blood glucose, insulin, c-peptide, adiponectin, leptin, glp-1, pyy and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.


Eligibility criteria:
inclusion criteria: * written informed consent * age between 18-65 years (inclusive) * men or women receiving effective contraception, postmenopausal or sterile * type 2 diabetes treated with no drugs or oral anti-diabetic agents metformin, sulfonylurea or glinides * body mass index 35 kg / m² or above * eligible to bariatric surgery according to has criteria exclusion criteria: * treatment of diabetes with glp1 analogues, dpp-iv (dipeptidyl-peptidase iv) or insulin * treatment with drugs that modify glucose homeostasis: glucocorticoids, anorexigens, antihistaminics, psychotropic drugs especially serotonergic antidepressants (except for the occasional use of a hypnotic or anxiolytic), atropine, laxatives, thyroid hormones (with the exception of a substitution dose ensuring a stable euthyroid at baseline), beta blockers, diuretics * pregnancy, intention of being pregnant, breastfeeding. * inability to understand the nature and aims of the study or to communicate with the investigator- high probability of non * compliance with the protocol * simultaneous participation in another trial * no affiliation to the french social security * loss of personal capacity resulting in state protection * deprivation of liberty by judicial or administrative decision

Keywords: type 2 diabetes obesity sleeve gastrectomy insulin glp-1
study on mechanisms of changes in liver disease and sex steroid metabolism during weight loss

Conditions: Obesity

Summary: the main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. in addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (pphrs) in these patients using a standard chewable meal. secondary objectives are investigating determinants for the changes in sex steroids, liver disease and pphrs. possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, ... .


Eligibility criteria:
inclusion criteria: * informed consent obtained * bmi \> 35 kg/m² exclusion criteria: * primary or secondary hypogonadism due to genetic causes (kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional. * type 2 diabetes mellitus treated with insulin or glp-1 analogues * current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics * cancer (within \< 5 years) * high-grade malignancies * serious co-morbidities such as renal, hepatic of cardiac failure * known or suspected abuse of alcohol or narcotics * mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
pet scans in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery

Conditions: Cervical Cancer

Summary: rationale: new imaging procedures such as fludeoxyglucose f 18 pet scan may improve the ability to detect cancer or recurrence of cancer. purpose: clinical trial to study the effectiveness of fludeoxyglucose f 18 pet scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.

objectives: * assess the feasibility of using fludeoxyglucose f 18 (fdg) positron emission tomography (pet) imaging in patients with primary or recurrent cervical cancer. * investigate the ability of fdg-pet scan imaging to detect lymph node metastases in these patients. * investigate the ability of fdg-pet imaging to identify locally advanced disease in early stage cervical cancers. * compare fdg-pet to ct scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer. * investigate the ability of fdg-pet to identify recurrent cervical cancer. outline: this is a diagnostic study. patients with primary cervical cancer receive fludeoxyglucose f 18 (fdg) intravenously followed 45 minutes later with positron emission tomography (pet) imaging over 60 minutes, as well as computed tomography (ct) scan. both diagnostic imaging techniques are to assess the abdomen and pelvis, and must be done within 2 weeks prior to surgery. patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings. patients with recurrent cervical cancer obtain fdg-pet scan and ct scan of the thorax, abdomen, and pelvis prior to surgical exploration for pelvic exenteration. all biopsy specimens are evaluated for correlation with diagnostic tests findings. projected accrual: a total of 30 patients (20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer) will be accrued for this study.

Eligibility criteria:
disease characteristics: * must meet one of the following criteria: * histologically confirmed primary invasive squamous carcinoma or adenocarcinoma of the cervix * history of cervical cancer suspected of being recurrent * known diagnosis of recurrent cervical cancer being considered for pelvic exenteration patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no insulin-dependent diabetes mellitus * no active serious infection not controlled by antibiotics * must tolerate being in the scanner for the duration of the study * not mentally retarded * no prisoners * not pregnant or nursing prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified

Keywords: stage i cervical cancer stage ii cervical cancer recurrent cervical cancer
erythromycin in parkinson's disease

Conditions: Parkinson's Disease; Levodopa

Summary: gastroparesis (slow stomach emptying) is a common feature of parkinson's disease. levodopa (sinemet), a common medication for parkinson's disease, can make gastroparesis worse. gastroparesis effects how the levodopa is absorbed and used by the body. this study will explore the possibility of using erythromycin, a drug commonly used (off label) for gastroparesis, along with levodopa to determine if there is improved levodopa absorption and motor function.

participants will be required to make four visits for evaluation. visit 1 is a screening visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit 4 is a follow up visit. participants will provide blood and urine samples during the visits. participants will also be required to complete questionnaires and a series of motor tests.

Eligibility criteria:
inclusion criteria: * subjects must have a definitive diagnosis of parkinson's disease (per united kingdom brain bank criteria), hoehn and yahr stage 1-3, * must exhibit unequivocal levodopa responsiveness * must be able to distinguish between the "off" versus "on" state * subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods * subjects may be on concomitant therapy with monoamine oxidase b inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods. exclusion criteria: * history of deep brain stimulation for parkinson disease * history of ablative (tissue removal) surgery for parkinson disease * presence of dementia (mmse\<25) * presence of active psychosis * history of any chronic gastrointestinal diseases * history of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy * any gastrointestinal surgeries in the past 3 months * severe dysphagia (difficulty swallowing) to pills or food * history of physiological or mechanical gastrointestinal obstruction * history of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract * history of gastric bezoars (undigested mass) * allergy to wheat, soy, milk, or nuts * presence of portable electromechanical devices such as pacemaker, defibrillator, or infusion pump * female subjects who are pregnant or lactating * symptomatic orthostatic hypotension (low blood pressure) * diabetes * presence of symptomatic anemia * abnormal liver or kidney function * cardiac arrhythmia (past or present) or abnormal qt interval on entrance ekg * known hypersensitivity to any of the study drugs * subjects receiving certain medications during specified time frames

Keywords: parkinson's disease levodopa motor fluctuations gastroparesis
effect of yellow pea protein and fibre added to a high-carb meal on glycemic response and food intake

Conditions: Obesity; Diabetes

Summary: the investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.


Eligibility criteria:
inclusion criteria: * non-smoking * no metabolic disease * bmi 20 - 25 kg/m\^2 * male * age 20-30 exclusion criteria: * intolerance to treatments * on appetite-modifying medications * restrictive eating * smoking * over or underweight * breakfast-skipping

Keywords: food intake satiety glycemia appetite blood glucose yellow peas fibre protein mixed meal
anosmia and / or ageusia and early corticosteroid use

Conditions: Covid19; Anosmia

Summary: time to recover of anosmia and / or ageusia and early corticosteroid use

in a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. the apparent volume of distribution was 1 l/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. the bioavailability of oral dexamethasone was 81% (95% ci = 54-121%). however, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone. time to recover of anosmia and / or ageusia and early corticosteroid use

Eligibility criteria:
inclusion criteria: * any case with covid-19 * age more than or equal to 18 years * mild to moderate severity exclusion criteria: * diabetes * any contra-indication for the interventional drug * mentally disabled cases
evaluation of the efficacy and safety of modified release afq056 in parkinson's patients with l-dopa induced dyskinesias

Conditions: Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders; Anti-Dyskinesia Agents

Summary: this study will assess the efficacy and safety of modified release afq056 in patients that have parkinson's disease l-dopa induced dyskinesias (pd-lid)


Eligibility criteria:
inclusion criteria: * males and females 30-80 years old * use of highly effective methods of contraception during study in women of childbearing potential * outpatients * clinical diagnosis of parkinson's disease according to uk parkinson's disease society brain bank clinical diagnosis criteria * score of \>/= 2 on updrs items 32 and 33 * dyskinesias for at least 3 months before baseline * on stable treatment regimen with l-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline * demonstrate capacity to complete accurate diary ratings * patients who have a primary caregiver willing to assess the condition of the patient throughout the study in accordance with protocol requirements * group 2 only: patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to bl1 and must maintain the stable dose of amantadine during the remainder of the study exclusion criteria: * atypical/secondary form of parkinson's disease * history of surgical treatment of pd, including deep brain stimulation * a score of 5 in the "on"- state on the modified hoehn and yahr scale * advanced, severe, or unstable disease other than pd * evidence of dementia * treatment with certain prohibited medications * amantadine within 2 weeks prior to bl1 visit (applies to group 1 only) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: parkinson disease l-dopa levodopa dyskinesia amantadine
immunotherapy of hla-a2 positive stage iii/iv melanoma patients

Conditions: Melanoma

Summary: the purpose of this study is to determine whether vaccination with tumor antigenic peptides and both cpg and montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

immune therapy with tumor antigenic peptides is generally quite well tolerated. however, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. further progress is required to improve the vaccines, with the goal to increase the strength of immune activation. the tumor antigenic peptides melan-a/mart-1 (eaa and ela) and tyrosinase (ymd) are combined with two drugs in this study, both of which are known to enhance immune responses: first, cpg 7909 oligodeoxynucleotides, and second, montanide isa-51. * group 1: vaccination with melan-a analog peptide + cpg and montanide adjuvants; * group 2: vaccination with melan-a natural peptide + cpg and montanide adjuvants; * group 3 : vaccination with melan-a natural and tyrosinase peptides + cpg and montanide adjuvants; * group 4 : vaccination with melan-a analog and tyrosinase peptides + cpg and montanide adjuvants.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iii or stage iv melanoma * tumor expression of melan-a +/- tyrosinase * human leukocyte antigen-a2 (hla-a2) positive exclusion criteria: * clinically significant heart disease * serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders * history of immunodeficiency disease or autoimmune disease * coagulation or bleeding disorders

Keywords: immunotherapy vaccination melanoma melan-a/mart-1 peptide tyrosinase peptide cpg montanide
open-label pk study of iron isomaltoside 1000 (monofer) administered by 500 mg iv injection or 1000 mg iv infusion to patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of monofer(r)in patients suffering from inflammatory bowel disease


Eligibility criteria:
inclusion criteria: 1. men and women, aged more than 18 years 2. subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the harvey-bradshaw index for crohn's disease and a mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis) 3. weight above 50 kg 4. hb \<12 g/dl (7.45 mmol/l) 5. transferrin saturation (tfs) \<20% 6. life expectancy beyond 12 months by investigator's judgment 7. willingness to participate after informed consent - exclusion criteria: 1. anaemia predominantly caused by other factors than iron deficiency anaemia 2. iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 3. drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or to iron sulphate) 4. known hypersensitivity to any excipients in the investigational drug products 5. subjects with a history of multiple allergies 6. active intestinal tuberculosis 7. active intestinal amoebic infections 8. decompensated liver cirrhosis and hepatitis (alanine aminotransferase (alt) \> 3 times upper limit normal) 9. history of immunocompromise and/or history of hepatitis b and/or c 10. acute infections (assessed by clinical judgment), supported by white blood cells (wbc) and c-reactive protein (crp)) 11. rheumatoid arthritis with symptoms or signs of active joint inflammation 12. pregnancy and nursing (to avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: contraceptive pills, intrauterine devices (iud), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches) 13. extensive active bleeding necessitating blood transfusion 14. planned elective surgery during the study 15. participation in any other clinical study within 3 months prior to screening 16. untreated b12 or folate deficiency 17. other i.v. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit 18. erythropoietin treatment within 4 weeks prior to screening visit 19. any other medical condition that, in the opinion of investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. example: uncontrolled hypertension, unstable ischemic heart disease or uncontrolled diabetes mellitus

Keywords: inflammatory bowel disease, ibd
an observational prospective long-term exposure registry of adult patients with moderate-to-severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with simponi.


Eligibility criteria:
inclusion criteria: * have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past * for enrollment into the simponi-exposed cohort meets one of the following: 1. the participant is currently receiving simponi ,or 2. the participant is continuing to receive simponi after participation in an ulcerative colitis study, or 3. the participant is scheduled to receive simponi within 30 days after enrollment * for thiopurine cohort: 1. the participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry 2. participant must not be receiving other approved biologic agents, including simponi, or any investigational agents at enrollment 3. participant may have received biologics other than simponi or investigational agents prior to enrollment exclusion criteria: * participants who cannot be treated with simponi or thiopurines * participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment * participants currently receiving an investigational or biologic agent other than simponi * participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Keywords: ulcerative colitis simponi (golimumab) thiopurines lymphoma malignancies
diagnostic usefulness of fluorine-18-α-methyltyrosine pet in combination with 18f-fdg in sarcoidosis patient

Conditions: Sarcoidosis

Summary: l-\[3-18f\]-α-methyltyrosine (fmt) is amino-acid tracer for positron emission tomography (pet), and is used for tumor detection because malignant tumor cells accumulate 18f-fmt based on the increased expression of amino-acid transporter. this study was conducted to investigate a usefulness of 18f-fmt pet in combination with 18f-fdg pet for the diagnosis of sarcoidosis in patients with suspected malignancy.


Eligibility criteria:
inclusion criteria: * eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of bhl in cancer patient. exclusion criteria: * the patients that pet imaging using 18f-fdg and 18f-fmt was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the pet study, and patient having diabetes mellitus.