Kornimate/medical-research-clean huggingface dataset:
bioavailability of different pramipexole slow-release formulations compared to immediate-release tablet in healthy male volunteers

Conditions: Healthy

Summary: study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets


Eligibility criteria:
inclusion criteria: * all participants in the study should be healthy males * participants should be ranging from 21 to 50 years of age * body mass index (bmi) within 18.5 to 29.9 kg/m2 * in accordance with good clinical practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * participation in another trial with an investigational drug (≤ two months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on in-house trial days * alcohol abuse (\> 60 g/day) * drug abuse * blood donation (≥ 100 ml within four weeks prior to administration or during the trial) * any laboratory value outside the clinically accepted reference range * excessive physical activities within the last week before the trial or during the trial * hypersensitivity to pramipexole, or other dopamine agonists * supine blood pressure at screening of systolic \< 110 mmhg and diastolic \< 60 mmhg * a haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/ml) * subjects involved in passenger transport or operation of dangerous machines
a pooled analysis of the data from two studies of ammonium succinate for menopausal symptoms

Conditions: Menopause Related Conditions

Summary: this study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. in both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.

both studies were conducted previously and were randomized, double-blind and placebo-controlled. they followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of greene climacteric scale symptoms severity reduction at week 12. nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected. naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. many alternatives exist, generally acting via estrogen receptors (er). the dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to er, instead acting by supporting the krebs cycle. it does not have phytoestrogenic ingredients.

Eligibility criteria:
inclusion criteria: * vasomotor and psychosomatic complaints * ability to comply to study protocol * signed informed consent exclusion criteria: * cancer (current or prior, based on medical history) * conditions requiring planned hospitalization in the next 6 months; * endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.); * any surgeries within 1 year of the screening; * hormone therapy within 6 months of the screening; * psychiatric diseases; * diabetes mellitus; * taking other supplements or medications that may affect the climacteric syndrome

Keywords: menopause ammonium succinate
evaluation of the efficacy and safety of 3d printing for orbital surgery.

Conditions: Thyroid Associated Ophthalmopathy; Surgical Procedure, Unspecified

Summary: this is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3d printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.


Eligibility criteria:
inclusion criteria: * diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in eugogo classification). * volunteers older than 18 years old. * ability to read. * acceptation to participate and signature of informed consent. exclusion criteria: * younger than 18 years old. * previous orbital surgery. * any coexisting disease preventing follow-up.
paravertebral analgesia associated with intravenous morphine pca after thoracotomy

Conditions: Pain

Summary: osteolateral thoracotomy is a painful surgical procedure.thoracic epidural analgesia (tea) is usually considered as the "gold standard" for postoperative thoracic analgesia. unfortunately, it's not always possible to realize it because of contraindications or because of technical failures.analgesia using a paravertebral block is an alternative to the tea : it provides an unilateral sensitive and sympathetic block using a catheter.in our study, the catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under direct vision, to insure maximal security also on patients on antiplatelets agents, anticoagulants or with haemostasis disorders (the placement of the catheter by the anaesthetist with the loss of resistance technique is contraindicated in these cases).patients will be randomized to receive either a continuous 48-hours infusion of ropivacaine 0,5% or saline serum in the control group.all patients are connected to a pca pump with intravenous morphine and will receive paracetamol and nefopam.the visual analogic scale (vas) at rest and on movement, total morphine consumption and side effects will be recorded during the first 48 hours after surgery. the aim of this study is to prove a decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation, bradypnea, urinary retention).


Eligibility criteria:
inclusion criteria: * patients scheduled for thoracotomy who presented with contraindications to tea.contraindications to tea are : * patient's refusal after informations about advantages and risks of the technique * anti platelets treatment that can't be discontinued * anticoagulants at a curative dosage- haemostasis and/or coagulation disorders: thrombopenia \ 1,5 / control, ptt \< 75%- systemic or local infection of the puncture point * 2 and 3 grade atrio-ventricular heart block without pacing * severe aortic valve stenosis * kyphoscoliosis * certain neurological disorders exclusion criteria: * patient's refusal to participate in the study * psychiatric disorder (impossibility to collect the informed consent) * patient under juridical protection * on going an other study * pregnancy, breastfeeding * non balanced epilepsy * 3 grade auriculae-ventricular heart block without pacing * severe hepatocellular insufficiency * anti arrhythmic treatment : class iii of the vaughan william's classification- skin infection of the puncture point * allergy to aminoamides local anaesthetic * surgical difficulties to insert paravertebral catheter

Keywords: epidural analgesia contraindications paravertebral nerve block analgesia ropivacaine visual analogical scale morphine side effects pain and thoracotomy
changes in body composition and nutritional status in patients undergoing liver transplantation

Conditions: Liver Cirrhosis

Summary: liver transplant is the goal treatment for every patient with end-stage chronic liver disease. quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others. body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.

body composition and nutritional status can be affected due to post-transplant pharmacologic therapy. this is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.

Eligibility criteria:
inclusion criteria: * liver cirrhosis (any etiology) * enrolled in waiting list for tliver transplant exclusion criteria: * hepatocellular carcinoma * chronic renal failure * congestive cardiac failure * extremity amputation * pregnancy

Keywords: liver cirrhosis liver transplant nutritional status bioelectrical impedance vector analysis
radiosensitizing and radioprotectve effects of curcumin in prostate cancer

Conditions: Prostate Cancer; Radiation Therapy

Summary: prostate cancer is the second most incident cancer among male population worldwide. radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. no clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate 2. age range of 50-80 3. ecog performance status 0-1 4. life expectancy \> 5 years 5. must be enrolled in a social security program 6. no other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years 7. no severe uncontrolled hypertension (systolic bp ≥ 160 mm hg or diastolic bp ≥ 90 mm hg) 8. no contraindication to luteinizing hormone-releasing hormone agonists 9. no contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) 10. no hip prosthesis 11. must not be deprived of liberty or under guardianship 12. no geographical, social, or psychological reasons that would preclude follow up exclusion criteria: 1. clinical stage t3 or t4 2. gleason score ≥ 8 3. serum psa ≥ 20 ng/ml and ≤ 100 ng/ml 4. other prior surgery for prostate cancer 5. concurrent participation in another clinical trial which would require approval upon entry to this trial 6. gastrointestinal disorders such as ibd, reflux and peptic ulcers 7. any adverse reaction to curcumin

Keywords: curcumin radioprotective radiosensitizer
wallflex biliary fully covered (fc) benign stricture study

Conditions: Biliary Stricture

Summary: the purpose of this study is to evaluate the safety and performance of the wallflex® biliary rx fully covered stent as a treatment of biliary obstruction resulting from benign bile duct strictures.


Eligibility criteria:
inclusion criteria: * age 18 or older * willing and able to comply with the study procedures and provide written informed consent to participate in the study * chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy) * indicated for ercp procedure with stent placement for: symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or bile duct stricture confirmed by cholangiogram and/or exchange of prior plastic stent(s) for management of benign stricture exclusion criteria: general: * placement of the stent in strictures that cannot be dilated enough to pass the delivery system * placement of the stent in a perforated duct * placement of the stent in very small intrahepatic ducts * patients for whom endoscopic techniques are contraindicated * biliary stricture of malignant etiology * biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery * stricture within 2 cm of duct bifurcation * symptomatic duodenal stenosis (with gastric stasis) * prior biliary self-expanding metal stent * suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome * known bile duct fistula * known sensitivity to any components of the stent or delivery system * participation in another investigational study within 90 days prior to consent or during the study additional specific to chronic pancreatitis patients: * developing obstructive biliary symptoms associated with an attack of acute pancreatitis additional specific to post-abdominal surgery patients: * history of hepatectomy * history of liver transplant additional specific to liver transplant patients: * live donor transplantation

Keywords: benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
trial to evaluate effect of lactulose on hard stools in patients with hemorrhoids or anal fissures

Conditions: Hemorrhoids; Anal Fissures

Summary: to demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. to compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.


Eligibility criteria:
inclusion criteria: * patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure. exclusion criteria: * patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

Keywords: lactulose randomised clinical trial hemorrhoids anal fissures
citicoline concentration in human vitreous

Conditions: Neurodegenerative Diseases

Summary: elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. the vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.

at the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, iop measurement using goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy. additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (cct) and corneal endothelial cells density (ecd) evaluations. patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery. five patients served as controls and received a vehicle solution without citicoline. the primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography. secondary aims were the comparison of citicoline and its metabolites concentration in the vitreous of treated phakic and pseudophakic eyes and the correlations with age and ocular biometric parameters including cct and ecd.

Eligibility criteria:
inclusion criteria: * age \> 18 years * ability to understand and sign the written informed consent * diagnosis of epiretinal membrane (erm) with surgical indication for pars-plana vitrectomy exclusion criteria: * laser treatments and ocular surgery in the past 6 months * hypersensitivity to the active ingredients used in the study * other systemic or ocular diseases different from erm that could affect the outcome of the study * aphakia or previous complicated cataract surgery * intraocular lens (iol) in the anterior chamber * treatment with systemic citicoline or other potential neuroprotective agents in the past 6 months * pregnancy or breastfeeding

Keywords: ophthalmic solution glaucoma retinal ganglion cells neuroprotective effect
vertical gbr lprf block vs. autogenous bone with dbbm

Conditions: Alveolar Bone Resorption

Summary: split-mouth rct, 25 months follow up. gbr protocol with lprf as grafting material in the test group and autogenous bone with dbbm as grafting material in the control group.

6 patients were included in this split-mouth rct. in control sites a horizontal gbr procedure was performed using a titanium reinforced dptfe membrane with a graft consisting of 50% autogenous bone and 50% dbbm. in test sites a titanium reinforced dptfe membrane was used, with a graft consisting of an lprf block. this was left to heal for 9 months. subsequently an implant was placed. at time of implant placement a bone biopsy was taken. after 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. cbct scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants. primary outcome measure is the bone volume as measured on the cbct scans. secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.

Eligibility criteria:
inclusion criteria: * males or females, with asa i or ii, between 18 and 80 years old * 2 implant sites requiring vertical bone augmentation prior to implant placement * both sites in the same jaw * good general health as documented by self-assessment exclusion criteria: * any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient * immunosuppression, diabetes, anticoagulation or antiaggregatory medication. * current pregnancy or breast feeding/ lactating at the time of recruitment. * radiotherapy or chemotherapy in head and neck area. * intravenous and oral bisphosphonate therapy. * smoking * unwillingness to return for the follow-up examination. * conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations * presence of osseous pathologies, that might interfere with normal wound healing * presence of oral lesions (such as ulceration, malignancy) * local inflammation, including untreated periodontitis * patients with inadequate oral hygiene or unmotivated for adequate home care
a pharmacodynamic study to evaluate the effect of a fixed dose combination pill on blood pressure

Conditions: Hypertension

Summary: the purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.


Eligibility criteria:
inclusion criteria: * subjects will be ≥18 years old * previously untreated systolic pressure result of ≥120\<160 mmhg and diastolic pressure result of ≥80\<100 mmhg exclusion criteria: * subjects must not have previously received any anti-hypertensive medication * must not have a systolic pressure \<120 mmhg or ≥160 mmhg and diastolic pressure result of \<80 mmhg or ≥100 mmhg * must not have had a previous coronary artery bypass graft (cabg) * must not have had a previous percutaneous transluminal coronary angioplasty (ptca) with a drug-eluting stent * must not have severe congestive heart failure (new york heart classification \[nyhc\] iii-iv).

Keywords: cardiovascular fixed dose combination pill hypertension
effect of aerobic training versus resistance training on plasma homocystiene in diabetic patients

Conditions: Diabete Type 2

Summary: the goal of this \[clinical trial\] is to \[ compare \] in \[ diabetic male patients \]. the main question to answer is : will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients? participants will take their medications and group of them do aerobic exercises and another group do resistance training

40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients. the patients will be randomly assigned to two equal (in number) groups: group (a) twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks. group (b) twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.

Eligibility criteria:
inclusion criteria: * 1- their ages will range from 40 -55 years 2- their body mass indexes will range between (25 to 35 kg / m²). 3-all patients are diagnosed with type 2 diabetes mellites. * diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·l-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·l-1 or higher two hours after an oral glucose challenge. (punthakee et al.,2018). * all subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled. 4- all patients are medically and psychologically stable exclusion criteria: 1. patients with uncontrolled blood glucose level 2. patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study. 3. patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease). 4. patients with musculoskeletal disorders (diagnosed with severe osteoporosis or severe osteoarthritis). 5. patients with bmi \> 35 will be excluded from the study.
effect of gemcabene on the pharmacokinetics of simvastatin in healthy volunteers

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.


Eligibility criteria:
inclusion criteria: * males and females * \>18 years of age * body weight 45 kg or greater exclusion criteria: * if female, of childbearing potential or lactation * history of significant adverse reaction to any fibrate lipid-lowering agent or hmg-coa reductase inhibitor

Keywords: pharmacokinetics lipid regulator