Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of torrent pharmaceutical limited's donepezil hydrochloride tablets under fed conditions

Conditions: Healthy

Summary: objective: to compare the rate and extent of release of the drug substance from the two tablet formulation of donepezil hydrochloride tablets 10mg of torrent pharmaceuticals limited and the aricept® tablets 10mg of eisai inc., dosing periods were separated by a washout period of at least 7 days. study design: randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects


Eligibility criteria:
inclusion criteria: * the volunteers were excluded from the study based on the following criteria: * sex: male. * age: 18 - 45 years. . * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: * the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
effectiveness of muscle energy technique (met) versus stretching exercises in acute and subacute postural neck pain

Conditions: Cervical Pain

Summary: this study will provide better evidence that which technique is more effective in acute and subacute postural neck pain. to find out the effectiveness of muscle energy technique (met) and stretching exercises in acute and subacute postural neck pain.

study design: randomized controlled trial study setting: the study will be conducted at the institute of physical medicine and rehabilitation, dow university of health sciences, karachi, pakistan. intervention: this study will identify effects of two intervention approaches. the experimental group consists of muscle energy technique (met) for upper trapezius and levetor scapulae muscle of neck. the control group will receive a stretching exercises program for upper trapezius and levetor scapulae muscle of neck.

Eligibility criteria:
inclusion criteria: * targeted population: students of mbbs, pharmacy and doctor of physical therapy. * age between 18 and 30 years * patient having acute or subacute postural neck pain * acute postural neck pain should not last longer than 4weeks * subacute postural neck pain should not last longer than 4-12 weeks. exclusion criteria: * cervicogenic headaches * musculoskeletal disorders involve the nerve root compression, i.e.; (intervertebral disc dysfunction and derangement syndrome) * whiplash associated disorders * fibromyalgia * spinal cord injury * neurological disorders i.e.; (multiple sclerosis, young parkinsonism etc.)

Keywords: proprioceptive neuromuscular facilitation (pnf) static stretching exercises visual analog scale
evaluation of the inflammatory and healing profile after root coverage with emdogain®

Conditions: Gingival Recession

Summary: the purpose of this study was the evaluation of inflammatory and healing profile after root coverage using of enamel matrix derivative. 16 volunteers were selected and submitted to root coverage surgery with subepithelial connective tissue graft, with and without enamel matrix derivative. the patient screening was based in the following inclusion criteria: bilateral recessions in maxillary anterior homologous teeth with aesthetical complaining ou hypersensitivity, non-smokers, healthy and no use of any medication that compromises periodontal health or healing. the split-mouth randomized model was followed in relation to test and control sites. the following clinical parameters were analyzed at baseline and 6-month post-surgery: recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness. in addition to the surgical analysis, evaluations of the following inflammatory markers were performed: il-1β, il -1ra, il-2, il-4, il-5, il-6, il-7, il-8, il-9, il-10, il12, il-13, il-15, il-17, eotaxin, fgf, gcsf, gmcsf, ifn-y, ip-10, mcp-1, mip 1a, pdgf-bb, mip 1b, rantes, tnf-α e vegf. these evaluations were performed at baseline, 7 and 14 days after surgery.


Eligibility criteria:
inclusion criteria: * bilateral gingival recessions in homologous teeth exclusion criteria: * smokers; * systemic diseases; * drugs affecting periodontal health/healing.
laparoscopy-assisted transgastric ercp

Conditions: Biliary Obstruction

Summary: we describe a case of a 57-year-old patient with altered rygb anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. a laparoscopic assisted trans-gastric ercp was successfully performed. the presentation of the case is presented as well a review of the literature.

the exclusion of the stomach after roux-en-y-gastric bypass (rygb) makes access to the biliary tree very challenging for the surgeon or the endoscopist. there are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ercp) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. we describe a case of a 57-year-old patient with altered rygb anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. a laparoscopic assisted trans-gastric ercp was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. the patient evolved favorably and was discharged on his second postoperative day without complications.

Eligibility criteria:
inclusion criteria: * patient with altered roux en y gastric bypass anatomy exclusion criteria: * patients without roux en y gastric bypass anatomy

Keywords: biliary disease gallstones obesity
sensitivity of ecg on detection of three different intravascular applied test doses of bupivacaine and epinephrine

Conditions: Anaesthesia; Toxicity

Summary: the purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epinephrine in anaesthetised children up to 16 years of age.


Eligibility criteria:
inclusion criteria: * age 0 to 16 * healthy * parental consent exclusion criteria: * asa \>1 * allergy against local anaesthetics

Keywords: local anaesthetics toxicity heart arrhythmia heart rate heart conduction regional anaesthesia paediatric anaesthesia cardio-vascular system prevention
safety and efficacy of sofosbuvir + velpatasvir with or without ribavirin in treatment-naive adults with chronic hcv infection

Conditions: Hepatitis C

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (sof) + velpatasvir (vel; gs-5816) with or without ribavirin (rbv) in treatment-naive adults with chronic genotype (gt) 1, 2, 3, 4, 5, or 6 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * chronic hcv infection * body mass index (bmi) ≥ 18 kg/m\^2 * hcv rna ≥ 10000 iu/ml at screening * use of highly effective contraception methods if female of childbearing potential or sexually active male * must not have cirrhosis exclusion criteria: * current or prior history of clinically significant illness other than hcv * screening ecg with clinically significant abnormalities * prior exposure to hcv specific direct acting antiviral agent * prior treatment of hcv with interferon or ribavirin * pregnant or nursing female or male with pregnant female partner * chronic liver disease of non-hcv etiology * hepatitis b * active drug abuse * use of any prohibited concomitant medications

Keywords: hepatitis hcv genotype 1 hcv genotype 2 hcv genotype 3 hcv genotype 4 hcv genotype 5 hcv genotype 6 treatment naive
study of s1 efficacy and toxicity as second-line treatment on inoperable or advanced gastric cancers

Conditions: Gastric Cancer

Summary: the primary purpose of the study is to investigate the correlation between the efficacy and toxicity of s-1 on gastric cancers and the expression of thymidylate synthase (ts), dihydropyrimidine dehydrogenase (dpd) and orotate phosphoribosyltransferase(oprt).

ts, dpd and oprt are the key enzymes on the metabolic pathway of 5-fu. we will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with s-1, such as the overall survival (os), progressive-free survival (pfs), lauren's classification and toxicity of s1, etc. we will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of ts, dpd and oprt. all of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment 2. aged 18 years or older 3. kps performance status of ≥ 70. 4. anticipated life expectancy of ≥ 3 months. 5. adequate organ function, including bone marrow, kidney and liver. * anc ≥ 1.5×109/l and hemoglobin ≥ 8g/dl and platelet count ≥ 100×109/l * serum total bilirubin ≤ 1.5 x uln, serum alt and ast ≤ 2.5 x uln (serum alt and ast ≤ 5 x uln, if liver metastases are present) * serum creatinine ≤ 1.5 x uln and clcr \> 60 ml/min 6. written informed consent can be obtained prior to their participation in the trial. exclusion criteria: 1. history of severe drug allergy , or an allergy to any components of s1 2. subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks 3. alimentary tract hemorrhage, diarrhea or aphagosis at the present stage 4. subjects with uncontrolled cns metastasis or epilepsia or severe psychiatric disorders. 5. subjects who are regarded to be unsuitable for this trial by the investigator. 6. subjects who are participating in other clinical trials 7. subjects with ascites draining or severe infection 8. pregnant or breast-feeding women
study to assess the reproducibility and sensitivity of quantitative sensory testing in patients with neuropathic pain

Conditions: Neuropathic Pain

Summary: conventional pain efficacy measures such as visual analogue scores (vas) are often unable to detect treatment efficacy in small-scale clinical trials. combining conventional pain efficacy measures with quantitative sensory testing (qst) may provide more sensitive and informative outcome measures in clinical trials.

methodology to assess reproducibility and sensitivity of quantitative sensory testing

Eligibility criteria:
inclusion criteria: * neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli. * a present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen. * stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study. exclusion criteria: * patients who have undergone neurolytic or neurosurgical therapy. * patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (type i and ii), and phantom limb pain. * patients who have previously been treated with pregabalin.

Keywords: methodology quantitative sensory testing neuropathies pain pregabalin
human muscle gene expression profiles in young and old men

Conditions: Elderly; Sarcopenia

Summary: to reach the goals of living longer in better medical conditions, many countries reach the same conclusion: new strategies have to be developed to avoid, or at least limit, the effects of age; this requires a better knowledge of the mechanisms of aging. our project focuses on the loss of muscle mass associated with aging, called sarcopenia. sarcopenia unavoidably leads to impaired mobility and poor balance, which contributes to loss of functional autonomy and to increased prevalence for severe falls. skeletal muscle also plays a central role as a reserve for energy and amino acids. hence, sarcopenia further triggers severe side metabolic effects such as frailty among elderly persons. the precise mechanisms of muscle aging are still mostly unknown, although many theories have been proposed. the present study aims at better understanding the mechanisms of skeletal muscle loss associated with aging. using muscle biopsies from young and old subjects, the differential expression profiles of mrna will be obtained through chips that will evaluate more than 39000 transcripts. on the same samples, proteomic analyses will involve two complementary approaches: (1) bidimensional electrophoresis (2dge) coupled to mass spectrometry (maldi-tof) for dominant proteins; (2) western-blot (more than 800 antibodies) targeting regulating proteins not detectable using 2dge. complementary histological studies (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major biomarkers in the muscle biopsies. the results of that research will have applications in the medium term and will lead to nutritional interventions to modulate specific metabolic pathways and improve the quality of life in the elderly.


Eligibility criteria:
inclusion criteria: * affiliated or beneficiary of a social security category * having signed the inform consent form * having signed the genetic consent form exclusion criteria: * antiaggregant platelet treatment * type 2 diabetes * body mass index \> 25 * severe renal disease * crp \> 10 * abnormal clotting test * allergies to local anesthetics

Keywords: aging biopsy skeletal muscle molecular biology genetic markers gene expression regulation young and old men healthy volunteers
glycosade v uccs in the dietary management of hepatic gsd

Conditions: Glycogen Storage Disease

Summary: to compare efficacy of glycosade® with uncooked corn starch (uccs for the dietary management of hepatic glycogen storage diseases (gsd).

'glyde' is a prospective, randomised, double-blind, crossover trial to compare the effects of two different starches used in the dietary management of gsd. the study will recruit 64 patients from six centres in the uk, usa, france and the netherlands. the planned duration per participant is 2 years. participants will be randomised into two equally sized groups: arm a- glycosade intake given first, followed by uccs 1-6 weeks later arm b- uccs intake given first, followed by glycosade 1-6 weeks later. the objective of this trial is to establish whether glycosade® improves outcomes for patients with gsd compared to uccs therapy by comparing the duration of normal blood sugars, lactate and ketone levels of patients with hepatic gsd (types i, iii, vi and ix) post equivalent intakes of uccs and glycosade®. the first part consists of two (blinded) 12 hour starch load tests administered randomly within a maximum 6 week period. participants will be randomised to receive either uccs or glycosade® for the initial intervention period crossing over to the other product for the second intervention period (part 1). the second part (unblinded) is a 24 month open follow up whereby participant's will continue on the product considered most suitable by the clinician and patient.

Eligibility criteria:
inclusion criteria: * diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). for those whom mutation analysis is not completed this will be assessed during the study. * aged 2 years or older (5 years or older in the usa) * established on full intake of uncooked corn starch therapy for at least 6 months exclusion criteria: * women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded. * children less than 2 years of age
caudal block vs local wound infiltration for hernia repair in children

Conditions: Anesthesia

Summary: to our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. the aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (cb) or local wound infiltration (lwi).

total of 80 children aged 6 month to 7 years of asa physical status i or ii, undergoing unilateral hernia repair will be enroled in the study. one group will receive caudal block (cb) and the other group will receive local wound infiltration (lwi). group cb will receive 1ml kg 0,25% bupivacaine and group lwi will receive 0,2 ml kg 0,25% bupivacaine. data taken will than be analyzed and interpreted. postoperative pain will be assess using the children's hospital of eastern ontario pain scale (cheops, 0-10)(8) and the faces legs activity cry consolability tool (flacc, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. the time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both cheops and flacc by the investigator. twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. the investigator, who will be blind to the treatment group, will document these data with the medical records.

Eligibility criteria:
inclusion criteria: * 6 month to 7 years * asa physical status i or ii * undergoing unilateral hernia repair exclusion criteria: * history of developmental delay or mental retardation * type i diabetes * known or suspected coagulopathy * known allergy to any local anesthetic * known congenital anomaly of the spine * signs of spinal anomaly or infection at the sacral or inguinal region

Keywords: caudal block local wound infiltration hernia repair
should integrilin be an integral part of adjunctive therapy in patients undergoing primary pci for st-elevation mi?

Conditions: ST-elevation Myocardial Infarction; Acute Myocardial Infarction

Summary: the aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of glycoprotein iib/iiia inhibitor eptifibatide as adjunctive therapy in patients undergoing primary percutaneous coronary intervention for st-elevation myocardial infarction in a large tertiary referral center. it is hypothesized that glycoprotein iib/iiia inhibitor use during primary percutaneous coronary intervention for st-elevation myocardial infarction/ acute myocardial infarction is superior to unfractionated heparin alone or bivalirudin alone. additionally, after propensity matching this superiority remains.

this is a retrospective, observational, data analysis of approximately 800 patients who underwent primary percutaneous coronary intervention at our institution since september 2000. patients will have either received eptifibatide pre-or during percutaneous coronary intervention or have received no eptifibatide. patients who received a thrombolytic prior to percutaneous coronary intervention will be excluded. this analysis is estimated to take 1-2 months.

Eligibility criteria:
inclusion criteria: * underwent percutaneous coronary intervention at washington hospital center since september 2000 * either received eptifibatide pre-or during pci or have received no eptifibatide. exclusion criteria: * patients who received a thrombolytic prior to percutaneous coronary intervention.

Keywords: major adverse microvascular integrity all cause mortality q wave mi
the effects of ly2409021 on the liver

Conditions: Diabetes Mellitus, Type 2

Summary: this is a study that involves multiple doses of study drug (60 mg of ly2409021, 15 mg of ly2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. this study will image the liver using magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs) in healthy participants and in participants with type 2 diabetes mellitus, when they take ly2409021 to see if liver changes happen at the same time as changes in blood tests. this study is approximately 11 weeks long, not including screening. a screening appointment is required within 28 days prior to the start of the study.


Eligibility criteria:
inclusion criteria: for all participants: * must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * must have a body mass index (bmi) of 18.5 to 29.9 kilograms per square meter (kg/m\^2) if a healthy participant, or a bmi of 18.5 to 35.0 kg/m\^2 if diabetic for participants with type 2 diabetes mellitus (t2dm): - on diet and exercise treatment, or taking metformin exclusion criteria: for all participants: * have signs or symptoms of liver disease * are infected with hepatitis b or hepatitis c * have donated more than 450 ml of blood in the last 3 months or if have donated any blood in the last month * smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic * have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (mri) scan for participants with t2dm: - are using insulin