Kornimate/medical-research-clean huggingface dataset:
double-blind, randomized study of the analgesic efficacy and safety of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared to placebo for management of acute postsurgical pain in anterior cruciate ligament (acl) reconstruction

Conditions: Pain

Summary: the primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (acl) reconstruction surgery. secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.


Eligibility criteria:
inclusion criteria: * included patients had uncomplicated arthroscopic acl reconstruction * subjects were to have a baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (vas) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility * subjects could not have received any medication or additional procedures that would confound the interpretation of the study results. exclusion criteria: * the patient was admitted to or retained in the surgical center/hospital for \>23 hours; * the patient underwent any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone; * the patient used conventional nonsteroidal antiinflammatory drugs (nsaids), selective cyclooxygenase-2 (cox-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery; * the patient received oxaprozin or piroxicam within 1 week prior to randomization; * the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery; * the patient had been treated with patient-controlled analgesia or nsaids subsequent to the end of anesthesia; * patient had a history of clinically significant gi disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.

Keywords: post surgical pain anterior cruciate ligament reconstruction arthroscopy perioperative pain
piezosurgical buccal plate repositioning technique for horizontal alveolar ridge augmentation

Conditions: Alveolar Bone Loss

Summary: achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. in the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. evaluation of the effect of silica-calcium phosphate nanocomposite (scpc) graft material versus demineralized freeze dried bone allograft (dfba) in horizontal alveolar ridge augmentation before implant insertion will be performed.


Eligibility criteria:
inclusion criteria: * patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm. * augmented area length in the mesial-distal direction of less than 20 mm. * adequate physically healthy condition. exclusion criteria: * a systemic disease that would contraindicate oral surgical treatment. * treated patients who had undergone therapy involving radiation * patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure. * patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
a controlled clinical trial on the use of a specific antivenom against envenoming by bungarus multicinctus

Conditions: Snake Bite

Summary: in northern vietnam, a vast majority of the most severe envenomed patients are bitten by bungarus multicinctus. hitherto, these victims have received supportive care only. the aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.

venomous snakebites constitute a serious health problem in many asian countries. in vietnam, the burden of snakebite on the public health stimulated calmette to conduct original studies at the vaccine institute in saigon over a hundred years ago and to develop the first snake antivenom ever. in northern vietnam, a vast majority of the most severe envenomed patients are bitten by bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite. supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. such specific therapy may dramatically reduce the consequences of the envenomation. in vietnam, no specific antivenom against b. multicinctus has been available until recently when it has produced for clinical use.

Eligibility criteria:
inclusion criteria: * envenomed by b. multicinctus * showed clinical signs of systemic envenomation (neuromuscular signs) * provided written informed consent (during the year 2006) exclusion criteria: * pregnancy * patients had a known history of intolerance to equine serum

Keywords: antivenom snake bite bungarus multicinctus vietnam
study of the combination of acp-196 and pembrolizumab in subjects with platinum resistant urothelial bladder cancer

Conditions: Metastatic Urothelial Carcinoma

Summary: study of the combination of acp-196 and pembrolizumab in subjects with platinum resistant metastatic urothelial cancer


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer * metastatic bladder cancer with disease progression on or after platinum-based chemotherapy * any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters * prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma * presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm \[≥ 15 mm for lymph nodes\] * ecog performance status of 0 or 1 exclusion criteria: * prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to \< 2 years. * known central nervous system metastases and/or carcinomatous meningitis * malabsorption syndrome, disease significantly affecting gastrointestinal function * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
a drug-drug interaction study of diltiazem and mk-5684 in healthy adult male participants (mk-5684-011)

Conditions: Prostatic Neoplasms

Summary: researchers have designed a study medicine called mk-5684 as a new way to treat prostate cancer. the purpose of this study is to learn what happens to mk-5684 in a person's body over time (a pharmacokinetic or pk study). researchers will compare what happens to mk-5684 in the body when it is given with and without another medicine called diltiazem.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting * body mass index (bmi) ≥18.0 and ≤32.0 kg/m\^2 * able to swallow multiple tablets exclusion criteria: the main exclusion criteria include but are not limited to the following: * history or presence of any of the following: * adrenal insufficiency * hepatic or renal impairment * clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events * second- or third-degree atrioventricular (av) heart block (except in participants with a functional artificial pacemaker) * clinically significant sick sinus syndrome * presence of any systemic fungal infection * chronic infection * glaucoma * hypothyroidism * stomach ulcer * ocular herpes simplex * has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including brugada syndrome) * history of cancer (malignancy) * unable to refrain from or anticipants the use of: unable to refrain from or anticipates the use of: any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
residual anti-pneumococcal immunity after pneumococcal immunization in anca-associated vasculitis

Conditions: Pneumococcal Infection; ANCA-associated Vasculitis

Summary: descriptive study of the residual anti-pneumococcal immunity in patients with anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis (aav) who have previously gone through pneumococcal immunization.

the purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (elisa) and opsonophagocytosis (opa) titres whether aav patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (ipd).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to american college of rheumatology criteria * anti-pneumococcal immunization in the past 36 months * history of anti-pneumococcal vaccination according to french recommendations (simple vaccine schedule with ppv23 or combine vaccine schedule with pcv13 followed by ppv23 8 weeks later) exclusion criteria: * known or suspected pregnancy * splenectomy * patient without social security coverage * patient opposal

Keywords: pneumococcal infection invasive pneumococcal disease (ipd) pneumococcal vaccine systemic vasculitis anca-associated vasculitis vaccinology immunocompromised auto-immune disease
khon kaen university's thyroidectomy registry

Conditions: Thyroid Nodule; Thyroid Neoplasms; Thyroid Cancer

Summary: the endoscopic thyroidectomy approach is gaining popularity in the surgical field. this registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.


Eligibility criteria:
inclusion criteria: * the patients who underwent thyroidectomy at khon kaen university exclusion criteria: * none

Keywords: endoscopic thyroidectomy
differential effect of high (200μg/kg/min) adenosine dose on fractional flow reserve in patients presenting variation of ffr ≥0.05 during the usual dose of adenosine infusion (140μg/kg/min).

Conditions: Coronary Artery Disease

Summary: fractional flow reserve (ffr) is an established invasive method for assessing the physiological significance of coronary artery stenosis. however, in recent studies it has been observed and reported some degree of variation in the fraction of the coronary artery to the aortic pressure (pd / pa) during the infusion of standard adenosine dose (140mg/kg/min). the observed variation may be attributed to a failure to achieve maximal hyperemia with the normal dose. the administration of adenosine at a higher dose (200μg/kg /min) may influence coronary flow reserve (ffr) eliminating pd / pa variation during adenosine infusion. this is a prospective study which will be conducted in patients after coronary angiography with at least one angiographic lesion ≥50% in coronary vessels. patients after written consent will undergo assessment of lesion severity with ffr under a three-minute infusion of adenosine 140mg/kg/min. in patients during steady state hyperaemia (determined by visual assessment) exhibiting variation in pd / pa ratio ≥ 0.05 (e.g. difference of max pd/pa minus min pd/pa) the examination will be repeated after 5 min with three-minute infusion under high dose adenosine (200mg/kg/min). the minimum ratio pd/pa per 3 beats will be offline analyzed. the ffr during steady hyperemia state is defined as the average of the minimum ratio pd / pa per three beats.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. patients with at least 1 ≥50% stenosis in a coronary vessel, subjected to ffr assessment, who exhibit variation in pd / pa ratio ≥ 0.05 (e.g. difference of max pd/pa minus min pd/pa) during steady state hyperaemia (determined by visual assessment). 3. written informed consent exclusion criteria: 1. left main disease (angiographically\> 50%) 2. cardiogenic shock / hemodynamic instability 3. previous cabg 4. increased risk of bradycardia on investigator clinical judgment 5. severe chronic obstructive pulmonary disease 6. coronary vessels with tortuosity or extremely calcified 7. severe left ventricular hypertrophy or severe valvular disease 8. stemi or non-stemi within the past five days 9. previous myocardial infarction in the distribution of the target vessel for the ffr 10. acute decompensated heart failure.

Keywords: coronary artery disease fractional floe reserve
immune modulation by ischemic pre-conditioning in healthy individuals: intracellular signalling in regulatory cells

Conditions: Ischemia Reperfusion Injury; Ischaemia Reperfusion Injury

Summary: the aim of the study is to investigate how phosphorylation of stat3, p38 mitogen-activated protein kinase (mapk), extracellular signal-regulated kinase (erk) and protein kinase b (akt) reacts to remote ischemic conditioning (ric) in healthy humans, which could point to mechanisms by which ric may protect against ischemia-reperfusion injury (iri), and if ric affects immune reactivity.

in ric brief episodes of non-lethal ischemia and reperfusion in one vascular bed, tissue or organ, has shown to have protective effects against iri in various organs. the protective effect of ric seems convincing, but to date it is not clear which mechanisms give ric its effects, and why effects are absent in some situations. effects of ric on the immune system are also not clear, but important if ric is used in transplantation and autoimmunity settings, and also in regards to infection risk. patients studied have often been given medical treatment and/or have comorbidities affecting the results. this project will measure how intracellular phosphorylation of stat3, p38 mapk, erk and akt, inflammatory cell patterns and cytokine production react to ric in healthy humans, and potentially give a better understanding of the mechanisms that mediate the protective effects of ric. the intracellular mediators studied are involved in the initiation of cytokine production and regulate apoptosis and activation of the inflammatory cells. an altered balance between leucocytes and their mediators could be of importance for ric effects, particularly in transplantation and autoimmunity, and this will be elucidated in our study. as a secondary end point the investigators will measure the effect of ric on pulse variability and blood pressure using a non-invasive device, since evidence regarding these aspects is sparse, although documented positive effects of ric have primarily been on the heart and vascular system.

Eligibility criteria:
inclusion criteria: * healthy and well exclusion criteria: * smoker. * taking regular medication. * any acute, chronic or systemic disease * no hard physical exercise 72 hours prior to study participation. * no alcohol or caffein-containing drinks 24 hours prior to study participation. * fasted for at least 6 hours prior to study participation.
neuromuscular electrical stimulation cycling

Conditions: Stroke

Summary: a new electromyography (emg)-driven neuromuscular electrical stimulation (nmes)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. the system will generate nmes to targeted muscle according to the user's voluntary intention, represented by the emg signal during cycling.


Eligibility criteria:
inclusion criteria: 1. diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke; 2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; 3. significant gait deficit (functional ambulatory category, fac, scale \<4 \[person cannot walk independently\]). exclusion criteria: 1. any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression; 2. severe hip, knee or ankle contracture that would preclude passive range of motion of the leg; 3. implanted cardiac device (e.g. pacemaker and internal defibrillator).
real-life efficacy of insulia® tool in patients living with type 2 diabetes treated with basal insulin therapy as part of a national telemedicine program (etapes)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to evaluate the insulia digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a french national telemedicine experimentation program (etapes) in a single-center study. the assumption is that a better metabolic control with this tool.

basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia. significant inertia in treatment optimization has been observed among both general practitioners and diabetologists. the insulia tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a french national telemedicine experimentation program (etapes) has been supported by the health authorities. the data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021. it is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients with type 2 diabetes. * initiation or adjustment of basal insulin. * prescription of insulia® for more than 6 months (between august 2018 and june 2021) * informed patient not opposed to the research exclusion criteria: patient opposed to the research
selective 5-ht4 receptor agonist and proton pump inhibitor (ppi) in subjects with gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: the aim of this study is to establish a dose-related effect of a selective 5-ht4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with gerd who have persistent symptoms while on ppi therapy.


Eligibility criteria:
inclusion criteria: 1. written informed consent form signed voluntarily before the first study-related activity. 2. aged between 18 and 70 years, inclusive. 3. subjects with a history of the cardinal symptoms of gerd (both heartburn and regurgitation) prior to ppi therapy. 4. subjects with symptoms of gerd for at least 6 months prior to the screening visit. 5. subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on ppi. 6. subjects have at least some improvement to the symptom of heartburn while on ppi therapy. 7. subjects on ppi therapy for at least 8 weeks prior to the screening visit of which the last 4 weeks are on a stable labeled dose for any gerd indication according to the country label, where a change of ppi therapy would not impact the symptoms (twice-daily dosing of ppi is not allowed in the last 4 weeks) exclusion criteria: 1. subjects who show no response to heartburn while on ppi therapy. 2. subjects with dyspepsia symptoms that are more predominant than their gerd symptoms (heartburn and/or regurgitation). 3. subjects with prior endoscopic anti-reflux procedure or major gi surgery or subjects with major gi disorders. 4. presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or aids. 5. alarm symptoms suggestive of malignancies or organic disease.
i-125 versus pd-103 for low risk prostate cancer

Conditions: Prostate Cancer

Summary: objective: to test the hypothesis that the shorter half-life of pd-103 versus i-125, will increase the rate of tumor eradication. research design a total of 600 patients with ajc clinical stage t1c-t2a prostatic carcinoma (gleason grade 2 to 6, psa 4 to 10 ng/ml) will be randomized to implantation with i-125 (160 gy) versus pd-103 (115 gy).

objective: to test the hypothesis that the shorter half-life of pd-103 versus i-125, will increase the rate of tumor eradication. research design a total of 600 patients with ajc clinical stage t1c-t2a prostatic carcinoma (gleason grade 2 to 6, psa 4 to 10 ng/ml) will be randomized to implantation with i-125 (160 gy) versus pd-103 (115 gy). methodology: patients will be randomized by the method of random permuted blocks. cancer status will be monitored by serial serum psa at 6, 12, 18 and 24 months and yearly thereafter. treatment-related morbidity will be monitored by personal interview, using standard american urologic association and radiation therapy oncology group criteria at 1, 3, 6, 12 and 24 months. patients with serum psa above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility criteria:
inclusion criteria: * males age 40-80 * psa 4-10 * gleason score 5-6 exclusion criteria: * lymph node positive

Keywords: prostate cancer radiation brachytherapy