Kornimate/medical-research-clean huggingface dataset:
reassure: the effect of rimonabant on hba1c in overweight or obese patients with type 2 diabetes not adequately controlled on 2 oral antidiabetic agents

Conditions: Diabetes Mellitus, Type 2

Summary: primary: to assess the effects of rimonabant on hba1c in patients with type 2 diabetes who are overweight or obese (body mass index (bmi) \> 27 kg/m² and bmi \< 40 kg/m²), have uncontrolled hba1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two oral anti diabetic medications - metformin (met) and sulfonylurea (su). secondary: to assess the effects of rimonabant on anthropometric measures, glucose measures, lipid measures, other measures and changes in quality of life


Eligibility criteria:
list of inclusion and exclusion criteria: inclusion criteria: * history of type 2 diabetes * hba1c between 7% to 9% (inclusive) * bmi ≥ 27kg/m² and bmi ≤ 40kg/m² * currently taking metformin and sulfonylurea. exclusion criteria: * uncontrolled serious psychiatric illness such as major depression * current use of antidepressants * severe renal impairment (creatinine clearance less than 30ml/min) * severe hepatic impairment known by investigator or aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limit normal * patient treated for epilepsy * pregnant or breast-feeding women * women of childbearing potential not protected by effective contraception * hypersentivity/intolerance to rimonabant or any of the excipents * presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety * use of insulin for longer than 1 week within 4 weeks prior to screening * chronic use of systemic corticosteriods * use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase iv * history of drug or alcohol abuse wihtin the last three years * heart failure class iii-iv (new york heart association classification) * severe hypertension * adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies * use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols * use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or st john's wort * participation in a clinical study within the 4 weeks prior to randomisation * patients involved in an existing weight loss program * presence of chronic hepatitis * use, or misuse, of substances of abuse * marijuana or hashish users * history of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study * history or presence of bulimia or laxative abuse * non-english speaking the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
tolerability, safety and efficacy of sigh breaths during nimv in motor neuron disease

Conditions: Motor Neuron Disease; Respiratory Failure; Amyotrophic Lateral Sclerosis

Summary: non-invasive mechanical ventilation (nimv) is the recommended standard of care as initial therapy for patients with motor neuron disease (mnd) with deterioration of the respiratory function. sigh_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with mnd in comparison to the standard ventilation support protocol.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * mnd diagnosis according to el-escorial criteria * non-invasive ventilation indications in accordance with the international guidelines exclusion criteria: * inability to adhere to study visit schedule or lack of reliable caretaker * presence of dementia * history of arrhythmia, heart failure or pneumothorax
a randomized trial comparing metered dose inhalers and breath actuated nebulizers

Conditions: Asthma

Summary: this study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.

albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. there is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. the effectiveness of breath actuated nebulization compared to mdi for treating asthma exacerbations is less well defined. metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.

Eligibility criteria:
inclusion criteria: * patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (pas)11 of 5 to 11. exclusion criteria: * subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease * congenital heart disease, tracheostomy, or were receiving diuretic therapy. * patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak english.

Keywords: pediatrics metered dose inhalers breath actuated nebulizers
combined effect of laser acupuncture and electroacupuncture in knee osteoarthritis patients

Conditions: Knee Osteoarthritis

Summary: background: knee osteoarthritis (koa) is a common degenerative joint disorder affected 250 million people globally. it can not only result in disability, but also associated with cardiovascular disease and mortality. the most common treatment for koa is non-steroidal anti-inflammatory drug. however, the effect of analgesic is limited and may complicate with side effect. hence, many patients search for complementary and alternative medicine. acupuncture is one of the most popular complementary treatment with good analgesic effect and less side effect. electroacupuncture (ea) or laser acupuncture (la) was reported effective in pain control in knee osteoarthritis patients. however, there is no study about combination effect of ea and la. methods: this protocol is a randomized controlled trial investigating the combination effect of ea and la on koa. fifty participants diagnosed koa with aged more than 50 years old and knee pain more than 3 months were recruited and randomly assigned to the experimental group (ea plus la) or sham group (ea plus la without laser output) in clinical research center. the subjects will undergo ea plus la treatment thrice a weeks for 4 weeks. the experimental group will receive acupuncture at gb33, gb34, sp9, sp10, and st36 with transcutaneous electrical nerve stimulator on the gb34+33 and sp9+10., and the la deliver 6 joule of energy at ex-le5, st35, and bl40. the subjects in sham group will receive the same way but the la is without any laser output. outcome measurement will include visual analogue scale (vas), western ontario mcmaster universities osteoarthritis index (womac), knee injury and osteoarthritis outcome (koos), body composition analysis, knee range of motion test, muscle stiffness test, standing on one foot test, and the 30-second chair stand test before intervention and after 4 weeks intervention. the result will be analyze and compared between the experimental group and sham group using the paired t test and one-way analysis of variance. objectives: the aim of this protocol is to investigate the combination effect of ea and la in koa patients.


Eligibility criteria:
inclusion criteria: * vas more than 3 point when daily activity * kellgren-lawrence grading scale grade 1 to 3 on knee x-ray * provided informed consent exclusion criteria: * history of knee arthroplasty, traumatic injury related joint deformity, * body mass index more than 35 * pacemaker insertion, photosensitivity * who had undergone intra-articular injection or acupuncture in recent one month * other factors that may affect the evaluation of the outcome, such as psychiatric disorder or moderate mental retardation etc.

Keywords: electroacupuncture laser acupuncture low-level laser therapy photobiomodulation complementary medicine
pentoxifylline treatment in acute pancreatitis (ap)

Conditions: Acute Pancreatitis (AP); Gallstone Pancreatitis; Alcoholic Pancreatitis; Trauma Acute Pancreatitis; Hypertriglyceridemia Acute Pancreatitis; Idiopathic (Unknown) Acute Pancreatitis; Medication Induced Acute Pancreatitis; Cancer Acute Pancreatitis; Miscellaneous (i.e. Acute on Chronic Pancreatitis)

Summary: the purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.

participants were randomized to either the treatment group (pentoxifylline medication) or the control group (placebo). participant took a pill orally, starting from the time of admission. participants received a total of 9 doses over the three days of hospitalization (72 hours). research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. the study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.

Eligibility criteria:
inclusion criteria * enrollment within 72 hours of diagnosis of acute pancreatitis (ap) * ability to give informed consent or a legal adult representative (lar) able to give informed consent for subject when needed as defined buy lar use guidelines. * adult subjects of age ≥18 years. exclusion criteria: * moderate or severe congestive heart failure * history of seizure disorders or demyelinating disease * nursing mothers * pregnancy * history of prior tuberculosis or risk factors for tuberculosis * evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and hiv) * evidence of active hemorrhage * paralytic ileus with severe nausea and vomiting

Keywords: post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis
a clinical study of ultrasound-derived fat fraction to assess metabolic dysfunction-associated steatotic liver disease

Conditions: Fatty Liver Disease

Summary: aims: to evaluate the diagnostic performance of ultrasound-derived fat fraction (udff) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard. materials and methods: obese individuals, who were found to have fatty liver by b-mode ultrasound and underwent udff measurement, along with liver biopsy results, were retrospectively selected from the first affiliated hospital of shandong first medical university.the inclusion criteria were as follows: (1) bmi over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional b-mode ultrasound; (3) serologic test results were available. the exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.


Eligibility criteria:
inclusion criteria: * bmi over 30 kg/m² * diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional b-mode ultrasound * serologic test results were available exclusion criteria: * patients who have undergone liver resection or have liver space-occupying lesions * pregnant women * patients with incomplete medical history data
upper limbs intervention in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. it is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. different areas are affected, including manual dexterity, strength, coordination and function. the objective of this study is to evaluate the improvement in these variables in patients with multiple sclerosis after a 8-weeks intervention focused on upper limbs.

the total estimated prevalence rate of multiple sclerosis has been reported to be 83 per 100 000 for the past three decades. it is also higher in northern countries and between females with a male ratio around 2.0. the highest prevalence rates have been estimated for the age group 35-64 years. the estimated european mean annual multiple sclerosis incidence rate is 4.3 cases per 100 000. multiple sclerosis can cause a variety of symptoms: hypoesthesia, muscle weakness, abnormal muscle spasms, or difficulty moving; difficulties with coordination and balance; dysarthria, dysphagia, visual problems fatigue and acute or chronic pain syndromes, bladder and bowel difficulties,cognitive impairment, or emotional symptomatology. the investigators focus on the benefits of an intervention on dexterity, strength, coordination and functionality.

Eligibility criteria:
inclusion criteria: * patients diagnosed with multiple sclerosis. * subjects who can complete the assessment battery of tests at the beginning and at the end of the study exclusion criteria: * auditive and visual disturbances. * cognitive problems. * psychiatric pathology. * sensorial disturbances. * traumatic pathology of the hand. * concomitant neurological conditions

Keywords: multiple sclerosis dexterity upper limbs
hypercapnia to prevent secondary ischemia in sah

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: delayed cerebral vasospasm and secondary ischemic infarction are feared complications after aneurysmal subarachnoid hemorrhage (asah). to date, there is no effective therapy to prevent these ischemic complications. the arterial partial pressure of carbon dioxide (paco2) is one of the main determinants of cerebral blood flow (cbf) in healthy subjects. it is yet largely unknown, if and to what extent modulations of paco2 can influence cbf in patients after asah. the trial is a phase 1 study in which the feasibility of hypercapnia in sah patients is tested. paco2 is gradually raised to 60 mmhg in 10 mechanically ventilated asah patients. cerebral oxygen saturation measured by nirs and cbf determined by an intracerebral thermodilution probe are the primary end points. if the feasibility is confirmed, this trial will be followed by a phase 2 dose finding study.

the course of aneurysmal subarachnoid hemorrhage (asah) is determined by the sequence of several ischemic episodes. immediately after asah, an increase of icp causes an increase of cbf. it is followed by an acute vasoconstriction over the next hours and days. typically between day 4 and 10 after asah, delayed arterial narrowing and a decrease of cbf occurs in approximately 50 % of asah patients and may result in cerebral ischemia and infarction. after the failure of the conscious-trial to improve outcome after asah, there is no specific treatment in sight to effectively prevent cerebral ischemic events after asah. under physiological conditions, the arterial partial pressure of carbon dioxide (paco2) is one of the main determinants of cerebral blood flow (cbf). an elevation of paco2 may also be a useful treatment on asah patients. this trial is designed as a phase 1 study to test the feasibility of controlled hypercapnia in mechanically ventilated asah patients with poor-grade sah. monitoring is performed by an external ventricular drainage (icp), near infrared spectroscopy (tissue oxygenation) and a thermodilution probe (cbf). the latter monitoring tools represent the primary end points of this study. in case of affirmed feasibility, a dose finding study will be launched as a next step.

Eligibility criteria:
inclusion criteria: * aneurysmal sah * sah hunt/hess grade 3-5 * sah fisher grade 2-4 * mechanically ventilated * external ventricular drainage/icp measurement exclusion criteria: * age under 18 * icp \> 25 mmhg for \> 2 minutes * ph \< 7.250

Keywords: aneurysm subarachnoid hemorrhage vasospasm cerebral ischemia stroke
evaluation of statnet device for electroencephalogram (eeg) recordings

Conditions: Epilepsy; Seizures

Summary: the purpose of the study is to develop an emergency electroencephalogram (eeg) device, statnet, that can be placed quickly by minimally-trained personnel and interpreted remotely for rapid identification of seizures.


Eligibility criteria:
inclusion criteria: * adults \> age 18 * epileptiform discharges present on routine eeg exclusion criteria: * open head wounds * medically unstable

Keywords: new onset seizures
the efficacy and safety of atock dry syrup with acute bronchitis patients

Conditions: Acute Bronchitis

Summary: clinical study to evaluate the efficacy and safety of atock dry syrup with acute bronchial patients


Eligibility criteria:
inclusion criteria: 1. children aged ≥6 months to \<12 years old 2. total bronchitis severity scale excluding sputum(bsses) ≥4 3. wheezing score ≥2 4. subjects who present symptoms of acute bronchitis within 48 hours from screening visit exclusion criteria: 1. subjects with chronic respiratory diseases (e.g., asthma, copd) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis) 2. subjects under treatment with corticosteroids, antibiotics medications 3. subjects with severe hepatic and renal impairment 4. subjects with a history of drug abuse 5. subject with positive results in hbsag or hcv ab or hiv ab tests at screening visit
chinese liver cancer clinical survey

Conditions: Primary Liver Cancer

Summary: in order to make better use of clinical resources of the real world, strengthen the standardization of plc diagnosis and treatment, and constantly improve the academic level of liver cancer in china, we intends to launch "chinese liver cancer clinical survey" project in cancer specialized hospitals and large general hospitals and to explore the best clinical pathway of plc multidisciplinary consultation.

primary liver cancer (plc) is one of the most common malignant tumors of digestive system and also a serious threat to the health and safety of chinese people, and has caused serious economic burden to the country. research purposes: to understand the clinical characteristics of patients with primary liver cancer (plc) in china; to investigate the etiology and pathogenesis of plc in china; to understand the current status of clinical treatment of plc in china, and to analyze the gaps among these conditions and domestic treatment guidelines, industry consensus, the international treatment guidelines; to understand the different treatment options and its clinical outcomes, and to explore the best treatment options; to explore the best clinical pathway of plc multidisciplinary consultation; to provide the basis for the development of clinical guidelines for plc in china.

Eligibility criteria:
inclusion criteria: * diagnosis of plc after january 1,2012; * first treatment and efficacy evaluation. exclusion criteria: * complicated with another primary malignant tumor and secondary liver cancer.
optimization of the ex vivo challenge: reproductive infections and contraception

Conditions: HIV

Summary: the development of surrogates to predict hiv prevention product safety and efficacy is a high priority. an ex vivo challenge model is one such promising surrogate. colonic tissue exposed to rectally applied microbicides in vivo and then challenged with hiv in the lab showed significant reduction in hiv replication when compared to tissue exposed to placebo gel. currently, the ex vivo challenge model for ectocervical and vaginal tissue is under development at the dezzutti lab at the magee womens research institute in pittsburgh, pa. currently the reproductive infectious disease research group is conducting a study designed to answer important questions about the ex vivo challenge model:which hiv virus is the best to use in the laboratory and what is the best indicator of hiv infection. the proposed study delineated here will investigate the effect of bv, hsv and contraceptive use on the model . there will be two arms to the study; the first will investigate the impact of hsv and bv status and the second, contraceptive use. vaginal and cervical biopsies will be collected from participants for the ex vivo challenge model.


Eligibility criteria:
inclusion criteria: 1. age 18-45 2. hiv uninfected. note: if a woman participated in a recent research study and has an hiv test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. otherwise, the potential participant should undergo testing at the first study visit. 3. willing and able to give informed consent to take place in the study 4. willing to undergo a pelvic examination and genital biopsies and hiv and hsv testing 5. willing to provide contact information 6. agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit exclusion criteria: 1. menopausal 2. pregnant or within 90 days of last pregnancy 3. hysterectomy 4. use of a diaphragm, nuvaring or spermicide for contraception 5. reports a course of antibiotic therapy in the 14 days prior to enrollment 6. known history of platelet disorder or bleeding disorder 7. participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment 8. pelvic exam findings concerning for cervicitis including abnormal cervical discharge, erythema and edema 9. use of any spermicide or spermicide-lubricated condom within one week of enrollment. 10. use of any internal vaginal device or product with the exception of tampons within one week of enrollment 11. any other condition that in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: bv, hsv contraceptive ex vivo challenge model