Kornimate/medical-research-clean huggingface dataset:
ex vivo immunotherapy for hyperglycemia in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Hyperglycemia

Summary: diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. our hypotheses is that liver would be the primary organ responsible for the metabolic disorder because of some unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading to hyperglycemia. the constant hyperglycemia would keep pressure on beta-cells in the pancreas to eventually exhaust their ability to produce and secret sufficient amount of insulin, exacerbating the disease. the immunotherapy would enhance the liver functions and correct the abnormal sugar metabolism. in addition, the ex vivo activated cells produce and secret growth factors which would help endothelial cells of blood vessels to reproduce and grow, resulting in reduced arteriosclerosis.

we plan to recruit 20 patients with type 2 diabetes mellitus who suffer hyperglycemia with or without medication. the patients will come to our hospitals for the treatment. a small amount of peripheral blood will be drawn and processed and cultured in our laboratory. the cultured cells (autologous) will be infused intravenously back to patients. levels of plasma hemoglobin a1c (hba1c) and other metabolic parameters before and after the therapy will be compared. the therapy is planned to take four weeks for each patient.

Eligibility criteria:
inclusion criteria: * 1. patients diagnosed with type 2 diabetes mellitus. * 2. 25 years of age or older. both sexes. * 3. hba1c ≧6.5% for more than 6 months with or without medication. * 4. capability of providing informed consent. exclusion criteria: * 1. history of malignancy. * 2. patients with active infections. * 3. seropositivity for hiv infection. * 4. history of myocardial infarction or unstable angina in the previous 3 months. * 5. pregnancy or nursing.

Keywords: diabetes mellitus type 2 hyperglycemia immunotherapy autologous
essential acute stroke care in low resource settings: a pilot study

Conditions: Acute Stroke

Summary: an investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting

this is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). this will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.

Eligibility criteria:
inclusion criteria: * adults (age ≥18 years) * a clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset * provision of written informed consent * subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible. exclusion criteria: * patients who have undergone intravenous thrombolysis or mechanical thrombectomy * patients who are planned for transfer to the intensive care unit * subarachnoid haemorrhage * participation in an interventional medical investigation or clinical trial currently or within the past 3 months.

Keywords: stroke ischemic stroke hemorrhagic stroke stroke package
frequency of oral care intervention study

Conditions: Respiratory Failure

Summary: tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse as part of clinical care. the purpose of this study is to determine how often tooth brushing should occur for adult patients with breathing tubes (mechanical ventilation), balanced with equivalence and safety.

a total of 345 adult subjects who are intubated and require mechanical ventilation will be randomly assigned to one of the three different tooth brushing frequency groups: once a day, twice a day or three times a day, up to a maximum of seven days. teeth will be brushed with a soft child size toothbrush will take approximately 2 minutes. following tooth brushing, the mouth will be rinsed with alcohol-free mouthwash and oral fluids will be removed with an oral suction tip. moisturizing gel will be gently applied. the complete intervention requires approximately 15 minutes. information will be collected will include clinical condition, medications, age, gender, and smoking status. once every day, digital pictures will be taken of each tooth (takes approximately five minutes) using a small intraoral camera to be evaluated for plaque by a dental hygienist that is blinded to frequency group assignment. once every day, gingival crevicular fluid samples (takes 30 seconds) to look for factors that predict infection. gingival crevicular fluid samples and digital pictures of the teeth will also be collected on day 1, day 3 and day 5 after extubation.

Eligibility criteria:
inclusion criteria: * within 36 hours of initial intubation, * have at least one tooth, and * they or their legally authorized representative are able to provide informed consent in english or spanish. exclusion criteria: * anticipation by the clinical provider of imminent patient death, or * medical contraindication to tooth brushing.

Keywords: oral care
examining effects of tysabri on cognitive fatigue using fmri

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this research study is to investigate the effectiveness of tysabri on cognitive fatigue in persons with relapsing-remitting multiple sclerosis (rrms). cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

the researchers aim is to investigate the effects of tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with rrms. the researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility criteria:
inclusion criteria: * age between 18-64 * diagnosed with relapsing-remitting multiple sclerosis or a healthy volunteer * if diagnosed with ms: has been newly prescribed tysabri, but has not yet started taking the medication * can read and speak english fluently exclusion criteria: * history of head injury, stroke, seizures, or any other significant neurological event other than ms * flare up of ms symptoms within the past month * history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of major depressive disorder * pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments * left-handed. * not able to have an mri

Keywords: multiple sclerosis cognitive fatigue
ocp vs metformin for improvement in clinical symptoms and metabolic markers in indian pcos women

Conditions: Polycystic Ovary Syndrome

Summary: objective: to assess effectiveness of isd (insulin sensitizing drugs) vs ocp (combined e\&p cyproterone acetate) in improving clinical, hormonal and metabolic features of pcos( polycystic ovary syndrome)women from india. intervention: randomized to receive metformin 1500 mg / day or ocp (ee+ca) life style advice to women with bmi ( body mass index) more than 28 , in both groups (ps: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) study period: 6 months clinical evaluation points and tests at enrollment and again after 6 month. clinical: bmi, waist circumference, hip circumference, acne score, fg (modified ferriman gallwey score ) (after no epilation for last 6 weeks), menstrual history biochemical: thyroid function tests, prolactin,total testosterone, lipid profile, fasting blood sugar \& 75 gm 2 hr glucose tolerance test (gtt), sr insulin, 25- hydroxy vitamin d (optional), (only radioimmunoassay / chemiluminescence assays) acronyms: ocp(oral contraceptive pills); pcos (polycystic ovary syndrome); fbs(fasting blood sugar); gtt(glucose tolerance test)


Eligibility criteria:
inclusion criteria: * pcos women diagnosed by rotterdam criteria * age \> 16 or menarche of at least 2 yr upto age 40. * diagnosed by rotterdam anovulation f.g. score ≥ 8 or total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc bmi\>23 * women not attempting pregnancy at present. exclusion criteria: * pcos women with bmi ≤ 23 * undergoing any treatment for acne hirsutism. including homeopathic, ayurvedic * known diabetic or hypertension .

Keywords: pcos metformin ocp metabolic parameters
a study to evaluate the efficacy and safety of oral vt-1161 in patients with acute vaginal candidiasis (yeast infection)

Conditions: Candidiasis, Vulvovaginal

Summary: the purpose of this study is to determine if the novel oral agent vt-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). vt-1161 has been designed to inhibit cyp51, an enzyme essential for fungal growth. inhibition of cyp51 results in the accumulation of chemicals know to be toxic to the fungus. cyp51 is the molecular target of the class of drugs referred to as 'azole antifungals'. all currently approved azole drugs have poor selectivity for cyp51 and this results in many of the side effects associated with the azole antifungals. the safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. vt-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).


Eligibility criteria:
key inclusion criteria: * females ≥18 and \<65 years * clinical diagnosis of symptomatic acute vvc * positive koh .at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation). * at least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation) * a minimum composite vulvovaginal signs and symptoms score of ≥6 * must be be able to swallow capsules exclusion criteria: * evidence of major organ system disease * history of cervical cancer * history of diabetes mellitus * pregnant * recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason * recent use of drugs to treat vaginal infections * recent use of immunosuppressive therapies
impact of whole-body vibration on anthropometric measurement and body composition in overweight and obese university students

Conditions: Obesity; Overweight

Summary: obesity has become a significant public health concern globally, particularly among university students, where lifestyle changes contribute to increased body weight and fat accumulation. the world health organization defines obesity as a condition characterized by excessive fat accumulation that presents a risk to health, with a body mass index (bmi) of 30 or higher being a common threshold for classification. in saudi arabia, the prevalence of obesity among young adults is alarming, necessitating effective interventions to combat this issue.


Eligibility criteria:
inclusion criteria: * male and female university students with bmi ≥ 25, and their age between 18-25 years. exclusion criteria: * musculoskeletal, neurological and cardiovacular conditionds,in addition to pregnancy and insrtion of pacemekers or other metal implants.
a one visit follow up of adults with fabry disease who started long-term enzyme replacement therapy as children

Conditions: Quality of Life; Renal Insufficiency; Cardiac Event

Summary: the objective of this study is to obtain follow up data on a cohort of well-studied patients with fabry disease who have been on ert since childhood for a total of about 15 years.

the long-term effect of initiating ert in childhood is unknown. prospective studies of children with fabry disease on 0.2 mg/kg agalsidase alfa every other week were performed. the patients were 7-17 years of age at initial study enrollment. the first open-label protocol was tkt023, a 6 months study (august 12, 2002-october 20, 2004) that was followed by an extension study tkt029 (june 10, 2004-june 15, 2011; clinicaltrials.gov identifier nct00084084). since completing tkt029, all us patients were switched to commercial agalsidase beta. therefore, these patients have now been treated for about 15 years.this study involves a one-visit follow up on these patients using the same protocol-driven studies as were used in tkt029. the long-term follow up data gathered will consist of a rare description of the disease profile in patients who were treated with ert since childhood.

Eligibility criteria:
inclusion criteria: 1. patients who participated in tkt029 and who are willing and able to come to dallas for 1 visit for standard of care testing. 2. sign the protocol informed consent form 3. have been on continuous commercial ert since tkt029 has ended exclusion criteria: 1. patients who are unable to understand the nature, scope, and possible consequences of the study. 2. patient does not give his written informed consent to participate in this study 3. patient is unable to comply with the protocol, e.g., uncooperative with protocol schedule, refusal to agree to all of the study procedures. 4. patient has been off ert for an extended period of time as assessed by the investigator.
effect of ca2+ ionophore on embryonic development and clinical outcome in cases with previous fertilization arrest

Conditions: Fertilization Arrest

Summary: we aimed to investigate the efficiency of chemical oocyte activation using readymade ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages.

many studies reported that ca2+ ionophore has a positive effect on embryo development in cases with complete or partial fertilization failure. however, only one preliminary report suggested a beneficial effect of ca2+ ionophore activation in four cases with fertilization arrest.

Eligibility criteria:
inclusion criteria: * patients with previous history of complete fertilization arrest. * ovarian stimulation with the gnrh agonist and recombinant fsh in a long protocol. exclusion criteria: * female age \>40 years

Keywords: fertilization arrest cleavage failure embryonic development calcium ionophore
study of a α1a adrenoceptor selective antagonist silodosin to treat severe benign prostatic hyperplasia(bph)

Conditions: Benign Prostatic Hyperplasia

Summary: this clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * is at least 50 years old * has a urinary disturbance associated with severe bph and has a total ipss score 20 or higher * has a qol score of 3 or higher * has a urine volume of 120ml or greater and a qmax of below 15ml/sec * has a prv of below 100ml * voluntarily decides to participate in this trial and sign with informed consent form exclusion criteria: * has been administered silodosin * has been administered an α1a-adrenoceptor blocker within one month * has been prescribed antiandrogens except 5α-reductase inhibitors within a year * has had phytotherapy within 3 months * has had prostatectomy * has had intrapelvic radiation therapy * has had transurethral microwave hyperthermia of transurethral needle ablation * is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (uti). * is conducting self-catherterization * has a renal impairment with a serum creatinine of 2.0mg/dl or greater * has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has ast/alt 2.5 times higher than the normal (upper) level * has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months * has experienced allergy to α1 receptor blockers * has orthostatic hypotension around the time of screening visit * has participated in other clinical trials within 8 weeks prior to screening visit * has a prostate specific antigen(psa) of higher 10ng/ml or has been diagnosed with tumor identified by a biopsy even though he has a psa of lower 10ng/ml (patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual psa levels) * has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.

Keywords: strong silodosin benign prostatic hyperplasia bph lower urinary tract symptoms associated with severe bph
comparison of everolimus- and biolimus-eluting stents with everolimus-eluting bioresorbable vascular scaffold stents

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents. the null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and tvr at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.


Eligibility criteria:
inclusion criteria: * elective pci * ability and willingness to provide written informed consent exclusion criteria: * st-elevation myocardial infarction in the previous 48 hours * moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and \<30ml/min respectively) * known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Keywords: percutaneous coronary intervention bioresorbable vascular scaffold stents everolimus biolimus
haic of folfox vs. haic of oxa for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) of oxaliplatin plus fluorouracil/leucovorin compared with haic of oxaliplatin alone in patients with hepatocellular carcinoma (hcc) with major portal venous tumor thrombus (pvtt).

sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (hcc) patients with portal venous tumor thrombus (pvtt). our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (haic) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to hcc with major pvtt. however, haic of fluorouracil is not such for advanced hcc. whether haic of oxaliplatin is as effective as haic of oxaliplatin plus fluorouracil/leucovorin is controversial. thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility criteria:
inclusion criteria: the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * diagnosed with major or main portal vein invasion (vp3 or vp4) * kps≥70； * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/µl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * serious non-healing wound, ulcer, or bone fracture * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic arterial infusion chemotherapy sorafenib oxaliplatin plus fluorouracil/leucovorin oxaliplatin