Kornimate/medical-research-clean huggingface dataset:
effects of lgi steam bread on glycemia control in t2dm in china

Conditions: Diabete Type 2

Summary: this was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. to investigate the effects of low glycemic index（lgi）related steam bread on glycemic control，islet function in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age ≥18yrs； * diagnosed as type 2 diabetes; * had been on a stable hypoglycemic regimen for at least 30 days prior to screening； * hba1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening; * fasting c-peptide ≥1.0ng/ml in the 90 days prior to screening; * be willing to accept and adhere to lgi steamed bread as a staple food for at least 14 days exclusion criteria: * diagnosed with type 1 diabetes, or secondary diabetes; * have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease; * has unstable cv disorders, including heart failure (nyha) class iii or iv), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmhg, or diastolic blood pressure ≥105mmhg); * an acute coronary syndrome event (acs) occurred within the 6 months prior to randomization
the safety and effectiveness of zidovudine plus acyclovir in patients with early hiv infection

Conditions: HIV Infections

Summary: this double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral retrovir / zovirax (azt and acv) therapy and oral azt therapy alone, in the treatment of early symptomatic hiv infection. efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic hiv infection. the effects of the combination and single azt therapy on immune function and viral replication will also be evaluated. study participants will be monitored for evidence of toxicity or intolerance to concurrent azt / acv administration and azt therapy alone.


Eligibility criteria:
inclusion criteria patients must have: * early aids related complex (arc). * willingness to be followed by the original study center for the duration of the trial (96 weeks). * ability to give informed consent. * patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas). exclusion criteria co-existing condition: patients with the following are excluded: * concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. * fever \> 102 degrees f persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry. * severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss). concurrent medication: excluded: * acyclovir (acv) therapy for chronic or recurrent herpes simplex. patients with an aids-defining indicator disease as outlined by the cdc surveillance definition for aids which includes opportunistic infections or neoplasms, hiv neurologic disease, aids dementia or the "wasting syndrome" are excluded. prior medication: excluded within 4 weeks of study entry: * any other experimental therapy. * drugs which cause significant bone marrow suppression. * rifampin or rifampin derivatives. * cytolytic chemotherapy. * drugs which cause significant nephrotoxicity or hepatotoxicity. * immunomodulating agents, including steroids, interferon, isoprinosine, immunoglobulin or interleukin 2. * excluded within 8 weeks of study entry: * antiretroviral agents.

Keywords: aids-related opportunistic infections drug therapy, combination acyclovir aids-related complex zidovudine
installation of non-invasive ventilation at home using telemedicine : a pilot study on feasibility and impact on ventilation compliance

Conditions: Neuromuscular Diseases; Kyphoscoliosis; Non Invasive Ventilation

Summary: neuromuscular diseases are frequently associated with respiratory failure, which requires non invasive ventilation (niv). currently, the niv installation is done during an hospitalization of several days. this hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment. for this reasons, the niv installation at home could be an interesting alternative for both the patient and the medical staff. the aim of this pilot study is to test the feasibility of niv installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.

for the study protocol, patients will be hospitalized for the first day to define the ventilation mode and initial parameters, and to choose the best adapted interface. then, the patient is discharged from hospital and parameters adaptation is continued at home during the following five days by the hospital medical staff, using telemedicine. an asv santé employee visits the patient at home everyday during 5 days to ensure follow-up.

Eligibility criteria:
inclusion criteria: * man or women aged over 18 years * neuromuscular disease or kyphoscoliosis * at least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia * at least one sign among : hypercapnia \> 45 mmhg, desaturation time \ 5 min, vital capacity \< 60% or pimax \< 60 cm h2o. exclusion criteria: * mechanic ventilation refusal * patient living alone * acute respiratory failure * patient who need a third party for the ventilation installation * severe respiratory limitation * home oxygen
a trial to evaluate the long term safety and tolerability of lacosamide taken as monotherapy in adults with partial-onset seizures

Conditions: Epilepsy; Partial-onset Seizures

Summary: this study is to evaluate the long-term safety and tolerability of lacosamide (lcm) 200 mg/day to lcm 600 mg/day taken in monotherapy in japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single anti-epileptic drug (aed) with marketing approval in japan.


Eligibility criteria:
inclusion criteria: * subject is male or female and ≥16 years of age * subject has a diagnosis of epilepsy, having experienced unprovoked partial-onset seizures (ia, ib, or ic with clear focal origin) that are classifiable according to the international league against epilepsy (ilae) classification of epileptic seizures, 1981 * subject experiences partial-onset seizures despite appropriately chosen and adequately tried treatment with 1 antiepileptic drug (aed) * subject has been treated for epilepsy with a stable dose of 1 marketed aed the use of benzodiazepines is permitted as rescue therapy for epilepsy. benzodiazepines may have been used as needed but not more frequently than once per week. exclusion criteria: * subject has a history or presence of seizures of other types than partial onset (ia, ib, or ic with clear focal origin) * subject is taking benzodiazepines for a nonepilepsy indication (exception: concomitant use of benzodiazepines is allowed if the subject is taking them on a regular basis, has been on a stable dose for at least 1 month prior to visit 1, and does not require changes in the dosage and administration throughout the study period. however, concomitant use of benzodiazepines on an as needed basis is not permitted.) * female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception, unless sexually abstinent, for the duration of the study * female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (ei-aeds: cbz, phenytoin, barbiturates, primidone, topiramate) who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception according to the world health organization (who) recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of ei-aeds or does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study * subject has sick sinus syndrome without a pacemaker, or a second or third degree atrioventricular (av) block, or subject has any other clinically relevant electrocardiogram (ecg) abnormalities * subject has a history of convulsive status epilepticus within the last 12 months prior to visit 1

Keywords: lacosamide epilepsy focal, partial-onset seizures with or without secondary generalization monotherapy
endovascular thrombectomy in covid-19 infected patients

Conditions: Ischemic Stroke; Covid 19

Summary: about 5% of covid-19 patients may present symptoms related to acute ischemic stroke (ais). treatment-management and outcomes related to mechanical thrombectomy (mt) for covid-19 infected patients harboring large vessel occlusion is largely unknown. this multicentric study aims to investigate morbidity, mortality and neurological outcomes after mt performed in patients with covid-19 infection.

since the identification of the first case of severe acute respiratory syndrome (sars) cov-2 infection in december 2019 in wuhan, china, the global number of confirmed covid-19 cases is roughly 5 000 000, with 216 involved countries. increasing evidence shows that sars-cov-2 may be associated with neurological manifestations, with up to 36% of patients showing neurological symptoms related to the neurovirulence of the sars-cov-2. it has been reported that roughly 5% of covid-19 infected patients may present acute ischemic stroke (ais), and these patients may have an unfavorable clinical evolution due to the systemic involvement of the infective disease. in addition, these patients are quite young: the mean age of covid-19 patients having ais is lower (56 years), compared to general population of ais patients (mean age=73 years). moreover, most of these patients require an intensive care units (icu) management. stroke mechanisms may be multiple and can include hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury, and severe inflammation. indeed, the dysfunction of endothelial cells induced by infection may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in severe covid-19 patients can be a trigger for thrombosis, increasing blood viscosity, and inducing hypoxia-inducible transcription factors. outcomes related to the treatment of covid-19 patients harboring large vessel occlusion and requiring mt is substantially unknown, but it is likely that the combined morbidity and mortality rate of the two pathologies is high. accordingly, patient's selection, treatment-management, and results should be urgently elucidated. involving 4 different countries (france, italy, spain, and us), this multicentric cohort study aims to analyze the largest possible number of covid-19 infected patients treated with mt for ais, with the intention to provide treatment-results and neurological outcomes, elucidating the best patient-selection and treatment-management.

Eligibility criteria:
inclusion criteria: - patients \>18 years infected with the sarr-cov-2 with acute ischemic stroke, and eligible for mechanical thrombectomy (based on the current guide-lines) exclusion criteria: - patients \<18 years ; no eligibility to mechanical thrombectomy ; absence of diagnosis of covid-19

Keywords: acute ischemic stroke related to large vessel occlusion mechanical trombectomy covid-19 sars-cov-2
physical therapy following total hip arthroplasty

Conditions: Hip Osteoarthritis; Surgery

Summary: 130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. one group received standard of care clinic-based physical therapy postoperatively (clinic pt) while the other group underwent progressive home-based exercises to do after surgery (home pt). patient surveys with hip osteoarthritis outcome scores (hoos) and sf12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. patients had the option to crossover into the other study group at their 6-week follow-up visit.


Eligibility criteria:
inclusion criteria: * scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the principal investigator * available for follow ups postoperatively exclusion criteria: * age \ 75 * preoperative bmi ≥ 40 * revision (i.e., non-primary) tha procedures * patients who have undergone tha in contralateral hip within the past 6 months * patient is scheduled for or anticipating tha on contralateral limb within 6 months * patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication) * current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation * cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting * history of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint * history of significant neurological and/or musculoskeletal disorders that may adversely affect gait after tha * history of inflammatory hip arthritis * history of septic hip arthritis in affected hip * patients requiring discharge to a rehabilitation center, skilled nursing facility, long-term care center, or convalescent home * non-english speaking * unable to give informed consent * currently enrolled in another therapeutic study for tha

Keywords: total hip arthroplasty physical therapy
turkish validation study of endometriosis health profile -30 (ehp-30) test

Conditions: Endometriosis

Summary: for the turkish validation study of the endometriosis health profile test (ehp-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.

the appointment of the patients consists of patients who were surgically diagnosed with endometriosis in our clinic. english and turkish translation will be verified after 2 different sworn translators.

Eligibility criteria:
inclusion criteria: * being surgically diagnosed with endometriosis * age between 18- 45 * not being pregnant exclusion criteria: * have been diagnosed with endometriosis by ultrasound * above 45 and under 18 years old * use psichiatrig drugs * being diagnosed with a psychiatric illness
postoperative pain management after total knee arthroplasty

Conditions: Postoperative Pain; Knee Arthroplasty

Summary: the study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after total knee arthroplasty in patients suffering from osteoarthritis

prospective, randomized, controlled study. approval of the study from the university hospital of patras ethics committee. the total knee arthroplasty procedure is performed always from the same team of orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. the same team of anesthesiologists (two anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia. preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg parecoxib (iv), 1gr paracetamol (iv), 150mg pregabalin (po), 8mg dexamethasone (iv) και 50mg ranitidine (iv). all patients receive subarachnoid anesthesia with ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height. three groups 1. continuous epidural infusion (control group) with ropivacaine 0.2% + clonidine 150μg. 2. continuous femoral nerve blockade infusion with ropivacaine 0.2% + clonidine 150μg. 3. continuous intraarticular infusion with ropivacaine 0.2% + clonidine 150μg. all the catheters remain for 48 hours while the infusion rate is 2ml/h + pca with 0,5ml/15min and lock-out maximum dose 4/h in total volume of 150ml. postoperatively all patients also receive; parecoxib, paracetamol, pregabalin, and ranitidine up to the third postoperative day (doses titrated). rescue analgesia: tramadol chloride 50-100mg x 2 /24h depending on patient's age and medical history.

Eligibility criteria:
inclusion criteria: 1. patients scheduled for unilateral total knee arthroplasty (tka) to treat knee osteoarthritis (oa) 2. fully conversant in the greek language 3. written informed consent to participate in the trial exclusion criteria: 1. age less than 50 years and greater than 85 years. 2. asa score \>iii 3. pregnancy 4. subarachnoid anesthesia failure 5. hypersensitivity/ allergy to certain agent used 6. participation in other research/ study 7. severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)

Keywords: epidural analgesia intra-articular infusion analgesia; femoral nerve block total knee arthroplasty
acute effects of a heat-not-burn tobacco product on pulmonary function

Conditions: Heated Tobacco; Respiratory Function; Tobacco Toxicity

Summary: background: iqos ("i-quit-ordinary-smoking,") is a type of the growing class of "heat-not-burn" (hnb) tobacco products. the effect of the acute exposure to iqos smoke on the pulmonary function of healthy smokers has not been studied extensively. objectives: evaluation of the acute effects of iqos on pulmonary function. methods: healthy non symptomatic smokers, underwent exhaled co measurement, spirometry including flows, volumes and diffusion capacity, and measurement of their respiratory resistances at 5, 10 and 20 hz (r5hz, r10hz and r20hz) with the use of an impulse oscillometry system (ios) before and 15 min after the use of an iqos.

all participants underwent pulmonary function tests (pft) (masterscreen pft, jaeger, wurzburg, germany) and total respiratory resistances measurement with an impulse oscillometry system (ios)( (viasys jaeger masterscreen ios system).from the basic pulmonary measurements (flows and dynamic lung volumes), forced expiratory volume in 1 second (fev1), forced vital capacity (fvc), tiffenau index (fev1/fvc, fev1%), peak expiratory flow (pef), maximal expiratory flow (mef) at 25%, 50%, and 75% of vital capacity, functional residual capacity (frc), total lung capacity (tlc), residual volume (rv), diffusion capacity (dlco) were measured. each manoeuvre was repeated for at least three technically acceptable forced expiratory flow curves in order to attain the best results. respiratory impedance at 5 hz (z5hz) and respiratory resistance at 5, 10, and 20 hz (r5hz, r10hz, and r20hz, respectively), reactance at 5, 10, and 20 hz and resonant frequency were assessed with ios. after smoking heated tobacco (iqos): 5 minutes after smoking iqos , they repeated again pfts and ios measurements.

Eligibility criteria:
inclusion criteria: 1. healthy smokers, 2. \>10 pack/years 3. receiving no medications 4. no co morbidity exclusion criteria: 1. aged \<18 years 2. pregnant 3. receiving any medications 4. any co morbidity

Keywords: pulmonary function iqos heated tobacco
acupuncture for obesity on serum metabolic parameters

Conditions: Obesity

Summary: this research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.

it is consisted with two sub research. first, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. the effect on serum metabolic parameters will be assessed at 0 and 6 weeks. second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.

Eligibility criteria:
inclusion criteria: * volunteers through announcements and advertisements * premenopausal adult women (19 years of age or more) * clinical diagnosis of obesity (body mass index: 25 kg/m2 or more) exclusion criteria: * previously or currently having endocrine disease such as hypothyroidism or cushing's syndrome, heart disease, lung disease, diabetes, malignant tumor, cholelithiasis, severe kidney impairment, severe liver impairment, anorexia nervosa or hyperorexia * experience of taking medicines which might affect body weight and the concentration of serum metabolic parameters such as anorectic, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medicines affecting absorption, metabolism, and excretion in the past 3 months * experience of taking beta-blocker or diuretic for the treatment of hypertension in the past 3 months * surgical treatment for the treatment of obesity * currently or might be pregnant or breast-feeding * experience of taking other experimental medicines in the past month * weight loss of 10% or more of previous body weight in the past 6 months * who stopped smoking in the past 3 months or who have irregular smoking habit * pacemaker * currently receiving any treatment for obesity * other inadequate subjects assessed by the study investigators

Keywords: acupuncture obesity metabolomics
multi-channel gastric electrical stimulation for the treatment of gastroparesis

Conditions: Gastric Stasis

Summary: investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a gi complication in diabetic patients. external gastric pacemaker system will be placed at the same time of implantation of enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.

Eligibility criteria:
inclusion criteria: * severe nausea and vomiting for at least 6 months * documented delayed gastric emptying * failed extensive medical treatment exclusion criteria: * previous gastric surgery * pregnancy or planned pregnancy * primary eating or swallowing disorders * scheduled or planned mri testing