Kornimate/medical-research-clean huggingface dataset:
a non-interventional study to investigate the current situation of asthma-copd overlap syndrome in patients over age 40 with persistent airflow limitation in china

Conditions: Asthma-COPD Overlap Syndrome

Summary: to investigate the distributions of the patients with acos, asthma and copd over age 40 with chronic airflow limitation in china.

sites must be tier 3 hospitals in china. investigators will mainly be determined according to the following criteria: * respiratory physicians working in the respiratory department of tier 3 hospitals * to include the expected number of patients in a maximum of 12 months, physicians should manage a reasonable number of asthma, copd or acos over age 40 with persistent airflow limitation (post-bd fev1/fvc\<0.7). * physicians should have patients' spirometric data available in the patient's medical files (post-bd fev1%pred and post-bd fev1/fvc). this nis will collect the data (e.g. medical record, patient or physician-reported data) from about 2000 consecutive outpatients with persistent airflow limitation(post-bd fev1/fvc\<0.7) in about 20 sites in china for one year. each site will recruit about 50-150 patients successively. the data will be collected under routine clinical practice. the treatments or examinations will be determined by their treating physicians. the data are expected to reflect the actual situation about acos. the study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, copd or acos with persistent airflow limitation（post-bd fev1/fvc\<0.7）in china from q4,2015 to q3,2016.

Eligibility criteria:
inclusion criteria: outpatients, age ≥ 40 years clinically diagnosed as asthma, copd/chronic bronchitis/emphysema or acos at least 12 months with persistent airflow limitation (post-bd fev1/fvc\<0.7) signed informed consent forms exclusion criteria: have been involved in other clinical trial within 3 months having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc with acute exacerbation inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator

Keywords: acos
image guided therapy in the treatment of gliomas

Conditions: Glioma

Summary: rationale: new imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain. purpose: this phase i/ii trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.

primary objectives: i. to correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas. secondary objectives: i. to determine the feasibility of defining the optimal target volume for radiation therapy using mr spectroscopy, diffusion, perfusion and functional imaging. ii. to monitor therapeutic responses following treatment using mr spectroscopy, diffusion imaging and perfusion study. iii. to monitor changes in neurocognitive functioning following image guided therapy. outline: patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (mri), diffusion-weighted mri, and perfusion-weighted mri. patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (imrt) 5 days a week for 6 weeks. after completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.

Eligibility criteria:
inclusion criteria: * histologically confirmed, newly diagnosed intracranial glioma * a diagnostic contrast enhanced ct/mri demonstrating the lesion prior to registration * karnofsky performance status \>= 60 * ability to undergo mr imaging with the use of gadolinium dye * patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative exclusion criteria: * inability to obtain histological proof of glioma * allergy to gadolinium contrast * any condition including metallic implants or cardiac pace makers that make the candidate ineligible for mr imaging * any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration * karnofsky performance status of =\< 50 * prior history of radiation therapy to the brain * pregnancy

Keywords: glioma biologic imaging magnetic resonance spectroscopy magnetic resonance imaging perfusion imaging diffusion imaging functional magnetic resonance imaging radiation therapy intensity modulated radiation therapy
comparison of azd6244 in combination with dacarbazine versus (vs) dacarbazine alone in braf mutation positive melanoma patients

Conditions: Melanoma

Summary: to assess the efficacy in terms of overall survival of azd6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with braf mutation positive advanced cutaneous or unknown primary melanoma


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of advanced (inoperable stage iii and stage iv) cutaneous or unknown primary melanoma * tumor sample confirmed as braf mutation positive exclusion criteria: * diagnosis of uveal or mucosal melanoma * any prior investigational therapy comprising inhibitors of ras, raf or mek * having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug

Keywords: braf mutation positive advanced melanoma advanced cutaneous melanoma unknown primary melanoma
effect of tranexamic acid based on pharmacokinetics in pediatric patients undergoing craniosynostosis surgery: randomized controlled trial

Conditions: Craniosynostosis Patients Undergoing Distraction Osteotomy

Summary: massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for distraction osteostomy under the diagnosis of craniosynostosis. 2. patients aged from 2 months to 6 years, either of whose patients had consented 3. asa class 1 or 2 exclusion criteria: 1. coagulopathy with either pt \> inr 1.5 or plt \< 50,000/dl 2. patients took any nsaids within 2 days, or aspirin within 14 days prior to surgery 3. history of convulsive seizure, epilepsy, any brain surgery 4. known drug allergic reaction to tranexamic acid

Keywords: tranexamic acid pharmacokinetics craniosynostosis
effect of pre-operative virtual visits on patients with head and neck cancer undergoing surgery

Conditions: Head and Neck Cancer

Summary: patients with head and neck cancer often undergo complex surgeries requiring significant care post-operatively. this presents considerable psychosocial challenges in addition to their need to physically recover from a large surgery. the study team will interview patients who have undergone virtual visits before their surgical procedures. the study aims to explore patients' experiences, satisfaction, and perceptions of virtual visits for informing and preparing them for surgery and their postoperative care needs. the study team will also analyze the effects of the virtual visits on financial costs and patient outcomes such as length of hospital stay, delayed discharges due to social issues, and whether the virtual visits identified any significant medical concerns, etc. the study team will compare these to a randomly selected cohort of patients who also underwent surgical resection and reconstruction for head and neck cancer that did not get pre-operative virtual visits.


Eligibility criteria:
inclusion criteria (pre-operative visit arm) * patients \> 18 years * underwent surgery for head and neck cancer with free flap reconstruction at the university of michigan * underwent a pre-operative virtual visit. inclusion criteria (no pre-operative visit arm) * patients \> 18 years * underwent surgery for head and neck cancer with free flap reconstruction at the university of michigan exclusion criteria (pre-operative visit arm) * patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the university of michigan. exclusion criteria (no pre-operative visit arm) * patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the university of michigan. * patient underwent a pre-operative virtual visit.
safety study for beta thalassemia subjects on ptg-300

Conditions: β-thalassemia; Ineffective Erythropoiesis

Summary: in this study will investigate long term safety and use of the ptg-300 in beta thalassemia patients.

the ptg-300-03 study will study beta thalassemia patients on ptg-300 for two years. the dose and dose frequency for each subject enrolling in the ptg-300-03 study will be based on the last dose and frequency received by the subject in the previous study ptg-300-02 and the subject's response at that dose. patients dose will be increased in a manner similar to that used on ptg-300-02 study. the maximum ptg-300 dose allowed is 80 mg/week.

Eligibility criteria:
inclusion criteria: * ntd and td β-thalassemia subjects who completed week 12 and week 16 respectively in study ptg-300-02. exclusion criteria: * subjects who discontinued prematurely from study 300-02 (before week 12 in ntd and week 16 in td).

Keywords: chronic anemia β-thalassemia
antiischemic effects of empagliflozin in diabetic patients with refractory angina

Conditions: Diabetes Mellitus

Summary: this study was aimed to evaluation of antiangial effect of a new fda drug approval on angina in diabetic patient with refractory angina

this was a prospective, double-blind, randomized pilot trial in which a total of 75 subjects were enrolled with t2dm and refractory angina, despite using conventional anti-anginal agents; and were randomly assigned to group a(empagliflozin group) or b(placebo group) by blinded envelopes method. the study was conducted in two tertiary centers in isfahan, iran. the protocol of the study was revised and approved by the institutional ethics committee of isfahan university of medical sciences; and each patient provided an informed consent before participating in the study. the primary aim of the trial was to examine the efficacy of empagliflozin versus placebo on angina frequency in subjects with t2dm, cad, and chronic stable angina who remain symptomatic, despite treatment with either one or two anti-anginal agents.the secondary outcome of this study was the evaluation of physical limitations, angina stability, treatment satisfaction, quality of life, and overall saq andeffects o empaglofolzine vs placebo on treadmill exercise duration, times to angina onset and to 1mm st segment depression and mean of heart rate recovery(hrr) prior to randomization and after 6 weeks of treatment at peak drug level.

Eligibility criteria:
inclusion criteria: 1- t2dm patients over 18 years of age with cad, who have had minimum 3-month refractory angina pectoris (ap) in spite of using full medical treatment , and were not suitable candidates for revascularization or cabg and reproducible angina, ischemic st-segment depression of at least 1 mm and limited exercise capacity on treadmill testing (3-9 minutes on a modified bruce protocol) while receiving full medical treatment . exclusion criteria: 1- new york heart association functional class iii to iv heart failure symptoms, 2- acute coronary syndrome in the past 2 months, 3-any coronary revascularization during the study period, 4- stroke or transient ischemic attack 5- hepatic or renal impairment, 6-prior treatment with empagliflozin 7- any relative or absolute contraindication to exercise test or specific condition that preclude accurate interpretation of the electrocardiogram(eg,left bundle branch block(lbbb),resting st depression more than 1 mm, pre-excitation or digoxin use). -

Keywords: diabetes mellitus-refractory angina-empagliflozine
fasting and nutritional therapy in patients with advanced metastatic prostate cancer

Conditions: Fasting; Prostatic Neoplasms

Summary: the aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with crpc or hormone-sensitive prostate cancer with high metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

prostate cancer is in germany with approximately 25% of all cancers the most common cancer among man. assumably there will be an increase in prostate cancer in the next few years because of demographic factors. the progressive metastatic prostate cancer often develops an androgen resistance. this so-called castration-resistant prostate cancer (crpc) is not responsive to androgen deprivation therapy. depending on symptoms and progression first-line chemotherapy - docetaxel and abiraterone are available. intermittent fasting as a form of caloric restriction has been studied most extensively experimentally in recent years. it showed consistent beneficial effects on relevant inflammatory and oncological pathways. in the field of preclinical oncology research groups have recently focused on intermittent fasting with chemotherapeutic treatment and promising experimental data have been published. in summary, the combination of fasting and chemotherapy was more effective in various cancer animal models than chemotherapy alone.

Eligibility criteria:
inclusion criteria: * diagnosis of crpc or hormone-sensitive prostate cancer with high metastatic load * cancer is treated to guidelines conventionally with chemotherapy or with a combination of hormone therapy and chemotherapy. exclusion criteria: * underweight (bmi \ 2 kg or \>5 kg in the last 1 or 3 months. * eating disorder * dementia * psychosis * terminal illness with a significant limitation of mobility and overall vitality * diabetes mellitus type 1 * renal insufficiency stage \> 2, gfr \<60mlmin / 1.73 m2

Keywords: fasting prostatic neoplasms complementary therapies urology
triamcinolone as adjunctive treatment to laser panretinal photocoagulation for proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

the current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. therefore this study is designed using both treatments in the same patient: intravitreal triamcinolone plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. these patients had their visual acuity measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography. patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye. for the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. patients whose condition does not improve may undergo new evaluation.

Eligibility criteria:
inclusion criteria: * type ii diabetes * symmetric proliferative diabetic retinopathy without high risk characteristics * informed consent signed exclusion criteria: * previous treatment for diabetic retinopathy * media opacities that may interfere with clinical, photographically or oct examinations * inability to understands the implications of the protocol * glaucoma or ocular hypertension * any other pathology that could cause retinal alterations * patients with any other situation that may interfere in study completion based in investigator´s opinion

Keywords: diabetes mellitus/ complications diabetic retinopathy triamcinolone laser coagulation tomography, optical coherence
genicular radiofrequency ablation efficacy in achieving total knee pain reduction trial

Conditions: Knee Arthroplasty, Total; Osteoarthritis; Radiologic Tibiofemoral Osteoarthritis

Summary: given the benefits of genicular nerve radiofrequency ablation (rfa) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (tka), this study is designed to determine the efficacy of preoperative genicular nerve rfa in improving acute and chronic postoperative pain as well as functional status in patients undergoing tka. patients will be randomized to one of two study arms: rfa group (genicular nerve thermal rfa) or control group (rfa needles placed in proper location without effective neurotomy).

total knee arthroplasty (tka) is a common and effective treatment for severe knee osteoarthritis. as the average age of the population increases in developed countries, the number of tkas performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. although tka is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. genicular nerve rfa has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. this study is designed to determine the efficacy of preoperative genicular nerve rfa in improving acute and chronic postoperative pain as well as functional status in patients undergoing tka.

Eligibility criteria:
inclusion criteria: * surgical candidate for total knee arthroplasty secondary to osteoarthritis * radiologic tibiofemoral osteoarthritis (kellgren-lawrence grade 2-4) exclusion criteria: * worst knee pain score on day of evaluation \<4/10 * already taking opioids \>100 mg/day of morphine equivalent dose * infectious etiology (over rfa insertion site or systemic) * workers compensation * history of adverse reaction to local anesthetic or contrast * history of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids * prior total knee arthroplasty * prior open knee surgery or ligament reconstruction * prior rfa of knee joint * connective tissue diseases affecting the knee * sciatic pain * pacemaker * pregnancy * severe medical disease * serious neurological disorders * serious psychiatric disorders * suicidal or homicidal ideation * bmi\>50

Keywords: radiofrequency ablation
mg induced changes from day 0 to day 28 on serum and urine bone metabolic parameters in 70 y old females (no 50).

Conditions: Unspecified Disorder of Bone Density and Structure

Summary: calcium and vitamin d substitution has for a long time been used to improve osteoporosis.the main storage place for magnesium is in the bone. magnesium is direct under calcium in the periodic system making it possible to interact with the crystal structure. some small studies have shown beneficial effects of magnesium substitution on osteoporosis. evidence has shown improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. it has been uncertain however, which of these factors can contribute to such a change. the effect of magnesium substitution 240 mg daily as therefore studied in two parallel groups where both received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the other received magnesium. this was studied on various expressions for bone metabolism after zero, seven and 28 days in elderly females aged 70 years old.

elderly 70 year old ladies who had been to an outpatient x-ray investigation were invited to participate in this study. they were all healthy without any signs of osteoporosis, or fractures.they were stimulated to participate by having done bone density measurements free. patients who had used biphosphonates, oestrogens, glucocorticoids , diuretics, immunomodulating agents, or prolonged use of heparin were excluded. patients with possible secondary osteoporosis due to primary hyperthyroidism or chronic lung disease were also excluded. the participants were randomized into placebo or mg-treatment groups. they were seen by the dietician, and blood and urine samples were taken at day 0, 7 and 28 at the same time these days. medicine was prepacked for intake twice daily. they received medicine for 30 days and should only take for 28 days. the number of tablets which should be left was controlled the last day. the participants were informed about the results of the bone density measurements taken the first and the last day. all the patient contacts were undertaken by the same dietician.

Eligibility criteria:
inclusion criteria: homeliving healthy female volunteers aged 70 years old were recruited by phone. exclusion criteria: persons who had used: * biphosphonates, * oestrogens, * glucocortocoids, * antiepileptic drugs, * diuretics, * immunmodulating agents, * prolonged usage of heparin. * patients with possible secondary osteoporosis and * diagnosis as: * inflammatory bowel disease, * primary hyperthyroidisms, * chronic obstructive lung disease

Keywords: calcium magnesium vitamin d bone turnover markers
dmt310-009 topical in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the objective is to evaluate the tolerability, safety, and efficacy of dmt310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris


Eligibility criteria:
inclusion criteria: * patient sex at birth, male or non-pregnant female at least 9 years of age * clinical diagnosis of moderate to severe acne vulgaris as determined by: investigator's global assessment (iga) at randomization; patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face * patient is willing to apply the investigational product as directed * patient is willing and able to comply with the protocol exclusion criteria: * patient is pregnant or planning to become pregnant * patient is taking a topical therapy on the face which may affect the patient's acne