Kornimate/medical-research-clean huggingface dataset:
cutaneous microcirculation and diabetic foot

Conditions: Diabetic Foot Proned Patients

Summary: 15% of diabetics have a diabetic foot (df) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without df. predicting the occurrence of an df is limited and only the occurrence of a diabetic wound up involved assessment and treatment. our team is behind the discovery of the pressure-induced vasodilation (piv) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. this gain in blood flow delays the onset of ischemia. however the involvement of piv in the df, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. the main objective of this study is to show that piv, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of df, taking into account the influence of age and neuropathy.


Eligibility criteria:
inclusion criteria: * adult men and women * presence of diabetes * signed acknowledgement form exclusion criteria: * no signed acknowledgement form * patients under 18 year-old
a trial comparing risperidone long-acting injection with oral antipsychotic in the treatment of early psychosis

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders

Summary: the purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (lai) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).

this is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder). duration of this study will be 24 months. study assessment visits will be conducted at screening, baseline, week 2, every 4 weeks till week 22, at week 28, every 12 weeks till week 88 and at week 104. all eligible participants will receive either risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or only their current oral medication. efficacy will be evaluated primarily by positive and negative syndromes scale (panss), time to relapse and social and occupational functioning assessment scale (sofas). participants's safety will be evaluated throughout the study mainly by abnormal involuntary movement scale (aims), barnes akathisia rating scale (bars), and simpson angus scale (sas).

Eligibility criteria:
inclusion criteria: * in-patients or out-patients * primary diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness * positive and negative syndrome scale (panss) score of 60-120 at visit 1 and 2 * currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive * able to complete self-assessments in either english or french exclusion criteria: * current primary axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to dsm-iv * current drug or alcohol dependence * treatment with a depot antipsychotic within 3 months of study start * confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone * risperidone non-responders (based on evidence of adequate trial of treatment)

Keywords: schizophrenia schizoaffective disorder schizophreniform disorder risperidone risperdal consta
impact of cmv status on hiv viral load decay

Conditions: Hiv

Summary: background: cytomegalovirus (cmv) infection is usually observed among patients with hiv infection. no study to date has investigated the impact of cmv infection on hiv viral load decay during antiretroviral therapy. methods: 345 consecutive hiv patients coinfected (n=300) or not (n=45) with cmv were enrolled. clinical, biological and virological data were collected from hiv antiretroviral therapy initiation to the day of hiv viral load undetectability if any.


Eligibility criteria:
inclusion criteria: * hiv patients starting an antiretroviral therapy * cmv serology available at antiretroviral therapy initiation * hiv viral load assessed at each follow-up visit after treatment initiation exclusion criteria: * hiv antiretroviral treatment initiation before june 2005
selective lymph node dissection using fluorescent dye in node-positive breast cancer

Conditions: Breast Neoplasms

Summary: in this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . by comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.

low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. the operator can track the lymphatic pathway without skin incision in real time. by these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. this is why we can identify the lymphatic metastasis pathway of breast cancer.

Eligibility criteria:
inclusion criteria: * operable breast cancer patient * preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection exclusion criteria: * breast cancer history * occult breast cancer * past history of axillary surgery * iodine hypersensitivity * pregnancy

Keywords: sentinel lymph node biopsy fluorescence breast neoplasms indocyanine green
postoperative adjuvant therapy for stage ii-iii gastric cancer

Conditions: Stage II-III Gastric Cancer

Summary: for patients with stage ii-iii gastric cancer after radical d2 resection and r0 resection, postoperative adjuvant therapy guided by ctdna-mrd (mrd-gate external cohort) was not inferior to the standard chemotherapy regimen (this cohort).


Eligibility criteria:
inclusion criteria: 1. patients who have undergone d2 gastrectomy, achieved r0 resection, and are pathologically diagnosed with stage ii-iii gastric cancer. 2. no preoperative neoadjuvant or adjuvant therapy received. 3. voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures. 4. age between 18-75 years, with no gender restrictions. 5. eastern cooperative oncology group (ecog) performance status of 0-1. 6. estimated survival of 6 months or more. 7. baseline hematological and biochemical parameters within specified limits: a. hemoglobin ≥ 80g/l. b. absolute neutrophil count ≥ 1.5×10\^9/l. c. platelet count ≥ 100×10\^9/l. d. aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. thyroid-stimulating hormone (tsh) ≤ 1 times the upper limit of normal (if abnormal, t3 and t4 levels must be normal). exclusion criteria: 1. pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline. 2. evidence of postoperative recurrence or metastasis. 3. previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy. 4. positive resection margins identified in postoperative pathology. 5. history of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer. 6. uncontrolled pleural effusion, pericardial effusion, or ascites. 7. severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ ii), uncontrolled arrhythmias, or myocardial infarction within the last 12 months. 8. uncontrolled infection, severe kidney disease, or other significant concurrent diseases. 9. allergic reactions to study drugs. 10. receipt of any anti-tumor therapy within 4 weeks prior to enrollment. 11. administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period. 12. positive hiv antibody, active hepatitis b or c (with specific viral load criteria). 13. positive for covid-19 nucleic acid or antigen test. 14. other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
how much is too much: assessing varying pressure pump pressures in post operative pain control in shoulder arthroscopy.

Conditions: Shoulder Arthroscopy

Summary: postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. an intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. one could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. unfortunately we could not find any literature in the english language regarding varying pressure pump settings on post operative pain control. for that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.


Eligibility criteria:
inclusion criteria: * patients attending st. joseph's hospital * shoulder pathology amenable to arthroscopic surgery * medically suitable for surgical management * able to consent for surgery. exclusion criteria: * unable to consent * active infection * active malignancy * drug or alcohol misuse * work related injury * lack of permanent home residence * previous surgery to affected shoulder * medical contraindiction to surgery * pregnant women
a study to evaluate the effectiveness of perampanel as only add-on treatment in participants with primary or secondarily generalized tonic-clonic seizures

Conditions: Seizures

Summary: the primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (pgtc) or secondarily generalized tonic-clonic (sgtc) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of epilepsy with pgtc or sgtc seizures based on focal or idiopathic generalized epilepsy 2. active epilepsy with gtc seizures, demonstrated by the occurrence of at least 1 gtc seizure within 3 months before inclusion 3. the decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study 4. receiving treatment with perampanel in line with the current fycompa (perampanel) smpc 5. perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (aed) monotherapy or must be planned to substitute one of two aeds of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. it will be specified which aed is planned to be substituted by perampanel upon inclusion. it is assumed that participants start treatment with perampanel closely after the baseline visit. retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. in this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated exclusion criteria: 1. participants with known psychogenic non-epileptic seizures 2. the participant had already received perampanel in the past 3. simultaneous participation in an interventional clinical study and/or taking an investigational drug

Keywords: e2007 perampanel fycompa primary generalized tonic-clonic seizures secondarily generalized tonic-clonic seizures
clinical pilates and aerobic exercise in patients with ankylosing spondylitis

Conditions: Exercise; Ankylosing Spondylitis

Summary: the aim of our study is to investigate the effect of clinical pilates exercises on functional status and quality of life when applied together with aerobic exercise in patients with ankylosing spondylitis (as).

according to the power analyzes 32 patients, who were diagnosed as ankylosing spondylitis, will be taken to the study. in the first session their spinal mobility, flexibility, dynamic and static balance, back and lower limb muscle strength, pulmonary functions and pulmonary muscle strength, disease activity level, fatigue level, functional exercise capacity will be assessed to determine functional status by a physiotherapist. also their quality of life and factors affecting the quality will be assessed. then the patients will be divided into two exercise groups randomly. patients in the first group will only do aerobic exercise, patients in the second group will do clinical pilates additional to the aerobic exercise which has the same protocol with the first group. patients will do the exercise for 8 weeks, 3 times a day individually with a physiotherapist . at the end of the 8 weeks they will be assessed with the same tests again.

Eligibility criteria:
inclusion criteria: - man and woman diagnosed with ankylosing spondylitis . exclusion criteria: * any neurological or muscle diseases * inability to continuously attend the exercise program * visual, hearing or mental problems that could prevent communication * using mobility aids * pregnancy * malignity * having a surgery recently * doing exercise regularly in last 3 months. * having a cardiopulmonary problem which is not under control.

Keywords: ankylosing spondylitis clinical pilates exercise aerobic exercise functional exercise capacity pulmonary function
hmg-coa reductase add-on in chronic kidney disease patients with proteinuria

Conditions: Chronic Kidney Disease; Proteinuria

Summary: this study is to evaluate the renal function of hmg-coa reductase add-on in chronic kidney disease patients with proteinuria.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 19 years 2. chronic kidney disease (ckd) with ckd stage g2 or g3 and 300 mg/g ≤ urine pcr ≤ 3000 mg/g 3. diagnosed with hypertension 4. written informed consent 5. patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization exclusion criteria: 1. type i diabetes 2. uncontrolled diabetic patients with hba1c \> 10% at screening 3. hypertensive patients whose mean blood pressure was not controlled at 160/90 mmhg or more in triplicate despite the use of antihypertensive agents at the time of randomization 4. calculated ldl-c ≥ 160 mg/dl at randomization 5. patients who have taken ras blockers (ace inhibitor, arb, and aldosterone antagonist) for 4 weeks prior to randomization 6. heart failure patients with nyha class iv 7. patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months 8. patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention) 9. patients taking immunosuppressive drugs 10. patients undergoing egfr \<30 ml/min/1.73 m2 (ckd-epi formula) or renal replacement therapy (dialysis or renal transplant) at screening 11. patients with a change in egfr (ckd-epi formula) value showing a difference of more than 30% in the last 6 months at screening 12. creatine kinase (ck) level ≥ 3x uln (upper limit of normal range) 13. patients who are pregnant or planning to become pregnant 14. contraindications stated in the spc of telmisartan or rosuvastatin 15. those participating in other clinical trials for investigational products at screening 16. patients deemed to be ineligible to participate in the trial by investigator
clinical study of utd1 injection in combination with capecitabine in patients with advanced and metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether utd1 injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.


Eligibility criteria:
inclusion criteria: 1. histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy; 2. patients who have previously treated with ≤4 chemotherapeutic regimes; 3. patients who have previously treated with an anthracyclin antibiotics and a taxane; 4. age 18 -70 years old, ecog performance status of 0-2; life expectancy of 3 months or more; 5. patients with at least 1 measurable target lesion determined by ct within 2 weeks prior to enrollment; 6. neuropathy \<ctc2 degree （nci ctc4.03）within 4 weeks prior to enrollment; 7. basically normal results from routine blood test within 1 week prior to enrollment; 8. basically normal liver and renal functions within 1 week prior to enrollment; 9. no abnormal function for major internal organs, no heart diseases. exclusion criteria: 1. received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial; 2. patients with documented hypersensitivity to cremophor el, or patients with previous taxane treatment related sae; 3. patients of pregnancy or breast feeding; 4. patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period; 5. patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment; 6. patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history; 7. patients with poor compliance; 8. patients not fitted for this study determined by the investigators.
perioperative pain management for cleft lip in children

Conditions: Perioperative Complication Pain

Summary: single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group c conventional group and 38 children group s infraorbital nerve block group.


Eligibility criteria:
inclusion criteria: * good physical condition. * age 6 months to 3 years. * scheduled to undergo operations for cleft lip repair. genders eligible for study are both . exclusion criteria: * children posted for combined procedures like congenital heart correction with palatoplasty . * parents refusal . * bleeding disorders( platelets count \ 1.5). * skin lesions or wounds at site of needle insertion . * co-morbidities as congenital heart disease , lung pathology or central nervous system * known hypersensitivity to local anesthetics or opioids .
a study of apatinib plus egfr-tki as first line treatment in patients with non-squamous nsclc harboring egfr mutations

Conditions: NSCLC

Summary: the purpose of this study is to evaluate the efficacy and safety of apatinib plus egfr-tki as first line treatment in patients with non-squamous nsclc harboring egfr mutation.


Eligibility criteria:
inclusion criteria: 1. age:18 to 75 years old (man or female); 2. pathologically diagnosed with non-squamous nsclc; 3. imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅲb - iv); 4. histologically or cytologic confirmed，harboring an activating egfr mutation (19del or 21 l858r); 5. none previous chemotherapy or targeted therapy.（note: neoadjuvant and adjuvant therapy is allowed）; 6. at least one measurable lesion (measuring≥10mm on spiral ct scan, satisfying the criteria in recist1.1)； 7. eastern cooperative oncology group (ecog) performance status of 0-2; 8. major organ function has to meet the following criteria: 1. hb≥90g/l； 2. anc≥1.5×109/l； 3. plt≥80×109/l； 4. alt and ast≤2.5uln, but≤5uln if the transferanse elevation is due to liver metastases; 5. tbil≤1.5uln; 6. serum creatinine≤1.25uln; endogenous creatinine clearance rate\>45 ml/min; 9. life expectancy greater than or equal to 3 months; 10. women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. exclusion criteria: 1. have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg); 2. patients who suffered from grade ii or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including qt interval male ≥ 450 ms, female ≥ 470 ms). grade iii-iv cardiac insufficiency according to new york heart association(nyha) criteria or echocardiography check: left ventricular ejection fraction (lvef)\<50%; 3. radiologically documented evidence of major blood vessel invasion or encasement by cancer; 4. a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 5. patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). has melena and hematemesis in two months; 6. coagulant function abnormality (inr \> 1.5 uln, aptt \> 1.5 uln), with bleeding tendency; 7. patients with pregnant or planning a pregnancy; 8. patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 9. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. less than 4 weeks from the last clinical trial; 11. the researchers think inappropriate.