Kornimate/medical-research-clean huggingface dataset:
lactate increase in peripheral artery disease

Conditions: Peripheral Artery Disease; Claudication, Intermittent

Summary: to our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. the determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. we use it in routine to evaluate the presence of functional limitation during tcpo2 tests on a treadmill. the present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpo2 "decrease from rest of oxygen pressure (drop) values for patients with peripheral artery disease (pad).

lactates sample (100 microliter) will be collected at rest ankle brachial index is measured at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the drop index (limb changes minus chest changes) patients walk on treadmill (2mph 10% slope) until exertional limb pain. lactates sample (100 microliter) will be collected at minute 3 of recovery from walking correlation of lactate increase to the sum of drop values wil be studied

Eligibility criteria:
inclusion criteria: * age \> 18 years old * patient able to walk on a treadmill * patient covered by the french health insurance * patient able to understand the protocol * patient agrees to be involve in the protocol and sign the consent form exclusion criteria: * patient refuses to participate at the this protocol * patient has a wash-out period for another clinical trial
impact and evaluation of the management of iron deficiency with or without anemia in patients with cancer

Conditions: Iron Deficiency Anemia

Summary: in oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams. in oncology, anemia is induced by multiple causes. iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. iron deficiency is characterized by a low level of iron . iron is a trace element required for life. it is a major component of hemoglobin allowing the transport of oxygen in red blood cells. there are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. since end of january 2014, intravenous iron-based injections have been reclassified for cancer patients at ico paul papin. the monitoring of iron deficiency with or without anemia is currently done in our institute, the ico-paul papin. there is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. this observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

the study is for patients with iron deficiency and / or anemia during treatment for cancer these patients will receive ferinject. patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months. patients will be followed for 6 months in the study

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with cancer regardless of the location * patient with specific treatment (chemotherapy +/- targeted therapy and / or radiotherapy, hormone therapy or surgery) * patient with functional iron deficiency or absolute with or without anemia * having given written informed consent prior to any procedure related to the study. exclusion criteria: * patient in a palliative situation not receiving specific treatment for their cancer * patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations * patient with myeloproliferative disease * contraindication to treatments for iron deficiency and / or anemia * pregnant woman, parturient or nursing mothers * patient has no valid health insurance * disorder precluding understanding of trial information or informed consent

Keywords: treatment related cancer,iron deficiency
impact of periodontal bacteria at baseline on the effectiveness of periodontal therapy

Conditions: Periodontitis

Summary: in light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either srp in addition to full mouth scaling or quadrant scaling

this trial was conducted in accordance with the world medical association's declaration of helsinki of 1975, and reviewed in 2008. the local ethical committee of the university of messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 102 patients, , aged 27 to 65 (mean age 44.2) were assessed for eligibility. in all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility criteria:
inclusion criteria: 1. good condition of general health, 2. a minimum of 2 teeth for each quadrant with a pocket depth (pd) ranging from 4-6 mm, 3. no involvement of the furcation, 4. a minimum of a six teeth per quadrant, respectively. exclusion criteria: 1. periodontal therapy during the last 12 months, 2. assumption of antibiotics during the last 6 months, 3. pregnancy, 4. any systemic condition which might affect the effects of the study treatment, 5. previous or current radiation or immunosuppressive therapies, 6. use of mouthwash containing antimicrobials during the previous 3 months, 7. no use of hormonal contraceptives, 8. medication by anti-inflammatory and immunosuppressive drugs, 9. previous history of hard-drinking, 10. smoking, 11. class ii and iii tooth mobility.
the hf-pol study - multicenter study of polish patients with hf and lvef >40%

Conditions: Heart Failure

Summary: hf-pol is the first polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40% designed by heart failure association of the polish cardiac society. the purpose of this study was to provide first characteristics of polish population patients with heart failure and ef\>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up.

hf-pol is the first polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40%. hf-pol study is conducted by the heart failure association of the polish cardiac society in cooperation with the committee for clinical initiatives of the executive board as part of the scientific platform initiative. the leading center of the study is the military medical academy memorial teaching hospital of the medical university of lodz, poland. the primary investigator is malgorzata lelonek; the steering committee includes malgorzata lelonek, mariusz gasior, and marcin grabowski. the study was approved by the bioethics committee at the medical university of lodz (no. rnn/240/21/ke; october 21, 2021). the purpose of this study was to provide first characteristics of polish population patients with heart failure and ef\>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up. patients have been recruited at each participating center since that center's activation on the ecrf.biz platform (a clinical data management system, https://rejestr.gbbsoft.pl/hf-pol). we collected data included demographics, medical history, concomitant medications, selected laboratory, electrocardiographic and echocardiographic results as well ascomorbidities. patients are diagnosed and treated according to the current clinical practice guidelines and the standard of care at participating centers. all consecutive patients meeting the inclusion and exclusion criteria are being enrolled. heart failure should be recognized according to the 2021 esc guidelines. the study allows recruitment based on results from medical records, especially for outpatients with a history of heart failure. the study population includes patients with heart failure and lvef \>40%. in total, a minimum of 1000 patients from 14 polish centers will be enrolled. patients will stay in 3-year follow-up.

Eligibility criteria:
inclusion criteria: * age \>18 years * documented ef \>40% * symptomatic chronic heart failure or acute heart failure (worsening of chronic heart failure or heart failure de novo) requiring hospitalization and intravenous agents exclusion criteria: * age \<18 years * dyspnea due to other causes than heart failure.

Keywords: heart failure with preserved ejection fraction heart failure with mildly reduced ejection fraction
biomarkers of early chronic obstructive pulmonary disease (copd) in smokers - longitudinal study

Conditions: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Lung Cancer

Summary: this is a longitudinal observational study to identify and validate protein biomarkers for copd (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. special emphasize is to correlate biomarkers to different phases of copd, to progression of the disease, and to treatment of the disease. furthermore, linkage between copd, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.


Eligibility criteria:
inclusion criteria: diagnosed with copd gold stage 0-iv exclusion criteria: patients with inflammatory diseases patients with cancer patients using immune system regulating drugs

Keywords: copd primary care smoking smokers ex-smokers lung cancer cardiovascular disease proteomics biomarkers biobank disease staging gold stage
s1 plus docetaxel versus capecitabine plus docetaxel first-line treatment in patients with advanced breast cancer

Conditions: Breast Cancer Recurrent

Summary: to compare the progression free survival(pfs) and safety of ts-s vs. tx-x in patients with advanced breast cancer first-line treatment

to compare progression free survival (pfs) of the s-1 combined with docetaxel followed by maintenance treatment with s-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.

Eligibility criteria:
inclusion criteria: * 18 ≤ age ≤ 75; * ecog 0-2, the expected survival time more than 3 months; * histologically or cytologically proven locally advanced or advanced her-2 negative breast cancer; * no chemical treatment after cancer recurrence; * at least one measurable disease ( as per recist1.1); * adequate bone marrow functions (anc ≥1.5×109 /l, plt ≥100×109 /l, hb ≥90 g/l); * adequate renal functions(serum creatinine ≤ 1.5 uln; creatinine clearance≥50 ml/min); * liver functions (serum bilirubin ≤ 1.5uln, ast/alt ≤ 2.5 uln); * written informed consent; * pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception. exclusion criteria: * previously chemotherapy with cytotoxic drugs * pregnant, lactating women did not take effective contraceptive measures * adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-fu-based chemotherapy or paclitaxel -based chemotherapy within 1 year after recurrence; * her-2 positive or unknown * other trails before 4weeks * affection of the absorption of drugs(unable to swallow、after gastrectomy、chronic diarrhea and intestinal obstruction * organs with rapid progression of invasion(liver and lung lesions more than 1/2 organ area or hepatic insufficiency) * central nervous system disorders or mental disorders * for docetaxel or fluorouracil or twain 80 had serious adverse reactions or allergy to 5-fu * severe upper gastrointestinal ulcer or absorption dysfunction syndrome * abnormal blood routine (anc \<1.5×109 /l, plt \<100×109 /l, hb \<90 g/l); * renal functions(serum creatinine \> 1.5 uln); * liver functions (serum bilirubin \> 1.5uln * brain metastases out of control * other unapplicable

Keywords: advanced breast cancer,first treatment, s1, capecitabine
the role of melatonin in the effective attainment of sleep electroencephalograms (eeg) in children

Conditions: Epilepsy; Electroencephalogram; Children; Sedation

Summary: this study aims to determine the safety and effectiveness of oral melatonin as natural inducer of sleep to acquire useful eegs in south african children following its introduction as the main agent used in the neurophysiology department at red cross children's hospital. this is an observational retrospective study.


Eligibility criteria:
inclusion criteria: * all children who were referred to the neurophysiology department who were either unable to keep still for their eeg, or required a sleep eeg as part of their epilepsy "work-up" and whose caregivers agreed to the administering of sedation with melatonin. exclusion criteria: * those children undergoing prolonged eeg monitoring (telemetry) or within 24 hours of status epilepticus (prolonged or cluster of seizures). * those children are not sedated as natural sleep is always attained with the prolonged monitoring studies, and for those with status epilepticus, there is usually evidence on the eeg of alteration secondary to the effects of status, and the medications administered to control the presenting event. * any child deemed to unwell to undergo a non-emergency procedure. * any child already receiving anticoagulant medications. * any caregiver who deferred sedation for their child was also excluded from the study and in the unit the procedure attempted without sedation.

Keywords: epilepsy electroencephalogram children sedation
vaginal changes and sexual function in patients with cervical cancer

Conditions: Cervical Cancer; Sexuality and Reproductive Issues

Summary: rationale: vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer. purpose: clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.

objectives: * obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage ib2 cervical cancer. * compare these differences between the patients in the two treatment groups in gog-0201. * determine the relationships between vaginal dilation activities and vaginal length changes in these patients. * determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer. * assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients. outline: vaginal length is measured using vaginal sound, a modified plastic vaginal dilator. the data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months. patients are followed every 3 months for 2 years. projected accrual: approximately 150 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * entered and treated on gog-0201 or eligible for and treated on either arm of gog-0201 * may have refused entry on gog-0201 as long as treatment is prescribed according to one or the other arm patient characteristics: age * under 70 performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: sexuality and reproductive issues stage ib cervical cancer
impact of tear substitute use on dry eye in gamers.

Conditions: Evaporative Dry Eye

Summary: clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (hyabak) versus no intervention.

adult attendees to a gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. participants will be randomized into 2 groups of equal size: 1. study group. 2. control group. the study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.

Eligibility criteria:
inclusion criteria: * 18 years or older * participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days. * voluntarily accept to participate and sign informed consent form exclusion criteria: * ocular, nasolagrimal or palpebral active condition different from dry eye disease. * history of ocular trauma or infecction in the last 3 months previous to inclusion. * history of refractive surgery. * visual acuity 0.5 or less in at least 1 eye. * ocular medication use in the 3 days prior to inclusion. * history of systemic condition asociated to dry eye. * use of systemic medication known to induce dry eye in the last 30 days. * known allergy to hyaluronic acid. * pregnant or lactating women.
lymph node metastases and arterial ligation in rectal cancer surgery

Conditions: Lymph Node Metastases

Summary: lymph node status is of major prognostic importance in non-metastatic rectal cancer. for oncological reasons, central arterial ligation of the inferior mesenteric artery (ima) is suggested. however, there is no conclusive evidence presented for this procedure. this study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.

prospective population-based study of specimens from patients that underwent surgical resection for rectal cancer in västmanland county, sweden. specimens were divided in 3 sections (a-c) and the total amount of lymph nodes and the location of lymph node metastases were analysed. multivariate analysis was used to explore the relationship between lymph node counts and age, gender, bmi, preoperative oncological treatment, type of surgery, tumour stage, vessel and specimen length.

Eligibility criteria:
inclusion criteria: * all patients that were curatively operated for rectal cancer in västmanlands county 2012-2016. exclusion criteria: * patients that were not operated or had another type of cancer.

Keywords: rectal cancer
a study of different doses of tbc3711 in patients with uncontrolled high blood pressure already taking medications for high blood pressure.

Conditions: Resistant Hypertension

Summary: the study was to determine the safe and effective dose of tbc3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

the study was stopped due to pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 august 2008. this decision was not based on any safety or efficacy concern.

Eligibility criteria:
inclusion criteria: * diagnosis of resistant hypertension. * a stable anti-hypertensive drug regimen for at least 30 days. exclusion criteria: * sustained blood pressure greater than or equal to 180/120 mmhg. * required use of thigh cuff for blood pressure readings. * uncontrolled diabetes mellitus.
safety of cardiac pacemakers in 1.5t tesla mri

Conditions: Heart Diseases

Summary: to evaluate short-term and long-term effects by mr imaging on the technical and functional status of medtronic pacemakers.

the presence of a cardiac pacemaker (pm) is currently considered an absolute contraindication to mr imaging, and most patients with pm are excluded from having mri. in 2002 there were approximately 2.4 million patients in the us with cardiac pm, and this number is growing by 80,000 annually. a previous study has shown that mri is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing mri on pm patients. the aim of this study is to develop a strategy for safe performance of mr imaging at 1.5t, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (sar) values to minimize the risk of lead heating, and pm reprogramming to avoid interference from time varying gradient fields. the safety of this approach is then evaluated in a large group of pm patients including assessment of potential myocardial thermal injury by measuring serum troponin i and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.

Eligibility criteria:
inclusion criteria: * urgent need for an mri examination * presence of a medtronic pm system manufactured between 1993 and 2004 * stable pacemaker physical parameters * battery voltage \> 2.7 v * battery impedance \< 2000 ohm * battery estimated remaining lifetime \> 6 months * lead impedances 200-2000 ohm * stable pacing parameters * pacing capture threshold \<2.5v at a pulse duration of 0.4ms * sensing \> 5mv * minimum 3 months since pacemaker and lead implantation exclusion criteria: * pm system manufacturer other than medtronic * history of ventricular tachycardia (vt) or ventricular fibrillation * unstable angina * myocardial infarction within the previous 3 months * cardiothoracic surgery within the previous 3 months * complete atrioventricular block * absolute pacemaker dependence * heart rate \< 40 bpm or * heart rate \< 60 bpm producing neurological symptoms * presence of an abdominal pacemaker with lead length \> 70 cm * presence of mri incompatible bioimplants or other mri incompatible materials * request for an mr examination of the chest, including the heart, breasts and thoracic spine

Keywords: pacemaker magnetic resonance imaging safety