Kornimate/medical-research-clean huggingface dataset:
patient blood mangement (pbm) using iv iron in patients with gynecologic cancer

Conditions: Gynecologic Cancer

Summary: to demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients

to demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients undergoing surgery, radiation therapy, and chemotherapy, and to establish a patient blood management program and introduce it as a standard treatment.

Eligibility criteria:
inclusion criteria: 1. women aged 20-80 years 2. untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer) 3. patients with ecog performance status 0-2 4. patients with asa ps 1-2 5. preoperative hgb ≥ 7 g/dl 6. patients who are scheduled for preoperative iron panel test (serum ferritin, iron, tibc) 7. in case of showing proper organ function wbc ≥ 3,000/mm3 platelets ≥ 100,000/mm3 creatinine ≤ 2.0 mg/dl bilirubin ≤ 1.5 x institutional upper limit normal sgot, sgpt, and alp ≤ 3 x institutional upper limit normal 8. patient who voluntarily signed the informed consent form exclusion criteria: 1. patient who unable to determine whether or not to consent on their own 2. patients with serious underlying diseases or complications 3. women who are pregnant or lactating 4. patients with concurrent infection 5. patients who are allergic to existing iron preparations 6. patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy 7. patients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder 8. patients with iron overload or iron utilization disorders 9. patients with serum ferritin \> 800ng/ml or tsat \> 50% on iron panel tests

Keywords: endometrial cancer ovarian cancer cervical cancer patient blood management iv iron
coordinating teams in primary health care.

Conditions: Musculoskeletal Diseases

Summary: patients who suffer from musculoskeletal pain often have more than one diagnosis. these patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. the investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. the purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. research data will be obtained from the patients journals, questionnaires, and clinical examinations..


Eligibility criteria:
inclusion criteria: * patient in one of the participating general practices * musculoskeletal complaints in 3 years before start of this study * informed consent exclusion criteria: -

Keywords: primary health care physical therapy specialty general practitioners general practice
assessing the reliability and validity of 4-meter and 10-meter walking test

Conditions: Stroke; Gait, Hemiplegic; Cerebral Infarction; Cerebrovascular Disorders

Summary: the 4-meter walk test and 10-meter walk test is currently applied to assess gait speed.these tools are frequently used in clinical trials and were also shown to be reliable measurement methods. there are ocassions where it is not possible to have a long corridor to measure gait speed. it is necessary to have a tool to evaluate gait speed in a small space as 4-meter walk test.

walking speed is an important aspect of gait and is commonly used as an objective measure of functional mobility in both clinical and research settings. the majority who have suffered a stroke tend to have gait disturbances. regaining locomotor ability is one of the primary goals in stroke rehabilitation, and it is most commonly measured using changes in self-selected walking speed. although many of them can walk independently, they do not do so with enough speed and endurance to allow them to perform their activities of daily living prior to stroke. not only is self-selected walking speed simple, cost effective, reliable, valid, sensitive, and specific, but it is also highly related to the severity of impairment and predicts functional walking status. it is recommended as a "vital sign" of health. improvements in walking speed of 0.1 m/s or more have been shown to be a predictor of good health. however, decreased walking speed has been related to worse health outcomes and frailty in older people. the 4-meter walk test (4 mwt) and 10-meter walk test (10 mwt) is currently applied using various timing protocols and distance covered that may affect data interpretation with a standard value, and comparisons among the studies. there are two protocols to measure walking speed, static and flying start. a static start (i.e., record the time used to cover a total walkway or from the start to stop walking) or a flying start (i.e., measured the time while walking in the middle of the walkway). the aim of this study is to investigate the test-retest reliability of the 4 mwt and 10 mwt and their correlation with 5-repetition sit-to-stand in chronic stroke survivors.

Eligibility criteria:
inclusion criteria: * all study participants are clinically diagnosed with stroke * adult participants, defined as \>18 years of age * have preserved cognitive ability: achieve a score equal to or greater than 25 points on the montreal cognitive assessment test. * have the ability to walk on a flat surface of at least 20 meters, with or without aid. exclusion criteria: * a history of lower extremities injury or surgery * a history of botulinum injection within 3 months * a history of inflammatory arthritis * a history of inflammatory myopathy or peripheral nervous disease * a history of other neurological disease as a parkinson, spinal cord etc.

Keywords: walking speed gait sit-to-stand reliability validity correlation
cervical cancer screening study in brazil

Conditions: Cervical Cancer

Summary: objectives: primary objective: to perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in brazil. secondary objective: analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.

wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the prevention department at barretos cancer hospital, a mdacc sister institution, in barretos, brazil. barretos cancer hospital will serve as the lead site for the study initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. the clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. the clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. the high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens. the entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.

Eligibility criteria:
inclusion criteria: 1. patients undergoing colposcopy 2. 18 years of age or older 3. negative pregnancy test 4. subjects must be willing and able to provide informed consent exclusion criteria: 1. patients under 18 years of age 2. positive pregnancy test 3. subjects unwilling and unable to provide informed consent

Keywords: cervical cancer cervical neoplasia cervical cancer screening colposcopy wide-field white light imaging wide-field fluorescence imaging acetic acid proflavine solution
an open, multicenter study of foscarnet treatment of acyclovir-resistant herpes simplex virus in patients with the acquired immunodeficiency syndrome and other immunodeficiencies

Conditions: Herpes Simplex; HIV Infections

Summary: to evaluate the safety and efficacy of intermittent intravenous (iv) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (hsv) infections in aids patients and other immunocompromised patients. to evaluate the necessity, efficacy, and safety of iv maintenance foscarnet therapy in preventing recurrent disease. to confirm the pharmacokinetics of intermittent induction and maintenance iv regimens.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * cyclosporine. patients must have aids as defined by the cdc, or be patients with other immunocompromised states (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency), and have herpes simplex virus (hsv) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). in vitro susceptibility data must be pending in the latter case. * patients must be able to give informed consent. * patients \< 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors. * expected survival of at least 6 months. prior medication: allowed: * cyclosporine. * ganciclovir. exclusion criteria co-existing condition: patients with the following are excluded: * known allergy to foscarnet. * any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). concurrent medication: excluded: * any potentially nephrotoxic agent (except cyclosporine). * immunomodulators. * biologic response modifiers. * investigational agents. patients with the following are excluded: * known allergy to foscarnet. * any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). prior medication: excluded within 7 days of entry: * any potentially nephrotoxic agent (except cyclosporine). * excluded within 14 days of entry: * immunomodulators. * biologic response modifiers. * investigational agents.

Keywords: aids-related opportunistic infections immune tolerance injections, intravenous herpes simplex immunity, cellular drug resistance foscarnet acyclovir acquired immunodeficiency syndrome antiviral agents
efficacy and safety of dexmedetomidine in the analgesic prophylaxis , in patients undergoing cardiovascular surgery

Conditions: Cardiopathy; Coronary Artery Disease; Valve Heart Disease; Pain

Summary: acute pain is one of the complications after cardiothoracic surgeries . it can delay patients´recovery and may increase patients´morbity and mortality. this study intends to evaluate dexmedetomidine, a highly selective α- 2 receptor agonist, that is currently applied safely and efficiently in intraoperative cardiac surgery. it has analgesic, sedative, anxiolytic and sympatholytic properties, without respiratory- depressant effect. the aim of this study is to investigate whether the intraoperative use of dexmedetomidine is better than the standard analgesia used in the intraoperative period to reduce pain and the consequences of it.

this project is a prospective, double-blinded and randomized clinical trial. eligible participants are assigned in a 1:1 ratio to either the intervention group (group dexmedetomidine) or control group (group saline 0,9%), after written informed consent to be obtained. the patients will undergo elective cardiac surgery, with extracorporeal circulation. in the operating room, patients will be monitored for pulse oximetry, invasive blood pressure, electrocardiograms, capnography, central venous pressure and nasopharyngeal temperature probe. induction of anesthesia is performed with intravenous midazolam, fentanyl, etomidate and neuromuscular blocking agent. anesthesia is maintained with sevoflurane. dexmedetomidine, at the rate of 0,3μg/ kg/h, or placebo will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass. placebo is a 0,9% saline. the follow up of the assessment of the groups will extend to the postoperative icu, where data will be collected, during the first 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * patients at least 18 years old and who are undergoing cardiac procedures (coronary artery bypass, valve replacement or combined procedure), with cardiopulmonary by- pass. exclusion criteria: * congenital heart disease * infective endocarditis * acute myocardial infarction (\<two weeks) * pregnancy * cancer * left ventricle ejection fraction \< 40% * cardiogenic shock * emergent procedure * use of vasopressor and/or inotrope, in the preoperative * liver disfunction * renal replacement therapy * nephrectomy * previous renal transplantation * patients who are participating in another clinical research

Keywords: dexmedetomidine cardiac surgery analgesia
health status and quality of life in the elderly

Conditions: Quality of Life

Summary: the study is designed to investigate the effect of amp886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.


Eligibility criteria:
inclusion criteria: * males and females 65-85 years old * ecog performance score 0 to 1 * body mass index 22-30 kg/m2 * body weight \>60 kg * habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk * comply with protocol and likely to be compliant with prescribed product exclusion criteria: * renal insufficiency or failure at screening * current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder. * comorbid medical conditions * use of prescription medication for chronic conditions * use of hormone replacement therapy (with the exception of levothyroxine) * uncontrolled hypertension * use of hemostatic agents * hemorrhagic disorder and/or coagulation disorder * clinically important bleeding within 90 days prior to screening visit * fat malabsorption syndromes * constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy * history of smoking within 1 year prior to visit 1.
assessment of efficacy of the consumption of a heat-treated lactobacillus paracasei (gm080) on atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of this trial is to assess the efficacy of the consumption of heat-treated lactobacillus paracasei (gm080) on atopic dermatitis as compared to a placebo treatment.


Eligibility criteria:
inclusion criteria: * infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group). * with mild to severe atopic symptoms: scorad ≥ 20 (at v0b). * having obtained his/her (or his/her legal representative's) written informed consent. exclusion criteria: * scorad inferior to 20 (scorad less than 20 at v0b). a scorad less than 20 at v0c is not an exclusion criteria. * infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine a). * infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. of note: infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (v0b), can continue to use this probiotic during the intervention period and will not be excluded. recent introduction of probiotics, within a month before the planned start of the study (v0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and v0b). * infants having other inflammatory skin diseases (urticaria, psoriasis). * infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency). * infants whose parents/caregivers cannot be expected to comply with the study procedures. * infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study. * infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (elidel®)) during the study. * infants who have undergone in the month before the start of the study (v0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. lotion and skin moisturizer are allowed but need to be monitored for frequency and area. * the investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. it will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.

Keywords: all subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a scorad equal or above 20
home support for mothers whose premature infants

Conditions: Infant, Premature, Diseases; Mothers

Summary: premature births are a challenging process for parents in many ways. especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. the aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.

the study was planned as a randomized controlled trial with a single blind, pretest-posttest design. this study will be conducted between february 2021 and march 2022 with premature infants mothers. the sample of the study will be mothers (n = 102) of premature infants discharged from antalya training and research hospital neonatal intensive care unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. in addition, mothers will be given an appointment for a phone call a week later. no intervention will be applied to the other 51 mothers after their discharge routine. data will be collected by mother-infant descriptive information form, perceived maternity self-efficacy scale (pmses), state anxiety inventory (sai). data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). ethics committee and institutional permission was obtained for the study. in addition, written consent will be obtained from the participants. statistical analysis will be done using spss 23.0 and significance will be evaluated at p \<0.05. support will be received in the analysis phase of the statistical information unit of akdeniz university. it is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.

Eligibility criteria:
inclusion criteria: * the infant was born prematurely (37 weeks of gestation + 6 days earlier), * does not have advanced congenital anomalies in the baby, * who will carry out the primary care of the infant at home, * reading and writing, * can speak and understand turkish, * mothers who agreed to participate in the study exclusion criteria: * incomplete filling of the forms * mothers who previously had training in newborn care

Keywords: infant mothers
weight watchers online

Conditions: Overweight; Obesity

Summary: the purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the weight watchers online program (wwo) and wwo plus the philips activelink physical activity system, over a 1-year period, compared to a control group.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 27 and 40 kg/m2 * all ethnic groups will be recruited * english speaking * have access to the internet via a computer, and basic computer skills exclusion criteria: * report health problems that make weight loss or unsupervised exercise unsafe or unreasonable * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire * are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months * are planning to move outside of the state within the next 12 months * report any cognitive or physical limitations that preclude use of a personal computer * have participated in a study conducted by the wcdrc or ut in the past 2 years * have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program * weight loss of ≥ 5% of initial body weight in the last 6 months * history of clinically diagnosed eating disorder excluding binge eating disorder. * previous surgical procedure for weight loss * currently taking weight loss medication * treatment of cancer within the last 6 months
safety of bosentan in type ii diabetic patients

Conditions: Diabetes Mellitus

Summary: this study evaluates the safety of topical bosentan in type ii diabetes patients

the study is a phase i, masked, placebo controlled clinical trial to assess safety of topical bosentan in type ii diabetes patients with no diabetes retinopathy

Eligibility criteria:
inclusion criteria: * signed informed consent; * type ii diabetes mellitus; * 18 or more years old exclusion criteria: * pregnant or breastfeeding women * known allergy or intolerance to investigational product or any of its excipients * severe corneal abnormalities * any relevant ocular / ophthalmic pathology that may put study results at risk in the opinion of principal investigator * any sign or symptom of diabetes retinopathy * any ocular surgery in the 6 previous months to study inclusion * uncontrolled diabetes in the previous 3 months to inclusion or hba1c levels ≥ 9% at baseline. * oxford scale or osdi scores compatible with study failure at inclusion visit. (oxford ≥ 5 or ostdi ≥ 13) * previous hepatopathy history or signs of hepatopathy at baseline. * contact lens use * actual treatment with the commercially available presentation

Keywords: diabetes