Kornimate/medical-research-clean huggingface dataset:
accuracy of tcom vs nirs in predicting wound outcomes in patients treated with or without revascularization

Conditions: Wound Heal

Summary: the primary purpose of this project is to compare the accuracy of transcutaneous oxygen monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic wounds of patients following revascularization procedures as well as those with conservatively managed chronic wounds. this study will also compare the efficiency and practicality of both methods in guiding treatment decisions and management of these wounds.


Eligibility criteria:
inclusion criteria: * are between the ages of 18-85 * presented with a non-healing lower extremity wound and have a wagner classification for wound healing of grade 1 or 2 exclusion criteria: * wagner grade 3-5 * congestive heart failure (chf) with a left ventrical ejection fraction (lvef) \< 30% * have had a below the knee drug eluting stent placed (paclitaxel is chemo, can make wounds worse)
preventing covid-19 in healthcare workers with hcq: a rct

Conditions: Covid-19

Summary: healthcare workers (hcw) at risk of covid-19 will have baseline serology for sars-cov-2 to see if they are already immune to covid-19. hcw will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or vitamin c on a weekly basis for three months. subjects will complete daily diary of symptoms and temperature, and will have repeat sars-cov-2 serology at 6 weeks and 3 months to determine seroconversion.

healthcare workers (hcw) at risk of covid-19 will have baseline serology for sars-cov-2 to see if they are already immune to covid-19. hcw will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or vitamin c on a weekly basis for three months. subjects will complete daily diary of symptoms and temperature, and will have repeat sars-cov-2 serology at 6 weeks and 3 months to determine seroconversion.

Eligibility criteria:
inclusion criteria: * healthcare worker at risk of covid-19 exclusion criteria: * known hypersensitivity or allergic reactions to 4-aminoquinoline compounds or its ingredients. * current, or history of, ocular macular disease or retinal damage. * current, or history of, subnormal glomerular filtration. * current use of tamoxifen citrate. * current, or history of, cardiomyopathy, atrial, nodal, or ventricular arrhythmias, torsades de pointes, conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy. * subjects taking other drugs that have the potential to prolong qt interval if taken with hcq.

Keywords: covid-19 healthcare workers prophylaxis hydroxychloroquine
evaluation of posterior component separation technique in the management of complex ventral hernia.

Conditions: Ventral Hernia

Summary: * assess short term outcome of posterior component separation technique(pcs) including the regain of the physiological function of the abdominal wall. * detect most common post operative complications related to awr techniques in a 6 months duration after operation.

posterior component separation(pcs) is one of the surgical techniques used in abdominal wall reconstruction plan foe management of relatively complex ventral hernia ,which cannot be treated with the conventional surgical way. with or without transverses abdominis release(tar) technique, (pcs) became widely accepted as surgical technique specially for large sized hernia defect, previous multiple laparotomies or unhealth abdominal soft tissue. this study has a primary outcome which is detection of recurrence rate in patients under went posterior component separation technique in a period of 6 month after operation.

Eligibility criteria:
inclusion criteria: * patients with complex ventral hernia with contraindication to the conventional surgical therapy. exclusion criteria: 1. patients with contraindication to long standing anesthesia. 2. patients with emergency hernia situation. 3. pregnant patients.
effects of static stretching versus post facilitation stretch of iliopsoas in non-specific low back pain

Conditions: Low Back Pain

Summary: this study is a randomized controlled trial and the purpose of this study is to determine the effects of static stretching versus post facilitation stretch of iliopsoas combined with core stability exercises in non-specific low back pain"

the purpose of this study is to determine the effects of static stretching versus post facilitation stretch of iliopsoas on pain, physical function, lumbar rom and hip rom in patients non-specific low back pain" adults (age : 30-50 years ) 1. numeric pain rating scale 2. goniometer 3. inclinometer 4. oswestry disability questionairre data will be collected before and after the intervention protocol for each participant. data collection procedure: participants of interest would be approached and explained about the research. informed written consent will be taken. pre and post intervention scores will be recorded.

Eligibility criteria:
inclusion criteria * gender: both male and female * individuals aged 30-50 years * non-specific low back pain for at least 3 months * pain radiating no further than the buttock * pain range between 3-8 on nprs * positive thomas test exclusion criteria: * diagnosis of systemic metabolic and/or neurological disorder, neuromuscular disorders, pregnancy * patients who have been receiving any other physical therapy treatment for nslbp in the same period of the interventions * patients having low back pain with any specific cause
light treatment effectiveness (lite) study

Conditions: Psoriasis; Psoriatic Plaque

Summary: to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet b phototherapy for the treatment of psoriasis

the primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet b phototherapy for the treatment of psoriasis. physician global assessment (pga) and dermatology life quality index (dlqi) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. this is a three year pragmatic, randomized, active comparator effectiveness study.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17) 2. age 12 or older 3. plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy 4. patient is deemed willing and able to comply with either in-office or in-home phototherapy: 1. in office: able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site 2. in home: has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions 5. new or established patient in the practice exclusion criteria: 1. patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints 2. patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following: 1. how to operate the phototherapy device 2. how to follow the dosing protocol 3. requirement to wear protective eyewear and genital protection equipment 3. patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit 4. psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0 5. patients deemed unsafe to be treated with phototherapy: 1. history of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation 2. history of arsenic intake 3. unable to tolerate standing for required duration of treatment due to age or physical function 4. history of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy 6. clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
training lay healthcare workers to optimize tb care and improve outcomes in malawi

Conditions: Tuberculosis

Summary: task shifting of less complex healthcare tasks to lay health workers (lhws) is increasingly employed strategy to address the global shortage of skilled health workers. despite availability of effective treatment, tuberculosis (tb) remains an important cause of mortality with 1.3 million lives lost globally to tb in 2012. the greatest proportion of new tb cases occurs in africa and over 95% of tb deaths occur in low income countries (lics). in response to the combined high tb burden and severe healthcare worker shortages in these settings, outpatient tb care is among the tasks commonly shifted to lhws. lhws are community members who have received some training but are not healthcare professionals. randomised trials show lhws improve access to basic health services and tb treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness. the investigators' goal is to improve tb care provided by lhws in malawi by implementing and evaluating a knowledge translation (kt) strategy designed to facilitate incorporation of evidence into lhw practice. the investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.


Eligibility criteria:
inclusion criteria: * all health centers in participating districts that routinely provide tb care will be included. * lhws who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews exclusion criteria: * health centers that do not routinely provide tb care * lhws unwilling or unable to give informed consent. * tb patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or lhws unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.
a prospective trial to assess breast cancer survivors and vaginal atrophy treatment outcomes

Conditions: Vaginal Atrophy; Genitourinary System; Disorder, Female; Vaginal Abnormality; Sexual Dysfunction; Sexual Problem

Summary: the focus of this study is to assess breast cancer survivors perspectives of viveve® treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (gsm). this will be assessed by the fsfi, fsds-r and diva questionnaires.

breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. estrogen suppression also reduces the likelihood of a breast cancer recurrence. therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. this therapy typically is administered for five years after a cancer diagnosis. regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. this study will evaluate the patient's perspective of vaginal therapy using the viveve® device in breast cancer patients.

Eligibility criteria:
key inclusion criteria: * 18 years or older * breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen * self-reported vaginal laxity * meet diagnosis of sexual dysfunction * patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points exclusion criteria: * cognitive impairment * women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention * women with active breast cancer disease * women currently on hormone therapy or who are pregnant * women who have had vaginal or pelvic surgery involving the genitalia
sexual function and wellbeing in females with rectal cancer

Conditions: Rectal Cancer

Summary: preoperative radiotherapy (rt) and pelvic surgery is recommended to many patients with rectal cancer. for women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. to address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

women with rectal cancer stage i to iii planned for abdominal surgery was included in the study. women treated with preoperative rt were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group. 142 participants were enrolled at five outpatient rectal cancer centres in sweden between 2008 and 2013. patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). women treated with preoperative rt for rectal cancer had an additional venous blood sample taken the day before surgery. changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.

Eligibility criteria:
inclusion criteria: * females diagnosed with rectal cancer stadium i-iii, planned surgery with or without preoperative radiotherapy. exclusion criteria: * rectal cancer stadium iv * previous radiotherapy to the pelvic region * inability to provide informed consent. * life expectancy less than 2 years.

Keywords: rectal cancer preoperative radiotherapy pelvic surgery sexual function wellbeing hormone levels
study of abt-751 in patients with refractory hematologic malignancies

Conditions: Hematological Malignancies

Summary: abt-751 is a new antitumor drug that that interferes with cell division. the goal of this clinical research study is to find the highest safe dose of abt-751 that can be given as a treatment for refractory hematologic malignancies. the safety and side effects of abt-751 will also be studied.

the current low cure rates in most patients with advanced hematologic cancers indicate the need to identify new agents that can be incorporated with current therapies to improve prognosis. the vinca alkaloids are effective broad-spectrum anti-leukemic drugs. microtubules are a major structural component of cells. they play a role in cell shape, cellular polarity, cellular movement, intracellular transport and the segregation of chromosomes during mitosis. the cellular microtubule dynamics are highly regulated. as cells enter mitosis, the interphase microtubules disappear and are replaced with a new network of microtubules that interact with the mitotic spindle. disruption of these new microtubules leads to cell cycle arrest. these important and highly labile microtubule arrays comprising the mitotic spindle are the principal target of oncologic antimitotic compounds. known antimitotic agents fall into three classes, the vinca alkaloids (vincristine, vinblastine, and vinorelbine), taxanes (paclitaxel and docetaxel), and colchicine-site binders. there are no colchicine-site agents currently approved for cancer chemotherapy. these three classes of compounds have distinct binding sites on the tubulin subunits. abt-751 is a novel orally administered antimitotic agent that binds to the colchicine site on beta-tubulin and inhibits polymerization of microtubules.

Eligibility criteria:
inclusion criteria * patients with relapsed or refractory acute leukemias (aml, all, mds \[raeb, raebt\], cmml in transformation with \>/= 10% peripheral blood/bone marrow blasts, cml in blast crisis), and patients with relapsed/refractory or transformed cll. * signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital. * ecog performance status \</= 2. * serum direct bilirubin \</= 2 mg/dl, serum sgot or sgpt \< 3 upper limit of normal, serum creatinine \</= 2 mg/dl, unless considered due to organ leukemic involvement. * age \> 16 years - a separate phase i study is being conducted in the pediatric population. exclusion criteria * any severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for study entry. * pregnant and/or lactating females. * those with documented sulfonamide allergy should be excluded from study participation.
aurexis® in cystic fibrosis subjects chronically colonized with staphylococcus aureus in their lungs

Conditions: Staphylococcus Aureus

Summary: patients who are at least 7 years old with stable cystic fibrosis who have staphylococcus aureus in their lungs will be enrolled into the study and receive one dose of aurexis® intravenously on study day 1, and will be followed until study day 57. aurexis is a humanized monoclonal antibody that is designed to combat staphylococcus aureus. the purpose of this study is to assess the safety and pharmacokinetic profile (concentration of aurexis in blood and sputum) of aurexis. additionally, certain tests and measurements will be conducted to preliminarily determine if aurexis demonstrates any benefit to these patients.


Eligibility criteria:
inclusion criteria: * male or female, ages \> 7 years old * diagnosis of cf as evidenced by sweat chloride test and/or genetic mutation testing * sputum sa cfus \> 10,000 per ml * ability to expectorate sputum * ability to tolerate nasal lavage and collection of breath condensate * willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential * informed consent obtained from subject or legal guardian, and assent if appropriate exclusion criteria: * burkholderia cepacia in sputum * subjects who have had changes to their treatment regimen for cf in the past 6 weeks * subjects can be screened 6 weeks after iv antibiotic completion * subjects can be screened 7 days after oral antibiotic completion * received an investigational drug within 30 days of study entry * received any immune globulin or blood product within 30 days of study entry * history of hypersensitivity to immune globulin preparations * undergoing any type of dialysis or expected to start dialysis within 30 days * pregnant or nursing females * considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations

Keywords: cystic fibrosis staphylococcus aureus lungs
acupuncture in the complementary treatment of diabetes mellitus type ii

Conditions: Diabetes Mellitus

Summary: this is a randomized clinical research, with triple blinded multicenter involving the federal university of rio de janeiro, through the school of nursing anna nery, as a proponent and research coordinator; and as a collaborative educational institutions, the federal university of espirito santo, represented by the department of nursing; and the higher school of sciences of the santa casa de misericordia de vitoria, through the master's programme in public policy and local development. as research, the study covers health units of the municipal family health maricá / rio de janeiro, the municipal victoria health / holy spirit, beyond the scope of integrated project research-service (pipa), linked to nursing anna nery / federal university of rio de janeiro. the object of investigation is the effectiveness of acupuncture in nursing care in complementary treatment of adult patients diabetes mellitus type ii.

this study has the general objective to evaluate the effectiveness of acupuncture as a complementary treatment to medication used in patients with diabetes mellitus type ii, based on the nursing diagnoses.

Eligibility criteria:
inclusion criteria: * be in possession of diabetes mellitus type ii only * it is undergoing treatment for at least 1 year properly prescribed (to be confirmed with the medication of revenue) * report difficulties in glycemic control, regular saving measures higher than recommended by the brazilian society of diabetes (postprandial up to 180mg / dl) exclusion criteria: * have a lower limb amputated or part of them (because of the location of the selected acupoints for the treatment protocol) * be insulin * being a smoker * be alcoholic * be in drug treatment for other diseases including obesity * be making specific diet for weight loss * practicing regular physical activity * be in possession of cancer * being pregnant
the impact of gaming on functioning among people with schizophrenia

Conditions: Psychotic Disorder

Summary: the goal of this clinical trial is to test whether gaming intervention works well for persons with psychotic disorder. the main question to be answered is whether gaming works well in improving functioning, some other clinical outcomes or causing any adverse effects. researchers will compare gaming group to usual care.

the overall goal of this study is to evaluate the effectiveness of gaming to improve functioning and clinical outcomes in people with psychotic disorders. feasibility of the intervention will also be assessed. our hypothesis are as follows: primary hypothesis: 1. gaming is more effective on improving functioning 3- and/or 6-months follow-ups comparing to usual practices (tau). secondary hypotheses: 2. gaming is more effective on improving clinical outcomes and treatment acceptance (symptoms, self-efficacy, the quality of life, drop-out from intervention) at 3-and/or 6-months comparing to usual practices (tau). 3. gaming do not cause more adverse effects up to 6 months, especially aggression at 3-and/or 6-months follow-ups comparing to usual practices (tau). the effectiveness of the gaming will be assessed using a controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design. feasibility will also be assessed.

Eligibility criteria:
inclusion criteria: * finnish speaking * a formal diagnosis of psychotic disorders (f20-f29, icd-10; to be identified in medical records or other reliable sources by staff) * age between 18 and 60 years old * ability to participate in the study based on their own free will * ability to provide written informed consent exclusion criteria: * clinical diagnostic criteria for a current major depressive, manic or hypomanic episode or mental retardation (icd-10) * severe visual impairment * signs or diagnosis of gaming addiction * lack of ability to decide one's own participation (under guardianship) * substance abuse (other than nicotine dependence) * head injury, hemiplegia, or other neurological disorder * electroconvulsive therapy (ect) in the past six months

Keywords: psychotic disorder gaming functioning