Kornimate/medical-research-clean huggingface dataset:
the cedar project: impact of mhealth for hiv prevention among young indigenous people who use illicit drugs

Conditions: Drug Addiction; HIV

Summary: this study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce hiv vulnerability among young indigenous people who use illicit drugs in a community-based setting. the study is nested within the cedar project, an ongoing cohort study addressing hiv and hepatitis c vulnerability among young indigenous people who use drugs in vancouver and prince george, british columbia, canada. indigenous collaborators and investigators, collectively known as the cedar project partnership, govern the entire research process. a stratified zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the cedar project mhealth intervention with consent. participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the weltel platform, and support from cedar advocates. those drawn from the cohort study population as the comparison group will continue on in the usual cedar project study under its existing informed consent with no change whatsoever to their participation in the overall study. the main outcome is an hiv propensity score, assessed at six months and one year. secondary outcomes include hiv risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. primary analysis is by intention to treat.


Eligibility criteria:
inclusion criteria: * currently enrolled in the cedar project * completed main cedar project baseline questionnaire and attended at least one follow-up visit since 2009 * had not tested positive for hiv * joined study in vancouver or prince george * alive at initiation of cedar project mhealth study

Keywords: mhealth indigenous hiv prevention substance use
feasibility and acceptability of offering self-sampling to non-attendees in primary care

Conditions: Cancer of the Uterine Cervix

Summary: the purpose of this study is to determine whether human-papillomavirus (hpv) self-sampling can be used as a primary screening test for unscreened women.

women residing in the canton of geneva, aged between 25 and 69 years, who haven't had a pap test in the last three years, will be invited to participate. participation to the study will be encouraged through public displays, social networks, and medical consultations. women meeting the eligibility criteria will be enrolled in the study. they will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a pap test or to perform and send back the hpv self-sample that they'll receive at their domicile. both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.

Eligibility criteria:
inclusion criteria: * no previous cervical cancer screening test in the last three years exclusion criteria: * pregnancy * previous hysterectomy
biological, genetic and environmental involved in the complications of sickle cell disease

Conditions: Sickle Cell Disease

Summary: the objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome. the establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.

some additional tubes will be taken during the usual control of blood test of the drepanocytic patient. a sample of urine will be also asked. tubes, after pre-treatment, will be sent to erasme hospital. a series ob biological but also genetic parameters, both at asymptomatic patients and those in aigüe phase of the disease, can be measured either immediately or a little time after the prelevement. in this way, we can study numerous domains linked to the physiopathology of the drepanocytose (hémolyse, vaso-occlusion, rheology, factors modulators of the clinical expression). the surplus of the collection could be used for other researchs. it's in this context that we also wish to constitute a biobank of serum, plasma and urine for these drepanocytic patients by surplus of taken material. the study is realized within the framework of an academic collaboration between institutions. the bank of takings will be located in the reference center of the pathologies of the red blood cell (laboratory of medical chemistry of the erasme hospital).

Eligibility criteria:
inclusion criteria: * patients 18 years or older with sickle cell syndrome * signing an inform consent form after validation on it by the ethics committees of the participating centers. exclusion criteria: * any pathology concomitant risk of nephropathy * severe cvo within the month preceding the sampling * transfusions within 3 months prior to sampling * pregnant patient or within 3 months post- accouhcement

Keywords: sickle cell disease nephropathy
omega tots long term follow-up

Conditions: Preterm Birth; Child Development

Summary: this is a continuation study to the omega tots trial (nct01576783). the purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

the overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (dha) plus arachidonic acid (aa) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the omega tots trial cohort (nct01576783).

Eligibility criteria:
inclusion criteria: * previous participation in omega tots (nct01576783). * current age of 8 years, 180 days to 10 years, 180 days. exclusion criteria: * child in custody of children's services for their window of eligibility
her-2 pulsed dc vaccine to prevent recurrence of invasive breast cancer post neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: the primary goals of this trial will be to determine the safety and immune activity of her-2 pulsed dc1 vaccine in patients with high risk her-2pos breast cancer with residual disease post neoadjuvant therapy. investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.

dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. there is a need to determine whether this icait dc1 can activate cd4 and cd8 t cells prior to or in combination with chemotherapy with or without added trastuzumab. this study began at the abramson cancer center of the university of pennsylvania and will be continued at h. lee moffitt cancer center and research institute.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years. * her-2 expressing stage i - iii breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy. * women of childbearing age with a negative pregnancy serum test documented prior to enrollment. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study. * have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them. exclusion criteria: * pregnant or lactating. * positive for hiv or hepatitis c at baseline by self report. * potential participants with coagulopathies, including thrombocytopenia with platelet count \ 1.5 and partial thromboplastin time \> 50 sec. * potential participants with muga \< 50% ef. * pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (pi).

Keywords: invasive breast cancer breast cancer immunotherapy vaccine dendritic cell neoadjuvant
comparison between endoscopic epidural neuroplasty and percutaneous epidural neuroplasty in low back and radicular pain

Conditions: Low Back Pain; Radiculopathy

Summary: pen(percutaneous epidural neuroplasty) can be performed percutaneously, may be manipulated to mechanically break up adhesions by catheter, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. in endoscopic epidural neuroplasty (een), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. both een and pen can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may provide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication. in this study, visual analog scale (vas) and oswestry disability index (odi) of patients with low back and radicular pain were compared in patients who had received een or pen at 1 day, 1 month, and 6 months after een or pen.

low back pain and lumbar radicular pain commonly occur in degenerative spondy-losis. low back and radicular pain have many underlying causes, one of which is scar-ring in the epidural space, which can cause pain for many reasons. the nerves may be trapped by scars, while the congestive veins in the epidural space can become enlarged and exert pressure upon the nerves. percutaneous epidural neuroplasty (pen) with a wire type catheter, first reported by dr. racz, has been widely practiced since 1989, and reduces pain by epidural adhesiolysis, epidural fibrosis and inflammation near the neural tissue. the pen procedure is used to dissolve some scar tissue around the entrapped nerves in the epidural space of the spine. pen can be performed percutaneously, using a racz catheter. the catheter may be manipulated to mechanically break up adhesions, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. in endoscopic epidural neuroplasty (een), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. both een and pen can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may pro-vide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication. in this study, visual analog scale (vas) and oswestry disability index (odi) of pa-tients with low back and radicular pain were compared in patients who had received een or pen at 1 day, 1 month, and 6 months after een or pen.

Eligibility criteria:
inclusion criteria: 1. age over 20 years 2. low back or radicular pain in the low extremities 3. persistent low back or radicular pain exclusion criteria: 1. systemic infection 2. skin infection at the injection site 3. uncontrolled diabetes mellitus 4. coagulation abnormalities 5. history of allergic reactions to local anesthetics or contrast agents
study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding

Conditions: Metrorrhagia

Summary: to evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding


Eligibility criteria:
inclusion criteria: * women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception * willingness to use barrier contraception (e.g., condoms) from screening to study completion * willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion exclusion criteria: * current diagnosis of organic uterine bleeding * history of endometrial ablation, or dilatation and curettage within 2 months of visit 1. * clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound \[tvu\]). * clinically significant abnormal results of breast examination (breast palpation). * positive pregnancy test at visit 1 * less than three months since delivery, abortion, or lactation before to start visit 1 * other contraceptive methods * any disease or condition that may worsen under hormonal treatment * smokers over the age of 35 * body mass index \>32

Keywords: heavy menstrual bleeding efficacy safety oral contraceptive estradiol valerate dienogest
metabiomics colon cancer clinical research study

Conditions: Colonic Neoplasms

Summary: the specific aim of the study is to determine the false negative rate of the metabiomics colon polyp and colorectal cancer assay for cancer.

the purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. in this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by metabiomics colon polyp and colorectal cancer assay and the percentage of false negative (test returns a negative for cancer) results determined.

Eligibility criteria:
inclusion criteria: * recently diagnosed with colorectal cancer (crc) and scheduled for colectomy * male or female, * age: 18-95 years, * able to comprehend, sign, and date the written informed consent form (icf), * able to give informed consent in english * women and minorities will be included. exclusion criteria: * history of inflammatory bowel disease * antibiotics within 2 weeks of sample collection. * colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection * any radiation therapy

Keywords: colonic neoplasms colon cancer microbiome
does fluid replacement from preoperative npo status improve postoperative recovery

Conditions: Osteoarthritis

Summary: the investigators are testing the hypothesis that administering 2l of body temperature warmed lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery of patients undergoing total hip and total knee arthroplasty.

hip and knee arthroplasty are safe and reliable surgeries for the majority of patients, but a small percentage experience major complications such as myocardial infarction, deep vein thrombosis (dvt), and pulmonary embolism (pe). as these complications are related to local tissue hypoxemia and patient immobility, interventions that can improve the ability of the heart to deliver blood to the tissue and help patients mobilize earlier in their postoperative course may decrease these complications. based on recent evidence, it has been shown that many patients are dehydrated before surgery, which can make them feel nauseous, tired, and increase their perception of pain making them less likely to mobilize. this predisposes them to dvts, pulmonary embolism, nausea and vomiting. peri-operative dehydration can also decrease the ability of the lungs to oxygenate the blood properly and can place additional stress on the heart, which can increase the risk of heart attacks. the specific aim is to determine if patients' peri-operative hemodynamics can be improved with preoperative administration of 2 l of lactated ringers, and consequently reduce postoperative complications and improve recovery in arthroplasty patients.

Eligibility criteria:
inclusion criteria: * all patients \>= 18 years of age, undergoing a total primary knee or hip arthroplasty exclusion criteria: * patients weighing less than 80 kg. * patients undergoing irrigation and debridement, explantation, or revision will not be eligible. * history of kidney disease, congestive heart failure, pulmonary edema, cirrhosis of the liver, or history of systemic fluid overloard will be excluded from the study. * no one will be excluded based on gender, ethnicity or race.

Keywords: knee arthroplasty hip arthroplasty
study for treatment of moderate or severe, periodic, "cyclic", breast pain

Conditions: Fibrocystic Disease of Breast; Fibrocystic Changes of Breast; Fibrocystic Mastopathy; Pain

Summary: * history of clinical breast pain for at least the last six months. * at least six days of moderate or severe breast pain per cycle. * fibrosis, cysts, nodules involving at least 25% of the surface of one breast. * euthyroid with no prior history of thyroid disease. * six months of daily therapy with molecular iodine. * placebo controlled vs active (1:1).

primary efficacy parameters will be measured by patient self-assessment of pain/tenderness using a categorical daily pain diary. clinical pain is defined as a patient assessment of moderate or severe pain for any given day. total clinical pain per menstrual cycle is calculated based upon the categorical ratings recorded in a patient's daily pain diary over the course of a complete menstrual cycle. a directed breast examination will be used as a secondary efficacy endpoint. changes in the brest examination will be determined by the physician after consideration of both the nature of the examination findings and the surface area of breast involvement. changes as noted after six months of therapy, relative to the screening visit (baseline) will be used to evaluate this endpoint.

Eligibility criteria:
inclusion criteria: * history of clinical breast pain. * documentation of 6 or more sequential days of moderate or severe pain by patient daily diary. * conservative measures such as local heat, non-prescription analgesics, and properly fitted garments are not effective for the treatment of symptoms * euthyroid with no prior history of thyroid disease. * premenopausal female between the ages of 18 and 50. * the presence of at least one palpable structure (nodules, cysts) and involvement (diffuse nodularity or breast thickening) of at least 25% of at least one breast surface. exclusion criteria: * history of thyroid disease * non-cyclic breast pain * treatment with gonadotropin releasing hormone (gnrh) agonist, danocrine, tamoxifen, raloxifene, or bromocriptine within three months of starting the trial * initiation or change of any hormonal therapy within 6 months of enrollment; including birth control pills, hormone replacement therapy, any progestin including norplant or depo-provera; * current treatment with iodine or iodine-containing medications or diagnostics * known hypersensitivity to iodine-containing products * breast implants; * oophorectomy (complete or partial) * uncontrolled hypertension; * breast biopsy breast biopsy within two months of screening; or expectation of a breast biopsy during the study for a suspicious mass present at baseline; * pregnant women or nursing mothers * history of malignancy within the previous 5 years other than basal cell or squamous cell carcinoma of the skin * history of breast cancer

Keywords: breast pain mastalgia cyclic mastalgia periodic mastalgia non-cyclic mastalgia fibrosis nodularity cysts fibrocystic breast disease fibrocystic breast condition fibocystic breast syndrome
topical imiquimod in treating patients with recurrent paget's disease of the vulva

Conditions: Vulvar Cancer

Summary: rationale: biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. applying topical imiquimod to the vulva may be an effective treatment for recurrent paget's disease. purpose: this clinical trial is studying how well topical imiquimod works in treating patients with recurrent paget's disease of the vulva.

objectives: * to assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary paget's disease. outline: this is a pilot, prospective, multicenter study. patients apply topical imiquimod cream to a target vulvar lesion 3 times weekly. treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. if the lesion is still present after completion of 12 weeks of imiquimod therapy, the patient undergoes surgical excision of the target lesion (and any other progressive lesions suspicious for evolving adenocarcinoma) at week 16. patients undergo punch biopsy and photographic assessment of a target vulvar lesion at baseline and again at 12 weeks. after completion of imiquimod therapy or after surgical excision, patients are followed at 6 weeks and then every 3 months for at least 2 years.

Eligibility criteria:
inclusion criteria: all patients presenting to the gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. the eligibility requirements are as follows: * age ≥18. * ability to give informed consent. * patients must have biopsy proven recurrent extramammary paget's disease confirmed at the participating site. exclusion criteria: * patients with known hypersensitivity to imiquimod. * pregnant and nursing women are not eligible * patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.

Keywords: paget disease of the vulva recurrent vulvar cancer stage 0 vulvar cancer stage i vulvar cancer stage ii vulvar cancer stage iii vulvar cancer imiquimod 07-029
evaluation of home program and telerehabilitation for the treatment process in patients with breast cancer-related lymphedema

Conditions: Breast Cancer Related Lymphedema; Telerehabilitation

Summary: during the covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'telerehabilitation'. the purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

our study is a randomized single-blind prospective study. patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. group 1: patients were given a brochure explaining the massage and exercises they should perform. they were periodically contacted by a physiotherapist and clinician to remind them of their tasks. group 2: patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. during each visit, patients' inter-limb volume difference, quick dash and life impact scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

Eligibility criteria:
inclusion criteria: * patients who had undergone breast surgery at least 3 months ago * had stage 1-2 lymphedema * had upper extremity lymphedema associated with breast cancer exclusion criteria: * signs of infection such as lymphangitis, cellulitis, fungal infections * those with documented lymph node metastases * those with bilateral lymphedema * those with other diseases affecting upper extremity functions * those with a history of previous surgery related to the upper extremity