Kornimate/medical-research-clean huggingface dataset:
epainq - feasibility study

Conditions: Breast Neoplasm Female

Summary: this is a feasibility study of a web-based pain self-management system aimed at providing support for acute postoperative pain and enhancing patient care. the epainq symptom questionnaire provides patients with immediate graded advice dependent on severity of issues reported. information about self-managing these issues are provided via instructions in epainq with hyperlinks to more detailed advice on the epainq website. patients log on daily postoperatively to complete the symptom questionnaire. women with invasive/non-invasive breast carcinoma due to be treated by surgery with curative intent will be approached to take part in this study. we will invite consecutive eligible patients, consenting as many willing patients as possible within a fixed 12 month recruitment period. there are 2 arms to the study: intervention -using epainq intervention \& standard care and a cohort (control) arm, which will be standard care only. primary aim: to test the feasibility of a web-based pain self-management system for breast cancer patients undergoing surgery secondary aims: 1. a) examine preliminary effectiveness of the system (impact on outcome measures, pain etc.) b) explore the potential associations between breast density, post-surgical scarring and pain and outcomes 2. to explore staff use and perceived usefulness of epainq in clinical consultations.


Eligibility criteria:
inclusion criteria: aged over 18 years of age at the time of diagnosis of cancer primary operable (tnm categories: t1, t2, t3, n0, n1, m0; invasive breast cancer or non-invasive breast cancer (diagnosed on core biopsy or diagnostic incision biopsy) ability to give informed consent access to the internet (those without access to the internet may participate in the cohort arm) ability to speak and write english exclusion criteria: * male disease unsuitable for surgery e.g. inoperable, locally recurrent or metastatic disease previously treated invasive breast cancer there will be a restriction to people who are able to speak/read english. this is due to lack of funding for translation of study documents pregnant women patients without capacity to consent or those with a major psychiatric disorder no internet access (those without access to the internet may participate in the cohort arm)
postural training for standing and sitting in men suffering from post-prostatectomy urinary incontinence

Conditions: Men Who Have Undergone Prostatectomy

Summary: existing research highlights the difficulty of identifying an optimal rehabilitation technique for improving male urinary continence. however, several authors have demonstrated the benefits of treatment based on improving movement control, often referred to as postural motor contro. the main principles are: respect for the neutral lumbopelvic position, reduction of intra-abdominal constraints and ecology of movement. with the aim of encouraging patient-centred clinical practice, patients are asked to fill in an assessment form on which they note the most disabling gestures with regard to their ui during the initial assessment. in our experience, 'sitting down or getting up from a chair' is the item most frequently and most severely reported. in practical terms, posture and body movements play a vital role in the management of pelvic strain. for example, excessive pressure on the bladder due to poor postural control would increase stress on the bladder. optimal postural control would have the advantage of reducing and promoting continence mechanisms. if we take the example of the transition from sitting to standing, postural control aims to improve neuromuscular coordination and promote continence. in the context of health education during the first session, it might be interesting to study the impact of modifying postural control when standing/sitting on urinary incontinence and how patients feel about it.


Eligibility criteria:
inclusion criteria: * men over the age of majority. * men who had had a prostatectomy within one year of inclusion. * positive response to the question 'do you leak urine when you stand or sit up? * patients with a medical prescription for post-prostatectomy urinary incontinence rehabilitation. * patients who are able to understand and follow the instructions relating to postural education when standing up or sitting down. * patients who have read and understood the information note and who have not objected to participating in the research. * patients affiliated to a social security scheme. exclusion criteria: * urinary leakage before prostatectomy (diagnosed by a doctor) * pad test ≤ 0 grams at the inclusion visit, before showing the postural control technique. * on anticholinergic treatment initiated less than 3 months ago. * impossible to carry out postural control education (spinal surgery, serious neurological or orthopaedic pathology). * patients deprived of their liberty by an administrative or judicial decision or protected adults (under guardianship or trusteeship). * participation in other interventions: individuals participating at the same time in other post-prostatectomy rehabilitation programmes or similar clinical studies.
effect of the direct renin inhibitor aliskiren on endothelial function and arterial stiffness in diabetic subjects

Conditions: Diabetes; Pre-hypertension; Hypertension

Summary: the study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or stage 1 hypertension.

patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. effects on blood parameters and arteries are evaluated in both groups.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * prehypertension or stage 1 hypertension exclusion criteria: * type 1 diabetes * stage 2 hypertension * ckd * recent mi, revascularization, cva or tia

Keywords: aliskiren endothelial function hypertension
tezacaftor/ivacaftor combination therapy expanded access program for patients 12 years of age and older with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: to provide tez/iva combination therapy to cf patients who are 12 years of age and older who completed vertex tez/iva combination therapy clinical studies (nct02565914 or nct03150719). to provide tez/iva combination therapy to cf patients in critical need who are 12 years of age and older, homozygous for f508del.


Eligibility criteria:
inclusion criteria: * males and females, 12 years of age and older with confirmed diagnosis of cf. 1. - completed vertex clinical studies nct02565914 or nct03150719, or 2. - are homozygous for f508del and have (1) discontinued orkambi within 12 weeks from start of treatment because of the onset of respiratory aes considered to be treatment related or (2) cannot initiate orkambi because of chronic treatment with an essential sensitive cyp3a substrate or a cyp3a substrate with a narrow therapeutic index and who meet at least 1 of the following criteria: * the highest percent predicted forced expiratory volume in 1 second (ppfev1) is \<40 in the 6 months before the date of completion of the request form, or * documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications, or * rapid and persistent loss of lung function, defined as at least a 20% relative decrease in ppfev1 in the last 6 months and sustained for at least 1 month despite appropriate treatment. exclusion criteria: * history of any comorbidity that, in the opinion of the treating physician, might pose undue risk in administering tez/iva combination therapy to the patient (e.g., history of advanced liver disease). * ongoing or prior participation in an investigational drug study (with the exception of vertex clinical studies evaluating tez/iva) within 5 terminal half-lives of the previous investigational study drug or 30 days, whichever is longer, of first administration of tez/iva. * subjects who are pregnant. * patients eligible for participation in ongoing clinical studies evaluating tez/iva or other cftr modulator therapies. other protocol defined inclusion/exclusion criteria may apply.
scleroderma: functional disability between the dominant and contralateral hand.

Conditions: Scleroderma, Systemic

Summary: systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. the aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. in case of limitation, the level of skin fibrosis, raynaud's syndrome and its complications, the search for painful joints with or without synovitis, and the presence of calcifications must therefore be assessed. management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. no study to date has compared the functionality of one hand to the other. the hypothesis is that there is a difference in range of motion limitations between the dominant hand and the contralateral hand. patients in the active file of the internal medicine a department of the limoges university hospital who meet the inclusion criteria will be offered the study by telephone. patients wishing to participate will be given an appointment on a dedicated consultation slot. during this visit, patients will be given an information note and their consent will be collected. the study examinations will be performed and the questionnaire completed. at the end of this visit, the study will be completed for the patient.

Eligibility criteria:
inclusion criteria: * group 1 : * major patient * diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new acr/eular criteria * cochin hand score less than or equal to 16 * group 2 : * major patient * diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new acr/eular criteria * cochin hand score greater than 16. exclusion criteria: * overlap syndrome (sharp or scleromyositis 2) * patient with another autoimmune disease * history of surgery or trauma to the hand with proven functional sequelae * presence of synovitis * patient with dupuytren's disease

Keywords: scleroderma dermatology
piperacillin as a part of antibiotic streamlining in the intensive care unit

Conditions: Gram-negative Bacterial Infections

Summary: the proposed endpoints of the study would be: comparative use of piperacillin versus broader spectrum agents (e.g., piperacillin/tazobactam, etc.) \[measured as defined daily doses per 1000 patient days\]; physician acceptance of piperacillin as part of a streamlining program \[measured as successful occurrences of the use of piperacillin as streamlining therapy\]; changes in susceptibility patterns of broad spectrum antibiotics \[measured as % gram negative bacilli susceptible to each of the commonly used broad spectrum antibiotics\]; and outcome of patients treated with streamlined therapy.

the following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antibiotics once organism is identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history.

Eligibility criteria:
inclusion criteria: * patients with gram negative infections treated with piperacillin/tazobactam and/or piperacillin

Keywords: pipercillin gram negative bacteria infections
study to evaluate the usability of pointcheck

Conditions: Neoplasms; Chemotherapy-induced Neutropenia

Summary: this a study about the usability of pointcheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. the study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. a final sample size of 60 oncologic outpatients will be enrolled and studied with the technology. the main objective is to evaluate the usability of pointcheck. secondary outcomes include a preliminary assessment of pointcheck diagnostic accuracy and precision. for this, study subjects will be tested twice with pointcheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated.


Eligibility criteria:
inclusion criteria: 1. study subjects must be able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. 2. male or female aged 18 years or above 3. diagnosed with hematological malignancy (e.g., lymphoma, myeloma) or breast cancer. 4. scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia. 5. able (in the investigators opinion) and willing to comply with all study requirements. exclusion criteria 1. participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator. 2. participants with a history of vasculitis, raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. 3. participants with circulating tumor cells in previous or current lab determinations. 4. unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmhg). 5. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 6. other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.

Keywords: medical device technology
three-port versus conventional laparoscopic surgery for colorectal cancer

Conditions: Colorectal Cancer

Summary: this study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（tlsc） compared with conventional laparoscopic surgery for colorectal cancer（clsc）.

at present，surgical treatments is the main means to cure colorectal cancer（crc）.the use of four or more ports has been routine in most laparoscopic colorectal resections. however，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. in order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (sils) is attracting increasing attention. but it is challenging and highly demanding techniques. becoming proficient at three-port laparoscopic surgery can make the transition to sils more nature.few studies about three-port laparoscopic surgery for colorectal cancer（tlsc） have been reported currently.more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for tlsc. this is a single-center, open-label, non-inferiority, randomized controlled trial. a total of 282 eligible patients will be randomly assigned to tlsc group and clsc group at a 1:1 ratio. it will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of tlsc compared with clsc.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \<30 kg/m2 * tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection) * pathological colorectal carcinoma * clinically diagnosed ct1-4an0-2 m0 lesions according to the 7th edition of ajcc cancer staging manual with or without neoadjuvant therapeutic history * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * previous gastrointestinal surgery * history of inflammatory bowel disease * history of familial adenomatous polyposis（fap） * pregnant woman or lactating woman * severe mental disease * intolerance of surgery for severe comorbidities * emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * requirement of simultaneous surgery for other disease

Keywords: colorectal cancer laparoscopic surgery three-port
lysosomal storage disease: health, development, and functional outcome surveillance in preschool children

Conditions: Mucopolysaccharidosis Type I (MPS I); Mucopolysaccharidosis Type II (MPS II); Mucopolysaccharidosis Type III (MPS III); Mucopolysaccharidosis Type VI (MPS VI); Krabbe Disease

Summary: hypothesis: children diagnosed with a lysosomal disease will exhibit developmental, adaptive, and behavioral strengths and difficulties depending upon 1) biomedical risk factors (i.e. the specific genetic disorder responsible for the illness); 2) available modifying interventions, whether medical or behavioral; and 3) social risks in the children's families, neighborhoods and communities. a valid and reliable telephone-based surveillance system can successfully collect the data required to elucidate these developmental, adaptive and behavioral strengths and difficulties.

children who have lysosomal disease experience declines in health status and central nervous system integrity which result in motor, communication, self-care, learning and behavioral challenges. medical interventions such as enzyme replacement therapy (ert) and hematopoietic stem cell transplantation can improve the health and functioning of children with lysosomal disease. to date, however, there is no established system for evaluating the health status, developmental status, behavioral outcomes or functional outcomes of these preschool-aged children across time and differing settings. the primary objective of this study is to develop a valid and reliable telephone-based data-gathering system for obtaining health status data, developmental status data, behavioral outcomes data, and functional outcomes data which reflect skills of daily living including feeding, moving, communicating and responding to others. the secondary objective of this study is to assess the validity of several early-childhood standardized assessment tools as compared to the standard neuropsychological assessment battery specified by the lysosomal disease network's 'neurobehavioral core.' the third objective of this study is to describe the impact of lysosomal disease upon the families of lysosomal disease-affected children.

Eligibility criteria:
inclusion criteria: children aged 1 to 84 months who have been diagnosed with mps types i, ii, iii or vi. children aged 1 to 84 months who have been diagnosed with some other lysosomal disease. children aged birth to 18 years who have been diagnosed with krabbe disease, or who have a positive screening for krabbe disease. exclusion criteria: children who do not have a lysosomal disease are excluded from this study.

Keywords: mps i mps ii mps iii mps vi krabbe disease globoid cell leukodystrophy galactosylceramide lipidosis mucopolysaccharidoses mucopolysaccharidosis rare diseases clinical research network lysosomal disease network enzyme replacement therapy hematopoietic stem cell transplant telephone-based surveillance hurler syndrome hunter syndrome scheie syndrome hurler-scheie syndrome sanfilippo syndrome maroteaux-lamy syndrome
interactions between antiretrovirals (arvs) and combined oral contraceptives (cocs)

Conditions: HIV/AIDS; HIV Infections

Summary: non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.


Eligibility criteria:
inclusion criteria: * willing to provide informed consent * willing to take cocs and follow all study requirements * has regular menstrual cycles every 21-35 days (when not taking hormonal contraception) * last menstrual period (lmp) \<35 days before study entry * has body mass index of 18-30 * negative urine pregnancy test as enrollment * documented hiv-1 infection * on nevirapine-containing art for at least three months (art group only) * cd4 cell count of greater than or equal to 350 (for non-arv group only) * currently sexually active and plans to stay sexually active for the next 6 months exclusion criteria: * medical contraindications to coc use * recent pregnancy (within 3 months) * has breastfed in last 3 months * last pregnancy was ectpoic * has been sterilized * has had any of the following conditions since last pregnancy, or since menarche if never pregnant: pelvic inflammatory disease diagnosis of infertility * has had dmpa within 6 months or net injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing) * has taken other hormonal therapies besides cocs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry * has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment * has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements * has taken any prohibited medication within 30 days before study entry * has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake * has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation

Keywords: ae aids alt art ast dcf dmc fda gcp hb sag ich ind irb iu mg mm3 pcr sae uln wb coc combined oral contraceptives