Kornimate/medical-research-clean huggingface dataset:
feasibility of 5% albumin compared with balanced crystalloid, as intravenous fluid resuscitation in adult patients with sepsis, presenting as an emergency to hospital

Conditions: Sepsis

Summary: the aim of this research study is to compare two different fluids (human albumin solution (has) and balanced crystalloid that are given via a drip to patients with severe infection (sepsis). the investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. this study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.

this trial will be an open label two-arm, multicentre, pragmatic, parallel group randomised trial of adult patients with community acquired sepsis recruited from the emergency department and medical and surgical assessment units across \~10 uk nhs hospitals. the treatment phase will be the first 6 hours following randomisation. 30-day and 90-day follow up will be conducted using routine data only. the exception to this will be the first 50 patients enrolled in the study, health related quality of life (hrqol) will be measured using the eq-5d-5l at baseline, 7 days and at 180 days. at baseline, the participant or their relative will be asked to recall the quality of life 4 weeks prior to the index hospital admission. questionnaires will be administered by direct patient completion or, postal or email survey with telephone follow up for non-responders after two mailings two weeks apart.

Eligibility criteria:
inclusion criteria: adult patients (18 years or older) who present to uk nhs hospitals with community acquired sepsis meeting all of the 4 criteria: 1. clinically suspected or proven infection resulting in principal reason for acute illness; 2. news score ≥5 (or news2 if adopted in recruitment site); 3. hospital presentation within last 12hrs; and 4. clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed. exclusion criteria: 1. \>1 litre of intravenous crystalloid fluid or any intravenous has administered prior to eligibility assessment; 2. requirement for immediate surgery (within one hour of eligibility assessment); 3. chronic renal replacement therapy; 4. known allergy/adverse reaction to has; 5. balanced crystalloid or has not available; 6. known adverse reaction to blood products; 7. palliation/end of life care (explicit decision by patient/family/carers in conjunction with clinical team that any active treatment beyond symptomatic relief is not appropriate); 8. religious beliefs precluding has administration; 9. previous recruitment in the trial; 10. known recent severe traumatic brain injury (within 3 months); 11. patients with permanent incapacity; 12. known recruitment in another ctimp studies within the last 30 days where co-enrolment has not been agreed.

Keywords: sepsis emergency care albumin crystalloid fluid resuscitation
pdgeneration: mapping the future of parkinson's disease

Conditions: Parkinson's Disease and Parkinsonism

Summary: to assess the feasibility, impact, and participant satisfaction of offering clinical laboratory improvement amendments (clia) certified genetic testing as part of clinical care for people with parkinson's disease (pwp).

the purpose of this study is to evaluate how offering clinical laboratory improvement amendments (clia) certified genetic testing for parkinson's disease (pd) genes to people with parkinson's disease impacts clinical care and potential enrollment in clinical trials. this multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through indiana university. the study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. all genetic test results will be returned to participants through a genetic counseling visit.

Eligibility criteria:
inclusion criteria: 1. meet movement disorder society (mds) clinical diagnostic criteria for parkinson's disease: probable diagnosis. 2. willingness to undergo genetic testing, and choose to be informed of genetic testing results for glucosylceramidase beta (gba), lrrk2 and 5 additional pd related genes (snca, vps35, prkn, pink-1, park7). 3. capacity to give full informed consent in writing, and have read and signed the informed consent forms (icfs) based on clinician's determination. 4. able to perform study activities (including completion of either online, in-person or paper surveys). 5. individuals must speak and understand the language of the informed consent. exclusion criteria: 1. diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus. 2. individuals who have received a blood transfusion within the past 3 months. 3. individuals who have active hematologic malignancies such as lymphoma or leukemia. 4. individuals who have had a bone marrow transplant within the past 5 years.

Keywords: parkinson's genetics pd genetics
osteopathic treatment and deep vein thrombosis (dvt)

Conditions: Deep Vein Thrombosis (DVT)

Summary: osteopathic treatment will provide: 1. a significant reduction of pain and swelling of the affected dvt leg 2. an increase in the quality of life (qol) for individuals with dvt of the leg 3. improved signs and symptoms of the post thrombotic syndrome of the affected dvt leg

thousands of individuals are affected by deep vein thrombosis (dvt) every year. medical treatment is aimed at preventing extension and recurrence of the blood clot (dvt) through the use of anticoagulation medication. compression stockings may be added for reduction of pain and swelling, but this therapy remains controversial amongst physicians. to date, there is limited manual therapies available for individuals affected with dvt. regular medical treatment, anticoagulation medication, along with osteopathic treatment may offer these individuals improved control of the symptoms associated with dvt. in the long term osteopathic treatment may provide an increase in the quality of life (qol) and improve the signs and symptoms associated with the post-thrombotic syndrome (pts), which can be burdensome for both the individual and the health care system. offering an effective add on treatment could provide individuals and the medical system with an additional means of treatment for the symptoms of dvt and also for the prevention of development of pts.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * first episode of symptomatic objectively confirmed proximal leg dvt without pulmonary embolism * 1 month of appropriate anticoagulation treatment * therapeutic level of anticoagulation (ie: warfarin, inr- 2.0-3.0) exclusion criteria: * \> 1 month + 7 days of anticoagulation * history of previously confirmed proximal or distal leg dvt * medically unstable individuals requiring hospitalization * history of peripheral vascular disease (pvd) * injury of affected leg (trauma within the last 6 months or leg currently casted) * history of previous stroke * uncontrolled hypertension * renal failure requiring hemodialysis or peritoneal dialysis * diagnosis of cancer in the last five years or currently receiving treatment for cancer * open heart or vascular surgery in the last year * any neurological condition (ie: ms, als, parkinsons, etc) * currently pregnant * geographic inaccessibility * unable to provide informed consent

Keywords: osteopathic treatment deep vein thrombosis proximal leg dvt
prepare: prep in pregnancy, accelerating reach and efficiency

Conditions: Pre-Exposure Prophylaxis; HIV Infections; Pregnancy Related

Summary: this study tests strategies for improving prep implementation in maternal and child health clinics using a difference-in-difference approach.

this study aims to improve integrated delivery of prep to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized prep delivery. strategies to be tested include a pre-developed package of strategies (video counseling, hiv self-testing, and optimized delivery).

Eligibility criteria:
inclusion criteria: * women receiving maternal and child health (mch) services hcw participating in satisfaction surveys exclusion criteria: * unwilling or unable to provide informed consent
the use and effectiveness of balloon for endobronchial ultrasonography

Conditions: Lung Cancer Staging

Summary: although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. furthermore, it is uncertain whether this leads to a better diagnostic yield. to our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with ebus. we hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.the aim of this study is to analyse whether the use of balloon during linear ebus 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.


Eligibility criteria:
inclusion criteria: * adults aged ≥18 years * patient referred for ebus guided tbna of mediastinal lns * the para-tracheal lymph node (ln) station 4r is planned to be biopsied. exclusion criteria -patient referred for ebus and 4r is not planned to be biopsed
erlotinib, cisplatin, and radiation therapy in treating patients with stage ib-stage iva cervical cancer

Conditions: Cervical Cancer

Summary: rationale: erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill tumor cells. erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells. purpose: this phase i trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage ib, stage ii, stage iii, or stage iva cervical cancer.

objectives: primary * determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage ib-iva squamous cell carcinoma of the cervix. secondary * determine the toxicity profile of this regimen. outline: this is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride. patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin iv on days 1, 8, 15, 22, and 29. patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy. cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. after completion of study treatment, patients are followed at 6 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell carcinoma of the cervix * stage ib-iva disease * scheduled to undergo standard radiotherapy and receive weekly cisplatin * ecog performance status 0-2 * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment * must be able to take oral medication exclusion criteria: * malabsorption syndrome * serious underlying medical condition that would impair the ability of patient to receive treatment * known hypersensitivity to erlotinib hydrochloride * psychological, familial, sociological, or geographical conditions that would preclude study compliance * less than 21 days since prior nonapproved or investigational drugs * prior chemotherapy * prior radiotherapy * prior anti-epidermal growth factor receptor treatment * prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition) * concurrent use of any of the following agents and therapies: * other antineoplastic or antitumor agents * other chemotherapy * other investigational agents * radiotherapy * immunotherapy * anticancer hormonal therapy

Keywords: stage iia cervical cancer stage ib cervical cancer stage iib cervical cancer stage iii cervical cancer stage iva cervical cancer cervical squamous cell carcinoma
ugytex® mesh versus subvesical plication in the surgical treatment of bladder prolapse

Conditions: Cystocele

Summary: the main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study pro-cure i.

secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years): a. the anatomic failure rate of cystocele (pop-q stage \> or = 2) b. late postoperative morbidity c. residual post-operative pain (visual analog scale (vas)) d. patient satisfaction via the pgi-i questionnaire e. quality of life via the pfdi and pfiq questionnaires f. sexual activity via the pisq-12 questionnaire g. the rate of vaginal erosion h. displacement and secondary shrinkage of meshs

Eligibility criteria:
inclusion criteria: * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patient included in, randomized and analysed in the procure study (nct00153257) exclusion criteria: * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * patient not included in the procure study
effects of ten-weeks progressive resistance training on neuromuscular performance, mobility, heart rate variability and sleep quality in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (me) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. the symptoms associated with ms include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. strength training has been shown to improve strength and mobility in persons with ms.

multiple sclerosis (me) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. the symptoms associated with ms include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. resistance training has been shown to improve strength, sleep quality and mobility in persons with ms.

Eligibility criteria:
inclusion criteria: * mild or moderate disability with clinical mild spastic-ataxic gait disorder. * stable phase of the disease. exclusion criteria: * expanded disability status scale (edss) \< 6. * relapsing disease within the preceding 12 months. * corticosteroid treatment within the last months before study inclusion.

Keywords: neurological disorders resistance training strength training sleep quality neuromuscular performance functional capacity
evaluating the efficacy of 2-octyl cyanoacrylate (2-oca) with four interrupted sutures in adult male circumcision

Conditions: Phimosis; Paraphimosis

Summary: this study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. the primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. to the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. the findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.

this non-blinded, randomized controlled pilot study is to be conducted at the men's health clinic in winnipeg, manitoba. all eligible patients undergoing circumcision will be invited to participate in the study. they will be randomly assigned in a 1:1 ratio using a computer-generated random list. patients will be randomized to 2-octyl cyanoacrylate (2-oca) with four interrupted sutures vs. standard suturing alone. in the post-operative recovery area, patients will be asked to complete a vas questionnaire. patients will then be brought in for their routine visit 6 weeks post-op. during the visit, closure of the wound as well as any potential complications will be assessed by a research team member. at that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. cosmesis and complications will also be assessed 12 weeks post-op.

Eligibility criteria:
inclusion criteria: * adult patients \>18 years of age undergoing circumcision will be included. exclusion criteria: * patients \<18 years of age who did not provide consent to be randomized.
t1 mapping in hiv patients with high and low cd4+ cell counts

Conditions: Heart Diseases; HIV

Summary: hiv-infection is associated with an increased risk for cardiovascular disease. especially patients with low cd4+ counts have a higher incidence of structural heart disease. myocardial t1 relaxation time, as well as t1-derived extracellular volume fraction are relatively new methods for non-invasive myocardial tissue characterization, including diffuse myocardial fibrosis. in our study hiv-patients with high and low cd4+ counts are examined on a 3t mri scanner (ingenia 3t, philips medical, best, netherlands). scanning protocol includes common ssfp sequences, stir imaging and lge \[late gadolinium enhancement\]. all hiv patients are treated in the hiv outpatient clinic of the hospital's internal medicine department and have an unremarkable history of cardiac disease. patients are recruited from all over germany. in order to obtain reference values, a subgroup of healthy, age-matched controls is included in this study. aim of this study is to show differences in t1- and ecv-values in the investigated subgroups. in addition, we also want to create cut-off values for healthy and affected myocardium in asymptomatic hiv-infected patients. this study could show whether myocardial t1 mapping is a potential screening parameter for beginning heart disease as part of an hiv-infection, and whether an application in routine diagnostic is reasonable.


Eligibility criteria:
inclusion criteria: * chronic hiv infection * no known cardiac disease * no cardiovascular risk factors exclusion criteria: * contraindications to mri (e.g. metal implants) * chronic kidney disease
breaking up sitting with a treadmill desk in office workers

Conditions: Cardiovascular Risk Factor; Type2 Diabetes; Sedentary Lifestyle

Summary: sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes and early death, even if you take part in the united kingdom government guidelines for physical activity of 21/2 hours per week of exercise. effective interventions to reduce the risk of these diseases are therefore needed. the aim of this study is to examine the effects of regularly breaking up sitting time with light intensity treadmill desk walking among office workers on health markers, sitting time and physical activity. if using a treadmill desk leads to benefits in these disease risk markers then this could be an effective strategy to improve employee health in the workplace. participants will be randomly assigned to the intervention group or the control group. after baseline activity and health measures, they will take part in the study for 4 weeks. intervention group: participants will have a treadmill desk placed in their office or a nearby location and will be asked to walk while working on the treadmill desk continuously for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift. there will be one treadmill desk between 2-3 people. control group: participants will be asked to work as usual at their regular workstation with no changes in their physical activity and dietary habits. sitting time and physical activity will be measured at baseline and during the last week f the intervention. a range of health and psychological measures will be taken at baseline and post-intervention.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 years who work for shifts lasting ≥ 6 h and spend ≥ 75% of this time sitting at their desk * work a minimum of 3 days per week exclusion criteria: * the presence of any known blood borne disease * self-reported diagnosed diabetes * physical activity contraindications * pregnancy * any major injury or illness, tobacco use, or any other health issue that my limit the participant in carrying out the required activity bouts. * any planned absence from their office for more than one week during the 4 week study period.

Keywords: prolonged sitting sedentary behaviour physical activity office workplace