Kornimate/medical-research-clean huggingface dataset:
understanding evaluation of patient information sheets by user testing method

Conditions: MS (Multiple Sclerosis)

Summary: the purpose of this randomized, open label, crossover, single site study is to compare the piss of two multiple sclerosis clinical trials to elucidate potential aspects of the given written information that could impact on the smooth running of the studies.

the participation to a clinical trial is based on two forms of information: the spoken information, usually given by a clinician during the enrolment meeting, and the written information, reported on the participant information sheet (pis). numerous studies performed to improve and enhance informed consent, have used different methods to evaluate the quality of the given information such as: interview, checklist, questionnaire, readability formulae. even if these tools can be useful, they show evident limits in detecting the real efficacy of the proposed consent form in terms of the patient's comprehension. user testing (ut) is a method originally developed in the 1990 in australia, to assess how a text about medicinal products performs with its intended users and not just its content. generally, the ut is based on an iterative 4-step process in a cohort of participants (the target group): * individual reading of the text; * individual questionnaire for a quantitative and qualitative evaluation; * a brief semi-structured interview to each participant; * a text revision to address any problems identified from participant feedback; then the revised document is tested again with a second cohort and this iterative process continues until all issues with the document are resolved. however, a methodological issue not yet explored is whether the ut could be used to compare two different piss, in order to elucidate aspects that could be involved in improving or worsening the understanding of a pis. ut has been recently used to evaluate the pis belonging to phase i and phase iii clinical trials (ct) in myeloid leukemia, immunomodulatory therapy and for poor responders in vitro fertilization. to date, in no case the ut method has been tested in patients affected by chronic disease like multiple sclerosis (ms). we want to apply the ut approach to highlight the critical issues and communication difficulties present in piss used in ms clinical trials.

Eligibility criteria:
inclusion criteria: pwms (60%) and caregivers (40%): for pwms: * 18 years or older; * ms diagnosis according to mcdonald criteria; * informed consent to the present study for caregivers: * 18 years or older; * in being a person who takes care of a pwms; * informed consent to the present study exclusion criteria: - not having taken part in one of the following trials evaluated in the present study: a) observational study of the prevalence of ccsvi in multiple sclerosis and in other neurodegenerative diseases (pis-a); b) brain venous drainage exploited against multiple sclerosis (pis-b).

Keywords: multiple sclerosis; patient information sheet; user testing
age-stratified outcome of pelvic floor muscle exercise for urinary incontinence

Conditions: Stress Urinary Incontinence; Urge Urinary Incontinence

Summary: in this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement. comparison of two age groups, controlled for bmi, parity and previous incontinence operations.

pelvic floor muscle exercise is an established conservative treatment for female urinary incontinence. up to now, the investigators don't know whether treatment outcome in elderly women is as good as in younger premenopausal women. the international incontinence society states 2009: "there is no good evidence to date to suggest that "healthy" older women with urinary incontinence do not benefit from pelvic floor muscle training as much as younger women". in this retrospective study the investigators analyze patient charts from 2003-2008 regarding subjective patients and physiotherapists reported outcome after physiotherapy as well as for objective parameters like the need of an incontinence surgery in the follow-up of at least 2 years. eligibility criteria are age younger than 50 years (premenopausal) and age older than 65 years and a urodynamically proven urinary incontinence. as incontinence forms the investigators include in this study the following three form: stress urinary incontinence, mixed urinary incontinence and urgency urinary incontinence.

Eligibility criteria:
inclusion criteria: * premenopausal women (\<50 years) with urodynamically proven urinary incontinence * postmenopausal women (\>65 years) with urodynamically proven urinary incontinence * 9 sessions of pelvic floor muscle exercise in a professional kinesiological setting inbetween 2003-2008 * follow up regarding need of incontinence operation up to june 2011 exclusion criteria: * women aged 50-65 years with urodynamically proven urinary incontinence * stool incontinence

Keywords: outcome of pelvic floor muscle physiotherapy female stress urinary incontinence urgency urinary incontinence mixed urinary incontinence
salvage stereotactic body radiotherapy of the prostate bed for biochemical recurrence after radical prostatectomy.

Conditions: Prostate Cancer

Summary: this is a a randomized phase ii/iii trial comparing salvage sbrt with standard of care (soc) regimens for patients with a persistent detectable psa or biochemical progression during follow-up after radical prostatectomy.

this is a multicentric randomized seamless phase ii/iii study comparing sbrt to conventional rt or moderately hypofractionated rt on the prostate bed. all subjects will be randomly assigned in a 1:1 ratio: 1. experimental arm: radiotherapy treatment in 5 fractions. 2. control arm: radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. for the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).

Eligibility criteria:
inclusion criteria 1. localized adenocarcinoma (cn0m0) of the prostate treated primarily with radical prostatectomy with definitive intent. 2. either persistent psa after prostatectomy (psa ≥ 0.1 ng/ml at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising psa amounts with a psa \>0.1 ng/ml , or three consecutive psa rises) 3. who ps 0-1 4. age ≥18 years 5. ability to understand and willingness to sign a study-specific informed consent prior to study entry 6. ability to understand and answer the epic-26 form in one of the languages available exclusion criteria 1. patients with a pt4 tumor at prostatectomy 2. patients with previously pathologically confirmed n1 3. patients with macroscopically involved margin at surgery (r2) 4. patients with a history of distant metastases 5. patients with a recurrence visible on imaging (local, pelvic, or distant). pelvic nodes with a small diameter \>1cm and/or positive on psma without other explanation, are considered as a pelvic recurrence. 6. latest psa \> 2ng/ml 7. patients with a ipss \>20 8. gleason 10 tumor 9. prior history of high-intensity focused ultrasound ablation (hifu), cryosurgery or brachytherapy of the prostate 10. prior pelvic radiotherapy 11. prior hormonal therapy started more than 6 weeks before randomization 12. history of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery. 13. other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.
early identification of warfarin maintenance dosage

Conditions: Atrial Fibrillation

Summary: initiation of warfarin therapy is problematic. the investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on inr value at day five after four days of 5 mg/day warfarin. to this end patients with atrial fibrillation starting warfarin are randomized in two arms.

the objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. in patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of vkorc1 genotype and patient's body weight.the second day warfarin maintenance dose is calculated on the basis of surface area and cyp2c9, cyp4f2 e vkorc1 genotype. in the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (pengo v, am j cardiol 2001). inr is checked on day 0, 5, 7, 9, 12, 15 and 19. primary end-point of the trial is the number of inr outside the therapeutic range of 2.0 to 3.0. secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.

Eligibility criteria:
inclusion criteria: * age \>18 years * indication to warfarin with inr between 2.0 and 3.0 exclusion criteria: * pregnancy * drug interactions * basal inr \> 1.2

Keywords: warfarin dose pharmacogenetic inr
randomized comparison of dcb for the treatment of superficial femoral and popliteal peripheral artery disease

Conditions: Angioplasty, Balloon; Catheterization, Peripheral; Popliteal Artery; Femoral Artery

Summary: this study evaluates the safety and effectiveness percutaneous transluminal angioplasty(pta) using drug-coated balloons for the treatment of superficial femoral and popliteal peripheral artery disease.


Eligibility criteria:
inclusion criteria: * age 19 and above * subject with claudication or critical limb ischemia(rutherford classification level 2\~5) * subject with total occlusion or stenosis ≥70%(de novo, restenosis) * vessel diameter 4\~6mm * success to guide wire pass * patients who don't have known hypersensitivity or allergy for dual-platelets * willing and able to provide informed written consent exclusion criteria: * acute stage * acute thrombosis in target limb or target vessel * failure to guide wire pass * distal outflow * lesion with poor inflow * life expectancy ≤ 2 years * allergic to paclitaxel * pregnant or breast feeding woman or disagree with contraception or having children

Keywords: drug-coated balloon superficial femoral artery popliteal peripheral artery
expanded access of fostamatinib in patients with persistent or chronic relapsing/refractory itp

Conditions: Immune Thrombocytopenic Purpura

Summary: c-935788-055 is an open-label, multi-center, expanded access (eap) study.

the purpose of the program is to provide fostamatinib in an expanded access setting to subjects who meet the selection criteria.

Eligibility criteria:
inclusion criteria: 1. adult patient with chronic or persistent itp. 2. must have failed or are unable to receive standard of care treatments for itp. 3. must have at least two platelet counts \< 30,000/µl during the last 2 months prior to screen date. exclusion criteria: 1. itp associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia. 2. subject has uncontrolled or poorly controlled hypertension. 3. any of the following laboratory abnormalities: neutrophil count of \ 1.5x uln, total bilirubin \> 2.0 mg/dl. 4. active hbv or hcv infection. 5. current or recent enrollment in an investigational drug or device study.

Keywords: itp immune thrombocytopenia
a study of tarceva for use in patients with relapsed or refractory metastatic non-small cell lung cancer

Conditions: NSCLC

Summary: tarceva, an orally available small molecule, has demonstrated potent activity in tumor models and humans. this randomized, open-label phase 2 study of tarceva alone and of tarceva plus velcade is designed primarily to determine the objective tumor response rates to these treatments in patients with stage iiib or stage iv non-small cell lung cancer (nsclc) that is refractory to or has relapsed after front-line chemotherapy.


Eligibility criteria:
inclusion criteria: 1)relapsed or refractory, stage iiib or stage iv nsclc that has been histologially or cytologically confirmed. 2)one prior line of conventional cytotoxic chemotherapy. 3)documented progressive disease(pd) during or since last prior therapy as determined by the investigator. 4)18 y/o or older. 5)have measurable disease by recist. 6)eastern cooperative oncology group (ecog) performance status 0 or 1. 7)life expectancy greater than 3 mo from the date of enrollment. 8)female patient is either post-menopausal, surgically sterilized or willing to use an acceptable method of birth control. 9)male pateint agrees to use an acceptable method of birth control during study treatment. 10)provide written informed consent before the conduct of any study-related procedure. 11)willing and able to comply with the protocol requirements. exclusion criteria: 1)previous treatment w/velcade. 2)pre-existing interstitial lung disease. 3)peripheral neuropathy of grade 2 or greater. 4)diarrhea or vomiting greater than grade 1 in intensity whether in the absence or presence of antidiarrheal and/or antiemetic therapy. 5)chemotherapy, radiation therapy, treatment wtih monoclonal antibodies, or major surgery w/in 4 wks prior to enrollment. 6)documented greater than 10% wt loss in the 6 wks. prior to enrollment. 7)inadequate organ function during screening as per laboratory values. 8)myocardial infarction w/in 6 months prior to enrollment. 9)brain metastases. 10)any malignancy other than nsclc occuring w/in 5 years of enrollment with the exception of basal cell carcinoma of the sin, and carcinoma in situ of the cervix. 11)hx of allergic reaction to compounds containing boron or mannitol. 12)known human immunodeficiency virus (hiv)+ or hepatitis b. 13)poorly controlled hypertension, diabetes mellitus, or pyschiatric illness. 14)pregnant or breast-feeding woman. confirmation that patient is not pregnant must be established by a negative serum (b-hcg).15)currently enrolled in another clinical research study or has received an investigational agent w/in 4 weeks prior to enrollment.
kovanaze vs. articaine in achieving pulpal anesthesia of maxillary teeth - pediatric

Conditions: Caries,Dental; Apical Periodontitis

Summary: the primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between kovanaze nasal mist and articaine needle anesthesia.

in june 2016, an intranasal delivery system of local anesthesia called kovanaze, gained fda approval. \[9\] kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. even though success rates between 83 and 90 % have been reported for adults and children \>40kg, \[10\] fda label (section 14.2) provides data for children (\>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. \[9\] * one 0.1 ml spray for patients weighing 10 kg to less than 20 kg; * two 0.1 ml sprays for 20 kg to less than 40 kg; or * two 0.2 ml sprays for patients weighing 40 kg or more. with the ability to avoid the traditional painful injection kovanaze offers promise in the field of maxillary anesthesia and this study intends to: 1. compare kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing \> 20 kg) 2. evaluate patient anxiety, tolerance and acceptability of kovanaze in patients undergoing dental procedures

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class i or ii * preoperative heart rate of 55 to 100 beats per minute * maximum blood pressure reading of 166/100 mmhg * treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia additional pediatric inclusion criteria: * children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth additional endodontic inclusion criteria: * adults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth additional general practice inclusion criteria: * adults who require restorations in the maxillary teeth that would need local anesthesia exclusion criteria: * inadequately controlled thyroid disease * five or more nosebleeds in the past month * known allergy to any study drug or para-aminobenzoic acid * history of methemoglobinemia * taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol); * taking oxymetazoline-containing products (i.e., afrin) in the last 24 hours.

Keywords: cavities
vonoprazan-based therapy versus standard regimen for helicobacter pylori infection management

Conditions: Helicobacter Pylori Infection

Summary: appropriately, half of the global population is infected with h. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. currently, the main challenge in the field of h. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens. the aim of the study is to assess the safety and efficacy of different h. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of clarithromycin, amoxicillin, and proton pump inhibitor to eradicate h. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

1. ethical committee approval is obtained from ethics committee of faculty of medicine, alexandria university. 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. patients with suspected h. pylori infection are recruited from alexandria university out-patient clinics 4. participants' demographic data, full medical and medication history, and detailed clinical presentation is documented 5. participants are tested for h. pylori infection using rapid h. pylori stool antigen test device 6. negative subjects are excluded while positive patients are randomly allocated to 3 groups of different h. pylori regimens (standard triple, vonoprazan dual, and vonoprazan triple) 7. following up treatment side effects while taking the medications. 8. assessing regimens effectiveness through patient retesting at least 1 month after treatment completion. 9. assessing patient compliance to different regimens during the final visit. 10. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 11. results, conclusion, discussion and recommendations will be given.

Eligibility criteria:
inclusion criteria: * patients with positive stool antigen test result for h. pylori * patients recently diagnosed with h. pylori infection and did not receive any treatment exclusion criteria: * patients sensitive to any of the regimens' components * patients who had received a previous eradication therapy and still show positive test results * recent use of antimicrobial agents, proton pump inhibitors, and h2 receptor blockers within 1 month * patients with gastric malignancy or who underwent previous gastric surgery * pregnancy and lactation * patients with major concomitant diseases, including psychic disorders

Keywords: helicobacter pylori vonoprazan standard triple therapy
monitoring by microdialysis of postoperative complications after proctectomy

Conditions: Rectal Cancer

Summary: the aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.


Eligibility criteria:
inclusion criteria: * rectal disease requiring proctectomy with anastomosis and stomy * proctectomy by laparoscopy or laparotomy * written consent exclusion criteria: * history of colorectal surgery * rectal surgery without anastomosis * breastfeeding or pregnancy * asa score iv

Keywords: rectum microdialysis anastomotic leaks
zinc for infection prevention in sickle cell anemia (zips)

Conditions: Sickle Cell Disease

Summary: a randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in ugandan children with sickle cell anemia (sca).

the study will be a randomized, placebo-controlled, double blind clinical trial in which 250 ugandan children 1.00-4.99 years of age with sca will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. the primary study outcome will be incidence of severe or invasive infections. secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or pcr), incidence of vaso-occlusive crisis (voc), change in height-for-age z-score, and incidence of zinc-related adverse events.

Eligibility criteria:
inclusion criteria: 1. documented sickle cell anemia (hbss supported by hemoglobin electrophoresis) 2. age range of 1.00-4.99 years, inclusive, at the time of enrollment 3. weight at least 5.0 kg at the time of enrollment 4. willingness to comply with all study-related treatments, evaluations, and follow-up exclusion criteria: 1. known other chronic medical condition (e.g., hiv, malignancy, active clinical tuberculosis) 2. severe malnutrition determined by impaired growth parameters as defined by the world health organization (who) (weight for length/height or height for age z-score \<-3, using who growth standards)

Keywords: zinc
gene therapy for x-linked chronic granulomatous disease (cgd) in children

Conditions: Chronic Granulomatous Disease

Summary: the aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous cd34+ cells of the peripheral blood of chemotherapy conditioned (busulphan) children with chronic granulomatous disease (cgd). also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.


Eligibility criteria:
inclusion criteria: * x-linked chronic granulomatous disease * history of life-threatening severe infections * no hla-matched related or unrelated donor * therapy resistent life threatening infections/organ dysfunction * no other treatment options e.g. hsct exclusion criteria: * \> 18 years of age * hiv infection * life expectancy \> 2 years * infections treatable by conventional therapy (antibiotics, antimycotics, allogeneic granulocytes)

Keywords: chronic granulomatous disease in children (=or< 18 years)