Kornimate/medical-research-clean huggingface dataset:
validity and reliability of the 6-minute walk test over a distance of 6 metres in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this study is to validate a different version of the 6 minutes walk test (6minwt), the 6minwt on 6 meters, instead of the 30 meters. the secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minwt6 and the 6minwt30 (according to speed at half-turn, other parameters: age, gender, height, edss score, type of disease, time since relapse).

the 6minwt is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (ms) patients. the protocol for this test recommends a distance of 30 meters (6minwt30) to perform the test. however, this distance is not always available in practices and patients' homes. the aim of this study is therefore to validate a protocol over a distance of 6 meters (6minwt6) and to evaluate its reliability : intra-evaluator and test-retest. the project focuses on the population of walking patients with ms. inclusion: adults, confirmed diagnosis of ms, expanded disability status scale (edss) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of french, have already completed a 6-minute walking test, be able to give consent by signature. exclusion: lung disease, heart disease, co-morbidity preventing 6minwt, relapse in the last 3 months, chronic fatigue ≥ at 8 (visual analog score-fatigue or rochester fatigue diary). 21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minwt. the alpha was set at 0.01, the power at 0.9 for a correlation of 0.8. each patient will enter the study for one week, corresponding to two visits. the participant will perform the 6minwt6 and the 360 degree turn test the first day and the 6minwt30 followed by the 6minwt6 after up to 45 minutes rest, the second day, a week apart.

Eligibility criteria:
inclusion criteria: * adults * confirmed diagnosis of ms * expanded disability status scale score 3 to 6.5 * to be able to walk 30 meters with or without aids * good understanding of french * have already completed a 6-minute walk test * to be able to give consent by signature exclusion criteria: * lung disease * heart disease * co-morbidity preventing 6minwt * relapse in the last 3 months * chronic fatigue ≥ at 8 (visual analog scale- fatigue)
trapeziectomy and suture suspensionplasty for thumb carpometacarpal arthritis - is in-clinic therapy needed?

Conditions: CMC Arthritis; Occupational Therapy; Hand Arthritis

Summary: the study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following cmc arthroplasty

while hand surgeons agree that strength and flexibility exercises are crucial after surgery, there is currently no consensus on whether the benefits of participating in formal hand therapy outweigh the investment required. the financial and time investments required to participate in formal hand therapy can be particularly large in patients living in rural locations, as access to certified hand therapists are often limited. therefore, a prospective, randomized trial of hand therapy utilization is warranted to explore this phenomenon. the purpose of this clinical trial is to assess the outcomes for post-operative therapy from in-clinic or at-home exercise therapies and analyze costs associated with the different therapies. for this clinical trial patients will be randomized to either in-clinic occupational therapy where patients come into clinic and undergo about 30-60 minutes of occupational therapy 1-2 a week with a physician or at-home exercise therapy where patients are provided instructions in clinic prior to hep-therapy and have check-ins with physicians at their normal follow-up appointments; each consisting of about 5-10 minutes of exercise at home everyday of the week. this study is a prospective, randomized, controlled trial to asses and analyze: 1. the outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (ot) and without in-clinic occupational therapy: home exercise program (hep). 2. the cost difference between the ot and hep groups as well as historical control patients that have undergone lrti for thumb carpometacarpal joint arthritis (including preoperative, intra-operative, and postoperative costs).

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years * patients undergoing cmc arthroplasty * ability to read and write in english * ability to provide informed consent exclusion criteria: * patients undergoing revision cmc arthroplasty * acute traumatic dislocation of the cmc joint as indication for surgery * concomitant treatment of mcp hyperextension

Keywords: cmc arthroplasty thumb arthritis hand therapy
a new technique for sacrospinous-sacrotuberous fixation for the treatment of uterovaginal and vaginal vault prolapse

Conditions: Uterovaginal and Vaginal Vault Prolapse

Summary: this prospective interventional randomized controlled trial is conducted to compare a new technique for sacrospinous-sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.


Eligibility criteria:
inclusion criteria: 1. age from 40 to 60 years. 2. pop q stage iii \& iv 3. uterovaginal prolapse. 4. vaginal vault prolapse. 5. bmi \>35. exclusion criteria: 1. age \> 40 years or \< 60 years. 2. pop q stage i or ii. 3. bmi \< 35. 4. previous repair of uterovaginal or vaginal vault prolapse. 5. comorbidity with stress urinary incontinence. 6. presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions. 7. any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Keywords: treatment
a study to evaluate the envista® aspire (ea) intraocular lens in subjects undergoing cataract extraction

Conditions: Cataract

Summary: a study to evaluate the envista® aspire (ea) intraocular lens in subjects undergoing cataract extraction

a non-interventional, prospective, multicenter, single arm, post-marketing clinical study to evaluate the envista® aspire (ea) intraocular lens in subjects undergoing cataract extraction

Eligibility criteria:
inclusion criteria: 1. subjects must be 22 years of age or older on the date the informed consent form (icf) is signed. 2. subjects with a post operative bcdva of 20/40 or better. 3. subjects must have the capability to understand and provide written informed consent on the institutional review board (irb) approved icf and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit. 4. subjects implanted bilaterally with envista aspire ea iols, powers ranging from + 6 to + 34.0 d, prior to enrollment into the study on or after 1 november 2023. 5. all subjects with a visually significant pco (bcdva worse than 20/40) who undergo a yag capsulotomy may be enrolled 30 days post yag procedure and with a postoperative bcdva 20/40 or better. exclusion criteria: 1. subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the investigator's judgment, could confound the results of the study. 2. subjects for whom a toric iol is indicated to achieve emmetropia. 3. subjects for whom monovision treatment is planned.
a phase i study to investigate the tolerability and safety of ono-4685 given as monotherapy in t cell lymphoma and cll/sll

Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary: a phase i study to investigate the tolerability and safety of ono-4685 given as monotherapy in t cell lymphoma and cll/sll


Eligibility criteria:
inclusion criteria: 1. patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the who classification of lymphoid malignancies: peripheral t-cell lymphoma(ptcl) * angioimmunoblastic t-cell lymphoma(aitl) * peripheral t-cell lymphoma, nos(ptcl-nos) * nodal peripheral t-cell lymphoma with tfh phenotype(nodal ptcl with tfh) * follicular t-cell lymphoma(ftcl) cutaneous t-cell lymphoma(ctcl) * mycosis fungoides(mf) * sezary syndrome chronic lymphocytic leukemia/small lymphocytic lymphoma(cll/sll) 2. relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator 3. ecog ps 0\~2 4. life expectancy of at least 3 months exclusion criteria: 1. patients with severe complications. 2. patients with multiple cancers.
testing different modes of cognitive behavior therapy

Conditions: Depression; Literacy

Summary: the purpose of this study is to test a novel behavioral treatment - adapted cognitive-behavior therapy (acbt) - against standard cognitive behavior therapy (cbt). the goal of the study is to determine if acbt confers improved outcomes for women with depression and low literacy. depression is a serious women's health issue. according to the world health organization, depression is the leading cause of disability worldwide with females reporting symptoms of depression at almost twice the rate of males. this study will provide pilot data to enable us to determine the effect size needed to detect a between-groups change in depression scores. the overall impact of this study will be empirical support for a novel form of treatment for women with depression, who also may lack adequate literacy, educational, or cognitive ability required to benefit from standard cbt.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. female 3. diagnosis of major depressive disorder (mdd) according to dsm-5 (diagnostic and statistical manual-5) (and no specifiers that pertain to exclusionary criteria (e.g. mdd with psychotic features) 4. able and willing to give informed consent 5. able to communicate in english 6. willingness to be randomized to therapy 7. willing to complete all study assessments 8. at baseline, no plans to move from the chicago area during the duration of the study exclusion criteria: 1. history of bipolar disorder 2. history of psychosis 3. current substance use disorder of moderate or severe level of severity 4. suicidal intentions or actions within the past three months 5. known neurologic disease (e.g., multiple sclerosis, parkinson's disease, cerebrovascular accident) and/or cognitive or neurologic impairment (e.g., alzheimer's disease) 6. current participation in other psychotherapy (not including psychiatric appointments pertaining to medication management) 7. inadequate vision or hearing to interact with study materials 8. being a prisoner, detainee, or being in police custody 9. any current involvement in litigation
starting technology in at risk type 1 diabetes study

Conditions: Diabetes Mellitus, Type 1

Summary: diabetes technology has revolutionized t1d management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled t1d (a1c\>8.5%). in order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly white, higher ses). therefore, the investigators propose to perform a pilot rct of hybrid closed-loop insulin pump therapy (hcl) in 40 diverse adult patients with poorly controlled t1d (hba1c \>8.5%) from the largest academic and safety net health systems in the los angeles region to determine the feasibility of a rct in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled t1d.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * a1c \>8.5% * not insulin pump user * primary language of english or spanish * have medical insurance coverage exclusion criteria: * no measured a1c in the past year * have comorbidities that can result in inaccurate hemoglobin a1c * have cognitive, physical or mental impairment precluding diabetes technology use * limited life expectancy (\<1 year) * pregnancy

Keywords: continuous glucose monitoring insulin pump hybrid closed loop systems diabetes technology health disparities
clinical biocompatibility evaluation of contact lens coatings

Conditions: Refractive Errors; Ametropia

Summary: the primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against purevision™ lenses, all pre-cycled with opti-free® replenish® multi-purpose disinfection solution.

in this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. lenses will be worn according to a randomized lens sequence assignment. each pair will consist of a test lens (test 1 or test 2) and a control lens.

Eligibility criteria:
inclusion criteria: * able to understand and must sign an informed consent; * successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * manifest cylinder less than or equal to 1.50 diopter (d) in each eye; * best corrected visual acuity (bcva) 20/25 or better in each eye; * va with habitual spectacles 20/40 in both eyes (ou) or better and willing to wear spectacles as needed during the washout period and during study lens exposure; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear; * any use of systemic or ocular medications for which contact lens wear could be contraindicated; * history of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye; * ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * current or history of pathologically dry eye in either eye that would preclude contact lens wear; * current or history of herpetic keratitis in either eye; * eye injury in either eye within 12 weeks immediately prior to enrollment; * history of intolerance or hypersensitivity to any component of the study lenses or solutions; * habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * other protocol-specified exclusion criteria may apply.
noncurative endoscopic resection of colorectal adenocarcinoma

Conditions: Noncurative Resection

Summary: patients with noncurative resection after esd for crc were considered for additional surgical treatment. then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. we performed a retrospective revision of outcome data by clinical report review or phone calls.

patients with noncurative resection after esd for crc were considered for additional surgical treatment. then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. we performed a retrospective revision of outcome data by clinical report review or phone calls.

Eligibility criteria:
inclusion criteria: - undergoing non-curative colorectal endoscopic submucosal dissection (esd). exclusion criteria: * histology other than cancer (adenocarcinoma). * history of inflammatory bowel disease (ibd). * genetic conditions predisposing to cr. * lost to follow up or less than 6 months of follow up.
mothers and babies at yorkhill thyroid health cohort

Conditions: Thyroid Function

Summary: this is an observational study in pregnant mothers and their newborn babies. the rationale of the study is to examine early markers of the effects of iodine insufficiency during pregnancy on thyroid stimulating hormone (tsh) and thyroglobulin in mother and baby.

iodine is a critical component of thyroid hormones, which are essential for normal growth, and brain development, most of the latter occurring during fetal life and in the first three years of life. maternal dietary iodine is the sole source for fetuses and for exclusively breastfed infants. recent evidence indicates that the uk female population is not iodine sufficient. thus a significant proportion of uk pregnant women will also be insufficient in dietary iodine with potential harmful consequences for their babies. we wish to investigate the relationship between maternal iodine status (sufficient versus insufficient) in pregnancy, the mode of neonatal feeding (exclusively breast fed vs exclusively formula fed); and the effect this has on the functioning of the newborn baby's thyroid gland, with provision for later cognitive followup assessment. in order to do this, we will determine: i) the iodine status of the mother during pregnancy and in the immediate postnatal period (dietary and urinary) and the newborn infant (urinary), ii) the thyroid function of the mother (thyroid stimulating hormone, thyroglobulin, t4 in serum during pregnancy, and thyroid stimulating hormone and thyroglobulin in dried blood spots postpartum) and infant (thyroid stimulating hormone in dried blood spots collected during a routine procedure). our hypothesis is that babies whose mothers are iodine insufficient will show higher levels of tsh and thyroglobulin than the babies of iodine sufficient mothers.

Eligibility criteria:
inclusion criteria: * healthy pregnant women * able to read, write and speak in english * attending a greater glasgow and clyde maternity unit exclusion criteria: * abnormal pregnancies. * mothers with known thyroid disorders. * preterm infants (born before 37 completed weeks). * multiple births. * infants with postnatal problems such as infection or malformation.

Keywords: iodine thyroid tsh pregnancy nutrition diet
pulmonary embolism response to fragmentation, embolectomy, & catheter thrombolysis: perfect

Conditions: Pulmonary Embolism

Summary: a prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (cdt) including percutaneous mechanical thrombectomy (pmt) for treatment of acute pulmonary embolism (pe)

the primary objective of this study is to capture high quality patient safety and effectiveness data on cdt for acute pe. the goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for pe patients undergoing cdt. secondary study objectives include the following: - to assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide) these objectives will be achieved through the capture of selected process data for patients included in the registry. data collected in this study may also be used to develop and refine standards of care for use of cdt for pe and to facilitate the design of randomized clinical trials

Eligibility criteria:
inclusion criteria: * must be age greater than or equal to 18 * obtain informed written consent. * diagnosed with acute pulmonary embolism (pe) (\< 14 days) * catheter-directed therapy (cdt) was performed to treat acute pe
treatment decision-making in patients with recurrent high-grade glioma

Conditions: Malignant Glioma; Life Experiences

Summary: this qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. with focus on the decision-making about treatment and care..

high-grade glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. the life expectancy is short, and a majority of patients experience recurrence of tumour growth. at time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care. in this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs. little is known about how the patients and their close relatives experience the recurrence and the decision-making process. the objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence. data will be generated through semi-structured interviews. interviews will be analysed and interpreted using a ricoeur inspired method of qualitative analysis. the study is part of a larger phd-study.

Eligibility criteria:
inclusion criteria: * the patient is offered surgical treatment (after an assesment done by the multidisciplinary team) * able to speak and understand danish * able to participate in an interview * able to give informed concent for participation exclusion criteria: * patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview. * relatives are excluded if the patient do not give concent for the participation of relatives

Keywords: high-grade glioma patient experiences decision-making patient involvement
economic evaluation of an education platform for patients with end-stage renal disease

Conditions: End-stage Renal Disease; Dialysis; Kidney Transplantation

Summary: 1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages. the total follow up duration is 18 months. primary endpoint is the cost utility of using app-based therapeutic intervention, secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), budget impact analysis


Eligibility criteria:
inclusion criteria: * severe end-stage renal disease internet, literacy informed consent exclusion criteria: * did not fill the screening questionnaire

Keywords: economic evaluation e health
a pilot clinical study to evaluate the feasibility of using the spc test

Conditions: Gastric Cancer

Summary: precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. in this study, we evaluated the clinical feasibility of the single patient classifier (spc) test, a new clinical-grade prognostic assay, in stage ii-iii gastric cancer patients.

a prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between september 2019 and august 2020 across nine hospitals. the spc test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. the primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. furthermore, 3-year disease-free survivals of risk groups were analyzed.

Eligibility criteria:
inclusion criteria: * being ≥19 years of age * having a histologically confirmed diagnosis of stage ii or iii agc according to the american joint committee on cancer (ajcc) staging system (sixth edition) * underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy * having no visually or microscopically detectable residual tumors. exclusion criteria: -those with insufficient quantity or quality of ribonucleic acid (rna) for analysis were excluded from the study.