Kornimate/medical-research-clean huggingface dataset:
effectiveness of 'functional range conditioning' in treating patients with chronic non-specific low back pain

Conditions: Chronic Low Back Pain

Summary: the aims of this study are to examine the effectiveness of functional range conditioning in patients with chronic non-specific low back pain in terms of improving hip internal rotation and strength of the hip abductors, and reducing pain and disability.

it will be a single blind two-arm randomized controlled trial. saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain will be invited to participate in this study. subjects who will fulfill the study's criteria and who are willing to participate in this study will be asked to sign an informed consent form. the primary outcome will be the active and passive range of motion (rom) of the hip internal rotators and it will be measured using digital inclinometer. the secondary outcomes in this study will be the maximum torque of the hip abductors (gluteus medius), concentric at a constant, low-speed, and high-speed. the peak torque and strength will be measured using isokinetic dynamometry, pain intensity will be assessed using a visual analog scale and disability will be assessed using oswestry disability index. all participants will have their information taken by the principal investigator. subsequently, participants will randomly be assigned to either the frc group or the conventional treatment group by the principal investigator. concealed randomization will be performed by means of a computer-generated table of random numbers. outcomes will be measured at baseline, week 4 and week 8 for all participants in both groups by an assistant researcher.

Eligibility criteria:
inclusion criteria: * saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain exclusion criteria: * hip, spine and knee pathology. * hip and knee replacement. * surgery and fracture within the last 6 months. * cancer. * pregnant women. * any medical condition that precluded safe participation in exercise programs such as significant cardiac, pulmonary, neurological disease or mental disorder.
virtual kidney check and follow-up

Conditions: Kidney Disease, Chronic

Summary: the goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (ckd) in first nations adults in manitoba. the main questions it aims to answer are: * to identify chronic kidney disease in first nations adults in manitoba * to risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category * to initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure participants will be randomized to: 1. patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin creatinine ratio 2. patient and primary care network contact via mail with a letter but no laboratory requisition the primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.


Eligibility criteria:
inclusion criteria: * age\>= 18 years * resident of manitoba * first nations * urban, rural or remote location exclusion criteria: * kidney failure (dialysis or transplant) * chronic kidney disease (estimated glomerular filtration rate \<60 milliliter/1.73square meter for 3 months) * screening for chronic kidney disease with estimated glomerular filtration rate or albumin to creatinine ratio in the last 2 years
multicultural healthy diet in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: this is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.

this is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. the study will recruit 20 adult participants with chronic kidney disease (ckd) from nephrology clinics in the bronx. the diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. the diet will also be tailored to needs of the ckd population including a focus on lowering sodium intake. the intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with ckd. the investigative team will assess whether the diet is feasible, acceptable, and safe in patients with ckd through dietary intake assessments, questionnaires and serum biomarkers. information from study will help inform the study design and intervention of a future large-scale, study aimed at improving ckd outcomes. the clinical site for the proposed study is at the albert einstein college of medicine and montefiore medical center.

Eligibility criteria:
inclusion criteria: * age ≥18 years * ckd stage 3 (estimated glomerular filtration rate (gfr) \ 30 ml/min/1.73m2) * residency in the bronx * english or spanish speaking * provide written informed consent exclusion criteria: * history of hyperkalemia, or baseline serum potassium (k) \> 4.8 * ckd stage 4 or higher (egfr \<30 ml/min/1.73 m\^2) * unwillingness to make dietary changes * history of kidney transplant * poorly controlled diabetes (hba1c \>9%) or insulin use * any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities
use of ehealth in communication with patients about prenatal diagnosis

Conditions: Downs Syndrome; Health Knowledge, Attitudes, Practice

Summary: the research aims at generating new knowledge about ways to inform pregnant women about prenatal screening for downs syndrome. the overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for downs syndrome, and thereby an option to make an informed choice. the project is planned as a research into whether the use of an ehealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

prenatal screening and diagnosis is testing for diseases or rare conditions in the fetus before birth. the aim is to assist the pregnant women to make their own decisions, and neutral and adequate counseling is a prerequisite during prenatal diagnosis. to make an informed choice, the pregnant women must be informed about the benefits and potential disadvantages of prenatal diagnosis and with this background be able to make a comprehensive evaluation, where ethical values will have a high impact. the overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for downs syndrome, and thereby an option to make an informed choice. the project is planned as a research into whether the use of an ehealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women. methods: part one consists of an identification of the problem part two consists of developing a website with relevant information about prenatal screening for downs syndrome. part three is an effect measurement. the effect of the intervention is measured through a randomized controlled trail in which the essentials of the measurement will be the pregnant women's knowledge and behavior in relation to prenatal diagnosis. twice 300 pregnant women will be included in the project. results: the research aims at generating new knowledge about ways to inform pregnant women about prenatal diagnosis and prenatal screening. the expected results are: * higher knowledge about prenatal diagnosis for the pregnant women. * less difficulty in making an informed choice for the coming parents. * easy access to high quality information. * equity in access to high quality information.

Eligibility criteria:
inclusion criteria: * pregnant women participating in screening for downs syndorme exclusion criteria: * respondents who do not speak, read and understand danish. * respondents who have opted out of health care services and prenatal diagnosis. * reespondenter who do not wish to participate. * respondents under 18 years. * respondents with a strong suspicion of threatening abortion * respondents whom are vulnerable * respondents with a late referral

Keywords: screening downs syndrome informed choice ehealth
high-fat yogurt and plasma lipids profile

Conditions: Plasma Lipid Profile

Summary: the goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. the main question it aims to answer are: -does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? in this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy people who do not use lipid-lowering, blood pressure control or diabetes medications exclusion criteria: * taking supplements of omega-3 fatty acids, or antioxidants
office hysteroscopy versus cervical probing for cervical stenosis

Conditions: Hysteroscopy

Summary: this study aims to estimate if performing a small caliber office hysteroscopic cervical negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind cervical probing done under general anesthesia. moreover, the investigators test the impact of drawing a detailed diagram after this procedure on the success of et in participants with failed mock or actual trials of embryo transfer (et).

it comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the office. participants were divided into 2 groups. group a comprised 64 cases subjected to small-caliber office hysteroscopic cervical negotiation while 58 cases were subjected to cervical probing under general anesthesia. main outcome measures included success to bypass primary cervical stenosis and complication rate

Eligibility criteria:
inclusion criteria: * nulliprous women. * failed cervical sounding on vaginal examination in the office. exclusion criteria: * previous operation on the cervix. * use of any medication to prime the cervix (primary). * multiparity: weather delivered vaginally or by cesarean sectrion

Keywords: hysteroscopy cervical stenosis probing
evaluation of tolsura when used as prophylaxis after lung transplantation

Conditions: Lung Transplant Infection

Summary: this is a single-center, observational study of tolsura pk sampling in lung transplant recipients

patients who are receiving tolsura as part of their clinical care will be asked to enroll and emr data and excess biological samples will be collected

Eligibility criteria:
inclusion criteria: * 18 years of age and older * hospitalized at upmc * placed on tolsura prophylactically by clinical team * patients who have had or will have a lung transplant. exclusion criteria: * redo lung transplant * recipient with dual liver-lung transplant * patients with previous history of sot * including other organ transplantation * patients with known pre-transplant colonization with moulds resistant to azoles * patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor * patients with a history of hypersensitivity reaction to an azole agent * patients who are kept npo (nothing by mouth, including meds) * recipients or donor with hepc pcr positive

Keywords: lung transplant
extension study of vibegron in men with overactive bladder (oab) symptoms on pharmacological therapy for benign prostatic hyperplasia

Conditions: Overactive Bladder

Summary: this study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (oab) symptoms on pharmacological therapy for benign prostatic hyperplasia (bph) who previously completed treatment in study uro-901-3005 (nct03902080).


Eligibility criteria:
inclusion criteria: * participant has completed participation of the 24-week double-blind treatment period in study uro-901-3005 (nct03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator. * participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * participant has the ability to continue to receive a stable dose of benign prostatic hyperplasia (bph) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ari. * in the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the bladder diary. exclusion criteria: * participant experienced any serious adverse event in study uro-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator. * participant is using any prohibited medications * participant has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 milligrams per deciliter \[mg/dl\] or 8.33 millimoles per liter \[mmol/l\] and/or non-fasting blood glucose \>200 mg/dl or 11.1 mmol/l) based on most recent available lab results in study uro-901-3005 or uncontrolled in the opinion of the investigator. * participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury \[mmhg\] and/or diastolic blood pressure of ≥100 mmhg) or has a resting heart rate (by pulse) \>100 beats per minute. * participant has systolic blood pressures ≥160 mmhg but \<180 mmhg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol. * participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.

Keywords: overactive bladder benign prostatic hyperplasia vibegron beta-3 adrenergic receptor (β3-ar) β3-ar agonist
silicone hydrogel soft contact lens 7-day extended wear basis

Conditions: Myopia

Summary: the objective of this study is to evaluate the safety and effectiveness of the bausch + lomb samfilcon a soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the bausch + lomb purevision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, investigator/sponsor masked study at approximately 35 investigative sites in the us. at the screening/dispensing visit, approximately one-half of the participants will be randomized to receive bausch + lomb investigational samfilcon a soft contact lenses (test) and approximately one-half of the subjects will be randomized to receive bausch + lomb purevision soft contact lenses (control). both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. the lenses are to be worn overnight for up to six consecutive nights per week. the lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. the lenses will be replaced with new lenses at the beginning of each month. lenses will be provided at the screening/dispensing, 3-month, 6-month and 9-month follow-up visits to maintain a monthly replacement schedule. participants will also be required to complete a paper diary.

Eligibility criteria:
inclusion criteria: * participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logmar) or better (distance, high contrast) in each eye. * participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand. * participants must be myopic and require lens correction from -0.50 diopters (d) to 6.00 d in each eye. * participants must have clear central corneas and be free of any anterior segment disorders. * participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study. exclusion criteria: * participants who have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * participants with an active ocular disease or who are using any ocular medication. * participants with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * participants using any systemic medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * participants who are not correctable to 42 letters (0.1 logmar) in each eye with soft spherical contact lenses. * participants who currently wear monovision, multifocal, or toric contact lenses.
animal-assisted intervention in adolescents admitted to acute psychiatric units.

Conditions: Mental Health Issue

Summary: the purpose of the present study was to evaluate the efficacy of aat intervention in adolescents admitted to the acute child and adolescent psychiatry unit, regardless of diagnosis, in terms of improving self-efficacy and reducing anxiety symptoms. to assess professional opinions on the effects of intervention on participants, and to determine participant satisfaction. these objectives were accomplished through a multicenter, non-randomized, open-label, two-arm controlled study of aat for adolescents with mental disorders.

the rationale of this study was to evaluate the efficacy of animal assisted therapy (with therapy dogs) in adolescents admitted to the acute child and adolescent psychiatry unit and regardless of diagnosis. the investigators conducted a multicenter, non-randomized, controlled, open-label, two-arm clinical trial in three hospitals. a total of 178 adolescents admitted to the acute child and adolescent psychiatry unit were included in the study. participants from the three hospitals were assigned to experimental group (n=114) and participants from one hospital were assigned to control group (n=64). both the experimental group and the control group carried out a total of two one-hour group sessions at the hospitals' own facilities, on a weekly basis for two consecutive weeks; with the additional assistance of the therapy dog in the experimental group. the investigators evaluated changes on self-efficacy and anxiety symptoms at pre-treatment and post-treatment; and they assessed professional opinions on the effects of intervention on participants at post-treatment, and determined participant satisfaction at post-treatment.

Eligibility criteria:
inclusion criteria: * be between 13 and 17 years of age. * willing to participate in the study on a voluntary basis. * delivery of the information sheet and signature of the informed consent (participant and legal guardian). * attendance at both group sessions from the intervention. exclusion criteria: * if in the initial interview they declared having allergy or fear of dogs. * history of aggression towards animals. * re-admissions who had already participated in the study. * if, when informed, the patient and/or his/her legal guardian did not wish to participate in the study.

Keywords: animal-assisted therapy mental health adolescent psychiatry hospital nonpharmaceutical interventions
remote monitoring of patients with functional mitral regurgitation undergoing mitraclip transcatheter repair

Conditions: Mitral Regurgitation; Heart Failure

Summary: hermes is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the mitraclip system.

the scope of the hermes study is to investigate whether the information obtained by remote monitoring in patients with severe functional mitral regurgitation who have undergone transcatheter mitral valve edge-to-edge repair with the mitraclip system may have the potential to guide treatment decisions at follow-up visits, and improve the quality of life. candidates to the mitraclip procedure on optimal medical therapy will be offered the opportunity to participate to the study by bringing home a tablet and a series of sensors and wearables to collect daily information on blood pressure, oxygen saturation, weight variation, heart rate, symptoms and compliance to therapy. these variables will be blinded, stored by the tablet and downloaded by the core institution at follow-up visits. clinicians will be encouraged to use these data to guide their decisions, personalizing drug therapies and follow-up schedules to the individual patient's need. patients that during the run-in phase (from enrollment to 30+-7 days) will have used the tablet for \>66% of the days will undergo the mitraclip procedure and continue to keep the tablet for up to 12 months (active group). patients that during the run-in phase (from enrollment to 30+-7 days) will have not used the tablet for \>66% of the days, will continue the study as a control group. predefined clinical follow up assessments for collection of study endpoints will be at 1 month post mitraclip, 6 months post mitraclip and 12 months post mitraclip. quality of life, assessed by means of the sf36v2 questionnaire, will be assessed at enrollment, pre mitraclip, at 1 month after mitraclip and at 12 months after mitraclip. a series of secondary endpoints, including 6mwt assessments and consumption of resources will be also assessed.

Eligibility criteria:
inclusion criteria: * symptomatic while on optimal medical therapy (nyha class iii-iv) * mitral regurgitation of functional etiology * suitable mitraclip candidate * life expectancy \>12 months exclusion criteria: * mitral regurgitation of primary etiology * refusal to sign the informed consent * dementia or neurological disorders that prevent the proper use of the tablet * inability to use the tablet, the sensors and/or the wearables, even with the assistance of family members * expected non-compliance with follow-up visits * end-stage chronic kidney disease on dialysis

Keywords: mitral regurgitation mitraclip remote monitoring wearables