Kornimate/medical-research-clean huggingface dataset:
the effect of the inclusion of soybean flour on glycemic responses

Conditions: Overweight and Obesity

Summary: foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. high glycemic index foods are also linked to an increased risk of developing diabetes. the partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety. in many regions of latin america, as well as in the middle east and north africa (mena) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. the results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes.

the purpose of this study is to compare different percentages of soy flour inclusion rates in recipes of bread, flour tortilla, and arepa (south american corn pancake) for its effect on satiation and glycemic and insulin responses. the hypothesis to be tested is that soy flour inclusion will improve the protein content, satiety profile and glycemic response of the products without significant increases in insulin responses (compared to the same products prepared with regular wheat flour).

Eligibility criteria:
inclusion criteria: * male and female between 21-45 years of age * all races/ethnicities * body mass index (bmi) \> 25 kg/m2 and \<40 kg/m2 (i.e., overweight and obesity, excluding severe obesity) * fat %: \> 30% for female or \> 20% for male exclusion criteria: * currently smokes or quit smoking nicotine cigarettes, vapes or e-cigarettes for less than 6 months ago * pregnant, breastfeeding, menopausal * hemoglobin: \<11g/dl for female and \<13g/dl for male * blood donation in the past 8 weeks * gluten intolerance (gluten allergy, wheat allergy, celiac disease), soy intolerance or allergy * presence of malabsorption syndrome * history of bariatric surgery * presence of inflammatory intestinal disease, liver, or kidney disease * diabetes (fasting glucose level \>126mg/dl or plasma glucose level 2h after glucose challenge \>200 mg/dl) or taking medicines to treat diabetes * polycystic ovary syndrome (pcos) * untreated hypertension * taking any medication that might affect glucose metabolism or the results of our study * history of cancer \<5 years ago * abnormalities in the metabolic panel test (e.g., liver enzymes \>2 times the upper limit). * seizures

Keywords: glycemic responses insulin satiety
lamazym aftercare study

Conditions: Alpha-Mannosidosis

Summary: the overall objective of this trial is to provide aftercare treatment with lamazym and to evaluate the safety of repeated lamazym i.v. treatment of subjects with alpha-mannosidosis whom previously participated in lamazym-trial.

this protocol only concern subjects where compassionate use program was not accepted. efficacy will be evaluated once yearly to follow the subject's progress in clinical parameters.

Eligibility criteria:
inclusion criteria: * the subject must have participated in previous lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17 * subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities * the subject and his/her guardian(s) must have the ability to comply with the protocol exclusion criteria: * presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the investigator, would preclude participation in the trial * any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the trial * pregnancy. pregnant woman is excluded. before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception * psychosis; any psychotic disease, also in remission, is an exclusion criteria * planned major surgery that, in the opinion of the investigator, would preclude participation in the trial
tadalafil-delivra and raynaud's phenomenon

Conditions: Raynaud Phenomenon

Summary: a 4-8 week observational feasibility study of the use of the use of tadalafil-delivra in the treatment of reynaud's phenomena (rp).

to determine if the feasibility of conducting a future rct using the chosen outcome assessments in rp patients at 2 rheumatology clinics. study design: observation of patients prescribed tadalafil-delivra 2% (tad-del) for the treatment of rp with defined feasibility objectives and data collection through efficacy and safety assessments. study objectives are: * at least 70% recruitment of eligible participants. * 100% data collection from at least 70% of all enrolled subjects. * estimate the standard deviation(s) of all outcome assessments. setting/participants: patients prescribed tad-del will be screened for study enrollment at 2 participating rheumatology clinics by the local research team. participants that meet all the eligibility criteria will be enrolled in the study as subjects. subjects will self-administer the medication as prescribed and return to the clinic for follow-up. data will be collected on outcome assessments at: baseline, 1 week and at 4 to 8 weeks of treatment.

Eligibility criteria:
inclusion criteria: 1. adults of both genders, age 18 to 75 years. 2. patients with a confirmed diagnosis of raynaud's phenomenon (rp). 3. written informed consent. 4. the presence of 1 or more digital ulcers (du), that is not related to calcinosis, anywhere on a finger that is symptomatic for rp- defined as a vas pain score of ≥25mm of 100mm or 1 -3 fingers that are symptomatic for rp under standard of care treatment (soc). symptomatic is defined as a vas pain score of ≥ 25mm of 100mm. 5. prescribed, but not currently being treated with tad-del. 6. maintenance of a stable background of prescribed treatment for rp including vasodilators, orally administered pde5i and pain medication. changes to administration of this concomitant medication will be documented in the case report form (crf). exclusion criteria: 1. unwilling and/or incapable of adhering to the study procedures and follow-up schedule. 2. use of other prescribed topical treatment for rp, such as nitrates. 3. active infection of the index ulcer 4. calcinosis at the site of the index ulcer 5. received iloprost or other prostacyclin treatment in the last 4 months. 6. unsuitable for study participation as determined by the clinical investigator.
our whole lives gemini: virtual integrative medical group visits for managing chronic pain

Conditions: Chronic Pain

Summary: the goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. the main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?

this study has 6 mandatory components and 1 optional component: * recruitment screening call * informed consent session * baseline survey session * intervention: engagement with the our whole lives (owl) an e-health platform: for 9 weeks, participants will all have access to a mindfulness program within owl, optimized for people with chronic pain. * live-online mindfulness group weekly * control: low dose engagement with owl with no group engagement. * follow-up survey sessions at week 10, week 16, and week 24. * online focus group/individual interview. participants will be asked to participate in an optional individual interview, or a one-hour focus group with other participants in the study who used the owl website as well. researchers will compare two groups that will be using the web-based platform. each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management.

Eligibility criteria:
inclusion criteria: * english-speaking adults * over the age of 18 * experiencing chronic musculoskeletal pain. (pain may have more than one source; pain must be non-malignant; participant must have an average pain intensity of ≥ 4 (1 out of 10) in the past 7 days; participant must meet the chronic criteria of a pain problem that has persisted at least 3 months, and has resulted in pain on at least half the days in the past 6 months) exclusion criteria: * inability to understand english at a level necessary for informed consent and understanding participation instructions, and participating in the group; * serious underlying systemic or co-morbid conditions or life event that precludes physical or cognitive ability to participate in the study. * severe depression * current mania or psychosis; * active heroin or cocaine use in the past 3 months * heavy alcohol use * known or planned pregnancy
post-marketing study focused on evaluating i+med's daydrop for improving signs and symptoms of mild/moderate dry eye

Conditions: Dry Eye; Dry Eye Syndrome (DES)

Summary: clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of daydrop treatment in subjects seeking relief from symptoms of dryness and eye irritation based on osdi questionnaire scores completed by patients.the study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria. the duration of the study will be 2 weeks, including 3 visits.

clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of daydrop treatment in subjects seeking relief from the signs of dryness and eye irritation, comparing the scores obtained at the end of the follow-up period with those established before the start of treatment (baseline condition), as measured by the patients according to the osdi questionnaire. the study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria of the protocol. the study duration will be 2 weeks, including 3 visits: baseline, visit 1 (after one week of treatment), and visit 2 (at 2 weeks from the start of treatment).

Eligibility criteria:
inclusion criteria: * patients of both sexes over 18 years of age. * patients presenting symptoms of dryness and ocular irritation with an osdi score ≥13 and ≤22. * ability to self-administer the drops. * ability to understand the patient information sheet and sign the informed consent. * willingness and sufficient ability, as judged by the investigator, to respond to the questionnaires included in the study. exclusion criteria: * pregnant women or those in the breastfeeding period. * known allergy or hypersensitivity to hyaluronic acid or any other ingredient in the product being studied. * patients who have undergone previous ocular surgery or experienced ocular trauma in the year prior to the start of the study. * severe dry eye diagnosis. * presence of inflammatory ocular surface pathology or anterior segment disease, or diagnosed with glaucoma. * use of parasympathomimetic or antipsychotic medications. * previous cataract surgery. * systemic corticosteroid treatment or topical treatment with any ophthalmic medication, except artificial tears, in the week before the start of the study. * sjögren's syndrome. * stevens-johnson syndrome. * history of allergic conjunctivitis.

Keywords: dry eye daydrop opthalmic tears
safe traction during ongoing lead extraction procedure (stop)

Conditions: Electrode Malfunction; Infections of Cardiac Electronic Implantable Devices

Summary: the study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.


Eligibility criteria:
inclusion criteria: * experience in pacemaker and defibrillator lead extraction exclusion criteria: * none
a pilot evaluation of the pregnant moms' empowerment program

Conditions: Violence; Depression; Posttraumatic Stress Disorder; Parenting; Infant Development; Child Behavior

Summary: this project will use a longitudinal design with assessments at baseline (t1), post-treatment (t2), 3 month post-partum (t3), 1 year postpartum (t4) and 3.5-5 years postpartum to examine whether the pmep improves participants': a) mental health (depression, ptsd) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. we hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. the pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. analyses will be conducted using intent to treat and per protocol methods. following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. participant interviews will take approximately 1.5 hours. mothers will be compensated with a gift card in the amount of 40 usd for each interview. in addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). following the baseline interview, the pmep will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. following the completion of the pmep groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. this interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. all women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.


Eligibility criteria:
inclusion criteria: * at least 16 years of age * experienced ipv in the past year * currently pregnant (\<33 weeks) * english speaking exclusion criteria: * insufficient fluency in english to participate in interviews/groups
"comparison of two methods of securing endotracheal tubes in intensive care : elastic adhesive strips vs lace in a protective sheath."

Conditions: Intubation Complication

Summary: every year, in france, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube. appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. however, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. these lesions are painful for patients and often unsightly as scar may remain. there are no formal recommendations for the use of any type of fixing system. thus, systems used to secure the endotracheal tube vary from one icu to another. the objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.


Eligibility criteria:
inclusion criteria: * patient hospitalized in intensive care unit * age over 18 * intubation for estimated duration \> 48h * patient treated with vasopressors * patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members. exclusion criteria: * pre-existing face lesions at icu admission along the path of the endotracheal tube fixing. * admitted patient already intubated upon transfer from another icu * nasotracheal intubation * patient in isolation for suspected covid or clinically proven covid * admitted tracheotomized patient * pregnant, nursing, parturient woman * lack of social security affiliation * moribund * incapable major (under guardianship, curatorship) * patient deprived of liberty by court order

Keywords: endotracheal tube securement facial skin tear lip ulcer critical care
surgical trial comparing ligasure assisted recto-sigmoid resection and omentectomy compared to stand

Conditions: Epithelial Ovarian Cancer

Summary: the objective of this prospective randomized surgical trial is to evaluate whether the use of the ligasure surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

this research study is a prospective, randomized trial. women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the fda-approved ligasure device during omentectomy and resection of the recto-sigmoid portion of the colon. the resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or older * all patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. * potential candidates must have signed an irb-approved informed consent (university of utah informed consent if their surgery will be performed at the huntsman cancer hospital, or intermountain health care consent if the surgery is to be performed at ldsh or imc. * only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. exclusion criteria: * none
descriptive and risk factors analysis of all-cause postoperative death in patients undergoing prolonged surgery

Conditions: Postoperative Death

Summary: the investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after prolonged surgery. the investigators identify all patients undergoing prolonged surgery which the operation time \>3 h, between 2000 and 2020, within the wuhan union hospital and all collaborators. the surgical patient cohort will be matched with the national death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. logistic regression analysis for prediction of postoperative death adjusted for different covariates. the model was externally validated in the remaining 40% patients.


Eligibility criteria:
inclusion criteria: * patients undergoing prolonged surgery exclusion criteria: * patients with incomplete electronic medical record information

Keywords: postoperative death prolonged surgery prediction model
opportunities in outpatient care

Conditions: Outpatient Care

Summary: the purpose of this research study is to determine whether there are things that intermountain can do to break down barriers to helping patients see their primary doctors or other outpatient clinics. to do this we will develop and test a classification scheme to help us understand how we might reduce some avoidable emergency department and instacare visits.

the study will develop a first-pass taxonomy that classifies the causes and effects of challenges and opportunities of outpatient care leading to potentially avoidable ed and urgent care center visits. the study will quantify the proportion of ed and urgent care center visits that result from a challenge or opportunity in outpatient care and classify the causes and outcomes according to the taxonomy. it will also define the 30 and 90 day episode costs of ed and urgent care center visits associated with a challenges and opportunities of outpatient care beginning the day of the ed or urgent care center visit.

Eligibility criteria:
inclusion criteria: * all emergency department/ic patients who can consent, including children. exclusion criteria: * unable to give consent * prisoners

Keywords: outpatient care emergency department visits
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss (ca-0004512)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: the purpose of the study is to evaluate the ability of injections of ji gami(tm) or ji gami(tm) do in combination with minoxidil to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * have no clinically significant disease or abnormal laboratory results taken at the screening visit. * agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study (other than minoxidil as required in this study). exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening (with the exception of minoxidil). * a history of drug or alcohol abuse within 1 year of study enrollment. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * any clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * dermatologic condition in donation or treatment area. * prior surgery in the treatment and/or study areas. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk. * hypersensitivity to minoxidil or the ingredients in the topical solution or foam formulations.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness