Kornimate/medical-research-clean huggingface dataset:
feasibility and acceptability of a remote glucose monitoring program for pregnant marshallese women

Conditions: Diabetes, Gestational; Diabetes Mellitus Type 2 Pre-Existing

Summary: the overall objective is to test the feasibility and acceptability of a remote glucose monitoring program among marshallese women with pgdm (pre-gestational diabetes mellitus) or gdm (gestational diabetes mellitus) and with limited english proficiency.

iglucose remote monitoring system. iglucose is a remote patient monitoring system. the iglucose monitor works by analyzing a small amount of blood placed on a strip that is inserted into the monitor, similar to a standard glucometer. the iglucose monitor will show the patient their glucose reading and will automatically send the patient's glucose reading to a database via cellular networks when the patient removes the strip from the device. the iglucose monitor does not require any recording on the part of the patient. the iglucose data is managed through a hipaa-compliant amazon web services (aws) database maintained by smartmeter. the data is available to the provider to monitor the patient's blood glucose levels accurately and in a timely manner, allowing for treatment to be adjusted. the data is available for the physician during every patient contact for review and discussion. patients will be provided with the iglucose monitor at the baseline data collection. a trained bilingual research assistant will review the iglucose guide with the participant, provide training on the use of the monitor, taking a blood glucose reading with the monitor, and the patient will use the iglucose monitor once in front of the research assistant. the patient will receive a packet of information in their language of choice (english and/or marshallese). the packet will include information on how to use the monitor (including the iglucose guide) and contact information if there are any problems with the monitor during the study. the patient will use the monitor as instructed by their healthcare team to monitor their blood glucose. the patient will return the equipment at the completion of the study. the participant will provide their physician's information as part of the study, so that the investigators may provide access to the iglucose blood glucose readings through the electronic guidebook and contact the physician post-intervention to complete a survey.

Eligibility criteria:
inclusion criteria: * women who self-identify as marshallese * 18 years of age or older * ≤30 weeks pregnant * receive prenatal care at university of arkansas for medical sciences (uams) and partner clinics and hospitals * have used a paper log for at least two weeks * have a diagnosis of pgdm (pre-gestational diabetes mellitus) or gdm (gestational diabetes mellitus). exclusion criteria: * women who are unable to use a glucometer by themselves * have not used a paper log * have a continuous glucose monitor * more than 30 weeks pregnant
secukinumab drug survival, effectiveness and tolerability in pediatric patients with psoriasis

Conditions: Moderate-to-severe Plaque Psoriasis

Summary: multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. retrospective data collection is planned at patients' inclusion.

this observational study will be performed at healthcare facilities treating pediatric psoriasis patients. the study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks retrospective data collection is planned at patients' inclusion. prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.

Eligibility criteria:
inclusion criteria: 1. written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study. 2. age ≥6 to \<18 years old. 3. established diagnosis of active moderate-to-severe plaque psoriasis defined as a pasi score ≥ 10, body surface area (bsa) involvement of ≥10% and pga score ≥ 3 only or with concomitant psoriatic arthritis. 4. failure or intolerance of prior psoriasis treatment. 5. patient was prescribed with secukinumab within 4-16 weeks before inclusion. 6. decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct. exclusion criteria: 1. known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex). 2. history of chronic recurrent infection. 3. clinically significant infection exacerbation, including active tuberculosis. 4. age \<6 years or ≥18 years. 5. pregnancy and breastfeeding. 6. patients participating in parallel in an interventional clinical trial. 7. patients participating in parallel in other novartis-sponsored non-interventional study generating primary data for secukinumab. 8. patients within the safety follow-up phase of interventional study. 9. active inflammatory bowel disease at inclusion. 10. patients who received any vaccine within 4 weeks prior to secukinumab initiation. 11. any medical or psychological condition in the investigator's opinion which may prevent the study participation.

Keywords: secukinumab, psoriasis, pediatric patients, nis
online mindfulness-based stress reduction for patients receiving chemotherapy

Conditions: Breast Cancer; Stress

Summary: the goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (mbsr) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy. the main questions it aims to answer are: * does an online mbsr intervention reduce stress levels (measured through the perceived stress scale) among participants? * does an online mbsr intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the pro-ctcae of the national cancer institute) among participants? researchers will compare the online mbsr intervention to no intervention to see if online mbsr reduces treatment-related stress. participants will: * participate in an online mbsr intervention or no intervention for 6 weeks * answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up


Eligibility criteria:
inclusion criteria: * female sex * age ≥18 years * diagnosis of non-metastatic breast cancer * plan to start neoadjuvant or adjuvant chemotherapy in \<4 weeks * internet access at home or in their mobile phone * availability to participate in the online mbsr intervention for 6 weeks * availability to answer the study surveys * provision of signed informed consent exclusion criteria: * disease recurrence * current meditation or mindfulness practice * inability to read or write

Keywords: mindfulness-based stress reduction chemotherapy-related stress breast cancer
feasibility pilot for the reboo-trial

Conditions: Obesity

Summary: this is a pilot testing the feasibility of the 'repurposing botulinum toxin in treatment of obesity in adolescents' trial (reboo-trial). the full-scale reboo will further investigate safety and efficacy of intragastric injections of botulinum toxin a into the antrum area of the stomach. these injections will be repeated every six months. the study sample will be adolescents with obesity who have not responded to standard conservative treatment.


Eligibility criteria:
inclusion criteria: 1. written (signed) informed consent 2. age and gender adjusted body mass index (iso-bmi) ≥ 35 or iso-bmi \> 30 with comorbidities including hypertension, non-alcoholic fatty liver disease, hyperlipidemia or impaired glucose tolerance 3. having partaken in a comprehensive multi-disciplinary lifestyle treatment for obesity of duration 12 months or more, without achieving a clinically significant weight loss (non-responder) exclusion criteria: 1. known hypersensitivity to excipients in the investigational medicine product (imp) 2. neuromuscular disorders 3. history of dysphagia 4. history of aspiration tendency or aspiration pneumonia 5. known lung disease under continuous treatment 6. congenital or acquired heart disease 7. previous experience of side effects to botulinum toxin type a 8. present gastric diseases or dysfunction 9. previous bariatric surgery 10. history of cancer 11. serious binge eating disorder 12. untreated hypothyroidism 13. use of aminoglycoside antibiotics or spectinomycin in the week prior to injection, or any other medicinal product that interfere with neuromuscular transmission (neuromuscular blocking agents) 14. medication known to affect appetite 15. syndromic obesity 16. mentally immature to a degree that there is doubt about the subject's ability to assent 17. issues relating to language or culture that may complicate trial participation 18. pregnancy or breastfeeding

Keywords: adolescent injections, intraperitoneal endoscopy botulinum toxins, type a onabotulinumtoxina
sensitization study of atx201 in healthy volunteers

Conditions: Sensitivity, Contact

Summary: this is a phase i, single-site study to evaluate the sensitization potential of topically applied atx201 gel, 2% and 4%, along with a placebo control, in healthy human subjects.


Eligibility criteria:
inclusion criteria: * good general health * body mass index no less than 19.0 and no greater than 36.0 kg/m² (inclusive). * demonstrates a fitzpatrick skin score of i - iv * female subjects must agree to use acceptable contraceptive methods from the screening visit through 90 days after the end of study (eos) visit; or postmenopausal status with no menses for at least 1 year prior to the screening visit. * willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to day 1 through eos visit. * willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the screening visit through eos visit. exclusion criteria: * reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to day 1), or currently diagnosed with hypertension or circulatory disease. * reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than vitamin a at normal dietary amounts) * reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex. * reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc. * reports a history of significant dermatologic cancers. * displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly * reports smoking or use of tobacco or nicotine delivery products within 14 days prior to day 1 through eos visit. * presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the investigator. * a female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study. * reports a history of drug or alcohol addiction or abuse within the past year. * reports having donated blood or plasma within 48 hours prior to day 1 through eos visit. * subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised. * subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to day 1 through eos visit.
efficacy of anisodamine hydrobromide combined with low-molecular-weight heparin in the treatment of patients with sepsis

Conditions: Sepsis

Summary: the study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.

objective: the study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection. methods: the study is a multi-center randomized controlled clinical trial. study population will include critically infected patients requiring vasopressor use. the critically infected patients will be randomly assigned to four groups in a ratio of 1:1. the groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group. interim analysis will be performed. the primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. the investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group. discussion: the treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. the study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years; 2. meets the diagnostic criteria for sepsis according to the "sepsis-3" ; 3. patient or their legal representative consents to treatment and signs an informed consent form. exclusion criteria: 1. patients expected to die within 24 hours after enrollment; 2. contraindications to low molecular weight heparin and scopolamine butylbromide drugs; 3. patients with thrombotic diseases requiring treatment with low molecular weight heparin; 4. patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney sofa score ≥ 3 points), etc.; 5. pregnant and lactating women; 6. patients participating in other clinical trials.
pain and opioids after surgery

Conditions: Opioid Use; Pain, Chronic; Pain, Postoperative; Quality of Life

Summary: the aim of this study is to document the perioperative opioid use and its safety in the uk and countries in europe and to describe its association with surgical complications, persistent pain and quality of life. in an international, prospective, observational cohort study, data about the perioperative pain management will be collected in all eligible hospitalised adult patients who undergo surgery in a designated "study week" in as many hospitals as possible in europe. baseline data will be collected, and participants followed up at one week, and at three and twelve months post-operatively. the primary outcome will be opioid use at three months after surgery. secondary outcomes will include opioid use during the preoperative month (preoperative use), during surgery and up to one week after surgery (or discharge, whichever is earlier), and up to the end of the postoperative year. additional secondary outcomes are the incidence of preoperative pain, persistent pain with/without the presence of neuropathic components, quality of life and surgical complications. the potential association between opioid use and pain outcomes will be investigated. this study could help to develop strategies to improve quality of care, through pain management, for patients undergoing surgery.

pandos is an international, prospective, observational cohort study. in a one week period (the designated "study week"), data will be collected in all eligible hospitalised adult patients who undergo surgery in as many hospitals as possible in the uk and europe. participants will be followed up for 12 months

Eligibility criteria:
inclusion criteria: * hospitalised adult patients (18 years and older) undergoing any inpatient surgery (elective or emergency) during the designated study week where an anaesthetist is involved (general anaesthetic, sedation, local anaesthetic). able to understand and has capacity to give written informed consent exclusion criteria: * american society of anaesthesiologists (asa) grade v or vi * refusal to participate. * lack of comprehension of validated questionnaires or inability to complete the follow-up for any reason. * lack of capacity to give written informed consent
validation of respiratory epithelial functional assessment to predict clinical efficacy of orkambi®.

Conditions: Cystic Fibrosis; Homozygous F508del Mutation

Summary: the purpose of the study is to investigate whether the correction of cftr function by lumacaftor/ivacaftor in a patient-derived primary nasal cell model is a surrogate biomarker for respiratory improvement in orkambi® treated patients.

orkambi® is a combination of ivacaftor (a cftr channel potentiator) and lumacaftor (a corrector partially rescuing the traffic of mutated cftr). this treatment is now marketed in france for patients homozygotes for the mutation p.phe508del, aged 12 and above. systematic use of this product is a concern due to the lack of predictive markers of efficacy, the highly variable respiratory improvement in patients and potential serious side effects. the purpose of this study is to investigate the predictive value for improvement of the respiratory function after 24 weeks of orkambi treatment of an in vitro test. this test quantifies the correction of cftr activity as assessed by the change of cyclic amp (camp) dependant chloride (cl-) secretion in patient derived human nasal epithelial (hne) derived primary culture after lumacaftor/ivacaftor 48 hours incubation.

Eligibility criteria:
inclusion criteria: * homozygous f508del patient aged 5 years or older * patient with an indication for orkambi® treatment according to the marketing authorization application * patient never received orkambi® in the past * patient able to perform fev1 * signed informed consent form by the patient (if aged ≥ 18 years), or by parents / legal guardian and patient's agreement (if aged \< 18 years) patient affiliated to the health insurance system exclusion criteria: * homozygous f508del patients who do not meet the treatment indications according to the marketing authorization application * patients refusing orkambi® * cf patients not homozygous for the p.phe508del mutation * active smoker * severe nasal mucosa disrepair * contraindications to xylocaine anesthesia, * participation with another interventional study with drug

Keywords: cystic fibrosis orkambi
low-carb versus mediterranean diet in pcos

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: this is a randomized controlled trial of two diets (low-carbohydrate and mediterranean diet) in the treatment of women with polycystic ovary syndrome (pcos). the trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . this study is an interventional, randomized controlled trial, open-labeled.

the study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . women with pcos are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a mediterranean diet. the adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.

Eligibility criteria:
inclusion criteria: * women with pcos between the ages of 18-40 years and with a body mass index of less than or equal to 45. * fulfillment of at least two of the following three criteria for pcos, adopted by the rotterdam consensus in 2003 (rotterdam eshre / asrm-sponsored pcos consensus workshop group): * signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone) * signs of chronic anovulation * ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche. exclusion criteria: * the presence of hyperprolactinemia * cushing's syndrome * ongenital hyperplasia of the adrenal cortex * hypothyroidism * androgen-producing tumors * regular use of drugs and dietary supplements that affect the function of the ovaries * adrenal glands * metabolism of carbohydrates * lipids * microbiota composition during the 2 months preceding the study * pregnancy * lactation * significant comorbidities

Keywords: microbiome obesity mediterranean diet low-carb diet
the effect of family education on functional level, activity level and families in children with cerebral palsy

Conditions: Children With Cerebral Palsy

Summary: the activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of gaziantep was evaluated. the effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated. the individuals included in the study were divided into two groups as patient and control. in the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. individuals in the control group were followed up with a home program. after 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.


Eligibility criteria:
inclusion criteria: * be in the age range of 3-18 years. * getting a diagnosis of cerebral palsy. * agree to participate in the study. exclusion criteria: * if the child interrupts supportive education for any reason, * failure of the family to ensure continuity in participation
aqualase versus torsional ip. a study on endothelial cells, corneal edema and corneal sensitivity

Conditions: Cataract

Summary: objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ecc), corneal edema (cct) and corneal sensitivity (ccs) in a sample of cataract patients. participants were recruited from the cataract service of the uha in a consecutive-if-eligible basis. eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the lens opacities classification system iii (locs-3) grading scale \[10\]. by means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) torsional group (tg) and b) liquefaction group (lg).


Eligibility criteria:
inclusion criteria: * diagnosis of senile cataract with stage 2 nuclear opalescence according to the lens opacities classification system iii (locs-3) grading scale exclusion criteria: * endothelial cell count less than 1900, * glaucoma, * iop-lowering medications, * former incisional surgery, * former diagnosis of corneal disease, * diabetes or autoimmune diseases

Keywords: cataract phacoemulsification liquefaction torsional ip endothelial cell count central corneal edema central corneal sensitivity