Kornimate/medical-research-clean huggingface dataset:
ertugliflozin type 2 diabetes mellitus (t2dm) pediatric study (mk-8835/pf-04971729) (mk-8835-059)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the safety and efficacy of ertugliflozin (mk-8835) in pediatric participants with t2dm on metformin with/without insulin. the primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin a1c (hba1c) more than the addition of placebo after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. has diabetes diagnosed by one of the american diabetes association (ada) criteria. 2. has body mass index (bmi) ≥85th percentile at screening or participant has a history of being overweight or obese at time of diagnosis of type 2 diabetes mellitus (t2dm). 3. t2dm for ≥2 years, or t2dm for \ 0.6 ng/ml at screening. 4. on stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to screening, or on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to screening and a stable dose of insulin for ≥8 weeks prior to screening. 5. contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. is a non-sterilized female who is currently not sexually active or who agrees to abstain from heterosexual activity or who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures. exclusion criteria: 1. has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes. 2. has known monogenic diabetes, or secondary diabetes. 3. has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin. 4. has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (sglt2) inhibitor. 5. is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication. 6. has previously taken an sglt2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents. 7. has a history of idiopathic acute pancreatitis or chronic pancreatitis. 8. has a history of severe hypoglycemia while on insulin.
a study of htd1801 in adolescents with primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis; Cholangitis; Cholangitis, Sclerosing; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adolescent

Summary: randomized, double-blind, active-controlled, parallel-group study of htd1801 in adolescents.


Eligibility criteria:
inclusion criteria: * weight ≥ 35 kg * previous cholangiographic evidence of psc by magnetic resonance cholangiopancreatography (mrcp) or direct cholangiography or liver biopsy findings * serum ggt ≥ 2 × upper limit of normal (uln) * on a stable udca treatment regimen for ≥ 8 weeks exclusion criteria: * secondary sclerosing cholangitis * percutaneous or endoscopically-placed biliary drain or stent * history of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year * ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to screening * concomitant overlap syndrome with primary biliary cholangitis (pbc) * significant hepatic decompensation * alternative causes of chronic liver disease * hospitalization for colitis within 30 days prior to screening * serum creatinine \> 1.2 x uln * hemoglobin \< 10 g/dl * glucose-6-phosphate dehydrogenase (g6pd) deficiency
intraoperative adsc administration during nerve release

Conditions: Neurotmesis of Peripheral Nerve (Disorder)

Summary: the goal of the investigator's observational, nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal cells (adsc) transplantation into the individuals with faiure in reconstruction of peripheral nerves. adsc will be used during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. all enrolled patients will have a documented at least 2-years clinical and electrophisiological observation. each patient will recive once 10 microinjections of adsc along the injured nerve, directly after nerve neurolysis. safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological (emg, sensory thyreshold) and dash survey.

the aim of the study will be an evaluation of undifferentiated adipose-derived stromal/stem cells (adsc) usage during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. patients who experienced failure of nerve reconstruction will be included in the study. during the revisional surgery, nerve fascicles will be released, and adscs will be isolated from harvested fat with enzymatic method in a standarized conditions. cells will be administered through microinjections along the fascicles and around the adjacent tissues after external neurolysis. the follow-up will be continued at least 36 months.

Eligibility criteria:
inclusion criteria: * clinically definite failure nerve reconstructed patients * lack of improvement after previous treatment * without severe, unstable chronic diseases * polish citizens exclusion criteria: * inr \> 2 before liposuction * primary haematological disease, including hypercoagulable states * previous/current history of neoplasm or comorbidity that could impact upon patient's survival * pregnancy /lactation * alcohol abuse, cocaine amphetamine, etc.

Keywords: adsc nerve release neurolysis stem cells scar peripheral nerves
development of a new impedance mapping system for ablation of atrial arrhythmias in patients

Conditions: Atrial Fibrillation and Flutter; Atrial Arrhythmia; Atrial Fibrillation Recurrent

Summary: precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. mapping of local myocardial electrical impedance may overcome these limitations.

clinical series: patients with atrial arrythmias undergoing catheter ablation of these will be submitted to mapping of both voltage and tissue impedance. likewise, the accuracy of the two maps identifying the extent of the substrate will be assesssed by gadolinium imaging. the impedance system is already constructed and certified for clinical research use.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years. * that they understand and sign the informed consent. * that they do not present any contraindication.- pass the exploration and tests prior to bioimpedance measurements. exclusion criteria: * age outside the range described in the inclusion criteria. * subjects who present any type of complication during the procedure. * pregnancy.

Keywords: impedance spectroscopy phase angle impedance magnitude electroanatomical mapping
intern health study 2024

Conditions: Depression; Mood; Sleep; Physical Activity

Summary: the aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. interns also tend to have lower sleep and decreased physical activity. the goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. the intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year. the primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. the second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the patient health questionnaire. the first secondary aim is to evaluate how mood notifications affect participants' weekly mood. the second secondary aim is to evaluate how activity notifications affect participants' weekly step count. the third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. in order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility criteria:
inclusion criteria: * medical intern during the 2024-2025 internship year * iphone or android phone user * logged into the intern health study mobile app, completed consent, and filled out baseline survey by june 30 prior to the start of intern year exclusion criteria: * none
detecting bladder cancer using the uromark test.

Conditions: Bladder Cancer

Summary: detect i is a prospective multicentre observational diagnostic study to assess the performance of the uromark assay to rule out bladder cancer in patients with haematuria. the study will recruit consecutive patients attending haematuria clinics as well as patients referred to urology outpatient clinics for investigation of haematuria. consenting patients will be provided with a urine sample collection kit and asked to provide a urine sample. an additional urine sample for control assay testing will be provided after the clinic attendance.

transitional cell carcinoma (tcc) of the urinary bladder is responsible for \>12,000 new cases of cancer and \>5,000 deaths per year in england and wales. most bladder cancers are non-muscle invasive bladder cancer (nmibc) and do not invade deeply at presentation, but 80% of tumours recur within 3 years. for muscle invasive bladder cancer (mibc), the 5 year survival is around 50%. cystoscopy is the standard test for detection of bladder cancer along with imaging to assess the upper tracts and the common presenting symptom is haematuria. cystoscopy is an invasive procedure and results in urinary infection in up to 5% of cases. cystoscopy is performed under local anaesthetic and patients are required to attend hospital clinics for the test. about one in 10 patients who are investigated for haematuria will be found to have bladder cancer. frequently, patients are not referred for investigation of haematuria at the time of first presentation and there is a delay in diagnosis of the disease. the early detection of bladder cancer by means of a non-invasive tumour marker test would impact on the management of the disease. there is an unmet need for a simple, non-invasive, highly sensitive and specific method for detecting bladder cancer. this study will determine the accuracy of uromark a high-throughput multiplex pcr test to detect bladder cancer in dna from urine. the study will address the unmet clinical need to improve detection of bladder cancer. the rationale for the trial is based on proof of concept studies which provide compelling evidence that a panel of methylation markers can be applied to detect bladder cancer with high sensitivity and specificity. it will be also be possible to collect and store fractions of urine for assessment of other dna related biomarkers as well as non-dna assays for example cellular proteins, soluble biomarkers in urine supernatant and rna transcripts in sediment cells. in this study we will compare the uromark assay with established assays including urinary cytology, fish as well as developing assays such as mcm5. in this proposal excess urine will be stored for these studies.

Eligibility criteria:
inclusion criteria: * participants must be over 18 years of age. * participants undergoing investigation for visible and non-visible haematuria. * able to give informed written consent. exclusion criteria: * unwilling to have standard haematuria investigations. * unable to give informed consent.
effects of nutriose®fb dietary fiber supplementation on satiety, body fat, and metabolic syndrome in overweight adult men

Conditions: Overweight; Metabolic Syndrome X

Summary: the purpose of this study was to determine the effects of nutriose® supplementation on body composition, satiety, and determinants of metabolic syndrome in overweight men.

previous trials of fiber supplementation have yielded equivocal results on body composition, satiety, and determinants of metabolic syndrome. this double-blind, randomized, placebo-controlled study was conducted to determine the effects of a proprietary soluble dextrin dietary fiber supplement (nutriose®) on these parameters in overweight males.

Eligibility criteria:
inclusion criteria: * males 20-35 years * body mass index of 24-28 kg/m2 * current employment and residence at one of three manufacturing plants with a controlled setting and with similar regimented working conditions 7 days a week exclusion criteria: * current or recent dietary fiber supplementation * use of lipid-lowering/hypertension medication * current insulin injection use * contraindication to fiber supplements, e.g. crohn's disease * allergy to wheat products * recent or current antibiotic use

Keywords: fiber metabolic syndrome overweight satiety
clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients

Conditions: Acne Vulgaris

Summary: in dermatology, assessment of people of color remains underrepresented in rcts (\<10%) and guidelines. acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. in darker skin type patients, i.e., fitzpatrick phototypes iv-vi, acne-related pigmentation (arp) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. whatever is the mechanism, arp (number, size, importance of dyschromia) impacts the quality of life in such patients. in moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially arp). however, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in arp. moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.the main objective: to assess the superiority at m6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of arp.multicenter randomized controlled trial - open study. the number of subjects required for the trial = 420


Eligibility criteria:
inclusion criteria: * women and men between 13 and 30-year-old * skin type iv, v and vi according to fitzpatrick skin types * moderate acne as defined by the french society of dermatology recommendations based on ecla grading https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * patients must have a cell phone able to take selfies pictures with a minimum definition of 5mb. * signed informed consent * affiliation to french social coverage. exclusion criteria: * mild and severe acne (ecla grading : french recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * past cure of oral isotretinoin * past cure of systemic antibiotics for acne in the last 6 months * phototype i-iii patients * abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline * pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hcg) * breast-feeding patients * refusal of effective contraception for women * contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin * vulnerable people: adult under guardianship or deprived of freedom
multimodal investigation of neural plasticity

Conditions: Mild Cognitive Impairment

Summary: this study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, hc) and in those with mild cognitive impairment (mci).

the goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or hd-tdcs) on brain functioning in those with mild cognitive impairment (mci). the findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). ultimately, this information may help develop new treatments for those with alzheimer's disease. the study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. functional magnetic resonance spectroscopy (fmrs), functional magnetic resonance imaging (fmri), and functional near-infrared spectroscopy (fnirs) will be used. the study also uses cognitive tests and questionnaires.

Eligibility criteria:
inclusion criteria: * normal cognition for hc and diagnosis of mild cognitive impairment (mci) for mci participants * right-handedness * magnetic resonance compatible, criteria that also apply for high definition transcranial direct current stimulation (hd-tdcs; e.g., absence of metallic or electronic implants in the upper body or head) exclusion criteria: * history of other contributing neurological or medical conditions known to affect cognitive functioning * significant mental illness * sensory impairments that limit ability to participate * history of alcohol or drug abuse/dependence

Keywords: tdcs glutamate mrs fmri fnirs
palmitic acid in the sn-2 position of triacylglycerols and postprandial lipemia

Conditions: Healthy Men; Raised Fasting Plasma Triacylglycerol Concentrations

Summary: the purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.


Eligibility criteria:
inclusion criteria: * healthy males * non-smokers * aged 40-70 years * fasting tag concentrations ≥1.5 mmol/l. exclusion criteria: * reported history of cvd (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/l), cancer, kidney, liver or bowel disease. * presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption. * history of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/men) * current self-reported weekly alcohol intake exceeding 28 units * allergy or intolerance to any component of test meals * unwilling to restrict consumption of any source of fish oil for the length of the study * weight change of \>3kg in preceding 2 months * body mass index \ 35 kg/m2 * fasting blood cholesterol \> 7.8 mmol/l * current cigarette smoker. * current use of lipid lowering medication

Keywords: lipemia vascular function blood pressure
an investigation to test a prototype nasal mask in the home setting

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is a prospective non-blinded and non-randomized clinical investigation. this investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. the clinical investigation will be conducted in new zealand and participants will interact with the user instructions in a one hour daytime visit. a minimum of 15 participants will participate in this trial.

this investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. the clinical investigation will be conducted in new zealand and participants will interact with the user instructions in a one hour daytime visit. this investigation is designed to evaluate the interpretation by participants of the user instructions. a total number of 20 participants, diagnosed with osa will be recruited for the trial. the participants will be recruited from the fisher and paykel healthcare database of subjects (ethics reference 18/nta/62). fisher and paykel healthcare will act as the investigator and sponsor for this investigation. this study will be conducted in accordance with ich/gcp guidelines. no deviation from protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. in such case, the deviation will be reported to the sponsor (bhavi ogra) as soon as possible.

Eligibility criteria:
inclusion criteria: * osa mask users * 18+ years of age * ability to give informed consent exclusion criteria: * inability to give informed consent
effects of nerve blocks on pain after caesarean section and postpartum depression

Conditions: Postoperative Pain; Cesarean Section; Postpartum Depression

Summary: at the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. you will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. at the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. immediately before surgery and 4-6 days after your surgery. an evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.


Eligibility criteria:
inclusion criteria: 1. having a good mental status, 2. those aged ≥18 years, 3. term pregnant (gestational age ≥ 36 weeks), 4. american society of anesthesiologists class ii-iii, 5. patients who underwent cesarean section with spinal anesthesia will be included. exclusion criteria: 1. having labor at term or obstetric emergency, 2. having a twin pregnancy, 3. having a diagnosed psychiatric disorder/using psychiatric medication, 4. those who are allergic to local anesthetics and/or drugs used in the study, 5. the patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively, 6. having peripheral neuropathy or neuromuscular disease, 7. patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

Keywords: nerve block, cesarean, postpartum depression