Kornimate/medical-research-clean huggingface dataset:
investigation on safety, tolerability, and pharmacokinetics of single doses of nnc0113-0987 in healthy male subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of nnc0113-0987 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ecg), vital signs, and blood assessments at the screening visit * body mass index (bmi) above or equal to 18.5 and below 30 kg/m\^ 2 exclusion criteria: * male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication * participation in another trial within 90 days prior to screening * subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator * subjects who are known to have hepatitis or who are carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies, or have a positive result to the test for human immunodeficiency virus (hiv) antibodies * history of acute idiopathic or chronic pancreatitis
study to evaluate the safety of allo-asc-dfu in the subjects with dystrophic epidermolysis bullosa

Conditions: Dystrophic Epidermolysis Bullosa

Summary: this is a phase i/ii open-label study to evaluate the efficacy and safety of allo-asc-dfu in patients with dystrophic epidermolysis bullosa.

allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a dystrophic epidermolysis bullosa.

Eligibility criteria:
inclusion criteria: 1. age : 10\~60 2. diagnosed with dystrophic epidermolysis bullosa based on immunofluorescence test. 3. bullous skin lesion sized over 10 cm\^2 4. test negative for serum β-hcg pregnancy test on screening, if the subject is fertile 5. a subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided. exclusion criteria: 1. a subject with history of epidermoid carcinoma within a year from screening. 2. a subject who requires antibiotics due to bacterial infection on skin. 3. a subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening. 4. a subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening. 5. a subject treated with steroids locally, within 30 days prior to screening. 6. a subject with 2-times the maximum-standardized value of alt, ast, alp, bilirubin, total protein 7. a subject with 2-times the maximum-standardized value of bun, creatinine 8. a subject with albumin below 2.0 g/dl. 9. a subject with hemoglobin below 6 g/dl (anemic). 10. a subject with allergic response to bovine derived protein and fibrin glue. 11. a subject administered with biologic agents or cell therapy, within 30 days prior to screening. 12. a subject administered with stem cell treatment by iv or subcutaneously to the target wound, prior to the trial 13. a subject who enrolled into another clinical trial, within 30 days prior to screening 14. a subject with serious disease that can affect on clinical trial. 15. a pregnant or breast-feeding subject. 16. a subject with history of drug abuse within 1 year of clinical significance 17. a subject who cannot proceed according to the protocol.

Keywords: epidermolysis bullosa stem cell
the use of bispectral index monitoring to assess depth of sedation in patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: an observational study to assess the bis reported level of sedation of patients with traumatic brain injury in the icu.

patients admitted to aberdeen icu with severe traumatic brain injury will have a bis electrode placed and observed for 24 hours. the study team will be blinded to the result, so not to influence treatment. all clinical care is at the discretion of the clinical team.

Eligibility criteria:
inclusion criteria: * adults (over 18) * diagnosis of traumatic brain injury * expected to survive * expected to require greater than 24 hours of sedation and mechanical ventilation exclusion criteria: * brain injury thought to be unsurvivable by icu clinical team * frontal decompressive craniectomy * use of ketamine infusion at recruitment or planned use within 24 hours * fractured frontal bone or severe overlying soft tissue injury * simple extradural haemorrhage with no other obvious intracranial injury * pregnant patient

Keywords: bispectral index monitoring sedation traumatic brain injury
teddy: spores of bacillus clausii in acute diarrhoea in children

Conditions: Diarrhea

Summary: primary objective: * to demonstrate the efficacy of a bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days. secondary objective: * to evaluate the clinical safety of the bacillus clausii probiotic strain versus placebo.


Eligibility criteria:
inclusion criteria: infants or children * non hospitalized infants or children * with acute diarrhea evident for less than 48 hours * having had three or more watery stools during the preceding 24 hours exclusion criteria: infants or children * with blood stools * having been treated with antibiotics or probiotics within the two weeks before the enrollment * suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold * with an history of seizures * with immunosuppressive conditions * with a current status requiring an antibiotic treatment * suffering from a chronic disease including chronic diarrhea whatever the origin * having received before inclusion one of the following treatments: * probiotics * prebiotics * drugs with adsorbing properties * drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan * drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents). * having participated in another clinical trial in the last 3 months prior to the start of the study
receiving genetic information: a quantitative survey

Conditions: Obesity

Summary: this study will evaluate the public's response to receiving genetic information via an electronic platform. it will comprise of an internet run quantitative survey.

there is currently a high prevalence of obesity in the uk. diets personalised to an individual's genetics could help to reduce the prevalence. however, how the public will respond to this information is unknown. the use of technology is very common and could provide an accessible platform to communicate genetic results to the public. therefore, this study will evaluate the public's response to receiving genetic information via an electronic platform. this study will comprise of an internet run quantitative survey. the survey will be circulated using relevant websites, internet forums, emails and social media. participants will be required to complete the survey once which will take around 10 minutes. the participants will not be required to complete the survey in a controlled setting, it may be complete wherever the participant feels comfortable. data analysis will take place at st mary's university.

Eligibility criteria:
inclusion criteria: uk citizens between the ages of 18 and 65 years
treadmill training and quality of life in parkinson's disease

Conditions: Parkinson's Disease

Summary: parkinson's disease (pd) causes motor and non-motor impairments that affect the quality of life of the subjects. the purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with pd. methods: nine subjects with pd, hoehn and yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. the training program was divided into three phases (a1-b-a2): treadmill training with additional body load (a1), control condition (conventional physical therapy group) (b) and treadmill training with load again (a2). each phase lasted six weeks. the quality of life and motor symptoms were assessed by pdq-39 and updrs, respectively. both evaluations and training were performed during on-phase of the medication cycle.


Eligibility criteria:
inclusion criteria: * hoehn and yahr (h-y) stages 2 through 3 * absence of dementia (mini-mental status examination - mmse, defined according to educational level) * capacity to ambulate independently for at least 10 meters exclusion criteria: * change medication (dopaminergic) during the study period * use treadmill for at least six months prior to the study * other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training

Keywords: treadmill training body load quality of life parkinson's disease motor symptoms
rapamycin coated balloon dilation catheter for arteriovenous fistula

Conditions: Peripheral Arterial Disease

Summary: verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.

to verify the effectiveness and safety of the rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by shanghai bomaian medical technology co., ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.

Eligibility criteria:
inclusion criteria: 1. avf has been established, with mature development and at least one successful completion of hemodialysis； 2. avf has significant hemodynamic abnormalities； exclusion criteria 1. the target lesion has undergone intervention treatment within 30 days； 2. an intravascular stent has been placed at any location along the vascular pathway；
18f-fdg versus 68ga-fapi-46 as pet tracer in er-positive breast cancer.

Conditions: Breast Cancer; Breast Neoplasms; Breast Diseases

Summary: the extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. therefore, adequate staging at diagnosis is a requisite for optimal treatment. in all patients diagnosed with locally advanced breast cancer (labc), distant staging using 18f-fdg pet/ct is recommended. however, the degree of metabolic uptake in the primary breast tumor is significantly lower in the er+ subtype compared to her2+ and triple negative breast cancer (tnbc). as a consequence, a suboptimal 18f-fdg uptake in er+ breast cancer patients can potentially lead to missed distant metastases. fibroblast-activating protein inhibitor (fapi) is a recently developed radiotracer that binds to fap, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. previous studies all show 68ga-fapi pet/ct to have a higher detection rate compared to 18f-fdg pet/ct. however, all previous studies were performed without considering breast cancer subtype. if the metabolic uptake by 68ga-fapi-46 is higher in er+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18f-fdg with 68ga-fapi-46 as pet-tracer in er+ breast cancer patients.


Eligibility criteria:
inclusion criteria: * female patient with histopathologically proven er+ breast cancer. * diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, for which 18f-fdg pet/ct or 18f-fdg pet/mri staging is performed. * willing and able to undergo the study procedures. * has personally provided written informed consent. exclusion criteria: * age \<18 * pregnancy * patients with secondary malignancies * no 18f-fdg pet/ct or 18f-fdg pet/mri scan. * contra-indications for pet/mri such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity * chronic inflammatory disease such as rheumatoid arthritis. * patients with severe hepatic or renal impairment (egfr ≤45ml/min/1.73m²) * inability to provide informed consent.

Keywords: 68ga-fapi-46 er+ breast cancer pet/ct pet/mri
a novel suturing technique of cystocele treatment

Conditions: Cystocele

Summary: the rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue.

the aim of this study is to compare patients who underwent cystocele repair using the rug weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional techniques. the investigators retrospectively reviewed 33 patients who underwent anterior vaginal wall repair with the rug weaving-like plication technique and 32 patients who underwent surgery using conventional colporrhaphy. the investigators recorded demographic data and operative details of the patients. at the 6-month postoperative follow-up,the investigators assessed patients' complaints, pelvic organ prolapse quantification (pop-q), modified oxford scoring (mos), and pelvic floor muscle strength. the investigators measured bladder wall thickness between the bladder and anterior vaginal wall using transvaginal ultrasonography (usg) and compared demographic data, operative details, and postoperative outcomes between the two groups.

Eligibility criteria:
inclusion criteria: patients operated on using the rug weaving plication technique exclusion criteria:patients operated on using the conventional anterior colporrhaphy

Keywords: anterior colporraphy naturel tissue suture technique
risk of hypoglycemia in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.

the day-to-day change of blood glucose is associated with the frequency of vascular complications and the quality of life of diabetic patients. in this study the frequency of hypoglycemic events in combination with postprandial hyperglycemia in type 2 diabetic patients on oral insulinotropic therapy will be observed. using more sophisticated technology than before the probability of type 2 diabetic patients on glibenclamide to experience hypoglycemic episodes will be registered. hypoglycemia is prone to cardiovascular complications in type 2 diabetic patients due to concomitant dysregulation of blood flow. with standardized test meals followed by exercise in a clinical setting hormonal counterregulation and cardiovascular parameters associated with hypoglycemia will be identified. the acute effect of different conditions of exercise and a single dose of either glibenclamide or placebo will be followed each day during the total three-day observation period. thus we will evaluate the frequency of and the risk factors associated with hypoglycemia and meal-related hyperglycemia in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * type 2 diabetes on glibenclamide with or without * glycated hemoglobin ≤ 7.5% * stable dosage for three weeks exclusion criteria: * hba1c \> 7.5% * fasting c-peptide below normal * concurrent infectious disease * pregnancy * malignant disease * inability to give informed consent

Keywords: diabetes hypoglycemia
biosimilar retacrit® in the treatment of chemotherapy-induced anaemia in oncology and haematology

Conditions: Chemotherapy-induced Anemia

Summary: the aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.

this is a longitudinal, observational, prospective, multicentre, cohort study, conducted on a representative sample of public and/or private hospital-based oncologists and haematologists practicing in metropolitan france.

Eligibility criteria:
inclusion criteria: * adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy. * patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (retacrit®) for anemia. * patients informed about the computer processing of their medical data and their right of access and correction. exclusion criteria: * patients with hemoglobin concentrations \>11 g/dl. * patients who have been transfused within the previous month. * patients who are hypersensitive to erythropoietin or one of its excipients. * patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology. * patients refusing to participate in the observational study.
pilot study with gft505 (80mg) in patients presenting with impaired glucose tolerance and abdominal obesity.

Conditions: Impaired Glucose Tolerance; Abdominal Obesity

Summary: the purpose of this study is to evaluate the efficacy of gft505 80mg compared with placebo in improving oral glucose tolerance test (ogtt), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of gft505 during 35 days.

the study period is 13 weeks maximum per patient : a screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. the duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. during the screening period, patients will be asked to start or continue adequate diet and exercise.

Eligibility criteria:
inclusion criteria: * male or post-menopausal female. * waist circumference ≥94cm for male, ≥ 80cm for female. * fasting plasma glucose (fpg) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit. * 2-hour glycaemia at ogtt (2hr after a 75g oral glucose load) ≥140 mg/dl (7.8 mmol/l). exclusion criteria: * body mass index (bmi) ≥ 40 kg/m². * blood pressure \> 160 / 95 mmhg. * known type i or type ii diabetes mellitus. * glycated haemoglobin (hba1c) \>7%. * a fasting tg \> 400mg/dl and a ldl-c \> 220mg/dl.

Keywords: impaired glucose tolerance ogtt ppars
efficacy study of pudendal neuromodulation for the treatment of neurogenic overactive bladder

Conditions: Neurogenic Overactive Bladder; Urinary Incontinence; Detrusor Overactivity

Summary: the study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

the medtronic interstim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems. this trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. after the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Eligibility criteria:
inclusion criteria: * incomplete upper motor neuron lesion * detrusor overactivity * two leaks or two notices of leaks per day * mean functional bladder capacity (volume voided per episode) of ≥100 ml exclusion criteria: * complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves. * degenerative disease of the central nervous system

Keywords: neurogenic overactive bladder urinary incontinence due to incomplete spinal cord injury neuromodulation neuromodulation for treatment of neurogenic overactive bladder patients with urge urinary incontinence and detrusor overactivity
hiv, abuse, and psychiatric disorders among youth

Conditions: HIV Infections

Summary: one subgroup of adolescents at particular risk for hiv is those with psychiatric disorders. furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. this study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. it is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer hiv-risk related behaviors and attitudes at posttest than peers in an information-based intervention.


Eligibility criteria:
inclusion criteria: * adolescent attending therapeutic school exclusion criteria: * adolescent is hiv positive * adolescent is developmentally delayed * adolescent is pregnant * adolescent has a history of sexual crime

Keywords: hiv prevention hiv seronegativity