Kornimate/medical-research-clean huggingface dataset:
safety and tolerability study of medi0382 in japanese preobese or obese subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a phase 2a study designed to assess the safety and tolerability of medi0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs placebo across 48 days in japanese subjects. the study d5674c00001 can be conducted with a reasonable expectation of safety and tolerability in japanese t2dm patients. the design of this study has taken into account the known benefits and risks of glp-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of medi0382.

this is a randomized, parallel-group, placebo-controlled, double-blind, multicenter phase ⅱa study to evaluate the safety, efficacy, and pharmacokinetics of medi0382 in japanese preobese and obese subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. subject fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1 ratio to four treatment arms. this is a phase iia study designed to evaluate the dose range for medi0382 to explore the safety profile, as well as blood glucose control and weight loss effects of medi0382 in japanese patients with t2dm. the design of this study has taken into account the known benefits and risks of glp-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of medi0382, such that benefit-risk balance for the japanese preobese and obese patients with t2dm in this study is considered favourable. a treatment period of 48 days is required to properly evaluate the dose range and safety and tolerability in three different doses. inclusion of placebo in the study allows appropriate basis of aes, glycaemic control, and weight loss. benefits related to participation in this trial include close follow-up of a subject's diabetes and treatment with anti-diabetes agents. although one of possible treatments is placebo, appropriate rescue therapy for worsening glycaemic control will be implemented if required.

Eligibility criteria:
inclusion criteria: * individuals whose hba1c range of 7.0% to 10.5% (inclusive) at screening. * individuals who are diagnosed with t2dm * individuals whose current condition at enrolment (visit 1) is drug naïve * bmi within the range of 24 - 40 kg/m2 (inclusive) at screening exclusion criteria: * subjects with any of the following results at screening: * aspartate transaminase (ast) ≥ 2.5 × upper limit of normal (uln) * alanine transaminase (alt) ≥ 2.5 × uln * total bilirubin (tbl) ≥ 2 × uln * impaired renal function defined as estimated glomerular filtration rate (egfr) ≤ 60 ml/minute/1.73 m2 at screening * participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

Keywords: diabetes medi0382 d5674c00001 t2dm type 2 diabetes
efficacy and safety of cashew nut oral immunotherapy in children

Conditions: Food Allergy in Children

Summary: allergy to nuts (cashew, pistachio, walnut, exotic nuts) is a frequent allergy in children, with a prevalence of up to 4.9% of the population and a low resolution rate (9%). among the nut allergies, cashew nut allergy is one of the most frequent in northern europe: in france 41% of children allergic to nuts are sensitized to cashew nuts. moreover, cashew nut allergy is associated with severe reactions that can be lethal in both adults and children. these reactions may even be more severe than those observed with peanuts, with more frequent respiratory and cardiovascular impairment. we note reactions for even limited contacts (cutaneous or mucous) and low reactogenic thresholds. however, the only recommendation for management at present is avoidance. the stakes of oral immunotherapy protocols cashew would be similar to those for peanut immunotherapy: to limit reactions in case of accidental intake, increase the reactogenic threshold and thus improve the quality of life of allergic patients. to date, only one study has focused on the efficacy and tolerance of cashew immunotherapy : the prospective nut cracker study conducted on 50 children aged 4 years or older with cashew nut allergy between 2016 and 2019, reports a good efficacy of immunotherapy on increasing threshold for cashew nut but also for pistachio and walnut, when there was a cross-over allergy. while the tolerance was similar to other immunotherapy protocols for the other foods. the objectives of part 2 of the cajesito study are (i) to evaluate the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew immunotherapy and (ii) to identify risk factors for severe risk factors for severe allergic reactions during oral cashew immunotherapy.


Eligibility criteria:
inclusion criteria: * patients under 18 years of age with a known allergy to cashew nuts cashew nut allergy and followed in the pediatric allergology unit of nancy university hospital. * patients who have received oral cashew immunotherapy for at least 18 months at 28/02/2023 exclusion criteria: * patients who have received oral cashew immunotherapy for less than for less than 18 months. * patients lost to follow-up for more than 3 years (last visit in 2020 or earlier)

Keywords: cashew nut allergy food allergen immunotherapy
immune response in patients with hepatitis b and c infection

Conditions: Hepatitis B; Hepatitis C

Summary: using peripheral blood mononuclear cells (pbmc) and serum collection from hbv and hcv infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.

hepatitis b virus (hbv) and c (hcv) are the leading causes of liver disease worldwide. approximately 400 million people worldwide are chronically infected with hbv world wide and it is estimated that 3% of the entire world population is infected with hcv and yet there is still no vaccine available. chronic viral hepatitis infection is primarily the result of a complex interaction between the virus and an impaired host immune response. the host immune response has a unique role in hbv and hcv infection because it contributes not only to viral control clinical recovery and protective immunity but also to the development of chronic hepatitis and liver cirrhosis. there is currently no cure for most patients who already have chronic hbv and hcv infection and a proportion of patients fail to respond to current antiviral regimens. since these patient remain at risk for disease progression it is crucial to investigate host immune responses and to determine the precise role of these responses in disease outcome. using peripheral blood mononuclear cells (pbmc) and serum collection from hbv and hcv infected patients in a number of different immunological assays, we hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression. this information can be utilised to develop more effective treatment regimens in order to reduce the current global burden of these diseases.

Eligibility criteria:
inclusion criteria: chronic hepatitis b patients at all stages of infection treatment naive and previously treated longitudinal samples from patients treated with antiviral agents and interferon chronic hepatitis c patients all genotypes - treatment naive and previously treated longitudinal samples from patients treated with interferon and static therapy exclusion criteria: coinfection with hiv coinfection with hepatitis delta excessive alcohol use autoimmune liver disease metabolic liver disease

Keywords: hepatitis b (hbv) hepatitis c (hcv)
effects of fat and carbohydrates in obese men

Conditions: Obesity; Steatosis

Summary: obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. the disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions. the hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. the central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. the common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. it is therefore necessary to better understand the impact of the different macro-nutrients. the purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.


Eligibility criteria:
inclusion criteria. * healthy men. * bmi 30-40. * fasting blood glucose \< 7 mm. * stable body weight last 2 months. exclusion criteria. * high intake of alcohol. * medication affecting glucose or lipid metabolism. * allergy towards important food items in the diet. * inflammatory bowel disease. * surgery or use of antibiotics last 2 months.
stem cell therapy for cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study was to study the effect of stem cell therapy on common symptoms of cerebral palsy patients.


Eligibility criteria:
inclusion criteria: * diagnosed cases of any type of cerebral palsy * age above 12 months. exclusion criteria: * presence of acute infections such as human immunodeficiency virus/hepatitis b virus/hepatitis c virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia.

Keywords: cerebral palsy autologous bone marrow mononuclear cells stem cell therapy
study of comparative bioavailability and pharmacokinetics of acm-001.1) and pindolol in healthy volunteers (hv)

Conditions: Cachexia

Summary: the aim of this early phase two-part study was to compare the bioavailability (ba) pharmacokinetics (pk) and pharmacodynamics (pd) of racemic pindolol with the benzoate salt of the s-enantiomer of pindolol (acm-001.1) and provide safety information. a total of 51 healthy male and female subjects were enrolled, and 48 healthy subjects completed the study. part 1 consisted of two groups to compare ba and pk, group 1 received two treatment sequences of a single dose of acm-001.1 versus racemic pindolol; group 2 ran in parallel with group 1 and assessed the pk of a single dose of racemic pindolol in a single period. part 2 consisted of four groups, to evaluate the steady state pk and pd of acm-001.1 with multiple ascending doses over 4 days.


Eligibility criteria:
inclusion criteria: * healthy males or non-pregnant, non-lactating healthy females * aged 20 to 45 years inclusive at the time of signing informed consent * body mass index (bmi) of 18.0 to 30.0 kg/m2 as measured at screening * weight of 50 to 100 kg at screening exclusion criteria: * subjects who had received any investigational medicinal product in a clinical research study within the 90 days prior to day 1, * subjects for whom pindolol was contraindicated: hypersensitivity to the active substance or to any of its listed excipients. * evidence of current severe acute respiratory coronavirus 2 infection. * history of any drug or alcohol abuse in the past 2 years. * females of childbearing potential who were pregnant or lactating. * history of clinically significant cardiovascular disease, raynaud's disease or phenomenon, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder. * subjects who were found to have mean heart rate less than 50 bpm at rest or mean systolic blood pressure (bp) less than 100 mmhg or mean diastolic heart rate less than 50 mmhg. * subjects who were taking, or had taken, any prescribed or over-the-counter drug or herbal remedies (other than paracetamol, hormonal replacement therapy/hormonal contraception). pindolol should not be taken in conjunction with agents which inhibit calcium transport.
prediction of non-motor symptoms in fully ambulatory ms patients using vocal biomarkers

Conditions: Multiple Sclerosis

Summary: the investigator will set up a study evaluating vocal biomarkers in people with ms in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with ms.


Eligibility criteria:
inclusion criteria: * relapsing ms * age over 18 * edss \< 4.0 * capability of written informed consent exclusion criteria: * not fluent in german language * relapse or steroids per os/intra venous \< 4 weeks prior to examination * km enhancing lesion in mri \< 4 weeks prior to examination * other previous disease affecting the speech * pregnant patients * mental disability and not able to understand the protocol and study tasks in german languagepatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts * patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)

Keywords: multiple sclerosis digital biomarker non-motor symptoms fatigue cognition depression voice analysis
impact of a personalized multicomponent exercise program in real conditions among older adults with hiv

Conditions: Frailty; Quality of Life; Physical Inactivity; Body Composition

Summary: longitudinal prospective multicenter study with intervention and control groups and a two-year follow up. participants will include 40 sedentary adults 50 years old or older with hiv infection and 20 sedentary adults 50 years old or older without hiv infection. our main objective is to analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (pmep) on physical function, frailty, and quality of life among older adults with hiv. as secondary objectives, we are going to analyze the effects of a pmep on body composition, muscle function biomarkers, immunological biomarkers, microbiome, and adherence to pmep in real conditions under intense, moderate nonexistent monitoring.

pmeps will be designed according to the specific characteristics of each participant and their grade of usual physical activity. physical activity will be registered on physical activity bracelets to get objective information in order to evaluate adherence to the pmep. a global evaluation of the patients will be made at baseline and months 3, 6, and 12. at each evaluation, samples of blood, stool, urine, and saliva will be taken, and a phone meeting will be scheduled at month 24.

Eligibility criteria:
inclusion criteria: * people living with hiv (control group not included) * age equal or older to 50 years old at initiation of study * sedentary individuals: \< 150 minutes per week of moderate physical activity. * absence of physical limitations which impede the performance of a light or moderate physical activity program exclusion criteria: \* individuals with one or more of the following diseases: * acute myocardial infarction (in the previous 3-6 months) or unstable angina * uncontrolled cardiac arrythmias * severe aortic stenosis * acute pericarditis/ endocarditis * poorly controlled high blood pressure (\> 180/100 mmhg) * acute thromboembolic disease * acute severe cardiac heart failure

Keywords: hiv frailty exercise physical function quality of life
circulating tumor cells in solid tumors

Conditions: Solid Tumor, Adult

Summary: the purpose of this study is to identify circulating tumor cells in patients with solid tumors. quantify and characterize these cells, collect patient information in regards to the patient's cancer. develop a database and a sample repository where future analysis could be done.

the primary purpose of this correlative study is to create a prospective database documenting the quantity and characterization of circulating tumor cells (ctcs) in solid tumor patients as identified by a various laboratory techniques and analyses. the investigators are developing this resource to provide data to achieve the following objectives: 1) correlate ctcs with known prognostic factors, 2) correlate ctcs with burden of disease, 3) evaluate the ability of ctcs to be used in the surveillance of disease recurrence, and 4) evaluate ctcs ability to be used as a biomarker for treatment response.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * biopsy proven solid tumor malignancy * seen at unc chapel hill hospital and health care system * consents to abstraction of their medical records * signed an institutional review board (irb)-approved informed consent document for this protocol exclusion criteria: * \< 18 years of age * dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
suprasorb® a + ag in the treatment of wounds at risk of infection and infected wounds

Conditions: Pressure Ulcer; Arterial Ulcers; Venous Leg Ulcer; Diabetic Ulcers; Surgical Wound; Skin Graft

Summary: the aim of this post market clinical follow up (pmcf) study is to confirm the performance of suprasorb® a + ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of suprasorb® a + ag wound dressing and rope within the certified indications and under the conditions of routine use.

this clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. all wounds of the included patients will be treated with suprasorb® a +ag antimicrobial calcium alginate wound dressings (and suprasorb® a + ag antimicrobial calcium packing rope - if required by the depth of the wound). at inclusion visit (v1, day 0), interim visit (v2, after 10 days ±3 days) and termination visit (v3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient is legally capable * presence of a heavily exuding wound * presence of one of the following wounds: * pressure ulcers * arterial ulcers * venous lower leg ulcers * diabetic ulcers or * postoperative wound * skin graft and donor sites * infected wound (tili score ≥ 5) or a wound with risk of infection (w.a.r. score ≥ 3) * wound area between 4 and 100 cm2 * it must be possible to display the entire wound area on one photo from a distance of 25-30 cm * patient has signed a written informed consent exclusion criteria: * treatment with suprasorb® a + ag antimicrobial calcium algi-nate wound dressing and rope or any silver containing dressing or topical drug during the last 3 weeks * known sensitivity to suprasorb® a + ag antimicrobial calcium alginate wound dressing and rope or any of their components * malignant wounds (tumor related wounds) * critical limb ischemia * infected wounds requiring systemic antibiotic therapy at baseline visit or infected wounds with surrounding skin requiring local an-tibiotics at baseline visit and/or during study conduct. * severe sensitive neuropathy (9-10 points on the neuropathie-symptom-score (diagnose und therapie der sensomotorischen diabetischen neuropathien. diabetes und stoffwechsel, 11, suppl.2 (2002)) * planned amputation within the next 1 months * a planned surgical operation in the region of the study wound within the next 4 weeks following inclusion * patient is not compliant regarding treatment of the underlying disease (e.g. compression) * dry wound * pregnancy or breast feeding * reliable severe malnutrition * patient is analphabet * participation in any clinical trial within the last 1 month and during participation in this study * legal incapacity
physical activity, kinesiophobia, and stoma compliance in urostomy patients

Conditions: Bladder Cancer

Summary: in this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.


Eligibility criteria:
inclusion criteria: * the patient group will include people between the ages of 40-75 who underwent urostomy surgery and a stoma after being diagnosed with bladder cancer. * the control group will include age-matched healthy people with similar age, body weight and height, without a previous history of cancer. exclusion criteria: * orthotopic surgeries will not be included in the patient group * being under the age of 40, * being diagnosed with lymphedema, * presence of active metastasis, * neurological pathologies that limit voluntary mobility, * orthopedic and cardiovascular pathologies, * having a learning disability or other cognitive or communication impairment. * the control group will be excluded if they have any history of cancer.