Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of inhaled pre-prandial human insulin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * treated with oad(s) for more than or equal to 2 months * body mass index of (bmi) less than or equal to 40.0 kg/m2 * hba1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in oad monotherapy and hba1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on oad combination therapy exclusion criteria: * recurrent major hypoglycaemia * current smoking or smoking within the last 6 months * impaired hepatic or renal function * cardiac disorders * uncontrolled hypertension * proliferative retinopathy or maculopathy
the permacol dutch cohort study

Conditions: Hernia of Abdominal Wall; Biologic Implant; Infected Hernioplasty Mesh

Summary: incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. it has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. in these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented. in the recent years the use of biological meshes has been gaining popularity. recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. they include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. these shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh. the aim of this study is investigate the short and long term effects of the permacol© biological mesh. also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.


Eligibility criteria:
inclusion criteria: * signed informed consent * complicated abdominal wall hernia repair * permacol© mesh implantation exclusion criteria: * no signed informed consent * operation other than complicated abdominal wall hernia repair * implant other than permacol© mesh implantation

Keywords: hernia of abdominal wall biologic implant infected hernioplasty mesh
effects of exosome adminstration in preventing early leakage in rectal cancer patients undergoing low anterior resection

Conditions: Rectal Cancer

Summary: the goal of this clinical trial is to assess the safety and efficacy of human placenta mesenchymal stem cells derived exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. the main question it aims to answer are do mesenchymal stem cell-derived exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer? if there is a comparison group: researchers will compare mesenchymal stem cells derived exosomes to placebo to see if it can prevent early anastomotic leakage. participants will receive intraperitoneal mesenchymal stem cells derived exosomes at the end of their surgery.

anastomotic leakage remains one of the most severe complications following colorectal surgery, leading to increased morbidity, prolonged hospitalization, and reduced quality of life. despite advances in surgical techniques and perioperative care, the incidence of early anastomotic leaks persists. practical strategies to reduce this risk are crucial for improving patient outcomes. recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation. these extracellular vesicles, derived from human placenta mesenchymal stem cells (hpmsc), contain bioactive molecules such as proteins, lipids, and rna that facilitate cellular communication and promote healing processes. preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation. this study aims to evaluate the safety and efficacy of intraperitoneal administration of hpmsc-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection (lar) for rectal cancer. we hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo, thereby improving postoperative recovery and reducing hospital stay.

Eligibility criteria:
inclusion criteria: -patients with stage ii-iii rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery exclusion criteria: * patients who need emergency surgery (presenting with peritonitis or signs of obstruction) * patients with apparent malnutrition or patients who have serum albumin levels of less than 3 g/dl * patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg/day or more) * patients with chronic pulmonary disease * patients who need more than two units of blood transfusion perioperatively
safety and performance of the trialign percutaneous tricuspid valve annuloplasty system (ptvas)

Conditions: Chronic Symptomatic Functional Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Heart Valve Disease

Summary: the purpose of this study is to assess the safety and performance of the trialign system for the treatment of symptomatic chronic functional tricuspid regurgitation (ftr) in patients with a minimum of moderate tricuspid regurgitation. the procedure will be performed with the ptvas device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have ftr with a minimum of moderate tricuspid regurgitation.

a prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. the study will include up to 60 subjects from up to 15 sites in europe and the united states. follow-up evaluations will be conducted through 5 years post implantation.

Eligibility criteria:
inclusion criteria: * chronic functional tricuspid regurgitation (ftr) with a minimum of moderate tricuspid regurgitation; * ≥18 and ≤85 years old; * nyha ii, iii, or ambulatory iv; * symptomatic despite guideline directed medical therapy (gdmt), at minimum, patient on diuretic use; * patient is at high risk for open heart valve surgery * lvef ≥35% * tricuspid valve annular diameter ≤55 mm (or 29 mm/m\^2) exclusion criteria: * pregnant or lactating female; * severe uncontrolled hypertension (sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg); * previous tricuspid valve repair or replacement; * severe coronary artery disease; * mi or known unstable angina within the 30-days prior to the index procedure; * any pci within 30 days prior to the index procedure or planned 3 months post the index procedure; * chronic oral steroid use (≥6 months); * life expectancy of less than 12-months
early discontinuation of empirical antifungal therapy and biomarkers

Conditions: Invasive Candidiasis

Summary: empirical antifungal therapy (eat) is frequently prescribed to septic critically ill patients with risk factors for invasive candida infections (ici). however, among patients without subsequent proven ici, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. the investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of eat among critically ill patients suspected of ici, as compared with a standard strategy, without negative impact on day 28-mortality. to test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.

patients requiring eat will be randomly assigned to: * intervention group: a strategy in which eat duration is determined by (1,3)-b-dglucan and mannan serum assays, performed on day 0 (day of eat initiation) and day 3. early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers. * control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ici, and who improve under antifungal treatment, or less in other situations.

Eligibility criteria:
inclusion criteria: * patient older than 18 years * who require eat for the first time in the icu (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ici) * with an expected icu length of stay of at least 6 days after eat initiation * informed written consent exclusion criteria: * neutropenia (neutrophil count \<500 cells /µl) * active malignant hemopathy * bone marrow transplantation in the last 6 months * polyvalent immunoglobulins in the past months * documented ici in the past 3 months * pregnancy or breastfeeding

Keywords: empirical antifungal therapy invasive candidiasis biomarkers de-escalation icu
a neoadjuvant study of abemaciclib (ly2835219) in postmenopausal women with hormone receptor positive, her2 negative breast cancer

Conditions: Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma

Summary: the purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (hr+), human epidermal growth factor receptor 2 (her2) negative breast cancer.


Eligibility criteria:
inclusion criteria: * have postmenopausal status. * adenocarcinoma of the breast. * breast tumor ≥1 centimeter (cm) in diameter, hr+, her2-. * neoadjuvant endocrine monotherapy is deemed to be a suitable therapy. * primary breast cancer that is suitable for baseline core biopsy. * have adequate organ function. exclusion criteria: * bilateral invasive breast cancer. * metastatic breast cancer (local spread to axillary lymph nodes is permitted). * inflammatory breast cancer. * prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated. * prior radiotherapy to the ipsilateral chest wall for any malignancy. * prior anti-estrogen therapy.

Keywords: cyclin-dependent kinase (cdk) 4/6 inhibitor cdk 4 and 6 inhibitor
impact of sglt2 on glucosuria in hnf1a-mody

Conditions: Maturity-Onset Diabetes of the Young, Type 3; Type 2 Diabetes

Summary: maturity onset diabetes of the young (mody) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. the most common cause of mody is due to mutations in the gene hepatocyte nuclear factor 1 alpha (hnf1a) and is consequently named hnf1a-mody (or mody3). hnf1a-mody is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (sglt2), but sglt2 is downregulated due to the mutation in hnf1a. investigators aim to evaluate the impact of the decreased expression of sglt2 on glucosuria in patients with hnf1a-mody compared to patients with type 2 diabetes (t2d) using a single dose of an sglt2 inhibitor during a glucose clamp experiment.

participants: patients with hnf1a-mody (n=12) and patients with t2d (n=12)

Eligibility criteria:
inclusion criteria: * age ≥18 years * hnf1a-mody verified by genetic testing (only patients with hnf1a-mody) * type 2 diabetes diagnosis according to world health organization (only patients with type 2 diabetes) * treatment with diet and/or a glucose-lowering drug (only patients with hnf1a-mody) * normal haemoglobin (males 8.3-10.5 mmol/l, females 7.3-9.5 mmol/l) * informed consent exclusion criteria: * nephropathy (estimated gfr \<60 ml/min/1.73m2 and/or albuminuria) * known significant liver disease and/or plasma alanine aminotransferase (alt) and/or plasma aspartate aminotransferase (ast) above 2 × normal values) * pregnancy or breastfeeding * treatment with sglt2 inhibitor * fasting plasma glucose \> 10 mmol/l * family history of hnf1a-mody (only patients with type 2 diabetes)

Keywords: sodium-glucose transporter 2 sodium-glucose transporter 2 inhibitors glycosuria
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of regn9035 in healthy adult volunteers and mildly hypertensive participants

Conditions: Healthy Volunteers

Summary: the primary objective of the study is to: • evaluate the safety and tolerability of regn5381 and regn9035 administered alone or sequentially. the secondary objectives of the study are to: * evaluate the ability of single intravenous (iv) doses of regn9035 (compared to placebo) to reverse the acute hemodynamic effects of regn5381 * evaluate the hemodynamic effects of single iv doses of regn5381 * evaluate the persistence of the hemodynamic effects of single iv doses of regn5381 and the reversal of regn5381 effects by regn9035 (compared to placebo) * evaluate the pharmacokinetics of single iv doses of regn5381 and regn9035 administered alone or sequentially


Eligibility criteria:
key inclusion criteria: 1. body mass index (bmi) between 18 and 32 kg/m2, inclusive, at the screening visit. 2. normal or mildly elevated blood pressure as defined in the protocol. key exclusion criteria: 1. history of unexplained syncope or autonomic dysfunction. 2. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease. 3. protocol-defined risk factors for cardiovascular disease. note: other protocol defined inclusion / exclusion criteria apply

Keywords: healthy volunteers mild hypertension high blood pressure
fluorescent-labeled igg for liver tumor detection

Conditions: Liver Cancer

Summary: this study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled igg probe (fluoab) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma). the main purposes of this study include: * to validate the safety and effectiveness of using fluoab in hepatic surgery. * to raise the surgical precision with guidance by fluoab fluorescence imaging.


Eligibility criteria:
inclusion criteria: 1. patients who have been diagnosed with liver tumor. 2. planned to receive hepatectomy. 3. liver function child-pugh a/b. 4. the expected lifetime is longer than 6 months. 5. approved to sign the informed consent. exclusion criteria: 1. enrolled in other trials in the past 3 months. 2. metastatic lesions were found. 3. undesirable function of heart, lung, kidney, or any other organs. 4. unable to tolerate a hepatectomy. 5. the researchers considered inappropriate to be included.
the loop trial in treatment of skin abscesses

Conditions: Abscess

Summary: this prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. two methods of drainage were compared: 1) the loop technique or 2) standard packing technique.

this prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, iv antibiotics, or repeat drainage within 10-day follow-up. the secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.

Eligibility criteria:
inclusion criteria: * subcutaneous skin abscesses necessitating drainage exclusion criteria: * abscess was on the hand, foot, or face * requiring admission or operative intervention

Keywords: soft tissue infection mrsa
efficacy and safety of sparc1310 in seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the study will assess the efficacy and safety of sparc1310 when compared to placebo and active control


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis * participants able to understand and willing to sign the informed consent form exclusion criteria: * anotomical deviations of the nasal septum that significantly impair ventilation or airflow * pregnant or nursing women * positive serology for infectious disease (hepatitis b or c, hiv) at screening * parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
phase iii double-blind, placebo-controlled study of azd1222 for the prevention of covid-19 in adults

Conditions: COVID-19; SARS-CoV-2

Summary: the aim of the study is to assess the safety, efficacy, and immunogenicity of azd1222 for the prevention of covid-19.

the covid-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. currently, there are no specific treatments available against covid-19 and accelerated vaccine development is urgently needed. a safe and effective vaccine for covid-19 prevention would have significant public health impact.

Eligibility criteria:
inclusion criteria: * increased risk of sars-cov-2 infection * medically stable exclusion criteria: * confirmed or suspected immunosuppressive or immunodeficient state * significant disease, disorder, or finding * prior or concomitant vaccine therapy for covid-19

Keywords: covid-19 vaccine
discomfort in intensive care patients - iprea-n

Conditions: Critical Illness; Discomfort

Summary: the purpose of this study is to investigate discomforts experienced by intensive care patients during their critical illness period. we will use the norwegian version of the questionnaire inconforts des patients de reanimation (iprea), the iprea-n.patients will be asked to rate18 questions about different possible discomforts on a 0-10 scale after their intensive care stay. furthermore we aim to test whether the questionnaire when translated into norwegian is useful in the norwegian patient population. the aim of the study is * to assess perceived discomfort in intensive care patients using the iprea-n questionnaire * to test psychometric properties of the questionnaire


Eligibility criteria:
inclusion criteria: * adult intensive care patients (\> 18 years), * understanding norwegian * having spent more than 48 hours in the intensive care unit. * ability to consent to participation and self-report discomfort exclusion criteria: * patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.
nusurface implant registry

Conditions: Meniscus; Degeneration; Knee Osteoarthritis; Knee Pain Chronic

Summary: the purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the nusurface® meniscus implant in the real-world post-marketing setting

patients eligible for the registry includes any patient who received or is scheduled to receive the nusurface® meniscus implant and meets the registry inclusion criteria (evidence of a personally signed and dated informed consent document). the nusurface implant regitstry is about data collection only and under routine standard of care by treating physician. data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.surveys used are koos; knee injury and osteoarthritis outcome score \& womet; western ontario meniscal evaluation tool.

Eligibility criteria:
inclusion criteria: * new or current treatment with the nusurface® meniscus implant * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the registry. exclusion criteria: * there are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.