Kornimate/medical-research-clean huggingface dataset:
phase i study of qls1103 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is a phase i, dose escalation and dose expansion study of qls1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of qls1103 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * 1. subjects must voluntarily agree to participate in the trial and sign a written informed consent form; * 2. aged ≥18 years old; * 3. histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor; * 4. failure of adequate standard treatment, or no effective standard treatment; * 5. eastern cooperative oncology group (ecog) performance status 0 to 1; * 6. life expectancy ≥12 weeks; exclusion criteria: * 1. subjects received systemic anticancer therapy within 4 weeks prior to the first dose; * 2. subjects received experimental medication or therapy within 4 weeks prior to the first dose; * 3. subjects received major surgery within 4 weeks prior to the first dose; * 4. persistent toxicity of national cancer institute common terminology criteria for adverse events (nci ctcae) grade \>1 severity that is related to prior therapy; * 5. cardiovascular and cerebrovascular diseases with clinical significance; * 6. active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
assessment of response to the conventional periodontal treatment based on the blood group phenotypes.

Conditions: Chronic Periodontitis

Summary: the aim of this study is to find out if one blood group phenotype is more responsive than the others to the nonsurgical periodontal treatment.

to the best of our knowledge, this is the first (research) randomized clinical trial that assesses how patient respond to the nonsurgical periodontal treatment based on their blood group phenotype.

Eligibility criteria:
inclusion criteria: * systematically healthy. * have at least 20 teeth excluding the third molars. * had not received any periodontal treatment or antibiotic therapy for dental or medical reason 6 month prior to the study. * diagnosed with generalized chronic periodontitis (\>30% of the sites have probing depth ≥4), and a minimum of six teeth with probing depth of 5-6 mm. exclusion criteria: * smokers and alcoholics. * pregnancy. * history of a systematic disease such as diabetes, leukemia, epilepsy. * participants who are unable to perform routine oral hygiene. * use of orthodontic appliances. * participants who are unable to perform routine oral hygiene.
perioperative music in obese patients under spinal anesthesia

Conditions: Obesity, Adolescent

Summary: the goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. it will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). the main question to answer: music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?


Eligibility criteria:
inclusion criteria: * patients who are \> 18 years old * patients with body mass index -βμι\>30 kg/m2 * patients who will give informed consent in receiving spinal anaesthesia * patients who will give informed consent in participating in the study exclusion criteria: * absolute contraindications of spinal anaesthesia, * severe psychiatric, cognitive or sensory impairment * mother language other than greek, * known hypersensitivity to midazolam, * renal impairment

Keywords: obese music anxiety
treatment of elderly patients with diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: to explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

the results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large b cell lymphoma was provided.

Eligibility criteria:
inclusion criteria: * above 70 years old，pathology proved to be diffuse large b cell lymphoma，estimated survival time \> 3 months，none of chemotherapy contraindication;at least one measurable lesion according to recist;none of other serious diseases;patients could be followed up;none of other relative treatments including the traditional chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent. exclusion criteria: * currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); pregnant or lactating women;serious medical illness likely to interfere with participation;chemotherapy contraindication such as cachexia; patients with other malignancies previously;serious infection;the evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Keywords: curative effect evaluation adverse reactions clinical characteristics pr pfs os
evaluation of the efficacy of xylitol nasal spray against sars-cov-2

Conditions: Covid19

Summary: the purpose of this study is to assess the efficacy of xylitol plus grapefruit seed extract (xlear) nasal spray as an adjunct treatment of covid-19.

after being informed about the study and potential risk, all patients giving written informed consent will undergo a brief screening period to determine eligibility for the study. once eligibility is confirmed, patients who meet the eligibility requirements will be randomized placebo control manner. patient will be assigned to xlear (2 puffs per nosetrils, every 3-4 hours a day) or placebo. patient will be followed for 1 week. inflammatory markers will be obtained on day 4 and repeat covid-19 rt pcr on day 7. follow up will be done on day 14 for all patients.

Eligibility criteria:
inclusion criteria: 1. adults of ages 18 to 90 years of both sexes 2. with positive sars-cov-2 carriage confirmed by nasopharyngeal pcr 3. signed informed consent 4. 1- mild symptoms: minimum respiratory symptoms or asymptomatic plus positive test 5. 2- moderate symptoms: respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air spo2 \ 88% or \ 92% with 2lt of oxygen) exclusion criteria: 1. patient with very low viral load (threshold cycle \[ct\] \> 25 per pcr). 2. known hypersensitivity to one of the constituents, particularly to xylitol or gse 3. under 18 years of age 4. women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test. 5. unable to provide informed consent or decline to consent or unwillingness to adhere to the standard of care protocol. 6. patients with severe symptoms -hypoxia (spo2 \<88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath 7. history of immunodeficiency or are currently receiving immunosuppressive therapy. 8. have had a planned surgical procedure within the past 12 weeks. 9. already part of this trial, recruited at a different hospital. 10. patient unable to perform oro-nasopharyngeal decolonization 11. patients with acute exacerbation of severe comorbidities like heart disorders chronic obstructive pulmonary disease (copd), heart failure new york heart association (nyha) class 3 and 4 and/or diseases with severe oxygenation problems 12. patients on remdesivir and/or other clinical trials.

Keywords: covid 19 intranasal spray therapeutics
photobiomodulation in temporomandibular disorder

Conditions: Pain; Temporomandibular Disorder

Summary: the general purpose of this project is to evaluate the cost-effectiveness of lil treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with tmd.

temporomandibular disorder (tmd) affects a significant portion of the population. epidemiological data show that the signs and symptoms of tmd start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults. the painful conditions of tmd can affect the quality of life of young patients, compromising the daily activities of these individuals. the present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with tmd with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with tmd; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with tmd. the study will be conducted at the odontological clinic of universidade nove de julho. it is a prospective trial of clinical and economic analysis. it will include 30 patients aged between 15 and 25 years with tmd, randomly assigned to a treatment group: g1 (low-power laser), g2 (occlusal plate) and g3 (placebo). the analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment. the outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the research diagnostic criteria for temporomandibular disorders (rdc/tmd). the cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied. the evaluation of the impact of the treatment on quality of life will be determined by applying the adapted euroqol-5d.

Eligibility criteria:
inclusion criteria: * people between 15 and 25 years * diagnosis of tmd in group i exclusion criteria: * individuals with dental-facial anomalies * orthodontic or orthopedic treatment * individuals who were taking muscle relaxants or anti-inflammatory medications

Keywords: temporomandibular disorder photobiomodulation pain
impact of a carrier (infection, colonization) of highly bacteria resistance on the patient's quality of life hospital environment

Conditions: Bacterial Infections

Summary: the quality of life of carriers detected infected or colonized by emerging highly resistant bacteria (bhre) following the implementation of specific hygiene measures during the discovery of the microorganism has been little studied. to date, there have been no studies to determine the quality of life (qol) in france of patients with hospitalized hbhrd.


Eligibility criteria:
inclusion criteria: * age\> 18 years old * have a positive bhre screening during the hospital stay and / or have a positive bhre clinical sample during the hospital stay * conscious patients * all types of stays in the hospital sector * all pathologies exclusion criteria: * known patients with bhre before hospitalization * pch immediately upon admission (history of hospitalization abroad, patients contacted during a previous hospitalization) * cognitive problem * patients not proficient in french (requiring an interpreter) * patients under guardianship
vacuum assisted closure for cesarean section

Conditions: Surgical Wound Infection

Summary: to study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

the prevalence of obesity (defined as body mass index (bmi, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the united states, according to cdc 2009-2010 statistics. obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. infection rates have been reported to be between 10 and 30%. the advent in 1997 of negative pressure therapy (npt), also known as vacuum assisted closure (vac), has vastly changed wound care management. briefly, vac has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "incisional vac") has provided a promising approach to reducing post-operative wound infection. incisional vac has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.

Eligibility criteria:
inclusion criteria: * patients that have undergone cesarean section for delivery; have a bmi greater or equal to 35. all cases of cesarean section including primary and repeat, scheduled and urgent. exclusion criteria: * patients who deliver vaginally; age less than 18 years old; silver allergy; non-english speaking
laao with dapt versus antithrombotic therapy

Conditions: Atrial Fibrillation; Coronary Artery Disease

Summary: this study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Eligibility criteria:
inclusion criteria: * patients with af who underwent pci and treated with laao and dapt or conventional antithrombotic therapy exclusion criteria: -

Keywords: left atrial appendage occlusion antithrombotic therapy atrial fibrillation percutaneous coronary intervention drug eluting stent
tocilizumab for cytokine release syndrome prophylaxis in haploidentical transplantation

Conditions: Cytokine Release Syndrome; Stem Cell Transplant Complications

Summary: tocilizumab will be administered prior to transplantation in order to prevent the onset of cytokine release syndrome and its complications associated to peripheral blood haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide

cytokine release syndrome (crs) is a common and potentially severe toxicity associated to haploidentical peripheral blood (pbsc) hematopoietic stem cell transplantation (haplo-hsct), which was described previously in the context of immunotherapies for acute lymphoblastic leukemia such as chimeric antigen receptor t-cells and blinatumomab. crs is characterized by immune system activation with a high level of circulating inflammatory cytokines including il-6. haplo-hsct recipients have a high incidence of post-transplant fever, with elevated il-6 in absence of documented infection. crs occurs more frequently when using pbsc, and severe cases have been associated to delayed engraftment, increased transplant-related mortality and lower survival. tocilizumab an il-6 receptor-targeted monoclonal antibody has been effectively used to treat crs in several scenarios, including haplo-hsct. therefore, there is considerable interest for the development of a successful strategy for crs prevention with tocilizumab, potentially eliminating complications. however, it is currently unknown whether the use of this monoclonal antibody can adversely affect the outcome of haplo-hsct recipients.

Eligibility criteria:
inclusion criteria: * haploidentical transplant recipients * informed consent signature * previous diagnosis of any neoplastic, metabolic or autoimmune disease exclusion criteria: * history of immune deficiency virus infection * hepatitis c or b virus infection * documented bacterial of fungal infection prior to tocilizumab infusion * previous use of tocilizumab

Keywords: tocilizumab haploidentical peripheral blood
fatty liver and ectopic fat in overweight and obese patients

Conditions: Steatohepatitis

Summary: the aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases. the aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients. fatty liver and ectopic fat accumulation will be particularly assessed.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 40 * alat level superior to normal level even after 3 months of diet * alcohol consumption \< 20 g/j for women and \< 30 g/j for men exclusion criteria: * hiv, hepatitis b virus, hepatitis c virus positive * known hemochromatosis * glycemia \> 1.26 g/l or under anti-diabetic treatment

Keywords: overweight obesity steatohepatitis ectopic fat
study enabling the collection of clinical data necessary for the second phase of development of the glycemic measurement device by analysis of exhaled air

Conditions: Type 2 Diabetes

Summary: a pilot study carried out by the company alpha-mos in 2017-19 showed that the analysis of volatile organic compounds contained in exhaled air could reliably predict blood glucose levels. subsequently, the company boydsense, a subsidiary of alpha-mos, produced the module in a box prototypes of portable, non-invasive volatile organic compounds analyzers that could be equipped with an on-board algorithm estimating blood glucose levels. the toulouse university hospital conducted the boydsense-gm study in 2021-2023, in partnership with boydsense, aiming to develop the first algorithm for calculating blood glucose levels based on the analysis of the breath of 100 patients living with type 2 diabetes and to carry out a first performance test of the module in a box prototype in 30 additional subjects with type 2 diabetes. these recent results confirmed the potential of this innovative blood glucose measurement technology and gave the first indications about the next developments needed to improve its performances. the characteristics of the air exhaled by a human are impossible to simulate. therefore, further development of the glucose calculation algorithm requires the production of additional clinical data, supporting the carrying out of the present study.

the boydsense-data+ study consists of measuring the concentrations of volatile organic compounds at the same time as capillary blood glucose measurements carried out as part of routine care of patients with type 2 diabetes and non-diabetic individuals at risk of type 2 diabetes. the volatile organic compounds measurements will be done using the module in a box prototypes previously used in the boydsense-gm study. the reference blood glucose levels will be capillary blood glucose values, measured with a properly calibrated blood glucose meter validated for hospital use.

Eligibility criteria:
inclusion criteria: * patient living with type 2 diabete or non-diabetic individuals characterized by overweight/obesity (body mass index \>= 25kg/m²) , admitted in the two departments of the toulouse university hospital (diabetology, metabolic diseases and nutrition as well as endocrinology, metabolic diseases and nutrition). * aged 18 years or more. * ability to sign informed consent. * affiliation to a social security scheme. exclusion criteria: * ongoing respiratory infection. * pregnancy or breastfeeding. * patient under guardianship, curatorship or safeguard of justice.

Keywords: blood sugar measurement exhaled air
vitrectomy without internal limiting membrane removal in the treatment of diffuse diabetic macular edema: a comparative kenalog vs bevacizumab intravitreal injection vs control study

Conditions: Diffuse Diabetic Macular Edema

Summary: diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. the purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.


Eligibility criteria:
inclusion criteria: * diffuse diabetic macular edema * non proliferative diabetic retinopathy * no vpp previa * no previous treament with laser, triamcinolone acetonide, and bevacizumab exclusion criteria: * proliferative diabetic retinopathy * previous pars plana vitrectomy * previous treatment with diabetic macular edema * focal macular edema * macular ischemia

Keywords: macula edema
assessment and tracking of long-term alefacept safety

Conditions: Psoriasis

Summary: subjects exposed to alefacept are to be enrolled. subjects will be contacted every 6 months to gather general health information.

there are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. after the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the atlas study center.

Eligibility criteria:
inclusion criteria: * psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.

Keywords: psoriasis alefacept amevive® drug exposure
protein intake associated with physical activity related to specific outcomes

Conditions: Cancer; Critically Ill; Surgery

Summary: this is a randomized controlled trial . the purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the icu in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.

surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. during the hospital stay some measurements will be done. such as resting energy expenditure (ree) before and after surgery; physical function evaluation; strength and quality of life. the proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Eligibility criteria:
inclusion criteria: * cancer patients * age greater than or equal to 18 years old * have a tendency to be admitted to the icu after the surgery * fill the eligible criteria to start enteral feeding within 72 hours * sign the consent form; exclusion criteria: * mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (fio2) \>60% or positive end expiratory pressure (peep) \> 12cm h2o * bronchopleural fistula * karnofsky \<50 * participant cannot b enrolled in another study

Keywords: cancer, icu, surgery, protein, physical activity