Kornimate/medical-research-clean huggingface dataset:
oral versus intravenous antibiotics for the treatment of pleural space infection: a randomized controlled pilot trial

Conditions: Pleural Infection

Summary: we aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.

pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. hence, british and american guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. our goal is to determine whether oral (po) therapy is non-inferior to intravenous (iv) therapy thereby decreasing risks of iv catheter related infections, vein thrombosis and health care costs. similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. however, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. the goal of this pilot trial is to assess the feasibility of the proposed study design.

Eligibility criteria:
inclusion criteria: * must meet our study definition of pleural space infection * age \> or = 18 years old * life expectancy \> 1 year * received intravenous or oral antibiotics for = or \< 7 d from surgical intervention or received a total of = or \< 7 d of antibiotics if no intervention performed exclusion criteria: * s. aureus bacteremia or endocarditis in the last 1 month * another concomitant infection requiring prolonged iv antibiotics * esophageal rupture or malignant pleural effusion * septic shock or systemic features requiring iv antibiotics * mycobacterial, fungal or parasitic pleural space infection * no oral antibiotic options available * unlikely to comply with therapy
voluntary termination of pregnancy: comparison of women's experiences depending on the method used.

Conditions: Voluntary Termination of Pregnancy

Summary: voluntary termination of pregnancy (abortion) is a major current societal issue. this is a very common situation, around 225,000 abortions are carried out every year in france. the french law of march 2, 2022 (no. 2022-295) extended the legal deadline for voluntary termination of pregnancy from 14 to 16 weeks of amenorrhea (sa). the recommendations have not been updated following this legal extension, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks). there are two pregnancy termination techniques practiced in france: medical or surgical. the drug method consists of drug-induced expulsion of the pregnancy. this method is carried out in the delivery room, and lasts several hours. the surgical method consists of an endouterine aspiration carried out in the operating room, which lasts approximately 30 minutes. at the toulouse university hospital, as in many centers in france, it is the patient who chooses the method, apart from a contraindication to one or other of these methods. due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. it is necessary to have quality studies to improve knowledge about late abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.


Eligibility criteria:
inclusion criteria: * any adult patient * having given her non-opposition after clear and fair information (patient who understands and reads french) * patient treated at the toulouse university hospital for an abortion between 14 and 16 weeks (dating by ultrasound) * singleton pregnancy * progressive pregnancy exclusion criteria: * protected adult patient (guardianship, curatorship, protection of justice) * developing psychiatric pathologies * fetal anomaly detected
sparobopan project (spanish registry of robotic pancreatic surgery)

Conditions: Robotic Surgical Procedures; Pancreatic Diseases

Summary: pancreatic robotic surgery (prs) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. in the pioneering centres, the results achieved are superior to those of open surgery. at present, it is not known how many centres perform crp, what type of operations they perform, what percentage of the total number of pancreatic operations crp represents and what results are obtained. the aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions. methodology: this is a one-year prospective multicentre registry involving all general and digestive surgery units in spain that have a davinci robotic platform and wish to participate and perform robotic pancreatectomies. all adult patients undergoing robotic pancreatectomy at participating spanish centres who meet the inclusion criteria will be included. the registry will be open until 31 march 2026 to include post-operative morbidity and mortality at 90 days. the number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. intraoperative complications will be measured according to the satava classification modified by halls et al. postoperative complications will be classified according to the clavien-dindo classification and the cci (comprehensive complication index). pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the isgps classification and biliary fistula according to the isgls classification.


Eligibility criteria:
inclusion criteria: * robotic pancreatic resections * asa i-iii * signed informed consent exclusion criteria: * less than 18 years old. * asa iv
irae prediction of anti-pd-1/l1 in lung cancer

Conditions: Immune Checkpoint Inhibitors; Lung Cancer

Summary: the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-pd-1/anti-pd-l1 immunotherapy for lung cancer

after being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. the follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Eligibility criteria:
inclusion criteria: * 18-80 years of age * stage i-iv lung cancer confirmed by histopathology or imaging techniques * receiving anti-pd-1/anti-pd-l1 immunotherapy (with indication and no contraindication) exclusion criteria: * other cancer treatment * other malignancies

Keywords: immunology biomarkers prediction multidimensional
study to assess the safety and effects of autologous adipose-derived stromal cells in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with alzheimer's disease and clinical outcomes?

autologous adipose-derived stromal vascular fraction (ad-svf) will be infused intra-venous and intra nasal. the therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Eligibility criteria:
inclusion criteria: * males or females, age 55 or older * diagnosis of probable alzheimer's disease, consistent with criteria from both: 1) national institute of neurological and communicable disease and stroke and alzheimer's disease and related disorders association (nincds-adrda) and 2) diagnostic and statistical manual of mental disorders (dsm iv) * up to date on all age and gender appropriate cancer screening per american cancer society (refer to section 9.3 for more details). exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease. for patients who have tested positive for hiv, htlv, hbv, hcv, cmv (igm \> igg) and/or syphilis ,then an expert will be consulted as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * systolic blood pressure (supine) ≤90 mmhg; * resting heart rate \> 100 bpm; * active clinical infection. * cerebrovascular accident within 6 months prior to study entry * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * patient or legal guardian if applicable us unwilling and/or not able to give written informed consent. * dementia due to any condition other than ad, including vascular dementia

Keywords: alzheimer's disease alzheimer's stem cell adipose-derived stem cells asc adsc
noom health for weight management

Conditions: Weight Loss; Obesity

Summary: the goals of the study are to use the noom mobile app to help individuals with weight loss and weight loss maintenance. this project will test the comparative efficacy of noom health vs. noom digital health for weight loss, quality of life, psychosocial functioning, and self-reported health status. it is expected that use of noom health will show post-intervention success relative to noom digital health as well as long-term success with weight loss maintenance. data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from noom health. it is also expected that confidence in the ability to lose weight will produce more successful results in noom health vs. noom digital health.

a total of 600 subjects will be enrolled in a randomized-controlled trial comparing the noom app (noom health) to a digital control (noom digital health) with 6 months of intervention and 6 months active maintenance in both groups. measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life. participants will complete informed consent and interviews via a hipaa-compliant videoconference (zoom) and other questionnaires via a redcap interface. all participants will complete screening/baseline procedures to determine eligibility and initial information. subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total). in noom health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. coaches will also interact with participants directly through the app. in noom digital health, participants will use a simplified version to log eating episodes and weight. both conditions will receive the same weight loss advice content. during the intervention, participants will complete monthly satisfaction surveys. additionally, follow-up measures will be conducted at 7 time points (screening/baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).

Eligibility criteria:
inclusion criteria: * participants must be interested in the noom app * bmi \> 27 kg/m2 * ages of 18 and 60 at entry to the study * speak english exclusion criteria: * contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone) * acute suicide risk * pregnant or planning to become pregnant during the study * current noom use

Keywords: weight loss mobile app digital health weight loss maintenance weight loss suppression obesity
arrest of interproximal caries lesion with 38% silver diamine fluoride solution

Conditions: Caries Arrested

Summary: this study was conducted to assess the efficacy of 38% silver diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. each bitewing was scored based on iccms radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest. interproximal caries included in this study, according to iccms criteria, were at stages- ra - caries limited to outer half of enamel ra2 - caries limited to the inner half of enamel ra3 - caries limited to outer third of dentine ra4 - caries limited to middle third of dentine


Eligibility criteria:
inclusion criteria: 1. children aged 5 to 9 years. 2. presence of at least 2 primary molars with interproximal caries. 3. carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with iccmstm scoring (ra1, ra2, ra3, rb4). exclusion criteria: 1. presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations iccmstm (rc5, rc6). 3. children or adolescents that refuse to participate in the study or present negative behaviours. 4. teeth with premature hypermobility 5. both physically and mentally disabled children

Keywords: caries arrest ,interproximal caries, primary molars, sdf
prevena incision management system wound care

Conditions: Ventral Hernia

Summary: comparison of ventral hernia repair using standard wound care versus prevena.

compare the outcomes for patients who have abdominal reconstruction for ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of prevena™ to those patients who have ventral hernia repair to those who have standard wound care.

Eligibility criteria:
inclusion criteria: 1. age 18 - 89 2. open ventral hernia repair with or abdominal wall reconstruction after midline or non-midline defects. 3. able to provide informed consent exclusion criteria: 1. immunosuppresses patients 2. children 0 - 17
a clinical trial to evaluate clifutinib in patients with relapsed or refractory acute myeloid leukemia(aml)

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of clifutinib besylate in relapsed/refractory aml patients with flt3-itd mutation.

it is a multi-center , open-label, single arm study conducted in 2 parts. dose-escalation part: subjects will receive oral clifutinib besylate once on c0d1.after 3 days,they will receive clifutinib besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days. expansion part:expansion cohort might be set to further investigate the safety and efficacy of clifutinib besylate at or lower mtd dose recommended by dose-escalation part.

Eligibility criteria:
inclusion criteria: * documented acute myeloid leukemia according to world health organization（who） criteria(excluding acute promyelocytic leukemia), with flt3-itd gene mutation,refractory after common or enhanced chemotherapy or relapse. * ecog performance status of 0-1. * subjects must have adequate organ function and meeting all of the following laboratory review before enrollment： * lood routine examination: wbc≤2000/mm3; * liver function: alanine aminotransferase (alt) and aspartate transaminase (ast) ≤2.5×upper limit of normal(uln); serum bilirubin ≤ 1.5 × uln; * renal function: serum creatinine ≤ 1.5×uln, or the creatinine clearance (crcl)≥ 60 ml / min calculated by the cockcroft-gault formula; * electrolyte: serum potassium≥3.0mmol/l; serum calcium≥2.0 mmol/l;serum magnesium≥0.5 mmol/l; * coagulation function:fibrinogen≥1.0g/l; activated partial thromboplastin time( aptt)≦uln+10s; prothrombin time(pt)≤uln+3s. exclusion criteria: * received flt3 inhibitors within 4 weeks prior to the administration; * received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of gvhd; * chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration; * nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration; * have taken live vaccines within 4 weeks prior to /or concurrent with the administration; * have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration; * documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(pml)/retinoic acid receptor alpha (rara) positivity found in the chromosome, variant acute promyelocytic leukemia; * with myeloid sarcoma or invasion of central nervous system; * nci ctcae 4.03 ≥ 2 grade of arrhythmia, or corrected qt interval(qtc )\> 450 ms ; patients with a history of torsion or congenital qt prolonged syndrome; active infectious disease judged by the investigator.
laryngeal reflex study under propofol anesthesia: effect of intravenous lidocaine

Conditions: Laryngospasm

Summary: to describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. to determine whether the co-administration of lidocaine blunts these reflex responses. the outcome of primary interest is the reflex laryngospasm. hypotheses: i: the severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml). ii:the incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.

based on our previous work assessing the laryngeal reflex responses in children, the use of propofol appears to be promising regarding a low incidence of laryngospasm. compared with a sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is a high incidence of other reflex responses, such as coughing and expiration reflexes. the use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized children. however, based on clinical studies its effectiveness in the prevention or attenuation of laryngospasm is controversial. in a previous work using a established stimulation model (stimulating the laryngeal mucosa with a small amount of distilled water under direct fiberbronchoscopic observation), we observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus of lidocaine. this effect had already diminished after 10 min. the laryngeal reflex responses differ largely in children anesthetized with either inhalational anesthetics or with propofol. the impact iv administered lidocaine on laryngeal and respiratory reflex responses in children anesthetized with propofol has not been assessed, although this combination might result in a profound suppression of laryngeal reflex responses.

Eligibility criteria:
inclusion criteria: * 25 - 84 months * gender: female / male * elective surgery or diagnostic procedure requiring general anesthesia exclusion criteria: * respiratory infection within the last 2 weeks * reactive airway disease under therapy * cardiovascular disease * neuromuscular disease * positive family history of malignant hyperthermia * known hypersensitivity to the investigational medical product * participation in another study * inability of the parents to read and understand the participant's information

Keywords: anesthesia children larynx
bcma-cs1 compound car (ccar) t cells for relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of bcma-cs1 ccar in patients with relapsed and/or refractory multiple myeloma.

bcma-cs1 ccar (compound car bcma-cs1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, bcma (cd269) and cs1 (slamf7). the use of two different targets widely expressed on plasma cells, bcma and cs1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. bcma-cs1 ccar bears two distinct functional car molecules expressed on a t-cell, directed against the surface proteins bcma and cs1.

Eligibility criteria:
inclusion criteria: 1. diagnosis based on the world health organization (who) 2008 2. patients have exhausted standard therapeutic options 3. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 4. female must be not pregnant during the study exclusion criteria: 1. prior solid organ transplantation 2. potentially curative therapy including chemotherapy or hematopoietic cell transplant 3. prior treatment with bcmaxcd3 or cs1xcd3 bispecific agents

Keywords: bcma cs1 bcma-cs1 ccar t cells cd269 slamf7