Kornimate/medical-research-clean huggingface dataset:
individualized perioperative open-lung ventilatory strategy with high versus conventional inspiratory oxygen fraction (iprove-o2).

Conditions: Hyperoxia; Postoperative Complication; Surgical Site Infection

Summary: the iprove-o2 trial aims at comparing the efficacy of high and conventional fio2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of ssi.


Eligibility criteria:
inclusion criteria: * age not less than 18 * planned abdominal surgery\> 2 hours. * signed informed consent for participation in the study. exclusion criteria: * age less than 18 years. * pregnant or breast-feeding. * patients with bmi \>35. * syndrome of moderate or severe respiratory distress: pao2/fio2 \< 200 mmhg. * heart failure: nyha iv. * hemodynamic failure: ci \<2.5 l/min/m2 and / or requirements before surgery ionotropic support. * diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmhg). * mechanical ventilation in the last 15 days. * presence of pneumothorax. presence of giant bullae on chest radiography or computed tomography (ct). * patient with preoperatively cpap. * participation in another experimental protocol at the time of intervention selection.

Keywords: oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
effect of sulthiame on eeg in childhood epilepsy syndromes

Conditions: Importance of Interictal Epileptiform Activity on Sleep EEG; Epilepsy in Children

Summary: the effect of sulthiame on eeg has been studied in epilepsy syndromes of childhood with sleep activation by comparing sleep eeg obtained at baseline and after 4 weeks of treatment. the aim of the study is to know if an effect is still identifiable after 2 weeks of treatment by performing sleep eeg recordings after 2 and 4 weeks of treatment, respectively.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy syndromes of childhood with sleep activation * failure of at least two anti-epileptic drugs (aed) * sleep eeg performed in the last 7 days before inclusion and showing interictal epileptiform discharges (baseline eeg) exclusion criteria: * previous trial with sulthiame * more than 2 aed at inclusion * use of corticosteroids at inclusion * change in the anti-epileptic treatment in the 7 days before baseline eeg
the impact of different feeding modes on patients with intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: this was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with intracerebral hemorrhage.the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage. the main questions it aims to answer are: compared to nasogastric tube feeding, can the intermittent oro-esophageal tube feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of patients with intracerebral hemorrhage compared to nasogastric tube feeding, is the intermittent oro-esophageal tube feeding safer. participants will be divided into two groups randomly, with different nutritional support respectively.

safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. nasogastric tube feeding has been the mainstay in china but has a significant risk of adverse events. intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace nasogastric tube feeding. this study reports the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy. however, in the field of intracerebral hemorrhage combined with tracheostomy, research on intermittent oro-esophageal tube feeding is still relatively limited. therefore, this study was carried out to explore the clinical effect of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for intracerebral hemorrhage. * with placement of a tracheotomy tube. * requiring enteral nutrition support. * age over 18 years. * able to cooperate with treatment and questionnaire investigation. exclusion criteria: * combined with tumors in the head, neck, esophagus, or gastrointestinal tract * an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus * with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys * with severe hemorrhagic disease or bleeding tendency; * with contraindications for enteral nutrition * with dysphagia caused by non-stroke-related reasons in the past
com902 (a tigit inhibitor) in subjects with advanced malignancies

Conditions: Advanced Cancer; Ovarian Cancer; Lung Cancer; Colon Cancer; Plasma Cell Neoplasm; Multiple Myeloma; HNSCC; Microsatellite Stable Colorectal Carcinoma; MSS-CRC

Summary: phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of com902 as monotherapy and in combination with com701 in subjects with advanced malignancies.


Eligibility criteria:
key inclusion criteria: * subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy. * subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study. * subject has eastern cooperative oncology group (ecog) performance status 0-1. for triplet combination mss-crc: * histologically confirmed adenocarcinoma of the colon/rectum * stage iv disease * mss-crc status by an fda approved test * disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin for triplet combination ovarian cancer: * advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma * platinum resistant ovarian cancer (proc) defined as disease recurrence \< 6 months after completion of a platinum-containing regimen: patients with primary platinum refractory disease are ineligible. primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy) * received ≤3 prior lines for proc; maintenance bevacizumab or parp are not included as a line of therapy * subjects who have received parp inhibitor therapy are eligible key exclusion criteria: * prior treatment with a tigit inhibitor. * prior treatment with an inhibitor of pvrig * symptomatic interstitial lung disease or inflammatory pneumonitis. * history of immune-related events that required immunotherapy treatment discontinuation for triplet combination expansion cohorts (mss-crc and proc): prior treatment with an anti-pd-1/pd-l1/2, anti-cd96 antibody, anti-ox-40 antibody, anti-cd137 antibody, anti-lag3, anti-tim3, anti-ctla4 antibody.

Keywords: tigit antibody pvrig antibody com701 low fc-effector function pembrolizumab
spinal manipulation and neuromuscular performance on amateur cyclists

Conditions: Manual Therapies

Summary: the present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.

the present study will follow a parallel, pre-post design. the aim will be to determine the acute effects of spinal manipulation therapy (smt) on different neuromuscular properties of recreational cyclists. specifically, the investigators will measure the maximum force production capacity and muscle activation of the knee extensors concomitantly during a maximal voluntary contraction, as well as the maximum and mean power attained during a wingate cycling test (i.e., 30 seconds 'all out'). participants will undergo the tests on two different occasions separated by at least 48 hours and a maximum of 2 weeks. the same tests will be conducted in both testing sessions, but participants will be randomly assigned into two groups (sham or actual smt) immediately before the second testing session.

Eligibility criteria:
inclusion criteria: * will be recruited from three different local triathlon and cycling clubs. * will have to cycle at least 4 hours per week during the preceding 3 months, and to have a cycling experience greater than 2 years exclusion criteria: * having suffered an injury in the month before the study that precluded regular exercise practice * having suffered any type of spine injury before the study * having previously received spinal manipulation therapy

Keywords: neuromuscular properties strength power performance
a phase iii study assessing the safety and efficacy of de-117 ophthalmic solution compared with latanoprost ophthalmic solution in subjects with oag or oht

Conditions: Open Angle Glaucoma or Ocular Hypertension

Summary: the purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of de-117 ophthalmic solution compared with latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * patients with open angle glaucoma or ocular hypertension in both eyes exclusion criteria: * patients at risk of progression of visual field loss * patients with severe visual field defect * patients with any diseases that preclude participation in this study for safety reasons
imaging biomarker in cancer drug induced ild

Conditions: Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Summary: drug induced interstitial lung disease (diild) is caused by iatrogenic injury to the lung parenchyma and can be caused by over four hundred different drugs in humans. diagnosing diild is a challenge for clinicians and radiologists as a positive diagnosis depends on exclusion of other causes including respiratory infection, occupational, recreational, and environmental exposures, specific respiratory disorders, and systemic diseases. the aim of this study is to qualify an objective ct scoring system for diild assessment. in addition, the quantitative information obtained from ct scans with densitometry and texture analysis will be explored.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * world health organization (who) performance status 0-2 * life expectancy \> 6 months * proven cancer diagnosis in a patient actively undergoing anti-cancer therapy * new onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any time during or within 4 weeks of the last dose of anti-cancer treatment * new onset radiological (cxr or ct) abnormalities within the lungs at any time during or within 4 weeks of the last dose of anti-cancer treatment (e.g. diffuse lung changes, infiltrative opacification in the periphery of the lung or ground glass changes) with a locally reviewed diagnosis of diild as the most likely explanation for the radiological abnormalities. * treatment for diild planned (e.g. drug withdrawal, interruption +/- supportive therapy including corticosteroids, oxygen, bronchodilators etc.). concomitant treatment with antibiotics, anticoagulants etc. is permitted pending results of investigations for differential diagnoses. * able to undergo pulmonary function tests (at a minimum spirometry and gas transfer (dlco)) * patients enrolled on other anti-cancer investigational trials are permitted at investigator discretion * informed written consent obtained according to national/local regulations * women of child bearing potential (wocbp) must have a negative serum (or urine) pregnancy test within 14 days before study registration exclusion criteria: * clinically suspected or confirmed radiological features of any malignancy involving the lungs at the time of study registration * claustrophobia, or inability to undergo non-contrast ct examination * known or suspected non-drug related ild (e.g. lung abnormalities due to other causes such as occupational exposure) * previous extensive thoracic surgery (e.g. lobectomy) * clinical, radiological or microbiological evidence of active lower respiratory tract infection * currently active, clinically significant heart disease, such as uncontrolled class 3 or 4 congestive heart failure defined by the new york heart association functional classification * any medical, psychological, sociological or geographical condition that could affect participation in the study and compliance with the study protocol

Keywords: drug induced interstitial lung disease (diild)
anterior suprascapular nerve block is an effective and diaphragm protective approach for arthroscopic shoulder surgery

Conditions: Diaphragm Paralysis Due to Local Anesthesia; Anterior Suprascapular Nerve Block; Analgesia, Arthroscopic Shoulder Surgery

Summary: interscalene block is still the gold standard in shoulder surgery analgesia. the most important side effect is diaphragm paralysis due to the phrenic nerve being affected. it may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. there are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. the aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.

interscalene block is still the gold standard in shoulder surgery analgesia. the most important side effect is diaphragm paralysis due to the phrenic nerve being affected. it may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. more distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. with the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml. there are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known. the effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. the method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation. the aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. one of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old * american society of anesthesiology (asa) score of 1-3 * scheduled for elective surgery. exclusion criteria: * patients with a condition that prevents peripheral nerve block * coagulopathies * chronic opioid use * stroke * polyneuropathy * cognitive dysfunction * communication difficulties * allergies to drugs used

Keywords: arthroscopic shoulder surgery interscalene nerve block anterior suprascapular nerve block analgesia, postoperative diaphragm paralysis
a study evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of crovalimab for the management of acute uncomplicated vaso-occlusive episodes (voe) in participants with sickle cell disease (scd).

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a voe) that requires hospitalisation in adult and adolescent participants with scd. the primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.


Eligibility criteria:
inclusion criteria: * body weight \>=40 kg. * confirmed diagnosis of hbss (scd genotype of sickle cell anemia) or hbsβ0 (scd genotype of sickle cell beta zero thalassemia). * vaccination against neisseria meningitidis serotypes a, c, w, and y. * vaccinations against h. influenzae type b and s. pneumoniae. * participants vaccinated against sars-cov-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine. * diagnosis of an acute uncomplicated voe, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics. * adequate hepatic and renal function. * hemoglobin \>=5 grams/deciliter (g/dl) * platelet count \>=100,000/microliter (µl) * participants receiving scd-directed therapies must be on a stable dose for \>=28 days. * for female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment. exclusion criteria: * more than 10 voes within the last 12 months prior to presentation, that have required a medical facility visit. * pain related to the current voe ongoing for \>36 hours. * acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism. * pain atypical of an acute uncomplicated voe. * evidence of or suspicion of acs. * evidence or high suspicion of a severe systemic infection. * major surgery and/or hospitalization for any reason within 30 days. * history of neisseria meningitidis infection within 6 months prior. * known hiv infection with a documented cd4 count \<200 cells/µl. * transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol. * immunized with a live attenuated vaccine within 30 days. * history of hematopoietic stem cell transplant. * known or suspected hereditary complement deficiency. * pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration. * participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.

Keywords: vaso-occlusive episodes pain crisis
observational study of oralair® in children 5-9 years with grass-pollen-induced allergic rhinitis with/without conjunctivitis

Conditions: Allergy

Summary: safety and tolerability of oralair in children 5 to 9 years of age during the first 30 days of treatment.

the purpose of this study is to further describe the safety and tolerability of oralair tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis. patients are followed for safety and tolerability during the first 30 treatment days.

Eligibility criteria:
inclusion criteria: allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed oralair. exclusion criteria: patients already participating in a clinical trial.

Keywords: rhinitis conjunctivitis grass pollen sublingual tablet allergen immunotherapy safety
impact of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer

Conditions: Cancer Survivor; Head and Neck Cancer; Lymphedema

Summary: rationale: collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment. purpose: this phase i trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

objectives: * to examine the association of secondary lymphedema, symptoms, functional status, and quality of life after treatment in patients with head and neck cancer. * to examine the possible factors contributing to the development of secondary lymphedema in these patients. outline: participants undergo a physical and external (e.g., submental area) and internal (e.g., larynx, pharynx, and oral cavity) lymphedema examination. demographics, background, and lymphedema treatment information are also collected. participants' medical records with head and neck cancer information and treatment are reviewed. participants complete surveys on vanderbilt head and neck symptom (vhnss), lymphedema symptom intensity and distress survey head and neck (lsids-hn), functional assessment cancer therapy-head neck (fact-hn), quality of life scale, hospital anxiety and depression scale (hads), and body image scale.

Eligibility criteria:
disease characteristics: * diagnosed with head and neck cancer * at least 3 months since completion of head and neck cancer treatment * participating in the pain and symptom management program at the vanderbilt-ingram cancer center * no current evidence of cancer * no metastatic disease patient characteristics: * no other active cancer * able to understand informed consent prior concurrent therapy: * see disease characteristics * no concurrent chemotherapy or radiotherapy

Keywords: cancer survivor lymphedema head and neck cancer
: protescal: prevention of hypertrophic scar and keloid formation post caesarean section

Conditions: Caesarean Wound; Hypertrophic Surgical Scar; Keloid Scar Following Surgery

Summary: this study aimed to evaluate the effectiveness of protescal in preventing post caesarean section hypertrophic scar and keloid formation.

a randomized controlled trial was conducted for six months involving 90 women who underwent caesarean section without any history of previous abdominal surgery and who were planning for further pregnancy. they were randomized into two groups. the protescal group was given protescal gel which was applied over the uterine incision site and subcutaneous tissue layer prior to skin closure (n = 45), whereas in the control group, no protescal gel was applied (n = 45). the primary outcome was to assess the healing of the external scar.

Eligibility criteria:
inclusion criteria: * all women undergoing elective caesarean section, without any history of previous abdominal surgery ; who planned for further pregnancy and consented to participate in this study. exclusion criteria: * patient that allergic to protescal * patient with previous abdominal surgery * patient refusal or patients who are not able to give consent

Keywords: caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing