Kornimate/medical-research-clean huggingface dataset:
application of rectus sheath block based-on incision in upper abdominal surgery

Conditions: Opioid Consumption

Summary: general anesthesia combined subcostal transversus abdominis plane (tap)or rectus sheath block (rsb)can significantly reduce the use of opiates in minimally invasive surgery.however, similar reduction was not observed in open abdominal surgery during perioperative period.therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified rsb under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.

for abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or rectus sheath block combined with general anesthesia was more effective in reducing pain scores and opioid consumption compared with general anesthesia alone. however, there was no statistically significant difference in supplementary fentanyl during operation. besides adequate pain relief around incisions, blunting visceral traction response has also an important role in hemodynamic stability.with the evidences for a potential mechanism for the antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with oxycodone can provide good visceral analgesia, the investigators supposed that visceral nociception was well suppressed by adequate antinociceptive drugs. the propofol combination with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic tone with decrease of blood pressure and heart rate.

Eligibility criteria:
inclusion criteria: * aged 18-85 years * anesthesiologists (asa) risk classification i to iv * scheduled to undergo midline incision of upper abdomen (from xiphoid to navel ) exclusion criteria: * patient refusal * any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder) * history of analgesics dependence * any difficulty with communication * allergy to the study drugs * heat rate \< 50 beats/minutes or ii-iii atrioventricular block * previous open surgery * previous definite history of malignant tumor * who had an estimated intraoperative blood loss of more than 500 ml
trilogy comparison study - pediatrics

Conditions: Respiratory Failure

Summary: the objective of this study (part ii) will be to compare the performance of the trilogy device and a conventional ventilator (participant's current device). both devices will be set to the participants' current mode and prescription settings.

a. primary hypothesis and end-point in patients with respiratory insufficiency, when compared to conventional ventilators, the trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (co2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (spo2) levels during various modes of ventilation. b. secondary hypothesis and end-points in patients with respiratory insufficiency, when compared to conventional ventilators, the trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified borg dyspnea scale).

Eligibility criteria:
inclusion criteria: 1. age \> 1years of age; \< 18 years of age 2. greater than 5 kg 3. considered clinically stable, with low flow oxygen requirements less than 15 lpm (or fio2 less than 60 %) and peep no greater than 10 cm h2o 4. requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (et tube) exclusion criteria: 1. clinically unstable, i.e., 1. acute respiratory failure 2. participants with refractory hypotension defined as systolic blood pressure less than 90 mm hg despite inotropic agents) 3. uncontrolled cardiac ischemia or arrhythmias 4. or as otherwise determined inappropriate for the study as determined by the investigator 2. patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders 3. pregnancy
study to evaluate the effectiveness and safety of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
inclusion criteria: * has a diagnosis of multiple sclerosis (ms) as defined by the 2017 revision of the mcdonald criteria with a relapsing remitting course of disease. * meets at least 1 of the following criteria for disease activity: i) at least 1 ms relapse/attack in the previous year prior to screening. ii) at least 2 ms relapses/attacks in the previous 2 years prior to screening. iii) evidence of 1 or more gadolinium-enhancing (gde) lesions on magnetic resonance imaging (mri) within 6 months prior to baseline (including screening mri). - has an expanded disability status scale (edss) score of 0 to 5.5, both inclusive. exclusion criteria: * diagnosis of progressive forms of ms. * active or chronic disease of the immune system other than ms. * clinically relevant cardiovascular, hepatic, neurological other major systematic disease. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: multiple sclerosis relapsing-remitting ozanimod zeposia®
calorie restriction diets on weight reduction, post weigh-in recovery and exercise performance in athletes

Conditions: Diet, Reducing

Summary: low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. this diet has effects on oxidizing fat and suppressing appetite. but short term evidences are still few. in combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. the purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.

this study used a randomized cross-over design. each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. the purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.

Eligibility criteria:
inclusion criteria: * must have at least 6 years of taekwondo training experience * must have participated in domestic or international competitions exclusion criteria: * smoking * cardiovascular disease * diabetes * hypertension * any medication in the past 3 months
non-myeloablative allogeneic hsct from hla matched related or unrelated donors for the treatment of low grade b cell malignancies

Conditions: Multiple Myeloma; CLL / SLL; Non Hodgkin's Lymphoma; Waldenstroms; Mantle Cell Lymphoma

Summary: a non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade b-cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade b-cell malignancies, which otherwise is an incurable disease. recent studies of non-myeloablative hsct have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant b-cell malignancies if the transplant is performed for low grade, low volume disease.

Eligibility criteria:
inclusion criteria: * stage ii or iii non-progressive disease multiple myeloma. * cll/sll, and low grade hodgkin lymphomas that are in a very good partial response or complete response with non-progressive disease. * ≤ 70 years old. * eligible and willing hla matched related donor. * bilirubin \<2xuln. * alt and ast \<3xuln. * lvef \> 40%. * creatinine clearance \>40ml/min. * pulmonary function dlco corrected to ≥ 70%. * minimum performance score of 70%. * platelet count \>130 x103 micro l. * ldh ≤1.5xuln. * no proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity. * no uncontrolled infections. exclusion criteria: * age \>70 years old. * performance status \<70%. * uncontrolled infections or is hiv positive * prior malignancies that are felt to have a \<80% probability of being cured. * pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant. * prior allograft * history of rapidly growing disease at diagnosis or at any progression or have mds. * no eligible and willing hla matched donor.

Keywords: low grade b cell malignancies nonmyeloablative transplant allogeneic
msc-exos promote healing of mhs

Conditions: Macular Holes

Summary: purpose: to assess the safety and efficacy of mesenchymal stem cells (mscs) and msc-derived exosomes (msc-exos) for promoting healing of large and refractory macular holes (mhs). hypothesis: msc and msc-exo therapy may promote functional and anatomic recovery from mh. msc-exo therapy may be a useful and safe method for improving visual outcomes of surgery for refractory mhs.

based on the purpose and hypothesis,the participants with large and longstanding idiopathic mhs underwent vitrectomy, internal limiting membrane peeling, msc or msc-exo intravitreal injection, and heavy silicon oil, air, 20% sf6, or 14% c3f8 tamponade. mscs were isolated from human umbilical cord, and msc-exos were isolated from supernatants of mscs via sequential ultracentrifugation. at the time of study enrollment, as well as physical examinations, best-corrected visual acuity (bcva) and intraocular pressure will be measured and fundoscopy be performed. all diagnoses of mh are going to confirmed via spectral-domain optical coherence tomography (oct), and the minimum linear diameter (mld) of each mh will be measured parallel to the retinal pigment epithelium.the participants are going to be followed up for at least 6 months via bcva measurement, fundoscopy, oct, and physical examinations.

Eligibility criteria:
inclusion criteria: 1.clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns exclusion criteria: 1. only one functional eye 2. in other clinical trials. 3. other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc. 4. eye had undergone vitrectomy or scleral buckling, cataract surgery, nd:yag laser less than one month ago. 5. contralateral eye has poor prognosis than the study eye. 6. idiopathic or autoimmune uveitis history. 7. aphakic eye 8. physical condition is poor that can not keep prone position. 9. secondary macular lesions 10. the equivalent spherical diopter of the study eye before any refractive correction or cataract surgery, which is greater than 6.0d or above 26mm of the ocular axis of the study eye. 11. intraocular pressure is higher than 25mmhg 12. within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis. 13. systemic condition is poor, such as the poor control of diabetes and hypertension, myocardial infarction, cerebrovascular accident, renal failure and so on,and the researchers assessed those who are unable to complete the trail.

Keywords: macular hole (mh) exosomes mesenchymal stem cells pars plana vitrectomy
measures of gait efficiency of three multi-axial, vertical shock and energy storing-return prosthetic feet during simple & complex mobility activities

Conditions: Amputation

Summary: many service members suffering major limb amputation(s) during active duty seek to return to active duty. the purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.

specific aims * compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments. * compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups. hypotheses: prosthetic feet with shock absorbing and torsional features will perform better in field activities. prosthetic feet with high energy return and low mass will perform better during treadmill running. non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects. relevance: this study has the potential to quantify differences between highly mobile amputees and non-amputees. additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. the study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. this has the potential to permit retention of already trained soldiers.

Eligibility criteria:
inclusion criteria (amputees): * unilateral transtibial amputee ambulating on a k4 prosthesis for \>1yr * k4 functional level * currently active duty military or other uniformed service (e.g. police), recently separated veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.) * schedule availability and willingness to comply with study protocols * aged \< 45 years * medical clearance, within the last 6 months, for participation in vigorous physical activities inclusion criteria (non-amputees) * currently active duty military, rotc, or other uniformed service (e.g. police) or recently separated veteran, or highly accomplished recreational athlete (e.g. marathoner) * schedule availability and willingness to comply with study protocols * aged \< 45 years * medical clearance, within the last 6 months, for participation in vigorous physical activities

Keywords: amputee transtibial military gait rehabilitation
comparison between surgical access and repeated applications of apdt

Conditions: Aggressive Periodontitis, Generalized

Summary: the aim of this study will be to compare the approach of repeated applications of apdt versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.

scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. a method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. however, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (apdt) was recently proposed. therefore, the aim of this study will be to compare the approach of repeated applications of apdt versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.

Eligibility criteria:
inclusion criteria: * diagnosis of generalized aggressive periodontitis (armitage, 1999; american academy of periodontology, 2015); * have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement); * present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region; * good general health; * agree to participate in the study and sign the informed consent form (tcle) after explaining the risks and benefits; exclusion criteria: * systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - asa iii / iv / v) that contraindicate the periodontal procedure; * have used antibiotics and anti-inflammatories in the last six months; * smoke ≥ 10 cigarettes/day; * pregnant or lactating; * chronic use of medications that may alter the response of periodontal tissues; * indication of antibiotic prophylaxis for dental procedures;

Keywords: surgical procedure residual pockets agressive periodontitis antimicrobial photodynamic therapy
efficacy and safety of dbs of the gpi in patients with primary generalized and segmental dystonia

Conditions: Dystonia

Summary: the purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic multifocal, segmental or generalised dystonia * duration of disease \> 5 years * age between 14 and 75 years * relevant disability in activities of daily living despite optimal drug treatment * informed consent signed by the patient * for adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary exclusion criteria: * mattis-score \< 120 * bdi \> 25 * previous stereotactic brain surgery * severe brain atrophy * increased bleeding risk * immunosuppression and increased risk of infection * relevant cerebrovascular disease * psychiatric disorders, which might interfere with the cooperation in the study * other contraindications for surgery

Keywords: deep brain stimulation internal globus pallidus dystonia
acute myeloid leukemia at initial diagnosis and/or relapse in children, teenagers and young adults: molecular profiling, multidrug testing and msc interaction studies

Conditions: Acute Myeloid Leukemia; Genetic Predisposition to Disease

Summary: pediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms. the main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.


Eligibility criteria:
inclusion criteria: * 0-25 years old * newly diagnosed de novo or secondary acute myeloid leukemia (aml) or * relapsed or refractory aml or * patients with genetic predisposition to develop aml or * patients without haematological malignancy nor aml genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care * signed informed consent of parents for patients aged less than 18 years old or signed informed consent of the patient for patients aged 18 and over. exclusion criteria: * refuse to participate * chronic myeloid leukemia (cml) * lack of health insurance (french social security) * under protection (tutelle, curatelle or sauvegarde de justice) * pregnancy or breastfeeding
study of novel immunomodulators as monotherapy and in combination with anticancer agents in participants with advanced hepatobiliary cancer

Conditions: Hepatocellular Carcinoma; Biliary Tract Cancer

Summary: gemini-hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

this phase ii, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of volrustomig or rilvegostomig as monotherapy (mono) and/or in combination with anticancer agents (combo) in participants with advanced hepatobiliary cancer (e.g., hcc, btc, etc.). this study has a modular design with independent substudies. in substudy 1, volrustomig and rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced hcc. in substudy 2, the efficacy and safety of rilvegostomig or volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced btc who have not received previous treatment for advanced/metastatic disease.

Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of signing the icf. * provision of a signed and dated written icf. * confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology. * adequate organ and bone marrow function. * at least 1 measurable not previously irradiated lesion per recist 1.1 * life expectancy of at least 12 weeks at the time of screening. * willing and able to provide an adequate tumor sample. exclusion criteria: * history of allogeneic organ transplantation. * active or prior documented autoimmune or inflammatory disorders. * uncontrolled intercurrent illness. * history of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency. * active infection, brain metastases or spinal cord compression. * participants co-infected with hbv and hepatitis d virus (hdv). * previous treatment in the present study. * for substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

Keywords: hepatobiliary cancer hepatocellular carcinoma biliary tract cancer gemini-hepatobiliary medi5752 azd2936 bispecific antibody volrustomig rilvegostomig