Kornimate/medical-research-clean huggingface dataset:
clinical trial comparing treatment of relapsing-remitting multiple sclerosis (rr-ms) with two doses of glatiramer acetate (ga).

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: teva is developing a 40 mg/ml ga injection, administered once daily under the skin, for the treatment of r-r ms. the study drug is a higher dose formulation of copaxone® (20 mg/ml ga), a marketed medication, approved for the treatment of r-r ms. ga is an immunomodulating drug that has anti inflammatory and neuroprotective properties. the study treatment duration is 12 months.


Eligibility criteria:
inclusion criteria: 1. diagnosis of confirmed and documented ms defined by the revised mcdonald criteria. 2. subjects must be of the relapsing-remitting (r-r) type. 3. subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented t1-gd enhancing lesion in the mri performed 12 months prior screening. 4. disease duration for at least 6 months. 5. ambulatory with converted kurtzke edss score of 0 - 5. 6. relapse free and stable neurological condition at least for 30 days prior screening. 7. age - 18-55 (inclusive) exclusion criteria: 1. previous use of copaxone (glatiramer acetate) 2. treatment with corticosteroids within 30 days prior screening or between screening and baseline. 3. chronic corticosteroids treatment - more than 30 consecutive days. 4. subject with any clinically significant or unstable medical condition. 5. subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter). 6. known history of sensitivity to gadolinium and inability to successfully undergo mri scanning.
behavioral economics in provider incentive design

Conditions: Diabetes

Summary: the shift towards value-based reimbursement in u.s. healthcare is accelerating. payment reform initiatives have taken many shapes-accountable care organizations, bundled payments, value-based purchasing, medical homes, global payment-but all share the common strategy of tying provider (physician, hospital, health system) reimbursement to performance on costs, outcomes, or both. yet, pay-for-performance has demonstrated little effect on physician behavior and patient outcomes. payers and provider groups are in need of novel approaches to structure provider incentives-both financial and non-financial-to better promote the delivery of quality, cost-effective care. in this project, the study team plans to study how behavioral economic principles can improve the effectiveness of physician incentives to deliver higher quality and lower cost care. they will test the application of specific behavioral economic principles including immediacy, social pressure, and loss aversion in incentive design and implementation. the study will contribute to an empirical foundation for re-design of existing physician incentive programs and implementation of new policies through secondary data analyses and a multi-arm experiment that evaluate the impact of promising behavioral economics principles on the effectiveness of provider financial and nonfinancial incentives.

the key goal of this project is to demonstrate how using behavioral economic principles to inform the structure of provider incentives and the practice environment can improve provider performance, especially in settings that are moving away from fee-for-service reimbursement and fragmented care towards new payment and delivery models that emphasize coordination of care and provider accountability. the project will build upon the recently completed 'phase 1' project in which a set of behavioral economic approaches to provider performance were identified that could meaningfully improve provider performance, a focused research agenda of high-priority tests of these concepts (i.e., content of this proposal) was developed; and information on how behavioral economics can be used to improve incentives for physicians was disseminated. for this phase, an experimental evaluation will be conducted of the impact of social pressure by varying individual and group incentives and the comparative effectiveness of two loss aversion framing methods (endowment versus performance gap) on provider performance via a multi-arm experiment. we will complement the quantitative evaluations with pre- and post-intervention qualitative surveys of physicians and patients to better understand the influence on behavior change, culture, acceptability of the incentive program, and patient reported outcomes on health and experience.

Eligibility criteria:
inclusion criteria: * physician at participating provider organization (pcp and specific specialties) exclusion criteria: * n/a
pilot study of peritoneal lavage with saline and ondansetron in laparoscopic cholecystectomy

Conditions: Postoperative Pain Management; Laparoscopic Cholecystectomy; Ondansetron; Postoperative Nausea and Vomiting

Summary: this is a pilot clinical trial evaluating whether adding ondansetron to a peritoneal lavage with saline during laparoscopic cholecystectomy can reduce postoperative pain and nausea. thirty-two adult patients undergoing elective gallbladder removal will be randomly assigned to receive either a standard saline lavage or a saline solution with ondansetron (8 mg) applied directly to the abdominal cavity at the end of surgery. both groups will receive standard multimodal pain management. the study aims to compare pain levels, incidence of nausea and vomiting, and quality of sleep within the first 24 hours after surgery. results will help determine if this technique can improve postoperative recovery and patient comfort.

this randomized, double-blind, controlled pilot trial will evaluate the efficacy of peritoneal lavage with saline solution plus ondansetron (8 mg) versus saline solution alone in patients undergoing elective laparoscopic cholecystectomy. all participants will receive standard multimodal analgesia as recommended by international guidelines. the intervention will be applied intraoperatively at the end of the procedure, followed by suction of the fluid and pneumoperitoneum. the primary outcome is the intensity of postoperative pain measured using validated scales (visual analog scale and revised faces pain scale). secondary outcomes include the incidence of postoperative nausea and vomiting (ponv), time to first rescue analgesia, total analgesic consumption, and sleep quality assessed by the richards-campbell sleep questionnaire. safety outcomes and adverse events related to the intraperitoneal administration of ondansetron will also be monitored. this study will provide preliminary evidence on the effectiveness and safety of intraperitoneal ondansetron as part of a multimodal postoperative pain and ponv management strategy.

Eligibility criteria:
inclusion criteria: age ≥ 18 years diagnosis of symptomatic cholelithiasis scheduled for elective laparoscopic cholecystectomy asa physical status i-ii ability to understand and sign the informed consent willingness to comply with study procedures and follow-up exclusion criteria: emergency or open cholecystectomy use of intra-abdominal drain at the end of surgery pregnancy or breastfeeding allergy or hypersensitivity to ondansetron or related compounds history of prolonged qt interval or current use of qt-prolonging drugs chronic opioid use or recent use of antiemetic agents severe hepatic or renal dysfunction psychiatric, neurological, or communication disorders affecting pain or sleep evaluation refusal or inability to complete postoperative assessments

Keywords: laparoscopic cholecystectomy ondansetron formulations intraperitoneal analgesia saline solution pain management postoperative nausea and vomiting
surgery or clincial follow up, in patients with bell' s palsy

Conditions: Bell Palsy

Summary: the purpose of this study is to investigate if an early surgical intervention on patienst with bell´s palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.


Eligibility criteria:
inclusion criteria: 1. patients with bell´s palsy 2. men and women aged 18-55 y 3. score \< 70 according to sunny brook scale (sb) 4. signed informed consent exclusion criteria: 1. high bloodpressure 2. diabetes 3. pregnancy 4. currently on immunodepressive treatment 5. smoker 6. psychiatric disorder 7. cor incomp, according to nyha grade: iv, kidney or liver disorder, that greatly influence patienst ability to receive surgery

Keywords: cranial nerve fascial paresis
a dose ranging study of delayed release beclomethasone for prevention of acute enteritis in patients with rectal cancer

Conditions: Enteritis

Summary: the purpose of this study is to evaluate the safety and preliminary efficacy of four doses of sgx201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.


Eligibility criteria:
inclusion criteria: * primary rectal cancer * planned course of conventional neoadjuvant radiation therapy before surgery * scheduled to receive chemotherapy * \>/= 18 years of age * negative pregnancy test exclusion criteria: * history of acute or chronic regional enteritis or inflammatory bowel disease * stool incontinence * uncontrollable diarrhea * abdominal-perineal resection or other surgery leaving patient without a functioning rectum * patients using colostomy or ileostomy * liver function tests \> 3x upper limit of normal, or bilirubin test result \> 1.5 the upper limit of normal * calculated creatinine clearance \<60 ml/minute * planned hyperfractionated or split course radiation * planned brachytherapy prior to completion of all external beam radiation therapy * prior pelvic rt * an on-going infection * ecog score \>/= 3 * leukopenia \<2,000 wbc/mm3 or hg \<10.5 g/dl * participation in an investigational drug trial within the previous 30 days * patients with a medical condition that would interfere with study compliance * known hypersensitivity to 5-fu or capecitabine * anticipated inability to tolerate oral administration of sgx201 * pregnant or breastfeeding
study on the treatment of nonthrombotic obstructive pulmonary hypertension

Conditions: Fibrosing Mediastinitis; Pulmonary Hypertension

Summary: through a randomized controlled trial (rct) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (fm-ph).eligible participants were randomly assigned to either the combined treatment group, receiving both pulmonary vascular intervention and rituximab lymph node injection, or the interventional-only group, which received pulmonary vascular intervention alone. at 3, 6, and 12 months post-treatment, the efficacy was assessed based on symptom improvement, hemodynamic changes, lesion volume reduction, etc. safety was mainly evaluated by comparing adverse event incidence between the two groups.


Eligibility criteria:
inclusion criteria: 1. diagnosed with fibrosing mediastinitis between november 2024 and november 2026, aged between 18 and 85 years. 2. the patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance. 3. chest ct revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms. 4. the subject signed the informed consent form prior to participation and is able to comply with the study protocol and one-year follow-up. exclusion criteria: 1. currently in the active phase of infection, including but not limited to tuberculosis, histoplasma capsulatum, and aspergillus infections; 2. the underlying primary disease, such as sarcoidosis, behcet's disease, or uncontrolled igg4-related disease, is currently not well controlled. 3. before treatment, a large amount of pleural effusion was still present. 4. pulmonary function tests (pft) showed fev1 \<30% of the predicted value, fev1/fvc \<30%, and dlco \<30%. 5. there are contraindications to bronchoscopy or endovascular intervention. 6. complicated by other end-stage organ dysfunction, such as child-pugh class c liver function or stage iv chronic renal failure. 7. complicated by severe immunosuppression.

Keywords: rituximab endobronchial ultrasound pulmonary vascular intervention
effectiveness of intraoperative neuromonitoring of external branch of superior laryngeal nerve in thyroid surgery

Conditions: Laryngeal Nerve Injuries; Thyroidectomy; Voice Change

Summary: the frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. the objective of this randomized controlled trial (rct) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

with increased interest in quality of life after thyroidectomy, preservation of proper vocal cord function and voice quality is an important issue in thyroid surgery. external branch of the superior laryngeal nerve (ebsln) and recurrent laryngeal nerve (rln) are crucial organs for innervation and integration of laryngeal muscular system. the ebsln innervates the cricothyroid muscle (ctm), which is important in adjusting the tension and length of the vocal cords. damage of the ebsln leads to ctm dysfunction, resulting in difficulty with high pitch phonation and decreased pitch range and reduced voice projection, which are important for voice professionals. as the intraoperative neuromonitoring was utilized as an adjunctive and objective tool to confirm the nerve presence and integrity, application of the intraoperative neuromonitoring system to confirm ebsln function pre- and post-dissection of the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle function. however, it remains unclear whether there is any intraoperative neuromonitoring techniques-added value to the clinical outcome of thyroidectomy in terms of identification of ebsln and preserved voice performance. therefore, this study could provide strong evidence of the application of the intraoperative neuromonitoring during thyroid surgery to identify and preserve ebsln function.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo thyroid surgery * patients who understand and agree to take part in this study exclusion criteria: * if the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.) * patients who are required with lateral compartment neck dissection * patients with recurrent thyroid cancer * patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present * patients with a history of vocal cord and larynx disease * history of hyperthyroidism (e.g., graves' disease) * taking anticoagulants (aspirin, warfarin, etc.) before surgery * disorders of coagulation * in the case of women, pregnant women and breastfeeding patients * patients judged inappropriate by clinical trial researcher

Keywords: external branch of the superior laryngeal nerve
comparative results of maxillary deficiency treatment by fixed tongue appliance and fixed facemask in growing patients

Conditions: Maxillary Deficiency

Summary: a new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

the above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

Eligibility criteria:
inclusion criteria: * growing patients * class iii with maxillary deficiency exclusion criteria: * previous orthodontic treatment * uncooperative patients
surgiquest airseal in robotic partial nephrectomy - (tarpan study)

Conditions: Subcutaneous Emphysema

Summary: a multi-center, prospective, randomized, controlled study to evaluate physician preference related to the use of the surgiquest airseal insufflation system (ais) vs. conventional insufflation systems (cis) for the management of pneumoperitoneum during robotic partial nephrectomy

a prospective, randomized, controlled multi-center clinical study designed to evaluate physician preference related to the use of the surgiquest airsealtm insufflation system (ais) vs. conventional insufflation systems (cis) for the management of pneumoperitoneum during robotic partial nephrectomy. subjects will be randomized in a 1:1:1 treatment device to control ratio into one of three (3) different study arms: 1) ais @ 12mmhg pressure, 2) ais @ 15mmhg pressure, and 3) cis @ 15mmhg pressure. 189 randomized subjects distributed in three arms of 63 patients. the three study sites are targeted to enroll 63 patients each, 21 patients in each of the three (3) study arms. it is expected that this will take up to 6 months.

Eligibility criteria:
inclusion criteria: 1. 18 to 80 years of age; 2. capable and willing to give informed consent; 3. acceptable candidate for an elective, non-emergent robotic partial nephrectomy; exclusion criteria: subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the endoscopic procedure 1.advanced refusal of blood transfusion, if necessary; 2.active systemic or cutaneous infection or inflammation; 3 pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4.uncontrolled diabetes mellitus 5.known, significant history of bleeding diathesis, coagulopathy, von willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline inr ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6.severe co-existing morbidities having a life expectancy of less than 30 days; 7.currently involved in any other investigational clinical studies; 8.significant anemia with a hemoglobin level less than 10 g/dl or a hematocrit less than 30%; 9.females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 10.extreme morbid obesity (bmi greater than 45 kg/m2) or underweight (bmi less than 20 kg/m2); 11. patients presenting with ascites -
the safety and efficacy of meplazumab in patients with covid-19

Conditions: Covid19

Summary: this is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical study. based on the results of the phase i clinical study, one repeat dose group and one placebo group are used for the standard treatment of the novel coronavirus pneumonia protocol (trial 8) the treatment regimen is a one-time intravenous infusion of either mprozumab or placebo on day 1 (d1) and day 8 (d8) of the treatment period at a dose of 0.2 mg/kg based on body weight. an estimated 150 subjects will be randomly assigned to either meplazumab or placebo in a 2:1 ratio a short-term efficacy evaluation was performed to determine the efficacy and safety of meplazumab in each subject within 14 days of initial administration and a long-term follow-up evaluation was performed 28 days after initial administration to determine the safety of meplazumab.


Eligibility criteria:
inclusion criteria: * 18 years ≤subject ≤ 75 years, male and/or female; * clinical confirmation of covid-19 patients in accordance with novel coronavirus diagnosis and treatment protocol (trial version 8) of the nhc * participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents) exclusion criteria: * subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent; * sars-cov-2 infection by pcr ≥ 96h; * platelet (plt) \< 50×10\^9/l, or hemoglobin (hgb) \< 60g/l; * total bilirubin (tbil) \> 2×uln (upper limit of normal value), or alanine transferase (alt), aspartate transferase (ast), alkaline phosphatase (alp) \> 5×uln; * glomerular filtration rate (gfr) \< 30ml/min·1.73m\^2, or serum creatinine increased by 0.5mg/ dl within 7 days, or oliguria (\<400ml/24hr), or anuria (\<100ml/24hr); * pregnant or breast feeding; * persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the icf; * subjects participating in another clinical study. there will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer; * he inestigators concluded that the patients had other reasons for not being eligible for the study.
cohort study of patients with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Structured Education

Summary: this study aims to clarify the underlying hereditary and autoimmune factors that contribute to clinical type 1 diabetes and gain a better understanding of the natural history of the disease.


Eligibility criteria:
inclusion criteria: 1. diabetes diagnosed according to the report of who (world health organization) in 1999; 2. insulin dependence from disease onset,thus diagnosed with type 1 diabetes; 3. all patients gave informed consent to participate in the study and the protocol was approved by the research ethics committee in second xiangya hospital, central south university. exclusion criteria: 1. secondary diabetes mellitus; 2. pregnant women; 3. malignant disease.
the diagnostic technology applied research of cdk5rap2 in breast cancer

Conditions: Breast Cancer

Summary: selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of cdk5rap2 of cancer tissue. at the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. detect the expression of cdk5rap2 before and after neoadjuvant chemotherapy.

the investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of cdk5rap2 of cancer tissue. at the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. detect the expression of cdk5rap2 before and after neoadjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. pathological confirmation of breast cancer 3. tumor stage(tnm):t2-4bn0-3m0 4. er(+) and/or pr(+). 5. premenopausal woman. 6. age≥40 years 7. measurable disease as per recist criteria 8. karnofsky≥70 9. laboratory criteria: * plt≥100\*109/l * wbc≥4000/mm3 * hgb≥10g/dl * alt and ast\<2\*uln exclusion criteria: 1. presence of metastatic disease. 2. inflammatory breast cancer. 3. bilateral breast cancer. 4. previous chemotherapy or hormonal therapy for current breast neoplasm. 5. other malignant tumor (concurrent or previous). 6. pregnant woman. 7. hypersensitive to any drug in cef regimen or any ingredient of zoladex. 8. any severe systemic disease contraindicating chemotherapy.

Keywords: expression of cdk5rap2