Kornimate/medical-research-clean huggingface dataset:
da vinci sp® investigational device exemption study in colorectal procedures

Conditions: Colorectal Cancer; Benign or Malignant Rectal or Colon Tumors

Summary: to confirm the safety and performance of the da vinci sp surgical system, instruments and accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

primary performance: * the primary performance endpoint will be assessed as the ability to complete the planned da vinci sp-assisted colorectal procedure without conversion to an alternate approach. conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da vinci sp surgical system in order to complete the planned procedure using the alternate approach. * performing an extracorporeal anastomosis is not considered a conversion \*\* use of additional assistant laparoscopic port(s) is not considered a conversion § laparoscopic or robotic with hand assistance primary safety: • the primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * bmi ≤ 35 * candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures * asa ≤ 3 * willing and able to provide a written informed consent document * willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years exclusion criteria: * clinical or radiological evidence of metastatic disease * life expectancy less than 6 months * cancer of the anal canal requiring an abdominoperineal resection * subjects with threatened mesorectal margins (≤1 mm) on mri or ultrasound (for lar only) * subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case * subjects undergoing both lar/tme and right colectomy during the same operation * preoperative colonoscopy demonstrating synchronous colorectal cancer * history of inflammatory bowel disease * subject has a known bleeding or clotting disorder * uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * subject is contraindicated for general anesthesia or surgery * subject had prior incisional hernia with mesh repair * subject belongs to vulnerable population * subject is pregnant or suspected to be pregnant intraoperative exclusion criteria: • subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
chemical renal ethanol sympatholysis under ct guidance use for the control of therapy-resistant hypertension

Conditions: Hypertension Resistant to Conventional Therapy; Kidney Failure, Chronic

Summary: in this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance. to limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted. the investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (abpm) one month after the sympathetic denervation.


Eligibility criteria:
inclusion criteria: * more or equal than 18 years old, * patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment: * in the last two months, * expected in the next three months, * renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmhg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation or * chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmhg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation * patient affiliated to social security or similarly regime * patient who signed the consent to participate in the study no inclusion criteria: * renal artery anatomy against-indicating the procedure including: * 3 homolateral renal arteries * kidney surgery including bypass surgery or renal artery reimplantation * volume-dependent type of hypertension * secondary hypertension (not included nephropathy) * orthostatic hypotension associated with symptoms during the previous year * medical history including: * acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion, * surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period * chronic alcoholism * anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day) * contraindication to the realization of an mri * included in another trial assessing a medicament or a medical device or a surgical procedure * protected person referred to in articles l1121-5 to l1121-8 of the code of public health

Keywords: ethanol sympathicolysis computer tomography guidance denervation kidney transplantation dialysis
study of promethazine for treatment of diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. the primary outcome will be the change in gastroparesis symptom severity, as measured by the gastroparesis cardinal symptom index (gcsi) at four weeks compared to baseline. participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. it is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.


Eligibility criteria:
inclusion criteria: * adult patients 18-65 years of age * clinical diagnosis of diabetic gastroparesis. * egd without evidence of gastric outlet obstruction within the past five years * gastric emptying scintigraphy test demonstrating \>10% solid food retention at 4 hours within the past three years. exclusion criteria: * the inability or unwillingness to provide informed consent * currently pregnant or breast feeding * prior placement of a gastric stimulator * pyloric botulinum toxin injection within the past 12 months * prior gastric surgery * history of a connective tissue disorder * use of narcotic medication within the past four weeks * hemoglobin a1c \>12 mg/dl within the past 3 months * current or recent (within past 4 weeks) use of promethazine, metoclopramide or domperidone * hypersensitivity or prior adverse reaction to promethazine * concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other agents likely to increase extrapyramidal reactions * concomitant use of tiotropium or ipratropium * narrow angle glaucoma * urinary retention * parkinson's disease * significant psychiatric disease * history of seizure.

Keywords: diabetic gastroparesis promethazine
influence of environmental factors on the efficacy of non-surgical periodontal treatment. a pre-post quasi-experimental study

Conditions: Non Surgical Periodontal Treatment; Periodontitis; Periodontal Diseases

Summary: periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. the success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with probing pocket depth \>5mm and presence of bleeding on probing); therefore, periodontal treatment is successful whenever this threshold is reached. moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. with regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to mediterranean diet to oral health status. the novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old; * presence of untreated periodontitis (papapanou at al. 2018); * ability and willingness to give informed consent. exclusion criteria: * pregnancy or lactation; * patients who underwent non-surgical periodontal therapy in the last 6 months; * patients taking immunosuppressive drugs; * inability or unwillingness to give informed consent.

Keywords: periodontitis non surgical periodontal treatment
video games to track cognitive health

Conditions: Dementia; Mild Cognitive Impairment; Cognitive Impairment; Cognitive Decline; Cognitive Changes; Acute Changes in Cognition; Acute Head Injury; Concussion; Mild Traumatic Brain Injury

Summary: the purpose of this study is to assess cognitive function using a rapid, portable, computerized neurocognitive testing device in a wide variety of clinical settings.

investigators will recruit participants from public places using the convenience sampling method. informed consent will be obtain from all participants/parents as well as assent from minors. participants will be asked to complete a brief yes/no questionnaire before the study begins. participants will be asked to complete a 10 minute battery of tests consisting of simple video games designed to measure cognitive health. no personally identifiable information will be collected during the tests and all test data will remain anonymous. data will be stored on servers with hipaa-level security. no participants will be asked to modify their normal behavior in any way. no feedback or results will be given to participants. the tests will not be distressing in any way. to meet the objective of detecting cognitive impairment, investigators will test a broad array of participants from ages 10 through 99 in several different settings in parallel. the targeted cognitive stressors of advanced age, head injuries, physical strain, sleep deprivation, alcohol ingestion, and marijuana ingestion will be compared to healthy baseline controls. collectively, these experiments aim to yield an end- deliverable of a rapid, non-invasive, portable piece of software that can be used to detect cognitive impairment. a subset of participants will be asked to take the tests up to three times, so the total testing time is a max of 30 minutes. a subset of participants will be asked simple auxiliary questions, such as "estimated in minutes, how long was your exercise or workout?". a subset of participants will be asked to wear a fitbit device to monitor their heart rate. a subset of participants will be asked to take a breathalyzer test (bactrack s80).

Eligibility criteria:
inclusion criteria: * aged 10 or older * function of both hands exclusion criteria: * inability to speak english or spanish * inability to read english or spanish * unable to provide informed consent
melatonin for huntington's disease (hd) gene carriers with hd related sleep disturbance - a pilot study

Conditions: Huntington Disease

Summary: the purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in hd gene carriers.


Eligibility criteria:
inclusion criteria: * verified hd mutation carriers. * patients who report sleep disturbance as measured by a score ≥5 on the pittsburgh sleep quality index (psqi); * stable concomitant medication (no change of medication during last 30 days prior to inclusion); * written informed consent by prospective study participant before conduct of any trial-related procedure; * participant must be able to make an informed decision of whether or not to participate in the study. exclusion criteria: * pregnant or nursing women; * woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, intrauterine device (iud), contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post menopausal; * presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus); * use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks; * severe cognitive disorders defined as a score \< 18 on the moca; * participation in another investigative drug trial within 2 months; * subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the investigator.

Keywords: huntington's disease melatonin
clinical impact of cytokine in cardiac surgery

Conditions: Coronary Disease

Summary: cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (cpb). activation of inflammatory cascades can cause a systemic inflammatory response syndrome (sirs) which is associated with increased morbidity and mortality. therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients. the clinical benefit of reducing proinflammatory cytokines such as il-6, il-8 and tnf-a with the use of a cytokine adsorbing circuit (cytosorb) during cbp remains unclear. therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during cbp.

patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. demographic, intraoperative, and postoperative data will be collected prospectively. furthermore, blood samples (1. before induction of anaesthesia 2. at the end of cpb 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.

Eligibility criteria:
inclusion criteria: * • elective myocardial revascularization exclusion criteria: * emergency procedures * declined informed consent * body mass index \< 18 * age \< 18 years * pregnant women * receiving chemotherapy * diagnosed with any disease state (e.g., aids) that has produced leukopenia * receiving antileukocyte drugs * receiving tnf-α blockers * receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen) * crp \> 5 mg/dl

Keywords: myocardial revascularization cytosorb inflammatory response cardiopulmonary bypass
a randomized, double-blind, three-arm, phase 3b study comparing the safety and efficacy of interferon gamma-1b with azathioprine, and azathioprine alone in patients with ipf receiving prednisone

Conditions: Lung Disease; Pulmonary Fibrosis

Summary: study gipf-003 is a phase 3b study designed to define better therapeutic use of ifn-gamma 1b in patients wtih ipf. the study will be conducted primarily in europe and will enroll 210 patients.


Eligibility criteria:

Keywords: idiopathic pulmonary fibrosis
a multicenter prospective observational cohort based on a breast cancer medical record database in china

Conditions: Breast Neoplasms

Summary: 1. to construct a prospective, multi-center breast cancer treatment cohort in china, and analyze the factors affecting breast cancer diagnosis and treatment. 2. to evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.

this research aims to: a. understand and analyze the current status of breast cancer diagnosis and treatment; b. publish an annual report on diagnosis and treatment; c. data sharing, dynamic evaluation; d. evaluate consensus and guideline promotion and implementation effects; e. propose and set clinical quality standards for industry associations, and propose improvement goals; f. provide a basis for industry associations to formulate specialized training programs; g. to provide assistance in the formulation of health insurance policies; h. provide a platform for clinical research on breast cancer; i. provide evidence for the formulation of clinical guidelines and consensus

Eligibility criteria:
inclusion criteria: * patients with malignant breast tumors must be diagnosed by cytology or histology, and their pathological types include but are not limited to breast carcinoma in situ, invasive carcinoma, and breast sarcoma. exclusion criteria: * none
preventing pressure injuries in patients undergoing lumbar spine surgery

Conditions: Pressure Injury

Summary: background：pressure injuries (pi) are one of the common comorbidities in surgery, meaning pi that occurs immediately after surgery or within hours to 3 days after surgery. the incidence of pi in spine surgery is about 5% \~ 66%. purpose：comparison of the difference in pressure injury rates positioning device cotton roll-coated viscoelastic polymer pads versus viscoelastic polymer pads for pressure injuries undergoing lumbar spine surgery methods：this experimental study used a split-body design with random assignment to compare the pressure-reducing effects of different materials on a patient's body contact points with a positioning device. the experimental group used a relton-hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads, while the control group used a relton-hall prone frame with a viscoelastic polymer pads.

the study focuses on patients undergoing lumbar surgery in a hospital in a certain area of northern taiwan, with an intended recruitment of 50 participants randomized into experimental and control groups. the study will use the pressure injury grading system developed by the national pressure injury advisory panel to assess the severity of pressure injuries at pre-operation, immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation.

Eligibility criteria:
inclusion criteria: 1. patients receiving lumbar nerve decompression combined with internal fixation and bone fusion. 2. use the positioning device relton-hall rack in prone position. 3. the operation time is more than 2.5 hours. 4. the surgical anesthesia is general anesthesia. 5. routine surgery registered on the surgery schedule. 6. before the operation, the skin was intact and there was no pressure injury. exclusion criteria: 1. emergency lumbar surgery patients. 2. under the age of 18. 3. the operation time is less than 2.5 hours. 4. preoperative skin incompleteness (obviously there is chest and iliac crest crush phenomenon). 5. percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic lumbar disc, peld).

Keywords: pressure injury positioning devices prophylactic
pilot study evaluating stress response and immune function in mechanically ventilated patients with alcohol use disorders treated with propofol or midazolam

Conditions: Alcoholism; Respiration, Artificial

Summary: the aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.

no detailed description

Eligibility criteria:
inclusion criteria: * diagnosis of alcohol use disorders * need for invasive mechanical ventilation * need for continuous intravenous infusion of sedative(s) exclusion criteria: * age \< 18 years * pregnant women * prisoners * receiving propofol prior to randomization * patient experiencing active alcohol withdrawal * immunosuppression * shock * attending physician does not feel patient is candidate to receive either propofol or midazolam * patient has contraindication(s) to receiving either propofol or midazolam * inability to enroll patient within 96 hours after initiation of mechanical ventilation * transfer from another intensive care unit

Keywords: alcoholism mechanical ventilation
evaluating the eapoc-copd system

Conditions: COPD

Summary: the eapoc-copd study is a stepped wedge cluster randomized controlled trial (sw-rct) designed to evaluate the effectiveness of the evidence at the point-of-care for copd (eapoc-copd) system, a digital clinical decision support system (cdss) integrated into primary care electronic medical records (emrs). the system aims to improve copd management by providing personalized pharmacotherapy recommendations, symptom and risk assessments, and self-management action plans, based on patient-reported data. study design: six primary care sites in ontario, canada will transition from usual care to eapoc-copd-supported care in a staggered manner over 56 weeks. each site will serve as its own control during the pre-intervention period. primary objective: to assess the impact of eapoc-copd on guideline-aligned pharmacotherapy optimization for copd, measured by the proportion of patients with medication escalation. secondary objectives: evaluate improvements in symptom/risk assessments (mmrc, cat), copd action plan delivery, influenza vaccination, smoking cessation support provision, pulmonary rehabilitation referrals, and copd symptom burden process measures: study investigators will also measure provider and patient uptake, satisfaction, and system feasibility will be assessed through emr data audits, patient/provider surveys, and system usage analytics population: all prescribers at the six primary care sites (physicians and nurse practitioners) will be eligible. the study will involve patients with physician-diagnosed copd, identified through emr searches. data collection: clinical outcomes will be obtained through chart reviews and data from the canadian primary care sentinel surveillance network (cpcssn), where available. patient-reported outcomes will be captured via questionnaires through the patient app/portal. sample size: an estimated 1860 copd patients will be seen during the study. with an expected baseline medication escalation rate of 13%, the study is powered to detect an 8% absolute increase (assuming an intra class correlation (icc) =0.1). analysis: a generalized linear mixed model (glmm) will assess primary and secondary outcomes, accounting for time trends, clustering, and the stepped roll out. significance: this trial will generate real-world evidence on the effectiveness of a point-of-care digital tool in closing copd care gaps, with potential for large-scale primary care implementation.


Eligibility criteria:
inclusion criteria: * providers working at clinical site currently using it infrastructure that allows for integration of eapoc-copd * providers caring for patients with copd exclusion criteria: * unwilling to use eapoc-copd system

Keywords: copd clinical decision support