Kornimate/medical-research-clean huggingface dataset:
psycho-social outcomes following emergency laparotomy

Conditions: Emergency Laparotomy

Summary: an emergency laparotomy (emlap) is a life-saving operation; but the aftermath for those that do survive can be lifechanging. each year, in excess of 25,000 emlaps are performed in uk. a national effort, through the national emergency laparotomy audit (nela), has managed to improve peri-operative care, and reduce 30 day mortality from 1 in 4 to less than 1 in 10. whilst this reduction should be commended, it also means that more patients are surviving with some form of new infirmity. this infirmity may be short-lived and reversible in some, and yet others may transition into a permanent chronic disease state. the impact of emlap on those individuals that "do not fully recover" is far-reaching and often interlinked, covering biological, social and psychological domains. this makes it difficult to describe the true problem, i.e. holistic morbidity and suggest an intervention to improve it. the primary aim of this work is to describe the holistic morbidity of emlap throughout the first year of a patient's recovery.


Eligibility criteria:
inclusion criteria: * 18 years or above * able to communicate in english * cognitively able to complete the questionnaire * able to provide informed voluntary consent * undergone an emlap during admission * clinical team anticipate to be "medically fit for discharge" within 48 hours (of consent) exclusion criteria: * any terminal diagnosis in which the clinical team do not anticipate life expectancy to exceed 6 months from the time of surgery * acutely unwell at the time of recruitment. these patients may still be eligible and can be re-screened and recruited at a later date, should their condition improve.

Keywords: emergency laparotomy laparotomy surgical outcomes psychosocial
early insulin treatment in patients with latent autoimmune diabetes

Conditions: Diabetes, Autoimmune; Diabetes Mellitus, Adult-Onset

Summary: among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed against the insulin producing beta cells in the pancreas. these patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs. patients with this latent autoimmune diabetes in adults (lada) have a considerable remaining beta cell mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes animal studies in diabetes prone mice have demonstrated potential positive effects of early insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. the aim of this study was to investigate the effect of early insulin treatment of lada patients, in respect to residual beta-cell function and metabolic control, compared to a group who were conventionally treated with diet and/or oral hypoglycaemic agents (oha) and insulin not before it was clinically needed.

all adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies. patients clinically classified as type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion. after randomisation to insulin treatment or diet and/or oha, the patients are followed up with fasting c-peptide every third month. a glucagon test is performed, and stimulated c-peptide and hba1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. the final outcome of the study is c-peptide, and change in c-peptide compared to baseline level, and hba1c, after 36 months.

Eligibility criteria:
inclusion criteria: * \>18 yrs * positive for pancreatic autoantibodies exclusion criteria: * \<18 yrs * significant concomitant diseases * not able to follow protocol
procedural pain management by multimodal sedation analgesia combining hypnosis in children with congenital heart disease

Conditions: Procedural Pain; Congenital Heart Disease; Heart Surgery; Hypnosis

Summary: the aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. the hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. this would make possible the reduction of cumulative dose of sedative medication and their side effects.

pain and anxiety are common in children with congenital heart disease. they are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure. removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. this procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). however, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression. a few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults. however, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease. hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. this would reduce the dose of analgesic drugs and improve the pain experience. the aim of peace-hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.

Eligibility criteria:
inclusion criteria: * patients aged ⩾ 6 years and \<18 years. * postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal). * patients affiliated with or benefiting from a social security or similar scheme. * oral consent obtained from minor children * written consent from the minor's legal representatives exclusion criteria: * psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain * absence of at least 1 legal representative of the minor child * french not understood

Keywords: congenital heart disease procedural pain intrathoracic drain hypnosis pain controlled heart surgery
comparison of outcomes of multiple platforms for assisted robotic-kidney (compar-k)

Conditions: Renal Carcinoma

Summary: the urology unit of aoui verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (rapn) procedures using two currently available platforms: * davinci®; * hugo®. the questions it aims to answer are: does the estimation of the post-operative complications suggest something? are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? participants will be invited to join one of these two experimental group: 1. surgery with the davinci platform; 2. surgery with the hugo platform.


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 90 years old; * patient with localized kidney tumor suitable for partial nephrectomy; * patient able to understand and sign the informed consent; * patient compliance with the follow-up program. exclusion criteria: * patient who do not fall within the inclusion age range; * patient not suitable for partial nephrectomy; * patient unable to understand and sign the informed consent; * patient unable to follow the monitoring program; * patient refusal to participate to the study.

Keywords: robotic-assisted surgery partial nephrectomy multiple surgical platforms postoperative complications operative outcomes
cares lumbar artificial disc registry

Conditions: Lumbar Degenerative Disc Disease

Summary: the purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (tdr) in patients outside the clinical trial setting.

the purpose of this study is to capture outcomes associated with use of total disc replacement (tdr) in patients treated with either the charite™ artificial disc or the prodisc®-l total disc replacement may be included in the registry.

Eligibility criteria:
key inclusion criteria: * treated with the lumbar tdr. * signed irb approved consent document. key exclusion criteria: * none known.

Keywords: arthroplasty spinal charite prodisc-l prodisc disc replacement lumbar
near infrared fluorescence cholangiography (nirf-c) during cholecystectomy -- use in acute cholecystitis sub-study

Conditions: Acute Cholecystitis; Acute Cholangitis

Summary: the purpose of this study is to evaluate an imaging system using indocyanine green (icg) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. we propose to define the effectiveness of nirf-c in identifying the cystic duct junction during cholecystectomy.


Eligibility criteria:
inclusion criteria: * age 18-89 * planned laparoscopic cholecystectomy exclusion criteria: * inability to provide informed consent * pregnant * allergy to icg, iodine, and/or shellfish * lactating

Keywords: acute cholecystitis acute cholangitis cholecystectomy
sedation during microelectrode recordings before deep brain stimulation for movement disorders.

Conditions: Movement Disorders; Parkinson Disease; Parkinsonian Disorders; Dystonia; Tourette Syndrome

Summary: the purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to sedation during deep brain stimulation surgery.

deep brain stimulation is commonly used for the treatment of movement disorders. electrode positioning is usually performed under local anesthesia in fully awake patients. the procedure is uncomfortable to the patients who have to remain motionless during the whole surgery. previous reports of electrode positioning under general anesthesia was found to be less accurate. this result was probably due to the effect of the anesthetics on the electrical activity of the basal ganglia. the purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to propofol sedation. electrical activity of single neurons will be recorded before and after sedation.

Eligibility criteria:
inclusion criteria: * candidate for deep brain stimulation surgery. * informed concent obtained. exclusion criteria: * suspected difficult intubation (by history or physical examination). * allergy to propofol, eggs or soy-beans. * history of sleep apnea syndrome.

Keywords: deep brain stimulation microelectrode recordings basal ganglia sedation propofol
high dose of dual therapy plus metronidazole for helicobacter pylori rescuetreatment

Conditions: Helicobacter Pylori Infection

Summary: dual therapy containing high dose of proton pump inhibitor (ppi) and amoxicillin had showed excellent eradication results with helicobacter pylori first-line treatment. however, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for h. pylori rescue treatment.this study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for h. pylori rescue treatment.


Eligibility criteria:
inclusion criteria: * participants with non-ulcer functional dyspepsia or peptic ulcer disease * ability and willingness to participate in the study and to sign and give informed consent * confirmed h. pylori infection and with previous treatment failure exclusion criteria: * less than 18 years old or older than 80 years * with previous gastric surgery * major systemic diseases * pregnancy or lactation * allergy to any of the study drugs * administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion
mri-guided lateral lymph node dissection in rectal cancer

Conditions: Rectal Cancer

Summary: to investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on mri

our study design is a multicenter, prospective, registry study. we would enroll 268 patients with lower rectal cancer whose preoperative mri showed laterally lymph node diameter ≥ 5mm. the postoperative adjuvant chemoradiotherapy is determined by the pathological results. for patients of stage ii and patients of stage iii with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 \~ 50.5 gy are recommended. the postoperative examination should be performed every three months in the first two years and every six months in the following three years. our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Eligibility criteria:
inclusion criteria: 1. age between 18-75 years old 2. pathologically confirmed as rectal adenocarcinoma 3. the tumor is located in the middle or lower rectum 4. preoperative mri assessment is t2-4 n+m0 5. lateral lymph node short diameter ≥ 5 mm (mri) 6. signed informed consent exclusion criteria: 1. previous history of malignant colorectal tumors 2. multiple abdominal or pelvic surgeries were performed 3. complicated with bowel obstruction, perforation or bleeding 4. patients undergoing palliative surgery 5. patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery 6. have a history of severe mental illness 7. pregnant or breastfeeding women （8) patients previously treated with iliac artery surgery (or its branches) (9) r0 resection cannot complete (10) asa grade ≥ iv

Keywords: lateral lymph node surgery magnetic resonance imaging oncological outcome
nocturnal parkinson's disease symptoms study group

Conditions: Parkinson's Disease

Summary: to study associate factor of noctural parkinson's disease symptoms and quality of life in parkinson's disease patients and caregivers.


Eligibility criteria:
inclusion criteria: idiopathic parkinson's disease patient exclusion criteria: 1. patient with secondary parkinsonism eg.drug-induced parkinsonism, vascular parkinsonism, exposure to toxin, encephalitis 2. patient with atypical parkinsonial syndromes eg. parkinson-plus syndrome, progressive supranuclear palsy (psp), corticobasal degeneration (cbd) 3. patient with heredodegenerative parkinsonism eg. spinocerebellar ataxias, wilson's disease, juvenile huntington's disease

Keywords: quality of life noctural parkinson's disease symptoms
percutaneous renal tumor cryoablation followed by biopsy

Conditions: Renal Cancer

Summary: this study is being done to test how effective cryoablation is in killing cancer cells. cryoablation uses freezing temperatures to treat cancer. cryoablation works by creating freezing temperatures within a needle probe. when this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. this study will allow us to check to see how well cryoablation works for kidney cancers. after the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.


Eligibility criteria:
inclusion criteria: * presence of at least one renal cancer smaller than or equal to 3.0 cm * adequate baseline imaging studies (ct/mri) within 8 weeks of treatment or as clinically indicated. * the following laboratory results should be within the following limits within the last 30 days prior to study day 1. repeat blood work will be necessary if too much time has elapsed prior to the interventions.: * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelet count ≥ 100 x 109/l * serum bilirubin ≤ 2.0 mg/dl * aspartate aminotransaminase (ast) ≤ 2.5 x uln * alanine aminotransferase (alt) ≤ 2.5 x uln * serum creatinine ≤ 2.0 mg/dl * gfr \>30 ml/min/m2 * international normalized ratio \< 1.5 (inr) * partial thromboplastin time (ptt) \<45 seconds * recovered from toxicity of any prior therapy * tumor accessible to probe placement without risk to adjacent critical structures. * tumor visible on non-contrast ct * patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians. exclusion criteria: * intercurrent medical condition that renders the patient ineligible for cryoablation * women who are pregnant or breastfeeding. * tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure * contraindication to mri in patients in which it is required. * coagulopathy as defined above (inclusion criteria). * patients unwilling to return for follow-up biopsy and imaging.

Keywords: kidney cryoablation 09-108
measurement of bite force in humans

Conditions: Dental Pulp Necrosis; Periapical Periodontitis

Summary: this protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.

this clinical trial consists of two parts. we will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. we will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).

Eligibility criteria:
inclusion criteria: 1. patient must be at least 16 years of age. 2. clinical indication for non-surgical root canal therapy (nsrct). 3. 1st or 2nd maxillary or mandibular molar or premolar 4. diagnosis must be chronic apical periodontitis (cap) with or without symptoms. 5. intact, mature apices. 6. american society of anesthesiologists (asa) i or ii. exclusion criteria: 1. failure to meet any of the above 2. previous nsrct 3. previous pulpotomy or pulpectomy 4. suppurative apical periodontitis 5. patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)

Keywords: pain normal pulp and normal periodontal status chronic apical periodontitis of pulpal origin
study of the impact of dpd activity on the efficacy of capecitabine

Conditions: Breast Neoplasm Malignant Female

Summary: this study evaluates the impact of dihydropyrimidine dehydrogenase (dpd) activity on the efficacy of capecitabine in patients with metastatic breast cancer. the dpd phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with capecitabine up to 24 month.


Eligibility criteria:
inclusion criteria: * age over 18, * performance status 0 to 2, * patients with metastatic her2 negative breast cancer, * patients eligible for capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, * determination of uracil level performed according to national recommendations, * patients with at least one lesion evaluable according to the recist criteria 1.1, or presenting at least 1 hypermetabolic lesion on pet-tdm according to percist 1.0 criteria. in the case of single cutaneous metastasis (s), it is required to make photographs of lesions with a measure of the lesions using a ruler, * patients receiving social coverage. exclusion criteria: * performance status\> 2, * contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, * presence of untreated or uncontrolled symptomatic cerebral or leptomeningeal metastases (unstable corticosteroid requirements) and / or non-clinically stable in the 3 months prior to inclusion, * history of cancer, with the exception of cancers in complete remission for more than 5 years, totally resected cutaneous basal cell carcinoma, in situ carcinoma or in situ cervical epithelioma treated, * vulnerable people
chronic pain after amputation

Conditions: Amputation, Traumatic; Pain; Postoperative Pain

Summary: this trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

this double-masked placebo controlled trial will randomize patients (n=125) who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks. patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment. study participants will also be interviewed by telephone to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain, at the beginning and end of the six-week trial and four months later.

Eligibility criteria:
inclusion criteria: * amputation six months ago or longer * pain for 3 months or longer exclusion criteria: * history of cardiovascular disease, seizures, or glaucoma * currently taking antidepressant medications * currently hyperthyroid or taking thyroid medication * currently pregnant

Keywords: amputation chronic pain amitriptyline
yoga training and retinal vasculature with parkinson's disease

Conditions: Cognitive Change

Summary: this study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function in persons with parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. parkinson's disease (h\&y 1, 2, and 3) confirmed by pretest administration of the updrs, 2. 55-90 years of age, 3. montreal cognitive assessment \> 17. exclusion criteria: 1. uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program; 2. cerebrovascular disease; 3. documented hiv infection or other immunodeficiency syndrome; 4. any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness; 5. a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases; 6. bilateral moderate or severe cataracts; 7. refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 diopters.
evaluation of the performance of a novel prostate biopsy system compared with standard of care biopsy needle on quantitative and qualitative tissue parameters

Conditions: Prostate Disease; Prostate CA

Summary: currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. this post-market study will assess the utility of the surecore biopsy needle and the corecare specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.

the safety and performance of the surecore and corecare devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the surecore needle. tissue samples will be randomized to retrieval with the swiping method or using the corecare device. adverse events will be documented both during the procedure and within 5 days after the procedure. the user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.

Eligibility criteria:
inclusion criteria: * adult male scheduled for prostate biopsy * able to provide informed consent * able and willing to provide verbal assessment of his condition 5 days post-procedure exclusion criteria: * unwilling to provide consent

Keywords: prostate ca needle biopsy