Kornimate/medical-research-clean huggingface dataset:
cerebellar non-invasive stimulation in ataxias

Conditions: Cerebellar Ataxia

Summary: cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. some limited studies verified the effects of cerebellar transcranial magnetic stimulation (tms) on ataxic symptoms, with good results. so far it is not known which patients could benefit. our hypothesis is that cerebellar tms could improve ataxic symptoms in some patients.

thirty patients with cerebellar ataxia will be included in our protocol. ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. after that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1hz tms over the located area. after the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. clinical and video evaluations will be conducted before and after active and sham cluster of sessions.

Eligibility criteria:
inclusion criteria: * identification of cerebellar ataxia based on neurologic examination * no improvement after rehabilitation * symptoms onset of at least 6 months exclusion criteria: * younger than 18 months * pregnant or breastfeeding women * participation in other clinical trials * epilepsy

Keywords: tms transcranial magnetic stimulation cerebellar ataxia
assessment of dolutegravir removed by hemodialysis in hiv-infected patients with end-stage renal disease

Conditions: HIV

Summary: data on the capacity of hemodialysis to remove dolutegravir (dtg) from plasma in patients with end-stage renal disease (esrd) on hemodialysis (hd) are lacking. if dtg was removed from plasma by hd, it would be possible to have subtherapeutic drug concentrations at the end of hd sessions.

the prevalence of chronic renal disease and end-stage renal disease (esrd) is increasing in the hiv-positive population. this means that an increasing number of hiv-infected patients will need renal replacement therapy.however, little is known about dtg removal from plasma by hd in patients with esrd. objective: to evaluate the effect of hd on dtg clearance as well as on dtg plasma concentrations at steady state in hiv-infected patients with esrd undergoing hd.

Eligibility criteria:
inclusion criteria 1. age 1 years old or older. 2. hiv documented infection (western blot) 3. esrd undergoing routine hemodialysis 4. stable antiretroviral treatment (no changes within the prior 2 weeks) 5. signature of informed consent exclusion criteria: 1. inadequate adherence to antiretroviral treatment (\<90% in the week prior to inclusion). 2. clinical evidence or suspicion that the patient will not be able to comply with the study protocol.

Keywords: hemodialysis hiv-infection
study evaluating the safety and efficacy of tigecycline in hospitalized patients with ciai

Conditions: Abdominal Abscess

Summary: in light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.

to evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. both the clinical response profile and the microbiological response profile will be assessed. the primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.

Eligibility criteria:
inclusion criteria: * hospitalized male or female patients greater than or equal to 18 years of age. * patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess. * patients with a complicated intra-abdominal infection such as: * an intra-abdominal abscess; * an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving \> 48 hours and less than or equal to 5 days of a non-study antibiotic. an intra-abdominal culture must be obtained from the infected site. * appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess; * perforated diverticulitis complicated by abscess formation or fecal contamination; * complicated cholecystitis with evidence of perforation or empyema; * perforation of the large or small intestine with abscess, or fecal contamination; * purulent peritonitis or peritonitis associated with fecal contamination; * gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation; * traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation. exclusion criteria: * patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed. * active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months. * anticipated length of antibiotic therapy less than 5 days.

Keywords: tigecycline complicated intra-abdominal infections ciai
a clinical trial evaluating diets for ibs

Conditions: Irritable Bowel Syndrome

Summary: diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (ibs). currently the only diet that is widely recommended and for which there is good evidence of efficacy in ibs is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-fodmap). while effective, the low-fodmap diet is burdensome and costly to patients and in clinical practice adherence to fodmap restriction is less than optimal. further, patients who respond to a fodmap restriction often are reluctant to reintroduce more fodmaps into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. therefore, there is a need for other dietary interventions for ibs that are less burdensome to patients. this clinical trial assesses the efficacy of two dietary interventions.


Eligibility criteria:
inclusion criteria 1. patients with ibs-d diagnosed per rome iv questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease) 2. aged 18-65 years at the time of screening 3. weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale 4. at least 80% compliance in daily diary entries during the 7-day screening period exclusion criteria 1. subjects adhering to a dietary ibs-treatments such as the low-fat diet, low fodmap diet, or gluten-free diet within the past 6 months 2. subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing ibs symptoms while on a lactose-free diet will not be excluded from the study). 3. subjects with a history of insulin-dependent or non-insulin-dependent diabetes 4. subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis 5. subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years. 6. bmi \< 18.5

Keywords: dietary intervention lifestyle intervention
clinical study for the impact of bio-absorbable felt (neoveil®) with fibrin sealant on removal of drainage tube after minimally invasive gastrectomy for gastric cancer

Conditions: Gastric Cancer

Summary: this study is to evaluate if bio-absorbable felt(neoveil®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.

we investigate the effect on drainage amount of bio-absorbable felt(neoveil®) after d1+b or d2 lymphadenectomy with distal gastrectomy for early gastric cancer. this study is an randomised controlled trial undertaken in 7 centers in south korea. patients with stage i-ii gastric cancer who is going to have curative distal gastrectomy with d1+b or d2 lymphadenectomy are randomly assigned to use bio-absorbable felt(neoveil®) or not to use it. block randomisation will be done by a central interactive computerised system, stratified by center.

Eligibility criteria:
inclusion criteria: * histologic confirmed gastric adenocarcinoma * patients who underwent laparoscopic distal gastrectomy. * preoperative clinical stage i diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography. * patients who underwent more than d1+b lymphadenectomy exclusion criteria: * vulnerable participants (pregnant women, under 20 year old, and so on) * liver or renal disease (ex. liver cirrhosis, end stage renal disease) * transfusion is needed preoperatively or postoperatively due to bleeding * preoperative or intraoperative evaluation confirm ascites. * patients who use anticoagulant preoperatively or postoperatively

Keywords: gastric cancer minimally invasive surgery distal gastrectomy bio-absorbable felt
long-term effects of intensive insulin treatment in type 1 diabetes

Conditions: Coronary Heart Disease; Stroke; Renal Failure

Summary: to investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

the stockholm diabetes intervention study (sdis) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (october 1982 to march 1984) to intensified conventional treatment (ict; n=48) or standard treatment (st; n=54). the randomized sdis study lasted for 7.5 years, whereas 96 patients were fully evaluated. thereafter patients were assigned to their regular clinical visits. in the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the sdis cohort until december 31 2011.

Eligibility criteria:
inclusion criteria: * born 1930 or later * type 1 diabetes * nonproliferative retinopathy * normal serum creatinine * unsatisfactory blood glucose control exclusion criteria: * alcohol/drug abuse * proliferative retinopathy
open-label extension of cp101 trials evaluating oral full-spectrum microbiota™ (cp101) in subjects with recurrence of clostridium difficile infection

Conditions: Clostridium Difficile Infection; Recurrent Clostridium Difficile Infection; C. Diff; CDI; Recurrent C. Diff; rCDI; C. Difficile; Recurrent CDI; FMT; Fecal Microbiota; Fecal Transplant

Summary: this is an open-label study evaluating the safety and efficacy of cp101 treatment in 1) subjects in cdi-001 who had a cdi recurrence within 8 weeks of receiving cp101 or placebo; or 2) adults with recurrent cdi who are eligible for direct study entry into cp101-cdi-e02. subjects who are experiencing recurrent cdi will undergo screening procedures. subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered cp101. approximately 200 subjects will receive cp101. the treatment duration will be 1 day. subjects will be monitored for recurrence of cdi, safety, and tolerability for 24 weeks following receipt of cp101. the primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of cdi.


Eligibility criteria:
1. ability to provide written informed consent; 2. previously enrolled in prism 3, had a cdi recurrence within 8 weeks of receiving cp101 or placebo, and have completed their prism 3 end of study visit; or recurrent cdi 3. an outpatient prior to treatment 4. has received a course of standard-of-care cdi antibiotics for the most recent cdi episode, has had an adequate clinical response, and has completed a washout period. exclusion criteria: 1. pregnant, breast-feeding, or considering becoming pregnant during the study 2. prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., crohn's disease and ulcerative colitis) 3. any prior diagnosis of diarrhea-predominant irritable bowel syndrome 4. systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following randomization 5. prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study 6. major intra-abdominal surgery within the past 60 days prior to screening 7. admitted to, or expected to be admitted to an intensive care unit for any medical reason. note: residents of long term care facilities are eligible study entry 8. history of total colectomy/ileostomy or bariatric surgery 9. planned hospitalization or invasive surgery during the study 10. severe acute illness unrelated to cdi

Keywords: clostridium difficile infection cp101 crestovo fmt cdi c. difficile c. diff recurrent clostridium difficile infection recurrent c. diff recurrent cdi finch fecal transplant fecal microbiota transplant rcdi finch therapeutics
standardisation of investigations of mild bleeding disorders

Conditions: Hemorrhagic Disorders

Summary: observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (mbd).

the working hypothesis of this prospective diagnostic study is that a standardised procedure in investigating patients with suspected mbd will lead to a better discrimination between patients with and without mbd and a more precise characterisation of mbd. the primary objective of this diagnostic study is to evaluate the efficiency of a standardised procedure of mbd in children and adults referred to their respective outpatient clinics for bleeding symptoms. the following endpoints will be evaluated: 1. the relative number of precise diagnosis (according to recognised classification of haemostatic disorders) in each clinical probability category; 2. the number of biological tests performed per patient in each clinical probability category; 3. the relative number of patients with no specialised investigations in the low risk group. the secondary objective is to evaluate the bleeding events during a one-year follow-up. follow-up will be performed with a phone call one year after the last consultation of the patient. the definition of a bleeding event will be any bleeding that promotes any specific medical attention (consultation, hospitalisation, transfusion, re-intervention in case of surgery). the detailed clinical history regarding each event will be collected. bleeding events will be correlated to the clinical probability assessed at inclusion.

Eligibility criteria:
inclusion criteria: * all patients aged more than two years-old referred by their physician (gynaecologist, paediatrician, general practitioner, surgeon, etc.) for investigations of a possible bleeding tendency will be included in this study. this prospective study will include consecutive patients attending the four outpatient clinics (division of angiology and haemostasis and paediatric onco-haematology unit, university hospitals of geneva). exclusion criteria: * pregnant women will be excluded because of modifications of the known modifications of the haemostasis system during pregnancy. adult patients without discernment capacity will be excluded.
comparison of insulin detemir produced by the current process and the nn729 process in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the nn729 process and by the current process in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 18.0 and 27.0 kg/m\^2, inclusive * non-smoker * fasting plasma glucose (fpg) maximum 6.0 mmol/l exclusion criteria: * known or suspected allergy to trial products or related products * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (iud) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant) * a history of alcohol or drug abuse
piracetam for treatment of cocaine addiction, phase ii - 4

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to follow patients in phase i of an inpatient study in an eight week open label assessment of piracetam in an outpatient treatment program.


Eligibility criteria:
please contact site for information.

Keywords: cocaine
study of ibi363 in patients with advanced first-line gastric cancer

Conditions: IBI363 + Chemotherapy

Summary: this is a phase 1b study designed to evaluate the safety, tolerability and efficacy of ibi363 in combination with oxaliplatin and capecitabine (xelox) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, ≥ 18 years and ≤75 years. 2. subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment. 3. subjects with at least one measurable lesion according to recist v1.1. 4. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 5. expected survival time ≥ 3 months. exclusion criteria: 1. women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. 2. active uncontrolled bleeding or a known bleeding diathesis. 3. subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
a longitudinal study in parkinson's disease (pd) patients

Conditions: Parkinson's Disease

Summary: this is a longitudinal study in patients with parkinson's disease (pd) carriers of a genetic mutation - substitution of gly with ser in position 2019 (g2019s) in the leucine-rich repeat kinase 2 (lrrk2) gene. the purpose of this study is to explore the association between genetic mutations in the known genes and their influence on disease manifestation over few years of follow up


Eligibility criteria:
inclusion criteria: * parkinson'd disease patients that already participated in a pasr cross sectional study exclusion criteria: * subjects with cognitive decline by the parameters defined in diagnostic and statistical manual of mental disorders (dsm)- iv * subjects with psychiatric disorder * subjects unable to sign a consent form
lateral pelvic lymph node dissection for rectal neuroendocrine neoplasms undergoing laparoscopic total mesenteric excision

Conditions: Rectal Neuroendocrine Neoplasm

Summary: the purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rnens) undergoing laparoscopic total mesenteric excision (tme). the hypothesis is that the rate of lateral lymph node metastasis is underestimated in rnens undergoing tme, necessitating concurrent lateral pelvic lymph node dissection.

this study is a prospective single-arm clinical study. 30 patients with rnens undergoing tme are planned to be included in the study. the purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in (rnens) undergoing laparoscopic tme. the primary endpoint is the rate of lateral pelvic lymph nodes metastasis. the primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rnens undergoing tme, necessitating concurrent lateral pelvic lymph node dissection. this study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients. in addition, the proportion of patients with radical resection (r0), surgical complication profile, and quality of life (qol) are also secondary endpoints.

Eligibility criteria:
inclusion criteria: 1. biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma); 2. meets any one of the following conditions: * preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm. * preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is t2 or higher. * preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as grade 3 differentiation. * recurrence after local excision under endoscopy. 3. eastern cooperative oncology group(ecog) performance score ≤ 1; 4. written informed consent; exclusion criteria: 1. complete intestinal obstruction; 2. hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment); 3. significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation； 4. pregnancy or breastfeeding; 5. alcohol abuse or drug addiction; 6. concurrent uncontrolled medical condition;
effect of anesthesia on force application during colonoscopy

Conditions: Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

Summary: the aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. force measurements will be performed using the colonoscopy force monitor (cfm). this device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. an equal number of male and female patients will be included in each group.

Eligibility criteria:
inclusion criteria: * male or female * age: 30-75 years * asa class i or ii * all ethnic and racial groups will be included exclusion criteria: * colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. examples include: colonic stricture, poor preparation, obstructing tumor. * specific pathology that would limit the extent of examination * asa class 3 or greater * pregnancy * monitored anesthesia using propofol for sedation. * vulnerable subjects. students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity

Keywords: colonoscopy force monitor endoscopist conscious sedation propofol