Kornimate/medical-research-clean huggingface dataset:
a prospective, randomized, placebo-controlled pilot study to characterize the intestinal microbiome and to evaluate the safety and fecal microbiome changes following administration of lyophilized prim-dj2727 or placebo given orally in subjects with nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus

Summary: potential subjects with non-alcoholic fatty liver disease (nafld) will be identified by gastroenterologists (study investigators). twelve eligible subjects with nafld will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or placebo capsules and dosed twice weekly for 12 weeks. .


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. for sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study. 3. for female subjects of childbearing potential, a negative urine qualitative hcg pregnancy test at enrollment and on the week 1, day 1 of the treatment prior to administration of study drug. 4. willing and able to sign an informed consent form and attend study assessments and follow up visits. 5. a documented diagnosis of nafld without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist. 6. history of diabetes mellitus 7. has an attending physician who will provide non-transplant care for the subject. 8. agrees to maintain a stable regimen including weight loss, exercise, medications to control lipids and glucose, and vitamin e therapy if already prescribed, during participation in the study exclusion criteria: 1. unable to take multiple capsules orally. 2. alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men. 3. hemochromatosis. 4. hepatic encephalopathy. 5. compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent) 6. receipt of systemic non-topical antibiotic therapy within 14 days of treatment day 1. 7. history of use of an investigational drug within 90 days prior to the screening visit. 8. positive results for active hiv, hepatitis b, or hepatitis c infections. 9. current history for active states of inflammatory bowel disease, irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures. 10. history of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives. 11. life expectancy of \< 1 year. 12. in the opinion of investigator, subject for any reason, should be excluded from the study.
study of the safety and effectiveness of photochemically induced collagen cross-linking in eyes with keratoconus.

Conditions: Keratoconus

Summary: this study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (ccl) at irradiance of 18mw/cm2 in eyes with keratoconus and ecstasia.

riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with riboflavin as evidenced by observing riboflavin in the anterior chamber. two arms in the study, one uses riboflavin with epithelium on and the other with epithelium off. once it is observed that the riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to ultraviolet light at an irradiance level of 18mw/cm2 for 5 minutes. a contact lens is applied until the epithelium has fully healed in 3 to 5 days. the study is for 6 months. the corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. the primary variable that is assessed to determine the efficacy of the drug is the kmax - steep corneal curvature. secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.

Eligibility criteria:
inclusion criteria general: 1. 12 years of age or older 2. signed written informed consent 3. willingness and ability to comply with schedule for follow-up visits 4. contact lens removal prior to evaluation and treatment 5. candidates must also have two of the following criteria: 1. presence of central or inferior steepening on the pentacam or orbscan map consistent with keratoconus. 2. axial topography consistent with keratoconus. 3. steepest keratometry (kmax) value of 47.00d inclusion criteria for ectasia: history of having undergone a keratorefractive procedure and 2 of the following criteria: 1. steepening by topography, either pentacam or orbscan 2. thinning of cornea 3. shift in the position of thinnest portion of cornea 4. change in refraction with increasing myopia 5. development of myopic astigmatism 6. development of irregular astigmatism 7. loss of bscva exclusion criteria: i. eyes classified as either normal or atypical normal 2. corneal pachymetry 350 microns at the thinnest point measured by pentacam in the eye to be treated 3. a history of chemical injury or delayed epithelial healing in the eye to be treated. 4. pregnancy (including plan to become pregnant) or lactation during the course of the study 5. a known sensitivity to study medications 6. patients with nystagmus or any other condition that would prevent a steady gaze during the treatment 7. inability to cooperate with diagnostic tests. 8. patients with a concomitant condition that, in the investigator's opinion, would interfere with or prolong epithelial healing. 9. taking vitamin c (ascorbic acid) supplements within 1 week of the cross-linking treatment. 10. patients who are unable to remain supine and tolerate a lid speculum for an extended period of time. -
a study on brain activity during transcranial direct current stimulation in stroke patients

Conditions: Stroke

Summary: the purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fnirs) when applying transcranial direct current stimulation (tdcs) for the purpose of enhancing finger function.


Eligibility criteria:
inclusion criteria: * unilateral stroke patients * chronic patients over 6 months after onset * subcortical stroke * patients with the movement of fingers exclusion criteria: * history of psychiatric disease * significant other neurological diseases except for stroke * difficult to perform this experiment * patients with metal implants * history of epilepsy * pregnancy * skin defect at the site of electrode attachment
the effect of nebivolol on insulin sensitivity

Conditions: Hypertension

Summary: the purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.

retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. this has led to the latest british hypertension society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. however the national institute of clinical excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. nebivolol is a newer class of beta blocker. some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. the aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.

Eligibility criteria:
inclusion criteria: * males or females aged 18 or above * blood pressure that meets any of the three following criteria: * bp should be \<140/85 mmhg on a maximum of two anti-hypertensive drugs exclusion criteria: * contraindications to beta-blockade * contraindications to thiazide use * if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, av conduction disturbances * concurrent treatment with verapamil \& dilitiazem * childbearing women * compelling indication for treatment with a beta blocker * any condition that will interfere with the treatment or the patient's ability to complete the study

Keywords: blood pressure insulin sensitivity beta blockers randomised double blind crossover trial
danish angle closure prevention trial

Conditions: Primary Angle Glaucoma Closure Suspect

Summary: to determine whether primary angle closure suspects (pacs) in a caucasian population benefit from prophylactic laser iridotomy.

prospective, randomised paired-eye design clinical trial comparing peripheral laser iridotomy in one eye with observation in the other over 5-years follow-up.

Eligibility criteria:
inclusion criteria: * primary angle closure suspect: ≥180 degrees (cumulative) irido-trabecular contact on darkroom gonioscopy, iop\<21mmhg, no peripheral anterior synechiae, no glaucomatous optic neuropathy * best-corrected visual acuity (bcva) \>0.8 on both eyes * caucasian exclusion criteria: * pseudophakia * previous iridotomy * clinically significant cataract with indication for surgery, * gaucoma * uveitis * unstable retinal conditions * ocular malignancies * pex * pds * systemic or ocular corticosteroid treatment
nor-sys: the norwegian stroke in the young study

Conditions: Death; Carotid Artery Disease; Cardiovascular Disease; Peripheral Artery Disease

Summary: nor-sys is a clinical research program about young ischemic stroke patients from 15 to 60 years. patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol. parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease. study inclusion time of patients and their families is 5 years. a biobank is build from samples from patients, partners and adult children. clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. clinical follow-ups for adult children are planned after 10 and 20 years. hypotheses: what do patients know about their parents clinical ischemic events? how much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? differences concerning risk factors and ultrasound findings between patients and partners? differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? biochemical markers related to ultrasound findings and artery disease.

equal examinations for patients, partners and adult children are: * standardized questionnaires * extracranial duplexsonography * duplexsonography of the abdominal aorta * duplexsonography of femoral arteries * duplexsonography of epicardial, intrabdominal and subcutaneous fat * peripheral ultrasound, ankle-arm index * ecg * blood pressure measurement * bmi and waist-hip ratio * blood samples

Eligibility criteria:
inclusion criteria: * documented ischemic stroke at age from 15 up to 60 years exclusion criteria: * stroke as end-of-life event among patients with cancer or other life-threatening disease * stroke caused by trauma

Keywords: young ischemic stroke families long-term follow-up
omega-3 fatty acids in chronic periodontitis.

Conditions: Chronic Periodontitis

Summary: omega 3 fatty acids is one such dietary supplement, known to modulate the host response in chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic cerebrovascular diseases, osteoporosis by producing resolvins and protectins without showing any inadvertent effects.addition of systemic omega 3 fatty acids with srp may enhance the therapeutic result of chronic periodontitis owing to host modulation \& anti-inflammatory properties. if proven, this can be used as a routine treatment modality.


Eligibility criteria:
inclusion criteria: 1. patients within age group of 30 to 55 years. 2. systemically healthy individuals. 3. patients with chronic generalized periodontitis (moderate and severe)according to center for disease control (cdc) working group, 2007 criteria. exclusion criteria: 1. patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy), 2. smoking, 3. chronic alcoholics, 4. pregnancy or lactation, 5. use of non steroidal anti inflammatory drugs, steroids or antibiotics / antimicrobials within september 2012 to august 2013, 6. confirmed or suspected intolerance to omega 3 fatty acids, 7. periodontal therapy done within the september 2012 to august 2013.

Keywords: omega 3 fatty acids c reactive protein host modulation chronic periodontitis
effects of vagus nerve stimulation (vns) as a treatment of persistent depression with comorbid personality disorders (impulse-vns

Conditions: Depression; Comorbid Personality Disorders

Summary: in this monocentre two-armed double blind randomised placebo-controlled study - in which the control group obtains the vns therapy within a defined space of time after 12 weeks - the impact of vagus nerve stimulation on depressive symptomatology of patients with therapy-resistant depressive personality disorders shall be analysed. particularly in comorbid disorders, medicamentous treatment shows exceedingly bad response rates. against the background of hitherto insufficient treatment strategies for chronic or persistent depression with comorbidities, the proceeding of a study on the effects of vns on depressive patients with comorbid disorders is absolutely essential.


Eligibility criteria:
inclusion criteria * embedding criteria according to "vns manual for doctors" * diagnosis of a recurrent depressive disorder (based on icd-10 criteria) and a comorbid personality disorder (according to skid i/ii) with an ailment period of more than six months * age 18-80 years * verbal iq (wst) 85 points * ham-d sum score \> 20 points * at least four depressive episodes in the anamnesis * no amelioration of current depressive episodes under two different antidepressants in appropriate dosage for six weeks * constant medication within the last two weeks (at the discretion of the supervising doctor) * written consent after informing the patient about the study * no vns treatment to date * no misuse of illegal drugs or alcohol * women in childbearing age are not permitted to participate in the study if a doctor has asserted the non-existence of pregnancy before the beginning of the study. furthermore, the procedure of a pregnancy test is recommended after the completion of the study. during the study, a reliable type of contraception (such as the pill) should be taken. the doctor provides further information. exclusion criteria according to "vns manual for the doctor" * present hospitalisation according to the federal states' psychkg * clinically relevant unstable bodily concomitant diseases * former vns treatment * reduction of intelligence with verbal iq \< 85 (wst) * conceivable use of an mrt examination after the implantation of the vns-system * for diagnostic examinations with the dtms and the mrt: electric devices (such as cardiac pacemakers, medicine pumps etc.) or pieces of metal (ferromagnetic, e.g. screws after bone fractures) within or at the body, or large-scale tattoos * conditions that do not allow to use vns, such as relevant dysfunctions of the heart's stimulus conduction system or cardiac arrhythmia, stomach ulcer, dysphagia, palsy of parts of the n-vagus nerve * insufficient knowledge of the german language * pregnancy or lactation * current misuse of substances

Keywords: vns depression personality-disorder stimulation
prism cardiac resynchronisation therapy (crt) randomised controlled trial

Conditions: Heart Failure

Summary: cardiac resynchronisation therapy (crt) is an established treatment for improving symptoms in patients with congestive heart failure (chf) by left ventricular (lv) pacing. crt can help to improve lv function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. there still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. the investigators hypothesize that by using cardiac mr and 3d echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest lv activation, the investigators can find the best place to implant the left ventricular lead. by avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. the researchers thus aim to increase the proportion of people who respond to treatment. the researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.


Eligibility criteria:
inclusion criteria: * \>18yrs of age * standard indication for crt=p or crt=d according to nice criteria (clinical symptoms of heart failure despite medical therapy, broad qrs \>120ms and significant lv dysfunction lef \<35%) * stable on optimal medical therapy for at least 3 months * no exclusion to pacing /icd * ischaemic or non-ischaemic aetiology exclusion criteria: * any contraindication to pacing /icd implant * contraindication to mr scanning * claustrophobia * significant renal impairment (estimated gfr \<30)

Keywords: cardiac resychronisation therapy heart failure imaging guided lv lead placement
feasibility of a minimally invasive image-guided surgery system for hepatic procedures

Conditions: Liver Cancer

Summary: this study was designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver procedure. the hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies. the surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. after registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3d) image. the surgeon will accept or reject the registration accuracy.

the pathfinder system used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system. preoperative computed tomography (ct) scans, obtained as standard of care, will be used to generate the image guided liver system 3d liver surface images used during the study. during the laparoscopic procedure, the pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure. a total study population will include 20 subjects that complete the laparoscopic procedure scheduled.

Eligibility criteria:
inclusion criteria: * scheduled for laparoscopic procedure * had a preoperative ct image that includes the liver exclusion criteria: * severe cirrhosis of the liver * kidney failure or dialysis * unable to consent

Keywords: liver cancer tumor pathfinder
autologous incubated macrophages for patients with complete spinal cord injuries

Conditions: Spinal Cord Injury

Summary: autologous incubated macrophages (procord) is being developed as a therapy for acute, complete spinal cord injury (sci). the therapy is intended to reverse the loss of motor and sensory function. following non-cns tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. while this process occurs in most tissues, including peripheral nerves, it does not occur in the cns, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege." in animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. the concept derives from the pioneering research of prof. michal schwartz at the weizmann institute of science.


Eligibility criteria:
inclusion criteria: * traumatic sci during last 14 days * age 16 to 65 years * complete spinal cord injury (asia a) * neurological level : c5 to t11 * mri showing lesion exclusion criteria: * women who are pregnant or breastfeeding * coma or other severe injury or disease * penetrating injury * ongoing mechanical ventilation * unsuitable based on mri or other factor

Keywords: paraplegia quadraplegia tetraplegia paralysis nerve regeneration acute, complete sci
transpulmonary thermodilution using an implented central venous access port

Conditions: Medical Oncology

Summary: perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. the investigators currently use a local hemodynamic protocol based on the data of the literature. according to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. the investigators chose to monitor the cardiac index (ci) with the transpulmonary thermodilution technique (tptd) (picco, pulsion medical system, munich, allemagne). the technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (cvc). the variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to stewart-hamilton's theory. many studies showed the reliability of this technique (bein j cardio thorac vasc anesth 2004, buhre cardio thorac vasc anesth 1999, felbinger j clin anesth 2005, felbinger tw j clin anetsh 2002, godie o ann thorac surg 1999). in our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. when picco monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. indeed, insertion of the cvc can be more difficult because of the port. it may be interesting to use the port for tptd in order to avoid the insertion of a new cvc. this would be possible only if the measurement of ci by the port was as reliable as the classical measurement with a cvc. the aim of this study was to assess whether measurement of the ci by tptd was possible and reliable via the port. the investigators conducted a prospective study comparing the measurement of the ci by tptd before and after fluid challenge via the port versus the cvc.


Eligibility criteria:
inclusion criteria: * presence of port * scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol * oral consent of the patient after oral and written information exclusion criteria: * age inferior to 18 * contraindication or failure to the insertion of the cvc * contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow