Kornimate/medical-research-clean huggingface dataset:
study assessing the efficacy and safety of stn1013600 ophthalmic solution 0.1% and 0.3% compared with placebo in subjects with presbyopia

Conditions: Presbyopia

Summary: this is a phase iia study to assess efficacy and safety of stn1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to placebo in subjects diagnosed with presbyopia. this study will consist of a screening period of up to 15 days followed by a 2 month treatment period. after the treatment period subjects will be followed for a one-month treatment free period.


Eligibility criteria:
inclusion criteria: * phakic presbyopic subjects, male or female between 47 and 55 years of age. * distance-corrected near visual acuity (dcnva) for each eye, as well as for binocular vision, 70 edtrs letters or worse (equivalent to 0.3 logmar or worse; or 20/40 snellen or worse) at 40 cm. to be reconfirmed at visit 2 (baseline). * best-corrected distance visual acuity (bcdva) for each eye of 85 etdrs letters or better (equivalent to 0.00 logmar or better; or 20/20 snellen or better) at 4 m. to be reconfirmed at visit 2 (baseline). exclusion criteria: * secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles). * any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study. * prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).

Keywords: santen, presbyopia, eye
a first-in-human clinical trial to evaluate the safety, effectiveness and surgical characteristics of cadence in patients with refractory glaucoma

Conditions: Glaucoma

Summary: to evaluate safety, effectiveness, and the surgical performance of cadence in patients with refractory glaucoma.

cadence a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. the device is implanted in the eye using an ab-externo approach

Eligibility criteria:
inclusion criteria: * 22-80 years of age. * moderate to severe refractory glaucoma * able to consent exclusion criteria: * women of child-bearing potential * intraocular surgery or laser within the last 3 months * ocular infection or inflammation within the last 6 months or currently active * current use of anti-coagulant therapy * history of bleeding disorder or coagulopathies * subject plans to undergo any ocular surgery (including cataract surgery) during the study period * history of corneal transplantation * history of ice syndrome or epithelial ingrowth/downgrowth * history of congenital glaucoma * elevated episcleral venous pressure -. persistent angle closure- * previous glaucoma filtration surgery- -presence of conjunctival scarring - * neovascular glaucoma * ac lens or scleral sutured iol * aphakia * inability to dc contact lenses * presence of intraocular silicone oil * vitreous in ac

Keywords: glaucoma
effect of piezoelectric surgery on quality of life and periradicular healing after endodontic surgery

Conditions: Periapical Disease

Summary: this study will compare the effect of piezo vs bur on quality of life and healing after endodontic surgery.

the goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.in this study after thorough clinical \& radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with us6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. they will be also requested to note down the details of analgesic intake. hemorrhage control during surgery will be assesed. clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative cbct taken to evaluate volume reduction of lesion postoperatively.

Eligibility criteria:
inclusion criteria: 1. patients with no general medical contra-indications for oral surgical procedures (asa-1 or asa-2). 2. patients of age 16 years and above. 3. the tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis). 4. the nonsurgical re-treatment was judged unfeasible or had previously failed. 5. the tooth had an adequate final restoration with no clinical evidence of coronal leakage. 6. the apical area of the root canal should be devoid of the presence of a post for at least 6 mm. 7. patients with no acute symptoms. exclusion criteria: 1. unrestorable tooth. 2. fractured / perforated tooth. 3. apicomarginal defects. 4. through \& through lesions. 5. teeth with deep pockets. 6. serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).

Keywords: piezoelectric surgery, quality of life, hemostasis
intervention to support the reintegration of former combatants and soldiers

Conditions: Appetitive Aggression; Post-traumatic Stress Disorder

Summary: the project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in dr congo when a specific intervention (narrative exposure therapy for forensic offender rehabilitation, fornet) is delivered by trained local personnel (phase 1). in a second step, the project aims to investigates the treatment success if this specific therapy is carried out by local personnel who have been trained by other local personnel ("train the trainer", phase 2) under the supervision of experts of the university of konstanz.

the reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. the present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in dr congo. the project consists of four steps: 1. training of selected ddrrr personnel(first generation)in fornet (a variant of narrative exposure therapy to treat trauma-related disorders and to reduce appetitive aggression)by experts from the university of konstanz. 2. treatment phase 1: intervention will be carried out by therapists of the first generation. the trained therapists of the first generation will be supervised from the experts of the university of konstanz. 3. training of a second generation of ddrrr personnel in fornet by the therapists of the first generation. 4. treatment phase 2: intervention will be carried out by therapists of the second generation. the trained therapists of the second generation will be supervised from the therapists of the first generation. the study is conceived as a randomized controlled study. in phase 1 and in phase 2, study participants will be randomized allocated to the intervention group (fornet) and the control group (no intervention). the treatment effect will be measured by pre-post and 6-months follow-up evaluations.

Eligibility criteria:
inclusion criteria: * ex-combatants who live in a transit camp in goma, congo. exclusion criteria:

Keywords: treatment of ex-combatants fornet for ex-combatants appetitive aggression post-traumatic stress disorder
db rct for specialized phototherapy in parkinson's disease.

Conditions: Parkinson Disease

Summary: this is a pivotal study to determine whether light therapy can improve non-motor and motor function in parkinson's disease, on top of current best medical treatment.

six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. the celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. the light is to be used each evening in the home for 1 hour, while the participant watches tv, eats dinner, reads, etc. the primary outcome measure is the parkinson's disease questionnaire-39 summary index (pdq-39si). the pdq-39 is a patient-reported, quality of life scale. the key secondary endpoint is parts 1 and 2 of the movement disorders society-unified parkinson's disease rating scale (mds-updrs). the mds-updrs parts 1 and 2 measure non-motor and motor function in parkinson's. participants will be assessed via online videoconferences.

Eligibility criteria:
inclusion criteria: diagnosis of parkinson's disease as determined by the study pi, in keeping with the uk pd society brain bank criteria for the diagnosis of pd responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year relatively good eyesight as attested to by participants (corrective lenses of at least 20/60) stable levodopa and other anti-pd medications for at least 28 days prior to screening - exclusion criteria: diagnosis of an atypical parkinsonian syndrome significant off state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study. an anticipated need for a change in dopamine replacement therapy, concomitant medications, otc/supplements, or other alternative therapies during the participant's involvement in the investigation history of previous light therapy use for pd -
continuous thetaburst stimulation for the treatment of refractory epilepsy - safety, feasibility and proof-of-concept

Conditions: Epilepsies, Partial

Summary: the purpose of this study is to investigate a novel stimulation protocol of repetitive transcranial magnetic stimulation (rtms) for the treatment of unifocal neocortical epilepsy, namely continuous thetaburst stimulation (ctbs). as this is a pilot study, the primary endpoint is on safety and tolerability of the treatment. however, information on clinical efficacy and mechanism of action will also be collected.

1. study design: this is an open label prospective pilot trial of continuous thetaburst stimulation (ctbs) in patients with unifocal neocortical epilepsy. the study comprises a 13-week period, consisting of 4 weeks baseline seizure frequency assessment, a one-week treatment period with baseline assessments on monday (t0) and stimulation sessions from tuesday to friday (t1-t4), and an 8-week follow-up period with short-term assessments immediately after the final stimulation session on friday afternoon (t4) and long-term assessments after 2 weeks (fu2) and 8 weeks (fu8). 2. objectives: the primary objective is to assess the feasibility, safety and tolerability of ctbs in refractory epilepsy patients. the secondary objectives are to assess the clinical efficacy and associated mechanism of action of ctbs in unifocal neocortical epilepsy. 3. rationale: an open label prospective design allows to make a first estimate on the safety, feasibility and tolerability of ctbs in refractory epilepsy patients. there are currently no reports available of ctbs performed in epilepsy patients. the ultimate aim is to assess clinical efficacy of ctbs with regard to seizure frequency, but a feasibility and safety study is a prerequisite in order to achieve this goal.

Eligibility criteria:
inclusion criteria: * refractory unifocal neocortical epilepsy with a well-defined ictal onset zone based on a standardized presurgical evaluation * ≥ 4 seizures/month, for at least six months * on a stable drug regimen for at least 2 months * iq \>70 * reliable completion of a seizure diary by patient or caretakers * therapeutic compliance in the past * informed consent signed exclusion criteria: * pregnancy, short-term birth wish or childbearing age without adequate birth control * history of psychogenic non-epileptic seizures * intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area * presence of pacemaker, implantable cardioverter-defibrillator (icd), permanent medication pumps, cochlear implants or deep brain stimulation (dbs) patients with a vagus nerve stimulator are not excluded, provided that adequate distance between the coil and the implanted material can be maintained. as the short duration of the study will not interfere with an ongoing presurgical evaluation and/or its eventual conclusion, the patients in the course of the evaluation or awaiting surgery are also eligible for inclusion.

Keywords: partial epilepsy unifocal neocortical treatment resistant transcranial magnetic stimulation thetaburst stimulation
a bioequivalence study of 3 formulations of ondansetron in healthy adults (0869-095)(completed)

Conditions: Chemotherapy-Induced Nausea and Vomiting

Summary: this study will assess the bioequivalence of a merck clinical trial formulation of ondansetron compared to a u.s. and non-u.s. marketed formulation of ondansetron.


Eligibility criteria:
inclusion criteria: * if female, subject is not pregnant or breast-feeding * subject is a nonsmoker * subject is in good general health exclusion criteria: * subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease * subject is taking prescription or nonprescription drugs that can not be discontinued during the study * subject is a habitual and heavy consumer of caffeine
2 year follow up of cosgod iii

Conditions: Neurodevelopmental Disability; Death

Summary: the cosgod iii trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. the first neonate was randomised in september 2017 and the last in october 2021. a prospective follow up of the included neonates until an age of two years was not feasible in the cosgod iii trial since funding for long-term follow-up was not available. however, data on long-term outcome of the included neonates into cosgod iii trial are of high interest. in many centres, who participated in the cosgod iii trial neonates are assessed routinely for long term outcome in outpatient clinics with bayleys iii/iv test or parca-r (parent report of children's abilities) questionnaire. aim of the present study is therefore to analyse in neonates, who were included into the cosgod iii trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).


Eligibility criteria:
inclusion criteria: * \> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months) exclusion criteria: * \< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)
dapagliflozin to prevent the incidence of contrast induced nephropathy after heart catheterization and percutaneous coronary intervention

Conditions: Left Cardiac Catheterization; Percutaneous Coronary Intervention; Acute Kidney Injury; Sodium-glucose Co-transporter 2 Inhibitors

Summary: left heart catheterization and percutaneous coronary intervention (pci) has become a useful tool in interventional cardiology, in which iodinated contrast media is used. although the use of iodinated contrast media (cm) is considered to be safe in patients with normal renal function, it is risky in patients with known chronic renal insufficiency (ckd) and diabetes mellitus. contrast induced nephropathy (cin) remains one of the most leading causes of in hospital acute kidney injury (aki), affecting morbidity and mortality. there are various mechanisms through which cm develop their nephrotoxic effects, including renal vasoconstriction and medullary hypoxia, tubular cell toxicity and reactive oxygen species formation. inhibitors of type 2 sodium- glucose co-transporter (sglt2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. however, although sglt2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. moreover, pleiotropic effects have been observed, including a reno-protective action. in addition to the effects mediated by intrarenal hemodynamic changes, sglt2-i also have direct anti-inflammatory and antifibrotic nephroprotective effects. indeed, sglt2-i suppress the production of reactive oxygen species, lessening glomerulosclerosis and tubulo-interstitial fibrosis. these findings suggest that the use of sglt2i could offer benefit by reducing/ preventing the nephrotoxic effects of contrast media leading to the assumption that the use of these drugs could prevent the incidence nephropathy after cardiac catheterization and percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * age\>18 years * written informed consent * glomerular filtration rate (gfr)≥ 30 ml/min/1.73m2 \[ckd stage g1-g3\] * percutaneous coronary intervention in patients with nstemi, ua, stcd and asymptomatic patients exclusion criteria: * active malignancy * participation in other intervention study * class i or equivalent indication for treatment with a sglt2 inhibitor * pregnancy or willing of pregnancy during the follow up period * active urogenital infection * diabetes mellitus type 1 * history of diabetic ketoacidosis * cardiogenic shock * egfr \< 29 ml/min/1.73m2 * patients with an indication for sglt2 inhibitor will be included in a prospective registry. their treatment will be determined by their attending physicians.

Keywords: dapaglifozin iodinated contrast media sodium-glucose co-transporter 2 inhibitors acute kidney injury
rotavirus efficacy and safety trial (rest)(v260-006)

Conditions: Rotavirus Infections

Summary: this study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Eligibility criteria:
inclusion criteria: * healthy infants exclusion criteria: * none specified
ivabradine in cirrhotic cardiomyopathy

Conditions: Cirrhotic Cardiomyopathy; Left Ventricular Dysfunction; Cirrhosis, Liver; Portal Hypertension

Summary: a total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2d echocardiography, will then be randomized by block randomization technique, to two arms in a ratio 1:1(group a) will receive carvedilol+ ivabradine targeted therapy for heart rate reduction while group b will receive carvedilol alone; and the dosage of drug in the treatment arm will be titrated every week to achieve target heart rate of 50-60/ minute. patients in the treatment arms, who are unable to tolerate carvedilol due to hypotension episodes, will be offered ivabradine alone to allow achievement of targeted heart rate reduction. all patients will be evaluated at 0,6, and 12 months. the end points will be clinical events, cardiac function improvement, renal function, and mortality.

the investigators have already demonstrated the role of targeted heart rate reduction in the management of lvdd in cirrhosis, but the previous study could not demonstrate the role of ivabradine alone in absence of betablocker therapy. this trial will be a validation cohort for the initial data obtained on this novel drug. the use of ivabradine can treat patients who do not tolerate betablocker therapy due to contraindications or adverse effects especially hypotension. diagnosis of ccm will be as per 2020 ccmc criteria. ccm is defined as systolic or diastolic dysfunction in the absence of alternative cardiac pathology in concordance with the cirrhotic cardiomyopathy consortium (ccmc) criteria. 9 systolic dysfunction was defined as an ejection fraction (ef) ≤50% or an absolute value of gls \ 34 ml/m2, tricuspid jet maximum velocity \>2.8 m/s, in the absence of pulmonary hypertension and the presence of measurable early to late diastolic transmitral flow velocity (e/a) ratio (e/a \>2 = grade 3 \& e/a 0.8-2 = grade 2 lvdd). persons meeting only 2 criteria will be termed as indeterminate for lvdd grade.

Eligibility criteria:
inclusion criteria: * age range of 18-65 years * cirrhosis, as diagnosed by histology or clinical, laboratory and usg findings, * lv diastolic dysfunction on 2d echocardiography exclusion criteria: * chronic renal disease * patient already on beta blocker * pregnancy and peripartum cardiomyopathy * hypertension * coronary artery disease * valvular heart disease * sick sinus syndrome/ pacemaker * cardiac rhythm disorder * hypothyroidism * hyperthyroidism * portal vein thrombosis * transjugular intrahepatic porto systemic shunt (tips) insertion * hepatocellular carcinoma * anemia hb \< 8gm/dl in females, and \< 9 gm/dl in males

Keywords: cirrhotic cardiomyopathy left ventricular diatolic dysfunction carvedilol ivabradine
automated early warning scoring on surgical normal wards

Conditions: Safety Issues; Emergencies

Summary: establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. upon meeting of predefined trigger criteria medical emergency teams (met) should be directed to these patients. the present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.

the deployment of an electronic monitoring and notification system is accompanied by data acquisition over 12 months (intervention) using four routine databases: hospital patient data management, anesthesia database, local data of the german resuscitation registry, and measurement logs of the automated patient monitoring and alert system (intervention period only). a preceding time period of 12 months served as control.

Eligibility criteria:
inclusion criteria: * admission to one of the participating wards exclusion criteria: * none
health effects of milk proteins in elderly subjects

Conditions: Healthy

Summary: the aim of the present study is to investigate effects of milk on body composition and muscle strength, inflammation, appetite, dna damage/repair and pbmc whole genome transcriptomics in elderly subjects.


Eligibility criteria:
inclusion criteria: * ≥ 70 years of age * reduced gait speed or * reduced "five times sit to stand test" or * reduced "timed step stair test " or * reduced grip strength * stable body weight (last 3 months) * mini nutritional assessment (mna®) score ≥ 17 * mini-mental status (mmse-nr) score: ≥ 24 * willing to participate according to the protocol exclusion criteria: * allergy/intolerance to milk/dairy products * high intake of milk and yoghurt * physical active subjects * known diabetes type i or ii, or hba1c ≥ 6,5% * recent events of acute cardiovascular disease including stroke * rapidly evolving diseases (active malignancy) or history of cancer (malignant tumors) last 3 years. * severe inflammation-related diseases such as e.g. crohn disease and arthritis * chronic obstructive pulmonary disease * increased blood pressure * high intake of alcohol * reduced kidney function (gfr \< 45 ml/min) * increased hscrp, asat, alat * increased or suppressed tsh * hormone therapy * systemic use of glucocorticosteroids (anti-inflammatory steroid hormones). use of spray and inhalator use is not exclusion. * disability preventing physical tests * using medications known to affect protein metabolism