Kornimate/medical-research-clean huggingface dataset:
enamel matrix derivative in non-surgical periodontal treatment

Conditions: Periodontitis

Summary: the aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.

enamel matrix derivative (emd) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis. the present study is designed as a single-blinded randomized controlled clinical trial. we plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (ppd). patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (srp) in combination with emd application into the affected pockets (test group, n=25) or to srp only (control group, n=25). before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.

Eligibility criteria:
inclusion criteria: * periodontitis stage iii * patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm ppd * given written informed consent form for participation in the study exclusion criteria: * systemic antibiotics within the previous 3 months * pregnant or breastfeeding women * any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome. * patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or i according to hamp

Keywords: enamel matrix derivative periodontitis non-surgical periodontal therapy
sphenopalatine ganglion block to treat shoulder pain after thoracotomy

Conditions: Ipsilateral Shoulder Pain

Summary: the purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (spg) block to manage ipsilateral shoulder pain (isp) after thoracotomy. this will be an open label preliminary pilot study to determine if spg block has potential utility to manage isp in post-thoracotomy patients. the primary outcome variable will be reduction of shoulder pain.

this is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (spg) block to manage ipsilateral shoulder pain (isp). it will determine if spg block has potential utility to manage isp in post-thoracotomy patients one hundred (100) patients will initially be consented in this study. patients have to develop isp and have a pain vas \>= 5. the study is seeking ten (10) eligible participants. patients will be followed after the spg block(s), and the duration of pain relief will be monitored by serial assessments of the vas. this assessment will occur for the initial spg block and for all follow-up blocks, if performed. the follow-up assessments will only involve having the patient rate the isp using a verbal vas; this will take less than a minute of patients time. in addition, all patients will have prn access to standard systemic analgesics as routinely ordered by the surgical service safety assessments will be performed on all subjects. blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each spg block for 90 minutes. dr. grant will monitor the subjects for 90 minutes after each spg block.

Eligibility criteria:
inclusion criteria: * any type of open thoracotomy or video-assisted thoracoscopic surgery (vats) * presence of post-operative isp, vas\>5/10 * american society of anesthesiologists class 1 - 4 * no allergy to lidocaine exclusion criteria: * american society of anesthesiologists class 5 * allergy to lidocaine * nasal pathology (e.g., deviated septum) * bleeding diathesis * any patient who the pi feels will be unable to comply with all protocol related procedures * shoulder pain prior to thoracotomy

Keywords: thoracotomy postoperative lidocaine sphenopalatine ganglion block
an internet intervention for alcohol problems with or without assistance from a health educator

Conditions: Alcohol Problem

Summary: the purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.

this project aims to study the previously evaluated multi-module internet intervention alcohol help center delivered with assistance from a health educator (ahc+a). the assistance will be in the form of email contact with the participant during the first two weeks after randomization. ahc+a will be tested against a group receiving access to the intervention without any such assistance (ahc). the investigators hypothesize that 1. participants allocated to ahc+a will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to ahc 2. participants allocated to ahc+a will display greater engagement with the intervention in terms of a higher number of modules completed compared to ahc 3. engagement with the intervention will mediate any effects on drinking behavior. a 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. follow-ups will be conducted at 3 and 6 months after randomization. online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' the advertisements will be placed across canada using locations found successful in previous trials to rapidly recruit participants (e.g. google adwords).

Eligibility criteria:
inclusion criteria: * a score of 8 or more on the alcohol use disorder identification test (audit) * a preceding week alcohol consumption of 14 standard drinks or more exclusion criteria: * being under 18 years of age
a clinical research of cd19 and cd22 targeted prime car-t cell in relapsed/refractory b cell lymphoma

Conditions: B Cell Lymphoma

Summary: this is a single arm study to evaluate the efficacy and safety of cd19 and cd22 targeted prime car-t cells therapy for patients with relapsed/refractory b cell lymphoma

although the anti-cd19 car-t cell therapies have gained significant results in patients with relapsed and refractory b-cell hematologic malignancies. there are patients who resisted anti-cd19 car-t cells or with cd19 negative relapse. to make further improvement, the investigators launch such a clinical trial using cd19 and cd22 targeted prime car-t cells for patients with relapsed and refractory b cell lymphomato evaluate the efficacy and safety of cd19 and cd22 targeted prime car-t cell therapy.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. diagnose as relapsed and refractory b -all, and meet one of the following conditions: 1. failed to standard chemotherapy regimens; 2. relapse after complete remission, high-risk and / or refractory patients ; 3. relapse after hematopoietic stem cell transplantation; 3. evidence for cell membrane cd19 or cd22 expression 4. all genders ages: 2 to 75 years 5. the expect time of survive is above 3 months; 6. kps\>60 7. no serious mental disorders ; 8. left ventricular ejection fraction ≥50% 9. sufficient hepatic function defined by alt/ast≤3 x uln and bilirubin≤2 x uln; 10. sufficient renal function defined by creatinine clearance≤2 x uln; 11. sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. with single or venous blood collection standards, and no other cell collection contraindications; 13. ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: 1. previous history of other malignancy; 2. presence of uncontrolled active infection; 3. evidence of disorder that need the treatment by glucocorticoids; 4. active or chronic gvhd 5. the patients treatment by inhibitor of t cell 6. pregnant or breasting-feeding women; 7. any situation that investigators regard not suitable for attending in this study (e.g. hiv , hcvinfection or intravenous drug addiction) or may affect the data analysis.

Keywords: cd19 cd22 car-t
safety and efficacy evaluation of co2 removal in combination with continuous veno-venous hemodialysis/hemodiafiltration therapy

Conditions: Acute Lung Injury; Acute Kidney Injury; Hypercapnia; Covid19

Summary: objective of the study is to assess the safety and efficacy of co2 removal by the multiecco2r (co2 removal system) on the multifiltrate/multifiltrate pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (crrt) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated by the investigator; and: 1. if patient is able to give consent: by the study patient 2. if patient is unable to give consent: by the legal representative or 3. if an emergency situation is determined: by an independent consultant physician * minimum age of 18 years study-specific: * body weight greater than 40 kg * acute kidney injury (aki) with clinical indication for crrt * hypercapnia with indication for ecco2r: (paco2 ≥ 55 mmhg at given best possible protective ventilation parameters: guiding parameters: tidal volume = 6 ml/kg pbw, peep to be adjusted according to the fio2 1, driving pressure \< 15 cmh2o, max. inspiratory pressure \< 30 cmh2o or tv\<=5 ml/kg when max. inspiratory pressure\< 30 cmh2o cannot be held) * vascular access and shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min * arterial line in place, allowing blood sampling * estimated life expectancy greater than 3 days exclusion criteria: * in case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required) * participation in an interventional clinical study during the preceding 72 hours * previous participation in the same study study-specific * severe ards (berlin definition): pao2/fio2 \< 100 mmhg * intracerebral haemorrhage * intracranial hypertension * acute myocardial infarction * hypersensitivity to heparin or known history of heparin induced thrombocytopenia (hit type ii), if heparin is used as anticoagulant * severe liver insufficiency or fulminant hepatic failure * uncontrolled bleeding and coagulation disorders, thrombocytopenia \< 75000µl * liver cirrhosis child pugh classification \> a * bmi \> 40 kg/m² * decision to limit therapeutic interventions

Keywords: co2 removal continuous renal replacement therapy blood-gas exchanger crrt multiecco2r
clinical safety and efficacy of s53p4 bioactive glass putty in spinal fusion surgery

Conditions: Spine Fusion; Spinal Deformity

Summary: a retrospective, single-tertiary centre observational study. the study population consists mainly of patients with instrumented posterolateral spine fusion operated at the department of neurosurgery or at the department of orthopaedics and traumatology in the turku university hospital. also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included. the approximate number of the above-mentioned operations with bonalive® putty is 400 - 500 between september 2013 and april 2021. in the operations, the bonalive® putty was used either alone, together with autologous bone (ab) chips, with milled allogenous bone chips, with demineralized bone matrix (dbm), with other synthetic bone grafts, or with a combination of the above-mentioned.

in the first stage of the investigation, the clinical safety and efficacy of bonalive® putty are assessed in a retrospective case-series, and the observations are compared to the existing literature. thereafter, a retrospective case-controlled study will be created to compare the use of a mixture of bonalive® putty and ab to ab alone for clinical safety and efficacy. the cases will be matched up with the controls by gender, age, smoking behavior, the number of operated levels and the site of operated levels as far as possible. the chosen surgical technique will be the most commonly used.

Eligibility criteria:
inclusion criteria: 1. performed spine fusion operation 2. bonalive® putty used in the operation exclusion criteria: 1. age under 18 2. use of other synthetic bone graft substitute or expander materials than bonalive® putty in the operation 3. less time than two years since the index operation and no ct-proof of intended bony fusion

Keywords: s53p4 bonalive bioactive glass putty spine fusion lumbar spine fusion
objective grading of mts with lsci and thermography

Conditions: Mesenteric Traction Syndrome

Summary: mesenteric traction syndrome (mts) is defined as hypotension, tachycardia and facial flushing in the first hour of surgery, caused by mesenteric traction/abdominal exploration. mts occurs frequently during abdominal surgery, with incidence around 80 % during open surgery, and lower during minimally invasive surgery. mts can be divided into different severities using the degree of facial flushing, with the most severe level of mts being associated with increased postoperative morbidity. today mts is diagnosed and graded subjectively by the surgical team, with marked difficulty and limitations. therefore the investigators developed a cut-off value using the laser speckle contrast imaging (lsci), which the investigators wish to confirm in a new cohort, while also examining whether lsci is interchangeable with digital thermography, which is simpler and cheaper to perfom. the investigators will measure facial perfusion during the first hour of surgery and take blood samples at predefined timepoints to use for biochemical verification of the different severities of mts. three cohorts we planned to include 45 open esophagectomies or gastrectomies 50 whipple surgery 20 robot assisted esophagectomies or gastrectomies these patients will be use in multiple articles examining different aspects of mts one study examining lsci and thermography for the identification and grading of mts will use 60 patients undergoing open esophagectomy or gastrectomy or whipple surgery, in this study patients will not be excluded if they are found to be disseminated. however we ended up including 37 open esophagectomies - due to few patients undergoing open esophagectomy, this were included over a time period of almost 2,5 years 50 whipple 11 robotic esophagectomies - due to lsci being impossible to use on robotic esophagectomies and thermography being diffciult to fit on these patients and as such not being feasible


Eligibility criteria:
inclusion criteria: * undergoing curative surgery for esopageal, gastric, doudenal or pancreatic cancer exclusion criteria: * known flushing disease * patients recieving nsaid and corticosteroid presurgery, whipple is allowed to recieve single dose of 125 mg methylprednisone as part of the standard of care at our facility. * palliative surgery * surgery not completed due to disseminated disease - patients will still be used in examination of lsci and thermography analysis even if desiminated
characterizing iodine-124 evuzumitide (at-01) in systemic amyloidosis

Conditions: Amyloidosis; Transthyretin Amyloidosis

Summary: this is a single center prospective study evaluating 124i-evuzumitide in patients with systemic amyloidosis. the purpose of this study is to 1)identify and characterize the distribution and uptake of 124i-evuzumitide in patients with transthyretin amyloid cardiomyopathy (attr-cm) and 2) correlate the uptake with the structure and function of different organs, including the heart. to achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (pet/mri). in a subgroup of patients who are unable to undergo pet/mr, computed tomography will be used instead of mri (i.e. pet/ct). in a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.


Eligibility criteria:
inclusion criteria: 1. subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance 2. patient willing to consent for the study and undergo the study procedures. exclusion criteria: 1. has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol 2. has a known allergy to potassium iodide treatment or to gadolinium. 3. patients on dialysis or those with egfr \<30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac mri. 4. has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124i-evuzumitide administration
enoxaparin in acute venous thromboembolic disease

Conditions: Venous Thrombosis

Summary: study objectives : * to evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.


Eligibility criteria:
inclusion criteria: * patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler usg (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors exclusion criteria: * patients with a history of heparin or warfarin treatment longer than 24 hours, * patients requiring thrombolytic treatment, * patients having thrombophilia diagnosis, * patients with prior deep vein thrombosis or pulmonary emboli evidence, * patients with familial bleeding disorder, * patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month * patients with renal failure (serum creatinine concentration \> 180 mmol/l or \> 2.03 mg/dl), * patients with severe hepatic failure * patients with history of allergy against heparin and protamine, * patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment, * patients participating in another clinical study within the last 4 months * patients who are pregnant the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ivf hyper-responders: oocyte vitrification compared with embryo freezing

Conditions: Infertility

Summary: the chances to achieve pregnancy after retrieving \>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. with the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle. the purpose of this study is to compare the outcome of these two approaches.


Eligibility criteria:
inclusion criteria: * ivf patients * ovulation trigger with decapeptyl 0.2 mg because of ovarian hyper-response: e2 on trigger day .12,000 pmol/l and/or \>15 oocytes. * normal uterus exclusion criteria: * \<20% fertilization rate
impact evaluation of different micturition modes on patients with medullar injury of quality of life and their occupations

Conditions: Medullary Injury; Micturition Disorder

Summary: the primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.


Eligibility criteria:
inclusion criteria: * adult patients with spinal cord injury; * live at home or in long-term care facility definitively; * have one of the following urination modes: 1. urine with indwelling catheter in place 2. catheter in suprapubic area 3. intermittent catheterization by urethra 4. intermittent catheterization by incontinent cystostomy 5. sphincterotomy 6. incontinent stomia (bricker) exclusion criteria:

Keywords: medullary injury micturition modes quality of life human occupation
phase 3 open-label extension study of td-9855 for treating symptomatic noh in subjects with primary autonomic failure

Conditions: Symptomatic Neurogenic Orthostatic Hypotension

Summary: a phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (msa, pd, and paf) and symptomatic noh over 182 weeks.

this is a phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (msa, pd, and paf) and symptomatic noh. the study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.

Eligibility criteria:
inclusion criteria: * completion of study 0170 and, in the opinion of the investigator, would benefit from long-term treatment with ampreloxetine. * the subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen). * the subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (study 0170) except, a score of \>4 in ohsa#1. exclusion criteria: * subjects may not be enrolled in another clinical trial. * psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study. * medical, laboratory, or surgical issues deemed by the investigator to be clinically significant. * hypersensitivity to ampreloxetine or the formulation excipients.

Keywords: symptomatic neurogenic orthostatic hypotension sympomatic noh multiple symptom atrophy msa parkinson's disease pd pure autonomic failure paf orthostatic hypotension oh ampreloxetine 171 low blood pressure dizziness fainting blacking out lightheadedness norepinephrine hypotension oak