Kornimate/medical-research-clean huggingface dataset:
continuous delivery room skin-to-skin-study for moderate and late preterm infants

Conditions: Preterm Birth; Mother-Infant Interaction; Infant Development

Summary: the goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. the main questions it aims to answer are: * does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway? * does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome? participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. researchers will compare these two groups to answer the proposed questions.

the planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. the working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. the study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.

Eligibility criteria:
inclusion criteria: * preterm birth between gestational age of 32 0/7 and 36 6/7 weeks * vaginal delivery * singleton * informed consent before birth exclusion criteria: * malformations or syndromes of the infant * resuscitation of the infant * maternal psychological or severe physical illness * lack of german language skills

Keywords: preterm behavioral epigenetics skin-to-skin contact
nexagon for the treatment of corneal persistent epithelial defects following severe ocular injuries

Conditions: Corneal Persistent Epithelial Defect

Summary: this study will enroll participants with a non-infected, corneal persistent epithelial defect (ped) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. it will assess the efficacy and safety of nexagon® (lufepirsen) plus standard of care versus nexagon-vehicle (placebo) plus standard of care. the recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by day 28 of treatment and remains re-epithelialized for at least a further 28 days.


Eligibility criteria:
inclusion criteria: 1. male and female of any age. 2. the presence of a non-infected, corneal persistent epithelial defect (ped) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes. 3. the ped is non-responsive to current standard of care for at least 14 days from injury. 4. the ped measures at least 2 mm along the largest diameter at day 1 of the treatment period. 5. providing written informed consent and ability to comply with the visit and dosing schedule. exclusion criteria: 1. have active ocular infection. 2. subjects with corneal perforation or impending corneal perforation. 3. subjects with any other past or present ophthalmic disease or medical condition that, in the investigator's opinion, may affect the safety of the subject or the outcome of the study. 4. subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect. 5. female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control. 6. subjects who have participated in an interventional clinical trial within 30 days prior to day 1.
hn-bio 02: a phase ii randomized study of the effects of delayed elective radiotherapy on head and neck mri and immune response biomarkers

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) hnscc receiving curative therapy. this research is part 2 of the hn-bio study.

this study will recruit up to 40 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) hnscc with primary tumor and/or involved lymph node suitable for repeat biopsy in clinic. after being informed about the study and potential risks, patients giving written informed consent will be randomized to receive conventional radiotherapy (single integrated boost or conventional two-phase at clinician discretion) or reversed two-phase treatment with delayed irradiation of elective nodal volumes. patients will not be informed of their randomization result. patients in both arms will undergo a baseline functional magnetic resonance imaging (fmri) scan and within 72 hours, when possible, a biopsy of the primary tumor +/- lymph node will be performed in an out-patient clinic. if a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible. in week 2 of radiotherapy, patients will have a second fmri scan and a paired biopsy within 72 hours of the scan, where possible. a further optional biopsy and paired fmri scan in week 4 will be considered for patients who are tolerating therapy without \>g1 toxicities. 16-24 hours prior to each biopsy the patient will take oral pimonidazole. at the time of each biopsy a blood draw will be performed.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * histologically proven head and neck squamous cell carcinoma * primary or nodal disease \> 3cm for biomarker imaging * eastern cooperative oncology group (ecog) performance status 0-2 * planned for curative surgery or (chemo)radiotherapy * willingness to undergo repeat mri imaging * able to receive and understand verbal and written information regarding study and able to -give written informed consent * adequate renal function: calculated creatinine clearance \>/= 30ml/min * be able to lie comfortably on back for 1 hour exclusion criteria: * as judged by investigator evidence of systemic disease that makes unsuitable for study * contra-indication for serial mri scans * previous solid tumor treated within last 5 years * pregnancy * history of gadolinium contrast allergy * non-reversible clotting abnormality
effect of enzymes on dental biofilm accumulation in healthy individuals

Conditions: Dental Plaque

Summary: the purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.

the purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. the null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.

Eligibility criteria:
inclusion criteria: * generally healthy males and females ≥18 years of age. * able to read, sign and receive a copy of the signed informed consent form. * have at least 20 natural teeth. exclusion criteria: * clinically visible active caries lesions and/or periodontitis. * significant oral soft tissue pathology based on a visual examination. * history of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients. * history of allergies to ingredients in the test product. * self-reported as pregnant or nursing. * self-reported serious medical conditions. * antibiotic or anti-inflammatory medication within 30 days of screening visit. * orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures. * acute sinusitis or severe oral-pharyngeal infections.

Keywords: enzymes dental plaque gingivitis oral microbiome
endocuff for surveillance of serrated polyposis syndrome

Conditions: Polyposis

Summary: serrated polyposis syndrome (sps) is a high-risk condition for colorectal cancer (crc). sps patients have a cumulative crc risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. recent studies have reported an increase of detection rate and mean per patient of adenomas with endocuff-assisted colonoscopy compared with standard colonoscopy. the purpose of this study is to assess the usefulness of endocuff-assisted colonoscopy to detect serrated lesions in sps patients undergoing surveillance compared to standard colonoscopy in a randomized fashion

according to own data and similarly to previous published studies, patients diagnosed of serrated polyposis syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. the study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the endocuff-assisted colonoscopy group. accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.

Eligibility criteria:
inclusion criteria: -adults with diagnosis of serrated polyposis syndrome undergoing surveillance colonoscopies after clearance of all lesions \>=5mm exclusion criteria: * patients with known strictures * partial or total colonic resection * acute diverticulitis * concomitant inflammatory bowel disease * suspected or proven lower gastrointestinal bleeding * non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure * inability to sign informed consent

Keywords: serrated lesions surveillance colorectal cancer endocuff sessile serrated adenoma colonoscopy
safety and effectiveness of zintevir (ar177) given to hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give zintevir (ar177) to asymptomatic (no symptoms) hiv-infected patients. zintevir belongs to a new class of anti-hiv drugs, the integrase inhibitors. hiv uses the protein integrase to infect a cell. integrase inhibitors block integrase and may stop replication of hiv.

zintevir belongs to a new class of anti-hiv drugs, the integrase inhibitors. the hiv-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. integrase inhibitors block integrase and may stop replication of the hiv-1 virus. in this open-label, phase i/ii study, 3 groups of hiv-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive, but do not have any symptoms of hiv infection. * have a cd4 count greater than 200 cells/mm3. * have a viral load (level of hiv in the body) greater than 4,000 copies/ml. * are at least 18 years old. exclusion criteria you will not be eligible for this study if you: * tend to have abnormal bleeding or other blood problems. * have an active aids-defining illness. * have a history of serious disease or illness. * abuse alcohol or drugs. * have received certain medications.

Keywords: hiv-1 dose-response relationship, drug hiv integrase inhibitors hiv integrase
exploratory study on pol6326 in stem cell mobilization

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether pol6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation


Eligibility criteria:
inclusion criteria: 1. have multiple myeloma in stage ii or iii, according to the criteria of durie and salmon. 2. male or female between 18 and 70 years of age, inclusive. male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment. 3. measurable disease, defined by one of the following: * serum m protein ≥1.0 g/dl by protein electrophoresis * quantifiable immunoglobulin levels and/or * urinary m protein excretion ≥200 mg/24 hours. 4. all patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry. 5. eastern cooperative oncology group (ecog) performance status of 2. 6. life expectancy of \>6 months. 7. have given their written informed consent to participate in the study exclusion criteria: 1. have non-secretory myeloma and/or plasma cell leukaemia. 2. history of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma. 3. any other clinically significant medical conditions. 4. history of cardiac disease nhya classification ≥3. 5. insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations: haemoglobin \ 1.5 x upper limit of normal (uln). alanine aminotransferase (alt) and alkaline phosphatase (ap) \>2.5 x uln. amylase and lipase \>1.5 x uln. serum creatinine \>2.0 x uln. prothrombin time (pt) and activated partial thrombo-plastin time (aptt) \>1.5 x uln. 6. pregnant or lactating female patients. 7. known history of hiv infection or chronic hepatitis b or c infection. 8. receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration. 9. prior radiotherapy to more than 3 vertebrae. 10. active serious bacterial or fungal infections; \>grade 3 national cancer institute (nci) common terminology criteria for adverse events (ctcae). 11. receipt of haematopoietic cytokines within 10 days of study drug administration.

Keywords: hematopoietic stem cells mobilisation autologous transplantation
different dosing regimens of stop-ast

Conditions: Hearing Loss; Tinnitus; Sensorineural Hearing Loss

Summary: the goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. participants will receive different appropriate dosages of prednisone tablets and oral ginkgo biloba tablets.

the purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.

Eligibility criteria:
inclusion criteria: 1. 18-60 years old; 2. primary complaint of subjective tinnitus ≤ 1 months of duration; 3. a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions: 1. a reduced distortion product otoacoustic emissions (dpoae) amplitude in individuals with normal pure tone audiometry (pta) results; 2. more than a pta threshold \> 20 db with frequencies between 125 and 8000 hz, but not exhibited idiopathic sudden sensorineural hearing loss; 4. a state of good general condition; 5. with good adherence to participation and signed informed consent. exclusion criteria: 1. active middle ear pathology; 2. patients who had received treatment for their current condition prior to the study; 3. both the pta and dpoae with normal outcomes; 4. hearing implants; 5. history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).
quality control of ce-certified phonak hearing aids - 2017_27

Conditions: Hearing Loss, Bilateral Sensorineural, Progressive

Summary: a methodical evaluation of new ce-labelled phonak hearing systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. the aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). this will be a clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * informed consent as documented by signature * smartphone user exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
short-term outcomes of subaxial cervical injuries

Conditions: Cervical Spinal Cord Injury

Summary: the subaxial cervical spine consists of levels c3 through c7 and includes both the bony anatomy as well as the ligamentous anatomy. injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both (1). cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident (2). devastating sequelae of subaxial cervical spine trauma include quadriplegia, functional loss, and permanent disability

initially, all patients with subaxial cervical spine fractures require immobilization in a rigid cervical orthosis (2). patients receiving conservative treatment are often prescribed a rigid cervical or cervicothoracic orthosis for 6 to 12 weeks with regular follow-up and interval radiographs to assess alignment. patients with fractures deemed unstable or neurologic compromise should undergo decompression and stabilization. intervention within 24 hours of injury leads to better improvement in asia scores (3). the recent ao spine subaxial classification system relies essentially on msct evaluation (reference). however, mri is superior to ct scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine (4). even though the investigators receive and treat a large number of patients with various subaxial cervical injuries in assiut university hospital each year, there is no consensus about the best treatment options and uncertainty about the outcome of these treatments. in this study, the participants will assess the short-term outcomes of all patients with subaxial cervical fractures who will be admitted to the participants' center regardless of the neurological status or treatment type used. the participants will also create a detailed prospective database to be used for another later study on the long-term outcome

Eligibility criteria:
inclusion criteria: * all patients presenting with subaxial cervical spine injuries with and without cervical cord injury between january 2022 and december 2022. exclusion criteria: * 1- patients who refuse to participate in the study 2- patients who are not available for 6 weeks follow up
reasons for mycophenolate mofetil dose reduction and impact on graft outcome in renal transplant recipients

Conditions: Acute Rejection of Renal Transplant; Renal Graft Loss

Summary: mycophenolate mofetil (mmf) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. however, mmf-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. this study's aim was to examine the reasons for mmf dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. methods: retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with mmf as part of their initial maintenance immunosuppressive protocol (n=749).


Eligibility criteria:
inclusion criteria: * all patients who received a single renal transplant at the university hospitals of leuven between april 1996 (when mmf was introduced in the leuven renal transplant program) and february 2007 and were treated with mmf (cellcept®, roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis. exclusion criteria: * if a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.

Keywords: reasons for mmf dose reduction
treatment of demodex blepharitis with ivermectin gel 0.1% plus metronidazole 1%

Conditions: Chronic Blepharitis

Summary: blepharitis is a endemic inflammatory disease caused mainly by demodex folliculorum and demodex brevis, this mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication. in this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites


Eligibility criteria:
inclusion criteria: * • patients with symptomatic demodex blepharitis for duration of at least 3 months. * age range: 18 yeras and older. * both genders and all ethnic groups comparable with the local community. * able to understand and willing to sign a written informed consent * able and willing to cooperate with the investigational plan. * able and willing to complete all mandatory follow-up visits. exclusion criteria: * • patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits. * children under 18. * pregnant women or expecting to be pregnant during the study. * systemic immune deficient conditions such as aids or under systemic immunosuppressant. * concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes). * concomitant use of systemic antibiotics or steroids. * contact lens wear * active ocular infection or allergy * unable to close eyes or uncontrolled blinking previous allergic reaction to metronidazole and / or ivermectin

Keywords: blepharitis , demodex, ivermectin, metronidazole