Kornimate/medical-research-clean huggingface dataset:
ivermectin nasal drops in post covid-19 parosmia

Conditions: Parosmia

Summary: the current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the otorhinolaryngology department, menoufia faculty of medicine to evaluate the effect of ivermectin nasal drops in the treatment of post covid 19 parosmia

the current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the otorhinolaryngology department, menoufia faculty of medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. to be included in the study, patients should be more than 18 years old, have a history of covid 19 infection more than three months ago as confirmed by pcr test, have a post copost-covidvid parosmia, and have no history of systemic steroid administration over the last one month. history of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to ivermectin were the exclusion criteria for this study. patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by excel program. case group will receive a 4 weeks course of ivermectin 1% in a dose of two drops per each nostril twice daily. control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily. assessment protocol: patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. the degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment. outcome measures: primary outcome measures will include a comparison between the pre and post treatment values of visual analog scales of parosmia, and a comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement. secondary outcome measures will include assessment of the side effects of ivermectin nasal drops among the case group.

Eligibility criteria:
inclusion criteria: * patients should be more than 18 years old, * patients having a history of covid 19 infection more than three months ago as confirmed by pcr test, * patients having a post covid parosmia, * patients having no history of systemic steroid administration over the last one month. exclusion criteria: * history of previous nasal surgery, * underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), * hypersensitivity to ivermectin.

Keywords: ivermectin olfactory dysfunction parosmia post covid-19 parosmia
adenovirus initiative study in epidemiology in spain

Conditions: Viral Conjunctivitis

Summary: the objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. this epidemiological study will include approximately 500 patients in spain. the planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility criteria:
inclusion criteria: * male or female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. * patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. * no history of hypersensitivity to corn starch, talcum powder or dacron (sampling fleece components). exclusion criteria: * current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. * previous enrolment in the present study. * any direct involvement with the study conduct at site or any family link with study site staff.

Keywords: adenoviral conjunctivitis diagnosed with adenoplus™ test
a study of ly2835219 in participants with cancer

Conditions: Neoplasm; Neoplasm Metastasis

Summary: the purpose of this study is to assess how the body handles abemaciclib when it is given with another drug called clarithromycin. the study doctor will measure the amount of abemaciclib that is absorbed into the blood stream and the time that it takes to remove abemaciclib from the body. the safety and tolerability of these drugs will be studied. each participant will complete 2 study periods in fixed order. after screening, period 1 will last approximately 8 days and period 2 will last approximately 15 days. participants who complete period 2 may continue to receive abemaciclib in 28-day cycles until discontinuation criteria are met.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of cancer (solid tumors) that is advanced and/or metastatic * have a performance status of 0 to 2 on the eastern cooperative oncology group (ecog) scale exclusion criteria: * no symptomatic central nervous system (cns) malignancy or metastasis

Keywords: advanced cancer metastatic cancer
effects of prehabilitation in gastric cancer patients with metabolic syndrome on perioperative outcome

Conditions: Stomach Neoplasms; Metabolic Syndrome X

Summary: a prospective randomised controlled trial to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Eligibility criteria:
inclusion criteria: * histologically-proven pre-operative stage i-iii gastric cancer * combined with metabolic syndrome * age limits from 18 to 80 years old * classified into american society of anesthesiology (asa) ii or iii surgical risk * no history of abdominal surgery on organs located at the abdominal supramesocolic level exclusion criteria: * combined with severe cardiac or pulmonary disease or other organ dysfunction * asa iv * the history of abdominal surgery * conversion to open surgery * the presence of gastrointestinal obstruction, perforation or necrosis; * declined to participate in this study

Keywords: gastric neoplasm metabolic syndrome prehabilitation pre-operative exercise laparoscopic radical gastrectomy
the record asia-pacific atrial fibrillation registry

Conditions: Atrial Fibrillation

Summary: the primary objective of this registry is to assess the control of atrial fibrillation (af) over one year in patients attending clinical or specialized practices. the secondary objectives are: * to describe key demographics and treatment features in af patients visiting cardiologists in various countries in asia-pacific. * to establish correlation between control of af and clinical outcomes. * to establish correlation between treatment strategies and af control.


Eligibility criteria:
inclusion criteria: * patient presenting with either: * history of atrial fibrillation diagnosed \< 1 year by standard electro-cardiogram (ecg) or by ecg-holter monitoring (treated or not or whatever rhythm at inclusion). * new atrial fibrillation diagnosed by standard ecg or by ecg-holter monitoring at inclusion visit. * patient eligible for a pharmacological treatment of af (by rhythm or rate control agent). exclusion criteria: * af due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.). * post cardiac surgery af (≤3 months). * mentally disabled patients unable to understand or sign the written informed consent. * patients unable to comply with follow-up visits. * patients with pacemaker, implantable cardioverter defibrillator (icd). * patients scheduled for pulmonary vein ablation, av node/his bundle ablation, or pacemaker implantation. * patient included in any clinical trial in the previous 3 months. * pregnant or breastfeeding women. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
local anesthetic treatments for overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (oab).

existing first-line treatments for overactive bladder are limited by requirements for chronic dosing and associated systemic side effects. small case series suggest that bladder instillation of lidocaine may be effective in downregulating the afferent neuronal activity of a sensitized bladder, leading to elevation of the urge sensory threshold and decreasing detrusor activity. however, neither the effectiveness over placebo nor the durability of the response has been previously investigated. comparison(s): we propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine instillation decreases symptoms of overactive bladder more than instillation of normal saline using a validated outcome instrument, the oab-q.

Eligibility criteria:
inclusion criteria: * female patient, 18 years of age and older * overactive bladder defined as: * urinary frequency defined as eight or more voids in a 24 hour period \> 50% of days of the week * symptoms of urgency * symptoms of at least three months duration exclusion criteria: * positive urine culture in the past month, or more than 3 episodes of bladder infection in the last 2 months * stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week; also insensate incontinence * pregnancy * seizure disorder or clinically significant renal disease, allergy to lidocaine, uninvestigated hematuria, or history of urinary/reproductive tract malignancy * post-void residual more than 200 cc

Keywords: administration, intravesical anesthetics, local
post-procedural manual manipulation for infant ankyloglossia

Conditions: Ankyloglossia; Breastfeeding Support

Summary: the goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. we hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance. infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. to monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. parents in the control group will not be instructed to perform any post-procedural manipulation. all participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.


Eligibility criteria:
inclusion criteria: * infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed. exclusion criteria: * infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy. * infants with a gestational age of less than 36 weeks, those in the nicu or post-partum unit, infants who didn't receive the vitamin k injection, and those with congenital anomalies or medical conditions affecting breastfeeding

Keywords: tongue tie breastfeeding exercises infant pediatric otolaryngology frenotomy
the safety and efficacy of the buprenorphine transdermal delivery system in subjects with osteoarthritis pain.

Conditions: Osteoarthritis

Summary: the objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. the double-blind treatment intervention duration is 60 days.

buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria:
inclusion criteria: * unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day. * taking \>/=3 opioid doses per day with or without acceptable pain control. exclusion criteria: * receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. * scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic pain osteoarthritis opioid transdermal
controlled study of mk-0431/ono-5435 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the safety and efficacy of mk-0431/ono-5435 in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and metformin as monotherapy


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy exclusion criteria: * patients with type 1 diabetes mellitus

Keywords: mk-0431 ono-5435 type 2 diabetes mellitus
modification of esin-osteosynthesis in a femoral fracture model and its transmission to clinical practice

Conditions: Femoral Fracture; Children

Summary: elastic stable intramedullary nailing (esin) is the standard treatment for displaced diaphyseal femoral fractures in children. however, some literature report high complication rates (10-50%) in complex fractures. data of our own patients with special emphasis on complications showed also mediocre results. thus, a biomechanical study was conducted to search for modifications. in this study the stiffness with a 3rd nail implanted was compared to the classical 2 c-shaped configuration. for each of the 3 configurations of retrograde esin (titanium nails) eight composite femoral grafts (sawbones®) with an identical spiral fracture were used: 2c configuration (2 c-shaped nails, 2x3.5 mm), 3cm configuration (3rd from antero-medial, + 1x2.5 mm) and 3cl configuration (3rd from antero-lateral, + 1x2.5 mm). each group underwent biomechanical testing in 4-point bending, iro/ero and axial compression (0°/9°). due to a significantly higher stiffness of 3cl in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department. all patients were followed prospectively. the following data was collected: type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, re-do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. at follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. patients' satisfaction was controlled by csq (clients satisfaction score, larsen et al 2002). further on the harris hip score was used. x-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age). level of evidence iv keywords: elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.

see above

Eligibility criteria:
inclusion criteria: * dislocated femoral fracture * esin osteosynthesis exclusion criteria: * no given informed consent * other osteosynthesis than esin

Keywords: elastic stable intramedullary nailing biomechanical testing fracture femur treatment children adolescents
clinical study of multiple dose genakumab for injection in chinese healthy adults

Conditions: Interstitial Lung Disease

Summary: to evaluate the safety and tolerability of multiple-dose subcutaneous injections of genakumab for injection in chinese healthy adult volunteers.

there are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. each subject receives genakumab or placebo once every four weeks for three times.

Eligibility criteria:
inclusion criteria: * 18 years ≤ age ≤45 years, and in good health; * body mass index is within the range of 19 - 26 kg/m\^2 (including 19 kg/m\^2 and 26 kg/m\^2); * no parental scheme from the screening period to 3 months after the study period. exclusion criteria: * participants have abnormal physical and auxiliary examination results with clinical significance; * history of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders, * participants who use any prescription drugs within 2 weeks prior dosing. * participants who receive (attenuated) live vaccines within 3 months prior to dosing; * participation in any clinical investigation within 3 months prior to dosing; * donation or loss of 400 ml or more of blood within 3 months prior to dosing; * tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms * positive results in hepatitis b surface antigen (hbsag), hepatitis c antibody, syphilis antibody or hiv antibody; * current or previous drug or alcohol abuse; * other conditions in which the investigator preclude enrollment into the study

Keywords: safety, tolerability, pharmacokinetics, genakumab
the effects of self-management education based on theory of planned behavior on patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aims of the study are as follows: * to improve self-management intention and behavior of patients with type 2 diabetes (t2 dm). * to promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life. * to improve resilience, well-being, fatigue and quality of life of patients with t2 dm in order to achieve the aims, we have set the following objectives: * to develop and apply self-management education program based on the extended theory of planned behavior. * to evaluate the efficacy of the educational program: 1. self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

this study employs a quasi-experimental study design with an intervention and comparison group and follow-up of 3 months; there will be two measuring points (baseline and 3 months after the intervention) , and 9 measures.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. duration of type 2 diabetes ≥3 months 3. without any severe complication and impaired cognition. exclusion criteria are: 1. severe physical handicap or mental illness 2. presence of other serious disease such as cancer and stroke.
a pilot study to explore the role of gut flora in eczema

Conditions: Eczema

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding eczema.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding eczema.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by patient 2. male or female patients age 18 and older. 3. diagnosis of eczema exclusion criteria: 1. refusal by patient to sign informed consent form 2. treatment with antibiotics within 2 weeks prior to screening 3. treatment with probiotics within 6 weeks prior to screening 4. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 5. postoperative stoma, ostomy, or ileoanal pouch 6. participation in any experimental drug protocol within the past 12 weeks 7. treatment with total parenteral nutrition 8. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 9. inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud

Keywords: microbiome
a study of the effectiveness of risk minimization measures related to depakine® (sodium valproate) in saudi arabia

Conditions: Epilepsy; Seizures

Summary: a cross-sectional, national, multicenter, survey-based study to assess the effectiveness of risk minimization measures related to depakine® (sodium valproate) in saudi arabia. the study duration will be 7 months from 30 november 2024 to 30 may 2025. the end of study is defined as the end of the data collection period. no intervention will be administered, and no study related visits are required.


Eligibility criteria:
inclusion criteria: * healthcare professionals working only in saudi arabia and * prescribers of depakine® (sodium valiporate) at least once in the six months leading up to survey completion or * obstetricians/gynecologists who consulted at least one women of childbearing potential treated with depakine® (sodium valproate) in the six months leading up to survey completion or * pharmacists who have dispensed depakine® (sodium valproate) in the six months leading up to survey completion exclusion criteria: * healthcare professionals who may have conflicts of interest with the survey (i.e. employed by regulatory bodies or pharmaceutical companies) * healthcare professionals (or with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome * healthcare professionals who are not prescribing depakine® (sodium valproate), except for obstetricians/gynecologists (who do not prescribe depakine® \[sodium valproate\]) * healthcare professionals having started to prescribe or dispense depakine® (sodium valproate) earlier than six months before survey completion the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.