Kornimate/medical-research-clean huggingface dataset:
prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery

Conditions: Cardiac Surgery

Summary: prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. the aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.

after informed consent, four centers and 436 eligible admissions will be recruited. eligible patients would be randomized (1:1:1:1) to nirmatrelvir/ritonavir group (nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days), ursodeoxycholic acid group (ursodeoxycholic acid group, 15mg/kg/day bid for5 days), combination group (nirmatrelvir/ritonavir and ursodeoxycholic acid for 5days) and control group.

Eligibility criteria:
inclusion criteria: * age ≥18 years * covid-19 nucleic acid test or antigen test positive history, without symptom or recover from covid-19 related symptoms ≥2 weeks * receive open-chest cardiac surgery * covid-19 nucleic acid test and antigen test negative and no signs of pneumonia in chest ct * patients with written informed consent. exclusion criteria: * emergency surgery * egfr ≤30ml/min * severe liver dysfunction * contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid
burden of invasive group b streptococcal (gbs) disease in young infants in china

Conditions: Invasive Group B Streptococcal Disease

Summary: evaluate the burden of invasive group b streptococcal (gbs) disease in young infants (up to 90 days of age) in china, in terms of incidence, case fatality rate and serotype distribution


Eligibility criteria:
inclusion criteria: 1. positive culture for gbs from one or more of the following normally sterile sites: blood, cerebrospinal fluid (csf), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain). 2. ≤90 days old at the time of gbs confirmation. 3. voluntary written informed consent provided. exclusion criteria: * none.

Keywords: group b streptococcus incidence case fatality rate serotype distribution
magnetic resonance imaging in metabolic diseases

Conditions: Metabolic Diseases

Summary: this study aims to leverage structural, functional, and metabolic magnetic resonance imaging (mri) of the brain to identify imaging features that correlate with clinical parameters. it is hypothesized that individuals with metabolic diseases exhibit distinct functional and structural brain differences compared to healthy controls. these differences may evolve over time due to changes in whole-body metabolism or body weight, influenced by factors such as the natural progression of the disease or therapeutic interventions. additionally, potential brain changes may correlate with body composition metrics, such as the fat content of specific body compartments. this is a prospective, single-center study conducted at ulm university hospital, designed to track the clinical and imaging histories of patients with metabolic diseases and compare them to healthy individuals. eligible participants include adults (aged 18 and older) capable of providing informed consent. recruitment will occur through routine clinical care or existing research studies. to provide a comprehensive understanding, the study will include both cross-sectional analyses and longitudinal follow-up of participants, integrating repeated assessments during routine medical visits.


Eligibility criteria:
inclusion criteria: * patients with metabolic diseases or * healthy control participants without metabolic diseases * written consent exclusion criteria: * history of traumatic brain injuries * preterm birth (≤34th week of pregnancy) of the study participant * history of brain surgery * structural brain changes (e.g., tumors, congenital abnormalities, etc.) * neurological developmental disorders (e.g., autism spectrum disorders, learning disabilities, intellectual disability) * epilepsy, * drug addiction * other severe neurological or severe psychiatric disorders (e.g., schizophrenia * pregnancy * acute clinically relevant inflammatory diseases * acute systemic or local infections * severe or etiologically unclear diseases depending on the principle investigators judgement * pre-existing intellectual impairment * significant limitations in language comprehension * absence of written consent * general exclusion criteria for mri imaging (e.g., pacemaker systems, neurostimulators, cochlear implants)

Keywords: metabolic diseases magnetic resonance imaging body composition
effectivity and safety of combination of spent grain wax, argan oil, shea butter and saccharide isomerate

Conditions: Acne Vulgaris

Summary: the clinical study will compare the efficacy and safety of combination of spent grain wax, argan oil, shea butter and saccharide isomerate cream post fractional co2 laser. combination of spent grain wax, argan oil, and shea butter was formulated to reduce skin irritation and allergy symptoms such as dryness, itch and rash. the combination cream applied on one side of the face while placebo will be applied on the other side of the face in 18-60 years old female post fractional co2 laser.

this study is an experimental study with a randomized controlled trial (rct) design on patients who met the inclusion criteria. all participants will receive pretreatment in the form of 0.05% tretinoin cream for two weeks, then all participants will undergo fractional co2 laser treatment. post laser treatment, the participants will be given cream a and b, which already randomized to be applied on to the face. all participants will be evaluated in day 3 and day 7 post fractional co2 laser. the results of therapy will mainly be assessed based on the dermoscopic photoaging scale (dpas), as well as visual analog scale (vas) for subjective symptoms and clinician erythema assessment scale (cea) for erythema and skin capacitance measured with tewameter.

Eligibility criteria:
inclusion criteria: * women aged 18-60 years old with an understanding of all the information given by written consent form * had undergone priming with tretinoin cream 0,05% for 2 weeks pre fractional co2 laser treatment exclusion criteria: * personal or family history of skin cancer, especially melanoma * consumption of systemic retinoic acid within 3 month of enrollment * use of any topical skin brightening or whitening preparations within 1 month of enrollment * pigmentary disorders or any dermatoses, which may affect the measurement within the study areas * a pregnant or breastfeeding mother * history of hormonal or endocrine diseases or taking medication for hormonal or endocrine diseases * inability to comply research protocols

Keywords: laser cream fractional co2 laser spent wax
muscle spasticity reduction in children with cerebral palsy by means of hippotherapy

Conditions: Neuromuscular Diseases in Children; Cerebral Palsy, Spastic; Spasticity, Muscle

Summary: the aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. the hip aductors spasticity will be measured using the modified ashworth scale (mas). the intervention will be performed in addition to traditional treatment.

the main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. furthermore, as a secondary objective is to evaluate the changes in modified ashworth scale (mas) after intervention in children ages 3-14.

Eligibility criteria:
inclusion criteria: * primor diagnosis of spastic cerebral palsy * children aged 3-14 exclusion criteria: * children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.

Keywords: hippotherapy cerebral palsy spasticity
eeva™ system study: noninvasive recording and visualization of individual embryos cultured to blastocyst stage

Conditions: Infertility

Summary: the purpose of this study is to demonstrate that the eeva system may be used to identify embryos on day 2 that are most likely to form blastocysts.


Eligibility criteria:
inclusion criteria: * women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. * at least 18 years of age. * total antral follicle count of at least 12 as measured by ultrasound prior to stimulation. * basal fsh \< 10 iu. * at least 8 normally fertilized eggs (2pn.) * fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. * willing to comply with study protocol and procedures and able to speak english. exclusion criteria: * planned preimplantation genetic diagnosis or preimplantation genetic screening. * gestational carriers. * use of reinseminated eggs. * concurrent participation in another clinical study. * previous enrollment in this clinical study. * history of cancer.

Keywords: in vitro fertilization assisted reproduction noninvasive imaging of embryos time lapse imaging of embryos traditional morphological grading of embryos prediction of blastocysts
lower silesian orbital atherectomy registry (loar)

Conditions: Safety Issues; Efficacy, Self

Summary: the lower silesian orbital atherectomy registry (loar), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (pci) performed with the support of the orbital atherectomy device due to the presence of calcified lesion in coronary arteries. data will be collected in two cooperating cardiac centers (department of cardiology, the copper health center, lubin, poland, and department of cardiology, provincial specialized hospital in legnica, poland).

the study population consisted of all consecutive patients with severely calcified coronary lesions undergoing percutaneous coronary intervention (pci) with the orbital atherectomy device at two cooperating cardiac centers (department of cardiology, the copper health center, lubin, poland, and department of cardiology, provincial specialized hospital in legnica, poland). all study patients had a clinical indication for pci based on current european society of cardiology (esc) revascularization guidelines, with local heart team support where appropriate. the decision to perform oa-assisted pci was left to the discretion of the operator, based on clinical and angiographic features with a concomitant assessment of calcification. only patients with moderate or severe calcification were enrolled. calcification severity was defined either by angiographic assessment or by intravascular assessment using intravascular ultrasound (ivus) and/or optical coherence tomography (oct). all patients were thoroughly informed about all therapeutic options and pci-related risks before giving written consent.

Eligibility criteria:
inclusion criteria: * the presence of moderately to severely calcified lesions. exclusion criteria: * lack of patient consent * target vessel perforation due to previous unsuccessful lesion preparation * pregnancy

Keywords: percutaneous coronary interventions calcified lesion coronary artery diseases orbital atherectomy lesion preparation
underwater emr vs. conventional emr for large non-pedunculated colonic polyp

Conditions: Colonic Polyp

Summary: to analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (emr) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (semr) versus underwater endoscopic mucosal resection, without submucosal injection (uemr).

underwater endoscopic mucosal resection (uemr) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. this technique was described in 2012 by kenneth binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. this "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. on the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.

Eligibility criteria:
inclusion criteria: * consecutive patients aged \>18 years, diagnosed with a large (\>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study. exclusion criteria: * polyps showing signs of deep submucosal invasion * inflamatory bowel disease with signs of activity * known or suspected pregnancy * patients unable or unwilling to provide informed consent

Keywords: colonic polyp endoscopic mucosal resection
mask usage and exercise during the covi̇d-19 pandemic

Conditions: Exercise Test

Summary: to determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (spo2), fatigue, severity of dyspnea, etc.). to investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (spo2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.

surgical masks are frequently used after the necessity to use a mask in the community.the effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.this study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue). exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. the materials used before and after each exercise test will be sterilized. during the exercise test, individual antibacterial filters will be used for each person.bruce protocol will be used to determine exercise capacity.

Eligibility criteria:
inclusion criteria: * volunteering to be included in the research, * being between the ages of 18-65, * having physical fitness to do exercise tests, * having a cognitive function that will allow active participation in the exercise test. * no chronic illness. exclusion criteria: * not to volunteer to participate in the research, * having any mental or physical condition that impedes performing exercise tests, * having any of the symptoms of covid-19, * having been diagnosed with covid-19 before, * having a history of contact with covid-19 patient * having a cardiac, neurological, orthopedic and respiratory disease * use of assistive devices while walking

Keywords: exercise capacity surgical mask exercise test
efficacy of vitamin d on top of pegylated interferon and ribavirin in patients with chronic viral hepatitis c null-responders

Conditions: Chronic Hepatitis C

Summary: vitamin d deficiency is commonly found in patients with chronic hepatitis c. the investigators hypothesize that the correction of hypovitaminosis d before the initiation of anti-hcv combination therapy and the maintenance of an optimal vitamin d status during antiviral therapy could improve the antiviral efficacy

an open-label, prospective evaluation of the efficacy of vitamin d supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis c genotype 1 or 4, nonresponders to a first antiviral therapy.vitamin d supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin d status

Eligibility criteria:
inclusion criteria: * chronic hepatitis c genotype 1 or 4 * hypovitaminosis d defined by a value \<30 ng / ml * patient non responder to previous antiviral combination therapy of pegylated interferon and ribavirin defined by a decrease in viral load \<2 log at week 12 of the first course (peg/rbv) * patient who received at least 80% of the optimal dose of pegylated interferon and ribavirin according to current recommendations * patient for which the investigating physician decided to initiate treatment for hepatitis c combination therapy exclusion criteria: * decompensated liver disease: child-pugh b\> 8 or one of the following criteria: bilirubin\> 35 micromol/l, tp \<50%, ascites, recurrent encephalopathy * positive serology for hbv and hiv * alcohol consumption exceeding 50 g/day * chronic intake of vitamin d * thrombocytopenia \<50 000/mm ³, neutropenia \<750/mm ³, hemoglobin \<11 g/dl * pregnant women
study on the safety of the drug bay2395840 at different doses, the way the body absorbs, distributes and excretes the drug including the effect of its formulation (tablet or liquid) and the effect of food on the absorption, distribution or excretion of the drug in healthy male participants

Conditions: Endometriosis

Summary: researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. the study treatment, bay2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. but, this is the first time that researchers will study bay2395840 in humans. in this study, the researchers will learn how safe bay2395840 is for the participants to take. they will also learn what happens to bay2395840 in the body. the study will include about 56 healthy adult men. all of the participants will take increasing doses of bay2395840, or a placebo. a placebo looks like a treatment but does not have any medicine in it. some of the participants will take their study treatment 1 time under diet 1 conditions. the other participants will take their study treatment 7 times with diet 1 or diet 2. the participants will take bay2395840 or the placebo as tablets or as a liquid by mouth. the participants will stay at the study site for up to 11 days . after that, they will visit the study site 1 more time. each participant will be in the study for up to about 14 weeks. during the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. the participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. an adverse event is any medical problem that a participant has during a study. doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.


Eligibility criteria:
inclusion criteria: * male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent. * body mass index (bmi) ≥18 kg/m\^2 and ≤30 kg/m\^2. * participants who are overtly healthy. * race: white. * male participants of reproductive potential who are sexually active must agree to use contraception methods. exclusion criteria: * any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ecg) deviating from normal and deemed to be of clinical relevance by the investigator. * any known disease that was forbidden in the study as specified in study protocol. * any medication or drug use that was forbidden in the study as specified in study protocol. * any abnormal finding in electrocardiogram (ecg), blood pressure or heart rate. * any clinical relevant deviation from normal range of laboratory parameters at screening. * history of covid-19. * prior contact with sars-cov-2 positive person or covid-19 patient within the last 4 weeks prior admission to the ward. * positive sars-cov-2 viral rna test.
wound dressing patch with kelulut honey-infused alginate (tri-gnate alginate) for effective wound care management

Conditions: Diabetic Foot Ulcers

Summary: the main aim of this study to effectiveness of dressing patch with kelulut honey (tri-gnate alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (manuka honey product). tri-gnate alginate is a product produced by researcher team which upgraded from raw honey into a dressing patch. 110 patients with diabetic foot ulcers is expected to enrol in this program. the patients will be assigned randomly into 3 groups namely as group 1 - patient that will receive tri-gnate alginate product in their dressing, group 2 - patient will receive manuka honey patch product and group 3 - the patient will receive standard care (bactigras dressing + dermacyn). prior to the applying of these dressing treatment, all the patient will receive maggot debridement therapy (mdt) to ensure the wound is clean. patient's wound condition will be monitored 7 times (t0 - t6) on alternate day basis for healing improvement.


Eligibility criteria:
inclusion criteria: 1. age 18 and above. 2. present with sloughly diabetes-based foot ulcer 3. has diabetic foot ulcers more than 2 weeks, less than 1 year. 4. hba1c reading than 9.0 5. ankle-brachial index pressure (abpi) should \> 0.8 6. no more than 1 diabetic foot ulcer per foot. 7. no known allergy to honey of bee products 8. keen on both honey and maggot debridement therapy (mdt) 9. dfu classification: wagner grade 2, 3 10. amputation possibly deferred exclusion criteria: 1. patient in critical state. 2. patient in confuse state. 3. patient do not understand malay or english.
a study of ct-868 in overweight and obese participants with type 2 diabetes mellitus

Conditions: Obesity; Type2 Diabetes

Summary: a study to assess the effect of ct-868 in hemoglobin a1c (hba1c) in overweight and obese participants with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * males or females with t2dm * bmi of ≥27 kg/m2, inclusive * 18-75 years old, inclusive * stable body weight for 3 months exclusion criteria: * significant medical history * uncontrolled diabetes * history of malignancy
phase 3 clinical trial to evaluate the efficacy and safety of ckd-314

Conditions: COVID-19 Pneumonia

Summary: a double-blind, multi-center, multi-regional, randomized controlled, phase 3 clinical trial to evaluate the efficacy and safety of ckd-314 in hospitalized adult patients diagnosed with covid-19

to evaluate the efficacy and safety of ckd-314 by comparing the study group and control group in hospitalized adult patients diagnosed with covid-19 pneumonia

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years 2. patients diagnosed with covid-19 infection and pneumonia 3. patients who have voluntarily decided to participate in the study and signed the informed consent form if a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained. exclusion criteria: 1. patients with history of hypersensitivity to the study drug 2. female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study 3. patients who are deemed to ineligible to participate in the study for other reasons by the investigator