Kornimate/medical-research-clean huggingface dataset:
the influence of hyaluronic acid injection following knee arthroscopy

Conditions: Cartilage Damage

Summary: this is a prospective, double blind randomized controlled trial. in this study we will investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when known or discovered cartilage damage greater than international cartilage research society score (icrs) grade 2 is found. the indication for arthroscopy is not necessarily the cartilage damage. a set of 3 consecutive injections will be administered and follow up of physical examination and questionaries will be done. our null hypothesis is that the administration of hyaluronic acid will show decrease pain and quicker rehabilitation and return to normal activity in patients with grade 2 and higher cartilage damage that had gone through knee arthroscopy.

the use of hyaluronic acid is well known as one of the treatment modalities for knee osteoarthritis (oa) .arthroscopy is a controversial treatment option for knee oa but in some cases, during knee arthroscopy done for other indication, cartilage damage is noted. this cartilage damage may slower the healing and rehabilitation process after knee arthroscopy. therefore we will evaluate the influence of hyaluronic acid injection on the healing and rehabilitation process following knee arthroscopy. all patients will be recruited prior to the arthroscopy. all patients will sign a concent form.patients will be randomly divided to 2 groups which are the 2 arms of this study - treatment group and control group. all patient will be examined by a senior orthopedic surgeon and will fill the pre operative questionnaires. mri scan of the operated knee prior for the surgery will be collected and evaluated.knee arthroscopy will be performed by 2 senior orthopedic surgeons. data and arthroscopic findings will be collected and documented during surgery. 2 weeks after surgery patients will be evaluated in the hospitals' outpatients clinic. the treatment group will be given a series of 3 injections of sodium hyaluronate 1%(arthrease, tm) - one injection per week. the control group will be given a series of 3 injections of placebo (bps - buffer phosphate solution - the buffer solution of the hyaluronic acid regular injections). the syringes will be blinded to the patients and the physician. questionnaires will be given at 2 weeks, 6 weeks, 3months and 6 months post operatively

Eligibility criteria:
inclusion criteria: * 18 years old * signing a concent form * assigned for knee arthroscopy. * known chondral lesion of at least icrs grade 2 in one or mor of the knee compartments per mri prior to knee arthroscopy. * cartilage lesion of at least icrs grade 2 in one or mor of the knee compartments that was found during the knee arthroscopy. exclusion criteria: * rheumatic disease * synovial disease such as (but not limited to) pigmented vilonodular synovitis (pvns) * infection of the operated knee - new or previous * pregnant women.

Keywords: hyaluronic acid knee arthroscopy pain reduction swelling osteoarthritis cartilage lesion rehabilitation following knee arthroscopy hyaluronic acid injection
feasibility of stereotactic navigation in laparoscopic surgery for colorectal cancer

Conditions: Colorectal Cancer

Summary: to evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

* in minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. conventional imaging, such as magnetic resonance imaging (mri) and computed tomography (ct-scan), can provide a detailed view of 2d or 3d internal anatomical structures. however, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). for this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto. * the proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. the study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients. * surgical navigation will be performed on the basis of preoperative images or intraoperative images.

Eligibility criteria:
inclusion criteria: 1. patient is over 18 years old 2. patient presents with cancer 3. patient has no contraindication to anesthesia and surgical resection 4. patient able to receive and understand information about the study and give written informed consent 5. patient (s) affiliated to the national social security system. exclusion criteria: 1. patient operated on urgently. 2. pregnant or lactating patient 3. patient in an exclusion period (determined by previous or current study). 4. patient under the protection of justice. 5. patient under guardianship or curatorship.

Keywords: stereotactic navigation colorectal cancer laparoscopy transanal surgery
effects of lactobacillus plantarum ps128 in children with asd

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. probiotics are regarded as active microorganisms. with sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. these reactions may further promote health, regulate metabolic disease progression and prevent complications. lactobacillus plantarum ps128 (ps128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. this study is to evaluate whether the consumption of ps128 can improve the symptoms of patients with asd. the current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of ps128 in school children with asd.


Eligibility criteria:
inclusion criteria: * (1) age 7 to 12 years old. * (2) ps128 group and placebo group: children with autism spectrum disorder, confirmed by autism diagnostic observation schedule. * (3) normal control group: children without autism spectrum disorder. exclusion criteria: * (1) receiving antibiotics within one month. * (2) probiotics used in powder, capsule, or tablet in two weeks (except for yogurt, yogurt, yakult and other related foods). * (3) patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy) * (4) those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet). * (5) those with a history of cancer. * (6) those who are allergic to lactic acid bacteria. * (7) not eligible judged by pi
natural history in primary mitochondrial myopathies

Conditions: Primary Mitochondrial Myopathies

Summary: this is a longitudinal study in a cohort of patients with a genetic diagnosis of primary mitochondrial myopathy to describe the natural history of the disease and identify clinical, biochemical, molecular, and radiological variables that allow evaluation of the severity and progression of the disease and may be useful in future clinical trials.

mitochondrial diseases (md) are among the most frequent inherited metabolic diseases. despite their high impact on patients, there are still no authorized drugs capable of modifying their clinical course. md are clinically and genetically heterogeneous disorders, with muscular symptoms being one of their main manifestations. when muscular symptoms predominate, the disorder is classified as a primary mitochondrial myopathy. in recent years, there have been significant advances in developing potential new treatments in this field. however, the absence of natural history studies makes the design and interpretation of clinical trials difficult and leads to long delays or even failures in the development of new treatments. the investigators propose to characterize in-depth a cohort of patients with primary mitochondrial disorders due to mutations in the mitochondrial dna (mtdna) or in genes located in the nuclear genome (ndna), from a clinical perspective but also a radiological, biochemical, and molecular point of view, and carry out a longitudinal follow-up of these parameters to identify those that are better correlated with severity and that allow measuring changes in the patient's clinical situation. with this objective, the investigators will analyze clinical variables (evaluation of motor function through manual force exploration, functional scales, and timed test, quality of life scales, serum biomarkers (growth differentiation factor 15 (gdf15) and fibroblast growth factor 21 (fgf21)), levels of heteroplasmy for cases harboring mtdna mutations and mtdna copy-number, and muscle magnetic resonance image of the lower extremities with quantification of fat replacement. all parameters will be evaluated at the beginning of the study and then annually during two years of follow-up.

Eligibility criteria:
inclusion criteria: * muscle symptoms: exercise intolerance and fatigue, myalgia, recurrent rhabdomyolysis, chronic progressive external ophthalmoplegia and/or muscular weakness * primary mtdna mutation or pathogenic mutations in ndna, especially in genes related to mtdna maintenance such as tk2, polg, twnk and rrm2b, among others. exclusion criteria: * none

Keywords: mtdna tk2 large scale single deletion multiple deletions polg twnk
evaluation of 4d magnetic resonance angiography (k-t blast) of supraortic vessels in acute ischemic stroke patients

Conditions: Stroke, Acute

Summary: the magnetic resonance angiography (mra) of supraaortic vessels is essential for the etiologic of stroke. however, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. an ultra-fast 3d mra originally developed for the cardiac imaging, k-t blast (broad-use linear acquisition speed-up technique) could be used to review the supraaortic vessels. this mra offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3d spatial resolution and high temporal resolution. these qualities are even more optimal with a high magnetic field (3t). the high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. this sequence is classified as a 4d mra.


Eligibility criteria:
inclusion criteria: * men and women over 18 years * eligibility for intravenous thrombolytic treatment (national institute of neurological disorders and stroke criteria) * permanent ischemic stroke confirm with encephalic mri (magnetic resonance imaging) * patient able of accepting protocol information * patient who received information about the protocol and had not expressed its opposition to participate exclusion criteria: * pacemaker * surgical ferromagnetic clips * cochlear implants * intraocular metallic foreign body * iron implants or objects likely to concentrate the radio frequency field * claustrophobia * known intolerance to contrast media (dotarem) * pregnant women (beta human chorionic gonadotrophin performed for biological assessment of thrombolysis) * patient with severe kidney with glomerular filtration rate \< 30 ml/min * persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
european sir-spheres surgical registry

Conditions: Hepatectomy

Summary: liver resection is the only curative treatment option for primary and secondary liver tumors. for some primary or secondary malignancies (hcc, net) liver transplantation is a possible treatment option. unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. in that case different treatment approaches are possible. for those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. for those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. one of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. however, tumor growth might be stimulated during the phase of hypertrophy. selective internal radiation therapy (sirt) with sir-spheres y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. it offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. it treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. therefore secondary liver resection after sirt might become possible4,5. sirt could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation. liver resection with local tumor treatment and hypertrophy induction after sirt seems to be a promising therapy option. previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy. aim of the european sir-spheres surgical registry - essure - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. this registry enables data collection on the real-life clinical application of liver resection/liver transplantation after sirt.


Eligibility criteria:
inclusion criteria: * 18 years or older * primary or secondary liver tumors * treatment of liver tumors with sir-spheres y-90 resin microspheres with the intention to make patient eligible for liver resection/liver transplantation * decision of a multidisciplinary tumor board on the patient's therapy regime * signed informed-consent form exclusion criteria: * under 18 years * not able to sign informed consent * no decision of a multidisciplinary tumorboard

Keywords: sirt liver resection hypertrophy liver metastases liver transplantation
joint outcome study continuation for children with severe factor viii deficiency

Conditions: Hemophilia

Summary: the original joint outcome study (jos) enrolled 65 boys with hemophilia from 16 sites nationally. the subjects were randomized to one of two arms (prophylaxis or an enhanced episode-based treatment)and were followed prospectively until the age of six. at the age of six, the proportion of children on each treatment arm who developed bone or cartilage damage as determined by x-ray or mri was assessed. in addition, the function and structure of the index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment scale specially designed for preschool children. the specific aim of the joint outcome study continuation (josc) is to extend observations of the children participating in the original jos until the subjects reach the age of 18 years in order to determine the natural history of joint development in hemophilia and the impact of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic arthropathy. in addition, plasma and dna will be collected and banked yearly for current and future studies of biomarkers and predictors of hemophilia outcomes.


Eligibility criteria:
inclusion criteria: * enrolled in the original jos study, "a randomized prospective study for the prevention of joint disease in children with factor viii deficiency" * written, informed consent of parent or guardian for the proposed study * the local hemophilia treatment center staff must evaluate the family's participation in the original treatment protocol and determine that the family is capable of complying with the continuation protocol exclusion criteria: * unable or unwilling to record the study information

Keywords: hemophilia joint cartilage damage prophylaxis factor viii fviii disease arthropathy
xperience pro pmcf study

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of xperience pro to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with xperience pro .

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the xperience pro in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patient treated with xperience pro according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: * not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) coronary balloon dilatation catheter
acclarent tympanostomy tube delivery system for the treatment of patients requiring tympanostomy tube insertion

Conditions: Otitis Media

Summary: this was a non-significant risk (nsr), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the acclarent tympanostomy tube delivery system (ttds).


Eligibility criteria:
inclusion criteria: * diagnosed with either chronic otitis media with effusion (ome) or recurrent acute otitis media (aom) and scheduled to undergo tympanostomy tube insertion exclusion criteria: * history of sensitivity or reaction to anesthesia chosen for the procedure * markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane * otitis externa * active acute otitis media * otitis media pathology requiring t-tubes * stenosed ear canal * anatomy that precludes sufficient visualization of and access to the tympanic membrane * anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
apremilast 30mg bid with narrowband uvb in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: 12 weeks open label with otezla® and nuvb, followed by 6 month double blind otezla® (apremilast) or placebo to subjects who obtain pasi 75 at week 12 of phototherapy

primary objective: to evaluate the effectiveness of otezla (apremilast®) in promoting maintenance of response in those subjects who obtained pasi-75 at week 12 of phototherapy.

Eligibility criteria:
inclusion criteria: subjects must meet the following criteria to be enrolled in this study: 1. male or female adult ≥ 18 years of age; 2. diagnosis of chronic plaque-type 3. moderate to severe plaque type psoriasis as defined at baseline by: * pasi score of 12 or greater, * pga score of 3 or greater * bsa affected by plaque-type psoriasis of 10% or greater, 4. able and willing to give written informed consent prior to performance of any study-related procedures exclusion criteria: subjects who meet any of the following criteria will be excluded from participation in this study: 1. forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis 2. subjects with previous exposure to apremilast 3. malignancy or history of malignancy, except for: * treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas; * treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years.
the effect of father-sensitive childbirth education on prenatal paternal attachment level

Conditions: Prenatal Attachment; Childbirth Preparation Program; Antenatal Education; Paternal Behavior

Summary: this study was planned as a randomised controlled trial to examine the effects of a "father-sensitive childbirth preparation class" on the level of prenatal attachment. the main question it aims to answer is: 1- how does a father-sensitive birth preparation class affect fathers' prenatal attachment levels? it was conducted between february 1, 2024, and october 1, 2024, with expectant fathers living in mersin province, whose spouses were experiencing their first pregnancy, who were between 20-32 weeks' gestation, and who were going to become fathers for the first time. a total of 99 expectant fathers were included in the study - 50 in the intervention group and 49 in the control group. the intervention group was given a "father-sensitive childbirth preparation training" consisting of four sessions, while the control group received a standard "childbirth preparation training", also consisting of four sessions. the "descriptive data collection tool" and the "prenatal father attachment scale" were used to collect the research data.


Eligibility criteria:
inclusion criteria: participants were: * over 19 years of age, * at least literate, * whose spouse was between 20 and 32 weeks pregnant, * whose spouse was primigravida, * whose spouse had a singleton pregnancy, * with no prior experience of pregnancy, childbirth, or parenting, * with no history of miscarriage, curettage, or perinatal loss, * whose spouse had no pregnancy-related complications or risk factors, * who had not previously attended any childbirth preparation training, pregnancy information classes, or parenting courses. exclusion criteria: participants were excluded if they: * had a spouse whose pregnancy was outside the 20-32 week gestation range, * had a spouse with a multiple pregnancy, * had any pregnancy-related complications or risk factors (high risk), * had prior experience of pregnancy, birth, or parenting, * had experienced miscarriage, curettage, or perinatal loss, * had previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

Keywords: childbirth preparation program paternal attachment antenatal attachment midwifery