Kornimate/medical-research-clean huggingface dataset:
trial concerning the frequency of parastomal hernia with or without a mesh

Conditions: Parastomal Hernia

Summary: specific aim: to compare patients with colostomies with or without mesh at the primary operation. primary endpoint is the incidence of parastomal hernia requiring surgery. all patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh. if the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

parastomal hernia is a relatively common and troublesome complication in patients with a stoma. the exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. a parastomal hernia may give the patient difficulties with appliance and leakage. from an economical point of view a stoma that requires special kinds of appliances is expensive. theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. no negative side effects with the use of a mesh have been reported in these studies. all earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. to understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial. specific aim: to compare patients with colostomies with or without mesh at the primary operation. primary endpoint is the incidence of parastomal hernia requiring surgery. all patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh. if the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Eligibility criteria:
inclusion criteria: * patient is scheduled for permanent colostomy elective or acute operation. the optimal site for stoma is marked preoperatively. * no previous stoma. * over the age of 18. * informed consent signed by the patient. exclusion criteria: * expected lifetime less then 3 years. * fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity). * previous stoma.

Keywords: parastomal hernia prophylactic mesh colostomy hernia
a probiotic that reduces atopic skin

Conditions: Atopic Skin; Children

Summary: to assess the efficacy and safety of the use of probiotics as food supplements in reducing the scorad index in children with atopic skin compared with placebo. this is a randomized, placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): experimental group (lactobacillus rhamnosus lra05) and placebo group (placebo). the reduction of the scorad index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).


Eligibility criteria:
inclusion criteria: 1. patients with atopic dermatitis in the sprouts phase with a moderate scorad index (16-40). 2. patients aged 2-14 years. exclusion criteria: * patients intolerant to gluten, lactose or cow's milk protein. * patients who change the type of diet during the study to improve their atopic dermatitis. * patients with atopic dermatitis in remission phase (absence of sprouts and with scorad index = 0). * patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study. * patients taking immunomodulators, topical or oral antibiotics, topical or oral antihistamines, oral corticosteroids or antineoplastics. * subjects whose condition does not make them eligible for the study, according to the investigator.

Keywords: atopic skin; eczema; child population; probiotic
biomarkers in patients with advanced rhabdomyosarcoma

Conditions: Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Embryonal Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Summary: this research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

primary objectives: i. to investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be involved in the paired box (pax)3, pax7, and patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas. outline: immunohistochemistry is performed for each candidate target (pax3, pax7, and patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Eligibility criteria:
inclusion criteria: * 8 tissue microarrays (tma) slides of the following diseases available: * alveolar rhabdomyosarcoma * embryonal rhabdomyosarcoma * anaplastic rhabdomyosarcoma
acute dose-dependent effects of dmt-bolus applications in healthy subjects (dmt bdr-study)

Conditions: Healthy

Summary: n,n-dimethyltryptamine (dmt) is a psychoactive substance with similar effects such as lsd or psilocybin. however, dmt is less well characterized than the latter substances. the present study is a modern randomized cross-over trial, investigating different intravenous dmt boluses over a broad dose range. thus, different doses will be tested and related to subjective and autonomic effects.

n,n-dimethyltryptamine (dmt) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (ayahuasca). dmt is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. dmt is rapidly metabolized by monoamine oxidase (mao) a. therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). however, to date no clinical study has investigated dose-response effects over a broad range of different doses of dmt within the same patient. the aim of the present study is to experimentally test different intravenous dmt bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of dmt in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. age between 25 and 65 years old 2. sufficient understanding of the german language 3. understanding of procedures and risks associated with the study 4. willing to adhere to the protocol and signing of the consent form 5. willing to refrain from the consumption of illicit psychoactive substances during the study 6. abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions 7. willing not to operate heavy machinery within 6 h of dmt administration 8. willing to use double-barrier birth control throughout study participation 9. body mass index between 18-29 kg/m2. exclusion criteria: 1. chronic or acute medical condition 2. current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders). 3. psychotic disorder or bipolar disorder in first-degree relatives 4. hypertension (sbp\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months 6. pregnancy or current breastfeeding 7. participation in another clinical trial (currently or within the last 30 days) 8. use of medication that may interfere with the effects of the study medication 9. tobacco smoking (\>10 cigarettes/day) 10. consumption of alcoholic beverages (\>20 drinks/week)
serum kisspeptin: a predictive marker of miscarriage or not?

Conditions: Miscarriage

Summary: this is a prospective observational study. eligible women undergo art treatment in our centre will be recruited for the study and each woman will only be included in the study once. informed written consent will be obtained. blood serum for hcg level is performed 14 days after the embryo transfer i.e. week 4. if the serum hcg level is \>10iu/l, the women are considered pregnant and blood will be saved and checked for kisspeptin level, another blood test is repeated 1 week later i.e. week 5. a transvaginal ultrasound and blood test will be performed 1 week later i.e. week 6 to confirm the fetal viability and the number of gestational sacs and locate the pregnancy. blood for hcg and kisspeptin levels are checked at weeks, 4, 5 and 6. ultrasound will be performed at gestational 8 weeks and 11 weeks. they will be referred for antenatal care when the pregnancy is confirmed on-going at 11 weeks. the purpose is to determine whether serum kisspeptin level in women who conceive in ivf is associated with an increased risk in first trimester miscarriage and compare with serum hcg level in the prediction of the first trimester miscarriage.


Eligibility criteria:
inclusion criteria: * women who have a positive pregnancy test following ivf or frozen-thawed transfer exclusion criteria: * women with renal failure are excluded due to assay interference with kisspeptin measurement
efficacy of sprint interval training on anthropometric measures

Conditions: Overweight and Obesity

Summary: due to the rising problem of overweight and obesity, many strategies are implemented to combat this issue and one of the most common ways is exercise training. aerobic exercise is a popular and effective conservative strategy for weight and adiposity management and commonly used exercise protocols are moderate-intensity continuous training (mict) and interval training (it). mict is typically defined as continuous effort that elicits 55%-70% of the maximal heart rate or promotes oxygen consumption equivalent to 40%-60% of the maximum oxygen intake. it involves repeated exercise with periods of recovery, which includes high intensity interval training (hiit) and sprint interval training (sit). hiit is exercising at 80% to 100% of maximal heart rate while sit involves "all-out" or "supramaximal" effort at the intensity of 100% of maximal oxygen uptake. multiple systematic reviews on the effect of sit on aerobic capacity or comparisons between other forms of exercise protocols to reduce body adiposity has been conducted, but so far no systematic review has been carried out to evaluate the efficacy of this protocol solely on anthropometric measures on young obese and overweight adults alone. hence, in this study, a systematic review of the effect of sit on anthropometric measurements in young obese or overweight adults will be reviewed, filtered and assembled.

keywords using "obese", "overweight", "sprint interval training", "interval training", "anthropometric measures","body mass index", "fat %" lean muscle mass will be searched through e-databases namely pubmed (including medline), pedro-search, science direct, google scholar, web of science, scopus and cochrane library for the suitable original full text studies. only randomized control trails will be included in this study and the "tool for the assessment of study quality and reporting in exercise" (testex) would be utilized to assess each individual study. testex has been validated and is specific to exercise training. the authors wish to use testex as it addresses several shortcomings that pedro does not e.g. exercise adherence, withdrawal, relative exercise training intensity. in addition, study quality assessment of training studies is more robust with testex. 2 independent evaluators will examine and screen each study for its efficacy to be included in the data analysis.

Eligibility criteria:
inclusion criteria: * male and female individuals aged 18-35 years old * overweight individuals with a bmi of 25.0 to \<30 * obese individuals with a bmi of 30.0 or higher * original full texts with sit as intervention, occurring 2 weeks or more exclusion criteria: * male and female individuals aged below 18 and above 35 years old * sit as intervention, occurring less than 2 weeks
muscular and joint symptoms in covid-19 patients: insights from syria

Conditions: Musculoskeletal Pain; COVID-19

Summary: observation study, shows the relation between musckeloskeletal symptoms with during and post covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue


Eligibility criteria:
inclusion criteria: * participants aged ≥ 18 years with a prior covid-19 infection or suspicious covid-19 infection and currently residing in damascus. exclusion criteria: * participants below 18 years, those unwilling to give consent, individuals with joint surgery history, pregnant women, or those who had taken immunosuppressive drugs before the study.

Keywords: fatigue joint pain covid-19 vaccination malaise
needs in education for pulmonary or cardiopulmonary transplanted cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: main objective : this project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis. specific objectives : evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation secondary objectives : * assess the state of health * assess the knowledge * assess gestural know-how * assess the cognitive know-how * assess the behaviour adopted in reality by the patient * assess motivation psychosocial factors of : * self-efficacy and inefficiency * representation of obstacles, disadvantages of treatment * sense of control over their health * feeling of being supported by health professionals, by his close * representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment


Eligibility criteria:
inclusion criteria: * patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis exclusion criteria: * patient with a psychiatric disorder * patient in intensive care * palliative patient * patient aged under 18 years old * patient refusal

Keywords: lung and heart transplantations mucoviscidosis educational needs
trial of subretinal injection of (raav2-vmd2-hmertk)

Conditions: Retinal Disease; Retinitis Pigmentosa

Summary: this study was to assess the safety of gene transfer via subretinal administration of raav2-vmd2-hmertk in subjects with mertk-associated retinitis pigmentosa (rp).

in this phase i open-label, dose-escalation trial, one eye of each patient (the worse-seeing eye in five subjects) will receive a submacular injection of the subretinal raav2-vmd2-hmertk. patients will be followed daily for 10 days and then at 30, 60, 90, 180, 270, 365, 540, and 730 days post-injection. data will be collected on (1) full ophthalmologic examination including best-corrected va, intraocular pressure, color fundus photographs, macular spectral-domain optical coherence tomography, and full-field stimulus threshold test (fst) in both the study and fellow eyes; (2) systemic safety data including cbc, liver, and kidney function tests, coagulation profiles, urine analysis, aav antibody titers, peripheral blood pcr and asr measurement; and (3) listing of ophthalmological or systemic adverse effects.

Eligibility criteria:
inclusion criteria: * mertk-associated retinal disease; * va: 20/100 or less in worse eye * ability to perform tests of visual and retinal function; * good general health based on a complete physical examination and hematology and chemistry studies performed at a pre-treatment evaluation; * ability to comply with research procedures; exclusion criteria: * pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or surgical complications (for example, glaucoma, corneal or lenticular opacities); * complicating systemic diseases (such as medical conditions causing immunosuppression) that would preclude the gene transfer, ocular surgery or known sensitivity or allergy to medications planned for use in the peri-operative period; * use of anti-platelet agents that may alter coagulation within 7 days prior to study agent administration; * use of immunosuppressive medications; * pregnancy or breastfeeding; * individuals (males and females) of childbearing potential who are unwilling to use effective contraception for 1 year following agent administration and barrier contraception for 3 months following agent administration; * any other condition that would prevent a subject from completing follow-up examinations during the course of the study and that, in the opinion of the investigator, makes the subject unsuitable for the study. * current, or recent (within the past 30 days, or 10 half lives of the drug) participation, in any other research protocol involving investigational agents or therapies. * recent (within past 6 months) receipt of an investigational biologic therapeutic agent.subjects will not be excluded based on their gender, race or ethnicity.

Keywords: retinal disease subretinal gene therapy mertk retinitis pigmentosa
long-term fate of moderate aortic regurgitation left untreated at the time of mitral valve surgery

Conditions: Aortic Regurgitation; Mitral Regurgitation

Summary: multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery. specifically, aortic valve regurgitation (ar) can be present in a considerable proportion of patients undergoing mitral valve (mv) surgery. in the society of thoracic surgeons database, con- comitant aortic and mitral surgery accounted for 57.8% of the total multivalvular procedures with an unadjusted mortality rate of 10.7%. when both the aortic and mvs exhibit severe disease, con- comitant valve surgery is well-accepted by the surgical commu- nity and supported by current guidelines. on the other hand, when the aortic valve (av) shows only moderate regurgita- tion, which would not be surgically treated if singly present, the appropriate management of the av pathology at the time of mv surgery is still under debate. the american college of cardiology guidelines state that aortic valve replacement (avr) is reasonable (class iia) in patients with moderate ar (stage b) while undergoing surgery on the ascend- ing aorta, a coronary artery bypass graft or mv surgery (level of evidence: c). conversely, the latest european society of cardiology guidelines on valvular heart disease define as con- troversial the decision to treat the av in patients with moderate ar who undergo mv surgery, considering the slow progression of this disease. in this group of patients, they advocate a heart team approach that will take into account the aetiology of ar, the life expectancy of the patient, the operative risk and other clinical factors. this disagreement may lead to uncertainty about how patients with less than severe ar should be managed during mv surgery, especially considering the burden of double-valve surgical procedures. the goal of this study is to evaluate the immediate and long- term outcomes, including the need for a new procedure on the av, in patients with moderate ar at the time of mv surgery.


Eligibility criteria:
inclusion criteria: general criteria for both groups * adult patients; * patients undergoing mitral valve surgery, with moderate-grade ar, as assessed by preoperative echocardiography; specific criteria group 1 (study group) - patients who have not undergone aortic valve surgery in conjunction with mitral valve surgery specific criteria group 2 (control group) - patients undergoing aortic valve surgery in conjunction with mitral valve surgery exclusion criteria: * patients who have not undergone mitral surgery * patients undergoing multivalvular surgery other than mitro-aortic surgery
a study to evaluate 611 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Sinusitis; Nasal Polyps

Summary: this study will evaluate the effect and safety of 611 in patients with chronic rhinosinusitis with nasal polyps (crswnp)

the main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (mfns) in reducing endoscopic nasal polyp score (nps) and nasal congestion/obstruction score (ncs) severity in eligible patients with crswnp whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (incs) therapy in comparison to placebo

Eligibility criteria:
inclusion criteria: * female and male patients aged ≥18 and ≤ 75 years at the time of screening. * bilateral crswnp. * bilateral nps of ≥5 with a minimum score of 2 in each nasal cavity * nasal congestion score of 2 at screening and a weekly average severity of 2 at time of randomization. * patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with scs anytime within the past 2 years; and/or had a medical contraindication/intolerance to scs; and/or received nasal polyp surgery 6 months before signing the icf. exclusion criteria: * patients with other nasal diseases or symptoms. * patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening. * patients who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. * history of cancer. * known or suspected history of immunosuppression. * known with allergic or intolerant to mometasone furoate spray or 611/ placebo