Kornimate/medical-research-clean huggingface dataset:
sonographic study of hip joint in hockey players

Conditions: Hip Joint Contracture

Summary: the aim is to determine whether the game of ice hockey has an effect on structural changes in the hip joint. the parameter to be investigated will be the increased frequency of structural changes of the hip joint in ice hockey players compared to a control group. participants in the study will undergo msk sonographic examination of both hip joints followed by functional hip mobility testing. the functional testing consists of three tests. data will be processed in ms office in ms word, and the resulting data will be subject to statistical evaluation.

the examined hip joint structure will be examined monographically and simultaneously using functional tests, the patrick test, a passive test of the range of motion in the hip joint to external and internal rotation in the joint, faddir test. approximately 20 probands will be enrolled in the study based on voluntary participation from a group of players of the charles university hockey team prague, who have a valid medical examination with no restrictions on eligibility for selected sporting activities. the second group will consist of approximately 20 additional probands from the u20 age group of ice hockey players enrolled voluntarily with a valid medical examination with no restrictions on eligibility for the selected sporting activities. in addition, approximately 20 volunteers of the same age range will be included in the study and form the control group. in total, there will be approximately 60 participants in the study. the conditions for inclusion in the first and second test groups will be an age range of 19-28 years, playing ice hockey for 6 years at least three times a week in the standard training regime of czech ice hockey clubs. the player must be a registered player, i.e. his/her health condition must be suitable for ice hockey. the exclusion criteria for the test group will be persons outside the defined age limit with acute or chronic illnesses for any reason and persons with post-traumatic hip and pelvic conditions. the inclusion criteria for the third control group will be the same age range of 19-28 years and no acute, especially infectious, diseases and persons with post-traumatic hip and pelvic conditions. this will be a normal recreational sporting population with no registration affiliation in any sport.

Eligibility criteria:
inclusion criteria: * a valid medical examination with no restrictions on eligibility for selected sports activities * playing ice hockey from the age of 6 at least three times a week in the standard training regime of czech ice hockey clubs * registered player, i.e. his/her health must be fit to play ice hockey. exclusion criteria: * persons outside the defined age limit * with acute or chronic illnesses for any reason * persons with post-traumatic hip and pelvic conditions

Keywords: hockey hip joint sonography
purified rabies vaccine for human use (chick-embryo cell)

Conditions: Rabies Post-exposure Prophylaxis

Summary: evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.


Eligibility criteria:
inclusion criteria: * male and female healthy subjects aged 10-60 years old exclusion criteria: * history of rabies immunization * previous exposure to a suspect rabid animal within the last 12 months * any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days * treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment * known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder * known hypersensitivity to neomycin, tetracycline, amphotericin-b, or any other vaccine component

Keywords: rabies vaccine post-exposure prophylaxis
phase i safety study of inhaled n-ip-00001 to determine tolerability and safety in healthy volunteers.

Conditions: Healthy

Summary: randomized, double-blind, placebo-controlled, dose-escalation phase i safety study of inhaled n-ip-00001, to determine tolerability and safety in healthy volunteers.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 55 years. 2. male or non-pregnant, non-lactating female 3. normally active and in good health as determined by the investigator or sub-investigator (who is a qualified physician)through physical examination, vital signs and laboratory parameters. 4. no current acute or chronic respiratory conditions. 5. fev1 ≥ 80% predicted. 6. ability to achieve reproducible fev1 spirometry, as determined by 3 acceptable maneuvres within no more than 5 attempted maneuvres. the best two values should be within 5% or 150ml of each other, whichever is greater. 7. ability to comply with study medication use, study visits, and study procedures as judged by the investigator. 8. able to understand and sign an informed consent. 9. non-smoker and has not smoked for at least 6 months. exclusion criteria: 1. bowel disease 2. bariatric surgery 3. evidence of biliary cirrhosis with portal hypertension 4. history of any drug or alcohol abuse in the past 1 year defined as \>21 units of alcohol per week for males and \>14 units of alcohol per week for females. where 1 unit = 360ml of beer, 150ml of wine, or 45ml of spirits. 5. history of lung transplant. 6. history of asthma. 7. history of allergic reactions to fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) 8. antibiotic treatment within 4 weeks prior to screening 9. recent (2 weeks) upper respiratory tract infection or covid 10. recurrent cough 11. poor venous access 12. unexplained, positive drugs of abuse or alcohol breath test results at the screening visit or positive alcohol breath test at check-in. 13. not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement 14. unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) and strenuous exercise for 24 hours prior to dosing. unwilling to abstain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) during confinement at the clinical unit'. 15. participants who have received any investigational drug in a clinical research study within the previous 30 days prior to screening or 5 half-lives, whichever is longer. 16. failure to satisfy the investigator of fitness to participate for any other reason. 17. currently taking any medication by the inhaled route. 18. those with commercial interest in the product or related products.

Keywords: safety tolerability inhalation
efficacy, safety, and tolerability study of act-129968 in patients with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this study will assess the efficacy and safety of act-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.


Eligibility criteria:
inclusion criteria * males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years. * evening reflective total nasal symptom score (p.m.rtnss) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or \> or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period. exclusion criteria * non-allergic rhinitis. * severe physical nasal obstruction. * acute or significant chronic sinusitis. * bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear. * ongoing chronic respiratory disorders. * asthma requiring use of short-acting beta2-agonists \> 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists. * diagnosis of aspirin or non-steroidal anti-inflammatory drug (nsaid)-induced asthma. * nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the screening visit. * ocular surgery within the 8 weeks prior to the screening visit. * ocular infections (bacterial or viral) within the 4 weeks before screening. * use of forbidden medications (prescribed or over-the-counter \[otc\]) * congenital or acquired severe immunodeficiency or known human immunodeficiency virus (hiv)infection.

Keywords: seasonal allergic rhinitis
second-line chemotherapy in castration resistant prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: this study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mcrpc) patients previously treated with docetaxel containing regimen. the primary endpoint is safety. secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.

the objective of this study is to explore new, biweekly schedule of cabazitaxel in metastatic castration resistant prostate cancer patients. a previous study has shown that the biweekly administration of docetaxel in 1st line setting of mcrpc is better tolerated than docetaxel administered every three weeks. also, the efficacy of biweekly docetaxel was better than three-weekly docetaxel and biweekly dosing presented a significant overall survival benefit (asco 2011, kellokumpu-lehtinen et al. as the occurrence of neutropenia in the tropic trial was rather high, the hypothesis is to reduce the incidence of severe adverse events by administrating cabazitaxel more frequently, yet maintaining the same dose intensity as in every three weeks´ dosing schedule. this study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of 60 patients with metastatic castration resistant prostate cancer (mcrpc) patients previously treated with docetaxel containing regimen.

Eligibility criteria:
inclusion criteria: * metastatic castration resistant prostate cancer * disease progression during or after docetaxel-containing regimen for mcrpc * surgical or medical castration * who performance status \< 2 * age \> 18 years * adequate bone marrow, liver and renal functions: hematology: * neutrophils \> 1.5 x 109/ l * hemoglobin \> 100 g/l * platelets \> 100 x 109/l hepatic and renal functions: * total bilirubin \<1 x uln * alat and asat \ 6 x uln is accepted * creatinine \< 1.5 x uln (ie nci ctc-ae grade \< 1) exclusion criteria: * prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment * prior therapy with radioisotopes * other malignant disease (except superficial non-melanoma skin cancer) within the past 5 years * serious liver disease * history of severe hypersensitivity reaction (grade \> 3) to polysorbate 80 containing drugs * concurrent or planned treatment with potent inhibitors or inducers of cytochrome p450 3a4/5 (a one week wash-out period is necessary for patients who already are on these treatments) * other serious illness or medical condition: * serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months * active infection * active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use of corticosteroids * auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis) * active grade \> 2 polyneuropathy

Keywords: metastatic prostate cancer
anxiety and / or depressive disorders in a population of french airline pilot

Conditions: Anxiety Disorders; Depressive Disorder

Summary: throughout their career, the medical abilities of airline pilots are regularly assessed. this population is exposed to occupational constraints and risks, in particular psychosocial, and could constitute a population at risk of developing anxiety and/or depressive disorders. however, mental health remains difficult to apprehend in this population because of a strong stigmatization of mental disorders and the risk of loss of medical certification to fly. in the literature, there are very few studies dealing with mental disorders in airline pilots and the results are heterogeneous, with a prevalence of anxiety and/or depressive disorders ranging from 1.9 to 12.6%. there is no study of this type among airline pilots employed in france. therefore it seems useful to determine the prevalence of anxiety and/or depressive disorders in this population and to describe the co-factors associated with these disorders.


Eligibility criteria:
inclusion criteria: * airline pilot, employed in france and unionized at the syndicat national des pilote de ligne (snpl) exclusion criteria: * none
liver function assessment - feasibility and dosing study

Conditions: Hepatic Failure

Summary: the purpose of this study is to 1) determine the feasibility of using cardiox liver function assessment system (lfa) to measure indocyanine green (icg) clearance; 2) determine an adequate dose based on lfa technology and 3) determine an adequate time period for lfa determination.

four cohorts of subjects will be enrolled. the fist two cohorts will receive fixed doses of icg dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of lft monitoring. the final two cohorts will receive weight based doses of icg dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of lft monitoring. additionally the final two cohorts will have serial blood draws before the icg dose and at 5, 10, 15 and 20 minutes post icg dose.

Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18 to 75 years, inclusive * informed consent documentation understood and signed. exclusion criteria: * known allergy or sensitivity to the icg or to iodide contrast dye * pregnant women or those nursing babies
zilver® flex™ vascular stent study

Conditions: Peripheral Arterial Disease (PAD)

Summary: this study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the zilver® flex™ vascular stent which has received the ce mark for commercial use. the study is designed as a single arm non-randomized post-approval study.


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment. * to be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present. exclusion criteria: * patient is \< 18 years of age. * patient is pregnant or breast-feeding. * patient is simultaneously participating in an investigational drug or device study. the patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study. * patient has had previous stenting of the target vessel. * patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis. * patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. * patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.

Keywords: peripheral arterial disease
comparison of circular(soave) and heart-shaped anastomosis in hirschsprung's disease

Conditions: Constipation

Summary: comparison of circular(soave)and heart-shaped anastomosis in hirschsprung's disease.

at present, the treatment for children with hscr is still surgery. the basic treatment principles of all surgical procedures commonly used in the world include confirming the location of the transitional zone between the intestinal tube with and without ganglion cells, removing the intestinal segment without ganglion cells, and reconstructing the digestive tract by anastomosis of the intestinal segment with ganglion cells with the anus or rectum. intact anal receptors and autonomic internal sphincter control are essential for autonomic bowel control, and the integrity of the internal sphincter directly affects the occurrence of soilage and fecal incontinence after surgery. therefore, how to deal with the internal sphincter during the operation, so as to avoid the recurrence of constipation caused by the spasm of the internal sphincter after the operation, and to retain the function of the internal sphincter for defecation control has been the focus of research. in the 1980s, professor wang guo, based on the experience of previous researchers, innovated the "heart-shaped anastomosis", which is a surgical procedure in which the dorsal rectum is split longitudinally to the dentate line without removing the internal sphincter, and then the normal colon is drawn out to make an oblique anastomosis with the rectoanal canal. a retrospective single-center follow-up of nearly 100 cases of "heart-shaped anastomosis" over a period of 20 years found that compared with traditional end-to-end colorectal anastomosis, patients with "heart-shaped anastomosis" had a significantly lower rate of fecal fouling and a long-term bowel function score (bowel function score, bowel function score). bfs) and quality of life-bref (qlb) were also significantly improved compared with the traditional operation (p\<0.05), and no other adverse events occurred. this study aims to determine the optimal surgical procedure for hscr by a prospective, multicenter controlled study comparing the "heart-shaped anastomosis" with the commonly used soave procedure. in summary, this project will compare the application of "heart-shaped anastomosis" and traditional surgery for children with hscr before operation, and comprehensively evaluate the advantages of "heart-shaped anastomosis" for defecation control from morphology to electrophysiological function through postoperative follow-up, combined with anorectal manometry.

Eligibility criteria:
inclusion criteria: 1. age\<14 years 2. hirschsprung's disease diagnosed by biopsy 3. surgical indication exclusion criteria: 1. age\>14 years 2. not hirschsprung's disease 3. surgical contraindication
short versus long interval to ileostomy reversal after ileal pouch surgery

Conditions: Ulcerative Colitis; Ileal Pouch; Ileostomy - Stoma

Summary: in patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (ipaa) surgery\* a short interval to loop ileostomy reversal will result in differences in complications and quality of life compared to a long interval to loop ileostomy reversal.

aim #1: to compare the comprehensive complication index (cci), the incidence of postoperative complications, including total number of complications per patient, percent of patients with complications, and total number of ostomy-related complications per patient among ipaa patients who have their ileostomy reversed after a short interval compared to a long interval. aim #2: to compare the short vs. long interval groups on measures of health-related quality of life (promis) and ipaa functional outcomes

Eligibility criteria:
inclusion criteria: * signed informed consents. * man or woman between 18 and 64 years of age. * ulcerative colitis (uc) or indeterminate colitis (ic) diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria. * patient will be scheduled for non-emergent proctocolectomy or completion proctectomy with ileal j-pouch anal anastomosis (ipaa) and loop ileostomy (ipaa). * clinical assessment of patient after ipaa surgery indicates that patient is suitable for early ileostomy reversal exclusion criteria: * age \ 64 years * colon or rectal cancer * crohn's disease or suspected crohn's disease * prednisone dose \> 20 mg per day (or equivalent other steroid dose) within 4 weeks of scheduled ipaa * body mass index (bmi) equal to or greater than 40 kg/m2 * hemodynamic instability (persistent pulse rate \ 120 bpm, systolic blood pressure \ 160 mm hg, uncontrolled cardiac arrhythmia, or active vasopressor drug use) * organ transplant recipient (e.g. liver, kidney, pancreas) * immunosuppression due to chemotherapy drug use or systemic disease. * sepsis * renal insufficiency (i.e. serum creatinine ? 2 mg/dl or need for dialysis) * therapeutic anticoagulation (e.g. venous thromboembolic disease, prosthetic heart valve) * blood hemoglobin \< 8 g/dl * serum albumin \< 2.5 g/dl * individualized decision by the surgeon to exclude the patient based on sound surgical judgment * pregnant patients and female patients who do not satisfy the standard of care requirements of participating centers for an elective surgical procedure. * clinical assessment of patient after ipaa surgery indicates that patient is not suitable for early ileostomy reversal * participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial * well-founded doubt about the patient's cooperation.
contribution of pet (positron emission tomography) scans for the preoperative assessment of symptomatic endometriosis lesions: tep-endorun

Conditions: Endometriosis

Summary: endometriosis is an inflammatory condition that is often treated by surgery. mri and ultrasound are used for the preoperative morphological assessment. currently, only surgery allows the exhaustive and qualitative diagnosis of lesions. the pet scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.


Eligibility criteria:
inclusion criteria: * patient aged over 18 and under 50 * patient with symptomatic endometriosis with indication for surgery * showing at least one typical endometriosis lesion on mri, greater than 5mm * accepting surgical management * having signed an informed consent after information * affiliate or beneficiary of a social security scheme exclusion criteria: * patient who has received an injection with gnrh (gonadotropin-releasing hormone ) analogues for less than 3 months (because it induces the quiescence of the disease which is no longer stimulated by estrogen secretion) * patient with a history of heavy abdominopelvic surgery * diabetic patient * patient unable to understand the interest of the study * patient already included in another therapeutic trial with an experimental molecule. * persons referred to in articles l1121-5 to l1121-8 of the phc (public health code) (corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person making the subject to a legal protection measure: guardianship or curators) * contraindications to pet scanner (major claustrophobia, contraindication or hypersensitivity to 18-fdg or one of its excipients, contraindication or hypersensitivity to ultravist® or one of its excipients, etc.) * contraindication to surgery or anesthesia