Kornimate/medical-research-clean huggingface dataset:
evaluate the safety, functionality, and the quality of life of patients who receive the freedom total knee ® system

Conditions: Knee Joint Pain

Summary: assess the safety and functionality of the freedom knee® system through a multi-center clinical trial. study endpoints include a comparison of pre-surgery versus post-surgery data for: 1. range of motion 2. quality of life measurements using knee society scale (kss) 3. survivorship as defined by 'no revision' of baseline implant 4. quality of life measurements using the womac score

the clinical study will involve a series of evaluations performed by your surgeon. these examinations are consistent with the normal surgeon care as part of total knee replacement surgery. the study objective is to assess the safety, functionality, and survivorship of the freedom knee system through a multi-center clinical trial. study endpoints include a comparison of pre-surgery (baseline) versus post-surgery data for range of motion and flexion, quality of life (kss), and survivorship (defined by 'no revisions'). additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.

Eligibility criteria:
inclusion criteria: * males and females 40-80 years of age * patients requiring knee prosthesis, and have been evaluated as appropriate candidates for atka by their orthopedic surgeon * patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation exclusion criteria: * previous major knee replacement of the affected knee joint * other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, nueropathic joints) * obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: bmi \> 35) * patients who are found to be non-compliant by their physician * patients with or having; malignancy - active malignancy, active or suspected infection, paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus. * the patient has a neuromuscular or neurosensory deficit. * female patients planning a pregnancy during the course of the study. * patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. * varus or valgus deformity \> 20 degrees
a retrospective and prospective natural history study of patients with whim syndrome

Conditions: WHIM Syndrome

Summary: this natural history study is a prospective and retrospective, observational study of whim patients. whim syndrome is a rare, genetic, primary immunodeficiency disorder (a disorder in which the body's immune system does not function properly). whim is an acronym for some of the symptoms of the disorder - warts, hypogammaglobulinemia (low levels of certain antibodies), infections and myelokathexis (too many white blood cells in the bone marrow).this study includes 10-year retrospective (retrospective phase) and up to 5-year prospective (prospective phase) components.

given the rarity of patients with whim syndrome, this study is being conducted to better understand the clinical course of untreated patients with whim syndrome. the goals of this natural history study are to define both the frequency and diversity of whim syndrome by specific genetic mutation, as well as to understand the clinical course and phenotype of untreated whim patients.

Eligibility criteria:
inclusion criteria: 1. has a confirmed clinical diagnosis of whim syndrome. 2. has signed the current approved informed consent form; patients under 18 years of age will sign an approved informed assent form and must also have a signed parental consent. 3. be willing and able to comply with the study protocol. exclusion criteria: 1. has, within 6 months prior to day 1, received a cxcr4 antagonist. 2. currently participating in an investigational study for treatment of whim. 3. has any other medical or personal condition that, in the opinion of the investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical study.

Keywords: cxcr4 mutation primary immunodeficiency disorder warts hypogammaglobulinemia infections myelokathexis human papillomavirus (hpv) neutropenia herpes
effects of volleyball intervention on health-related fitness in primary school students

Conditions: Physical Inactivity; Adolescent Obesity; Physical Fitness; Body Composition; Healthy Lifestyle; Exercise

Summary: the goal of this study is to find out if doing a 16-week volleyball program integrated in physical education classes at school can make primary school students stronger, faster, and have better endurance. the study also wants to see whether the program can lead to changes in the students' body weight, body fat, and muscle mass.

eighty-eight healthy primary school students (mean age 13.3 years) were randomized to a tgfu volleyball intervention group (vg) or a control group (cg). cg participants attended three regular physical education (pe) classes per week, while vg participants attended two regular pe classes and a tgfu volleyball intervention that was implemented in the third pe class. the main part of each volleyball intervention session was based on the "teaching games for understanding" (tgfu) model. this approach emphasizes the development of fundamental skills and tactical understanding of the game by utilizing modified games, such as small-sided games and mini-volleyball. by using this method, participants are able to increase their interaction with the ball and engage in moderate-to-vigorous gameplay intensity more frequently. the primary study outcomes were assessed before and after the 16-week intervention for both vg and cg participants. the main hypothesis is that implementation of the tgfu volleyball intervention in the physical education curriculum will lead to greater improvement in body composition and physical fitness outcomes among seventh-grade primary school students compared to those who receive traditional physical education classes, demonstrating that this intervention can be an effective method for reducing adiposity and promoting physical fitness levels among adolescents.

Eligibility criteria:
inclusion criteria: * seventh grade primary school students * were not exempt from participating in physical education classes * did not have any health conditions (pediatric disease, orthopedic conditions, injuries, respiratory or cardiovascular disease) * voluntary participation * obtained informed consent from parents or legal guardians exclusion criteria: * exempted from participating in physical education classes * currently participating in other interventions * the presence of acute or chronic infectious disease * the presence of injury * not able to attend all intervention sessions * not obtaining informed consent from parents or legal guardians * do not want to participate voluntary

Keywords: physical activity exercise training physical education volleyball small-sided games health-related fitness body composition physical fitness adolescents primary school
clinical evaluation of posterior indirect adhesive restorations

Conditions: Dental Caries; Endodontically Treated Teeth; Dental Restoration Failure of Marginal Integrity; Wear, Occlusal; Indirect Posterior Restoration

Summary: clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.

indirect adhesive restorations are indicated in large class ii defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. the need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. updated approaches now include the use of composite resins as luting agent. this study will be carried out as a prospective study, with assessment of the restorations after three years. pass 11 software was used to calculate the sample size. at least 77 indirect adhesive restorations will be included for this study. patients referred to istanbul okan university faculty of dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. the patients who will not meet all the inclusion criteria will be excluded from the study. a signed informed consent form will be obtained from all patients before beginning the study. restorations will be evaluated clinically and radiographically according to fdi world dental federation criteria over 3-year period. three main groups- esthetic, functional, biological properties- and their sub-categorizes of fdi world dental federation criteria will be scored on a scale of 1 to 5. statistical analysis will be performed using r (v.3.5.3) software and the sign.test function in the bsda package (p \<0.05).

Eligibility criteria:
inclusion criteria: * significant loss of dental hard tissue * endodontically treated teeth in posterior region * replacement of large compromised existing restoration * large class ii restoration * age of 18-60 years * good oral hygiene * presence of interproximal contact to at least one neighboring teeth * in occlusion with antagonist teeth * cavity preparation with at least one cuspal coverage exclusion criteria: * serious medical problems or allergies to substances and/or products to be used * severe periodontal problems * poor oral hygiene * direct pulp capping * presence of parafunctional behaviors * pregnant or breast feeding

Keywords: indirect restoration adhesive restoration cementation composite resin
impact of medication reconciliation intervention on the rate of preventable adverse drug events (ades) and healthcare utilization

Conditions: Adverse Drug Events

Summary: the implementation of a medication reconciliation intervention including: medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list, on the development of adverse drug events within 30 days post discharge as primary outcome. secondary outcome is the evaluation of its impact on health care resource utilization

this is a randomized controlled trial in 587 patients randomized to intervention and usual care. the intervention is medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list. usual care is ward pharmacy practice. the primary outcomes are preventable and potential adverse drug events at 30 days post discharge. the secondary outcome is health care utilization: length of stay, emergency room visits, unplanned hospital visits, readmissions and travel abroad to seek medical attention.

Eligibility criteria:
inclusion criteria: * admitted to one of the two medical wards, male and female medical wards. * was on at least one medication prior to admission * spoke arabic or english and can be (the patient or care giver) interviewed for medication history * stayed in the hospital for at least 24 hours * discharged on at least one chronic medication or is at least on one chronic medication even if not prescribed upon discharge exclusion criteria: * could not be interviewed due to language barrier, impaired cognition or other reasons and did not have a care giver * was under specialties other than medical specialties, but was admitted to medical wards because of lack of beds in their respective wards * was pregnant * was already included in the study at a previous admission * left the hospital against medical advice * with length of stay of \>60 days.

Keywords: adverse drug events, preventable, potential, counselling, medication reconciliation
an italian observation of antiretroviral treatment in participants taking darunavir/ cobicistat plus emtricitabine and tenofovir alafenamide fumarate

Conditions: Human Immunodeficiency Virus (HIV)

Summary: the purpose of this study is to describe the effectiveness of darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide (d/c/f/taf), measured as virological response at week 48 as per food and drug administration (fda) snapshot algorithm through collection of daily practice data in the italian setting.


Eligibility criteria:
inclusion criteria: * having a confirmed diagnosis of human immunodeficiency virus-1 (hiv-1) * must sign a participation agreement/informed consent form (icf) allowing data collection and source data verification in accordance with local requirements * taking darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide (d/c/f/taf) as per summary of product characteristics (smpcs) since at least one month before enrollment: i) experienced participants \[group 1 and 2\]: a) started their antiretroviral (arv) treatment not before 1/1/2015, b) having at least 1 year of arv treatment history at study enrollment, c) group 1, having always been treated with darunavir (drv) since the start of arv treatment as naïve, d) group 2, not having been treated with drv before starting of d/c/f/taf, ii.) naive (any viral load (vl) participants (group 3) exclusion criteria: * participants unable to read, to write, to understand and sign the icf * currently enrolled in an interventional study * currently enrolled in an observational study sponsored or supported by janssen * chemotherapy scheduled during study observation
in-depth immunological investigation of covid-19.

Conditions: Coronavirus Infections

Summary: the contagious trial (covid-19 advanced genetic and immunologic sampling; an in-depth characterization of the dynamic host immune response to coronavirus sars-cov-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to sars-cov-2 infection, which is urgently needed for directed medical interventions.

the overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in uz leuven because of sars-cov-2 infection. for this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (bal) fluid and lung tissue samples will be collected from pcr- or ct-confirmed covid-19 patients, with varying degrees of disease severity. assessed characteristics will be compared between severe and non-severe covid-19 patients, and between covid-19 positive and negative ('control') patients.

Eligibility criteria:
inclusion criteria: * patients \>/= 18 years old and * hospitalised with pcr-confirmed and/or ct-confirmed sars-cov-2 disease exclusion criteria: * age \< 18 years old * no informed consent

Keywords: covid-19
postoperative complications in patients with obesity hypoventilation syndrome

Conditions: Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Hypercapnia; Post-Op Complication; Acid-Base Imbalance

Summary: obstructive sleep apnea (osa) and obesity-hypoventilation syndrome (ohs) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. there is a need for simple screening tools to identify such patients at high risk. the current multicenter observational study aims to investigate occurrence of osa and ohs in obese individuals undergoing elective abdominal surgery and further address its impact on perioperative and postoperative complications.

obstructive sleep apnea (osa) and obesity-hypoventilation syndrome (ohs) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. there is a need for simple screening tools to identify such patients at high risk. the current multicenter observational study aims to investigate occurrence of osa and ohs in obese individuals undergoing elective abdominal surgery by using questionnaires (stopbang questionnaire, berlin questionnaire, and epworth sleepiness scale) and arterial blood gases. perioperative and 72-h postoperative complications will be documented.

Eligibility criteria:
inclusion criteria: * patients undergoing elective abdominal surgery * body-mass-index \>=30 kg/m2 * ability to read and speak * signed informed consent. exclusion criteria: * use of diuretics * use of theophylline * use of respiratory depressing drugs * severe lung disease (fev1/fvc\<%50) * severe hearth failure (ef\<%35) * central nervous system or muscle disease * untreated hypothyroidism * renal failure (gfr\<50) * total parenteral nutrition more than 72 hours * hypokalemia * hyponatremia * hypomagnesemia * hypoalbuminemia * known sleep apnea or obesity hypoventilation syndrome * blood transfusion from blood bank within 72 hours prior to surgery

Keywords: obstructive sleep apnea obesity hypoventilation syndrome hypercapnia post-op complication acid-base imbalance
a double-blinded evaluation of safety and efficacy of hylaform and hylaform plus compared to zyplast.

Conditions: Facial Wrinkles

Summary: a clinical study to investigate the safety and efficacy of hylaform and hylaform plus for correction of facial wrinkles.


Eligibility criteria:
inclusion criteria: * bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale exclusion criteria: * pregnant/lactating women * patients who previously received permanent facial implants or using ovet-the-counter products
a study evaluating gemcitabine plus bosutinib for patients with resected pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the pancreas. * complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). positive microscopic margins are allowable. * no measurable disease. * ecog performance status 0 - 1. * ≥ 18 years of age. * ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks). * ca 19-9 ≤ 2.5 times the upper limit of normal. * anc (absolute neutrophil count) ≥ 1500/μl * hemoglobin ≥ 9 gm/dl (may be transfused or may receive epoetin alfa to maintain this level) * platelet count ≥ 100,000/μl * inr ≤ 1.5 (except those subjects who are receiving full-dose warfarin) * total bilirubin ≤ 2.0 mg/dl * ast and alt ≤ 2.5 times the upper limit of normal * serum creatinine ≤ 2.0 * negative pregnancy test for women of childbearing potential (serum or urine beta-hcg). * all patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. * women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards. * at least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment). exclusion criteria: * any prior systemic or investigational therapy for pancreatic cancer. * grossly positive surgical margins. * any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula. * history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications. * serious active ongoing infection, including any requiring parenteral antibiotics. * patients with a "currently active" second malignancy other than non-melanoma skin cancer. patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse. * pregnancy (positive pregnancy test) or lactation. * known central nervous system disease. * inability to swallow pills/tolerate oral intake. * inability to comply with study and/or follow-up procedures.

Keywords: pancreas pancreatic bosutinib ski-606 gemcitabine gemzar patients with resected pancreatic cancer
contamination of testicle tissue by rt-pcr in participants with solid tumors

Conditions: Minimal Residual Disease; Fertility Preservation

Summary: for prepubertal patients, cryopreservation of testicular tissue is the only option available to preserve their fertility before cancer treatment. but testicular autograft raises the issue of the risk of reintroduction of potentially malignant cells. the aim of our study is to develop a specific and sensitive method for residual disease detection in the testicular tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of testicular tissue cryopreservation.

some solid tumors have high risk of metastatic localization including in testis. there is concern over the possible presence of malignant cells in testicular tissue that could cause a recurrence of the primary disease after reimplantation. thus, the possibility of testicular tissue involvement needs to be evaluated with sensitive molecular methods. based on our experience in detection by rt-pcr of minimal residual disease (mrd) in neuroblastoma since 1994 \[tchirkov et al. 2003\] and in testicular tissue cryopreservation since 2012, we want to develop a specific and sensitive method for residual disease detection by rt-pcr in order to evaluate the tumor contamination of testicular harvested tissue. study population: we chose 3 models of pediatric solid tumors with high risk of metastases and which often require sterilizing treatments (chemo and/or radiotherapy): neuroblastoma, ewing tumor and alveolar rhabdosarcoma. we will use four tumor cells lines: imr32 and sk-nsh for neuroblastoma; rd-es for ewing tumor; rh-30 for rhabdosarcoma. we plan to use 20 fragments per line. study duration: 12 months study design: testicular tissue without known malignancy but with a condition warranting a biopsy (fertility assessment) will be harvested. the harvested testicular cortex will be treated to recover all viable sperm and then, we use remaining tissue to be contaminated with tumor cells lines. then, detection of the specific transcript will be done by rt-pcr in fresh tissue and after freeze/thaw. total rna will be extracted with the tri-reagent and qrt-pcr will be performed using the "taqman" technology. primary endpoint: to reach a sensitivity about 1/106 cells.

Eligibility criteria:
inclusion criteria: * men in childbearing age whose fertility assessment require a testicular biopsy may be included exclusion criteria: -

Keywords: polymerase chain reaction fertility preservation