Kornimate/medical-research-clean huggingface dataset:
evaluation of hq® matrix soft tissue mesh for the treatment of inguinal hernia

Conditions: Inguinal Hernia

Summary: the purpose of the study is to evaluate the safety and effectiveness of hq® matrix soft tissue mesh for the treatment of inguinal hernia. half of participants will receive hq® matrix soft tissue mesh, while the other half will receive ultrapro® partially absorbable lightweight mesh.

hq® matrix soft tissue mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the bombyx mori (b. mori) silkworm. the porous network structure makes it soft and pliable and convenient to implant. the mesh is mechanically strong, biocompatible, and long-term bioresorbable. the pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. the mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. it is sterile and for single-patient use only. ultrapro® partially absorbable lightweight mesh (ethicon, inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. it offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility.

Eligibility criteria:
inclusion criteria: 1. diagnosed clinically as inguinal hernia; 2. need to be treated with open tension-free hernioplasty; 3. bmi ≤ 40 kg/m\^2; 4. aged from 18 - 70, male or female; 5. the patients voluntarily signed the subjects' informed consent form. exclusion criteria: 1. surgeries that cut the gastrointestinal tract or the gastrointestinal tract ruptures accidently; 2. surgeries that repair the inguinal hernia intraperitoneally; 3. patients that have done the hernioplasty earlier and undergone multiple recurrence (recurrence rate ≥ 2); 4. the surgical wounds are contaminated; 5. patients that are treated with coagulant; 6. patients with serious complication; 7. patients with pregnancy or lactation; 8. patients with mental disease including serious hysteria.do not have legal capacity or have restricted capacity; 9. those allergic to the test products; 10. patients that participated other clinical trials in the last 3 months; 11. patients who, according to other doctors' opinion, are unsuitable to use this material for the treatment.
pain perception of dental local anesthesia using "dentalvibe comfort system" in a group of egyptian children

Conditions: Dental Anxiety

Summary: the aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of dentalvibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.

the aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of dentalvibe comfort system in comparison to maxillary infiltration injection alone. intervention: history taking from the child and the parent including personal, medical and dental history as in the examination sheet (appendix a) to assess inclusion criteria. clinical procedure: intervention group: clinical examination using mirror and probe to assess inclusion criteria. before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec. demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally. the cheek will be retracted and the device will be turned on. 1ml of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, septodont) will be injected using a 27 gauge needle which will be delivered over 1 min. control group: as that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off. assessment: objective assessment will be performed by observing the patients behavior using the flaac scale during the anesthetic injection and needle insertion. subjective evaluation will be obtained using the wong-baker faces pain rating scale.

Eligibility criteria:
inclusion criteria: 1. healthy children aged 6-7 years old. 2. apparently healthy children. 3. cooperative children. 4. children with carious maxillary bilateral primary molars indicated for extraction. exclusion criteria: 1. children who are allergic to amide group. 2. children with neurologic disorders. 3. children with mental disability. 4. presence of periapical or gingival legion. 5. severe gingivitis.
identification of the region of vitamin d responsiveness

Conditions: Diabetes; Hypertension

Summary: hypothesis: low vitamin d status is associated with increased insulin resistance and increased blood pressure. approach: multiple regression analysis of information extracted from a large database accumulated by a canadian health foundation, specifically evaluating statistical associations between serum 25(oh)d levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for bmi, age, sex, and waist circumference.

data obtained from the entry records of 4,116 adult men and women in calgary,alberta previously enrolled in the pure north s'energy foundation's health program. individuals with a clinical diagnosis of diabetes mellitus or a homa-ir value above 16 were excluded. standard statistical analyses carried out. an association between 25(oh)d and the endpoints of interest was first established. the residual values after adjusting homa-ir, serum insulin, quicki, and blood pressure for bmi, age, sex, and waist circumference were then regressed against serum 25(oh)d using 40-percentile data blocks, stepping upward from the lowest 25(oh)d values by 5 percentile increments through the 7th decile. regression coefficients are then computed for each data block and each outcome variable. the location (along the 25(of)d continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Eligibility criteria:
inclusion criteria: * age \> 18 exclusion criteria: * diabetes * elevated homa-ir (\>16)

Keywords: vitamin d associational study
small cell lung cancer community engagement to eliminate research discepancies

Conditions: Small-cell Lung Cancer

Summary: this study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with sclc, in the context of a bio-specimen collection study. the study will also assess self-reported preferences and needs of patients with sclc, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.

this is a non-interventional, non-treatment, non-randomized, single coordinating center, study to determine the feasibility of decentralized bio-specimen collection in usa-based adult subjects with sclc, to be conducted in conformance with good clinical practices. potential study subjects will be referred to contact staff through a dedicated study webpage form or dedicated study phone hotline at the coordinating center (alcmi) who will handle informed consent, coordinate remote blood sample collection with study subjects, and collect medical records to confirm diagnosis and treatment history. subjects will also be asked to complete a baseline and follow up questionnaire/survey documenting their self-report diagnosis, treatment history, factors impacting care and quality of life, and needs/preferences regarding supportive resources. patients who have been diagnosed with either extensive stage primary sclc or patients diagnosed with primary nsclc who experienced histological "transformation" with a sclc component after initial diagnosis and subsequent treatment (transformed sclc; tsclc) will be invited to volunteer for this study.

Eligibility criteria:
inclusion criteria: 1. men or women greater than or equal to 18 years of age at the time of consent 2. ability to read, write and communicate in english 3. provide voluntary consent to participate in this study, documented via a signed informed consent form (icf) 4. willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required 5. willing to comply with the requirements of the study 6. diagnosis of extensive stage primary sclc or tsclc exclusion criteria: 1. known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements 2. subjects who previously enrolled to this study note: concurrent enrollment in other clinical trials is not exclusionary

Keywords: sclc lung cancer
phase ii study of shj002 sterile ophthalmic solution compared with vehicle in participants with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this study is to measure efficacy and safety with shj002 sterile ophthalmic solution compared to vehicle in participants with dry eye disease (ded). shj002 is an antisense oligonucleotide to neutralize a specific microrna.

participants will be randomized to treatment with shj002 ophthalmic solution or vehicle which will be administered to each eye bid for 84 days.

Eligibility criteria:
inclusion criteria: 1. male or female participants 18 years of age or older inclusive, at the time of signing the informed consent. 2. have ded in both eyes for ≥ 6 months 3. female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test exclusion criteria: 1. ocular surface corneal disease, other than ded. 2. lid margin disorder other than meibomian gland dysfunction (mgd) 3. presence of any ocular condition 4. any history of eyelid surgery or intraocular/ocular surgery 5. cauterization of the punctum or punctal plug 6. use of lid scrubs containing chemicals or baby shampoo, or eye makeup 7. use of any of the contraindicated drugs medications 8. any changes in the dosing of any chronically used systemic drug 9. disease, condition, or disorder that in the judgement of investigator could confound study assessments or limit compliance to study protocol 10. known history of alcohol and/or drug abuse within 12 months 11. known allergy or contraindication to any component of investigational product (ip) formulation or diagnostic agents. 12. participation in any drug or device clinical investigation within 30 days

Keywords: dry eye disease
effect of kinesio taping in muscle fatigue

Conditions: Muscle Fatigue

Summary: the aim of this study was to determine the effect of kinesio taping on lactic acid in an running anaerobic test.


Eligibility criteria:
inclusion criteria: * they should practice physical activity 2-4 days a week. exclusion criteria: * history of surgery in the lower limbs * muscle-tendon injury or trauma in the lower limbs (ll) in the last six months * cardiovascular and / or respiratorydisease * any allergies related to the bandage material.

Keywords: bandage treadmill lactate acid
effect of shock-wave therapy on the resorption and bone formation in maxillary postextraction sockets

Conditions: Loss of Teeth Due to Extraction; Bone Resorption

Summary: the extracorporeal shock wave therapy (eswt) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies. the investigators main hypothesis is that the application of extracorporeal shock wave therapy (eswt) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth should prevent further residual alveolar bone resorption and will enhance vital bone formation. the investigators null hypothesis is that applying extracorporeal shock wave therapy (eswt) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth has no influence in the alveolar bone remodeling process. therefore, the investigators main objective is to evaluate the efficacy of the eswt in the prevention of alveolar bone resorption after an extraction with a volumetric exam through computer tomographies (ct) analysis. the investigators secondary objective is to determine the effect of eswt in the internal bone healing process of these postextraction alveolar sockets, measuring the bone density in the ct (hounsfield units) and the histomorphometric exam. methodology: randomized and open clinical trial with 20 patients (10 per group: with or without eswt treatment) that comply the inclusion and exclusion criteria. in the first appointment the tooth extraction will be performed, while in the second visit (two weeks later), ct scan will be made to all patients and eswt will be applied in the experimental group. finally, in the third visit (ten weeks later), a new ct scan will be done and an implant will be placed in the zone taking previously a bone sample with a trephine bur. the expected results are an improvement in the quantity and quality of the alveolar bone before the implant placement.


Eligibility criteria:
inclusion criteria: * ages between 18 - 65 years old. * non-smoking patients. * patients committed to rehabilitate the extraction socket with an implant. * lack of pathology in the surrounding area. * cooperative patients with serious commitment to follow the investigator's postoperative visits, who must sign the informed consent. * patients that need a conventional anterior maxillary single tooth extraction. exclusion criteria: * systemic illnesses (asa iii or above) that could contraindicate a surgical intervention or modify the wound healing. * patients with cardiopathies. * patients taking hormones, calcium or oral or endovenous bisphosphonates. * patients with uncontrolled periodontitis / periimplantitis. * smokers. * patients with implant/s in the upper maxilla. * surgical extractions that require rising a flap or ostectomy. * bone defects larger of 2 mms in alveolar sockets due to cortical bone defect or resorption, fenestrations or/and dehiscences. * guided bone regeneration need. * periapical radiolucency larger than 2-3 mms.
serum and tissue metabolite-based prediction of sentinel lymph node metastasis in breast cancer

Conditions: Breast Cancer; Lymph Node Metastasis

Summary: breast cancer is a malignant tumor with the highest morbidity and mortality among women worldwide. accurate staging of axillary lymph nodes is critical for metastatic assessment and decisions regarding treatment modalities in breast cancer patient. among patients who underwent sentinel lymph node biopsy, about 70 % of the patients had negative pathological results and in other words, these 70 % of the patients received unnecessary surgery. at present, imaging and pathological diagnosis is the main measure of lymph node metastasis in breast cancer. however, limitations remained. artificial intelligence, including deep learning and machine learning algorithms, has emerged as a possible technique, which can make a more accuracy prediction through machine-based collection, learning and processing of previous information, especially in radiology and pathology-based diagnosis. with the intensification of the concept of precision medicine and the development of non-invasive technology, the investigators intend to use the artificial intelligence technology to develop a serum and tissue-based predictive model for sentinel lymph node metastasis diagnosis combined with imaging and pathological information, providing specific, efficient and non-invasive biological indicators for the monitoring and early intervention of lymph node metastasis in patient with breast cancer. therefore, the investigators retrospectively include serum samples from early breast cancer patients undergoing sentinel lymph node biopsy, including a discovery cohort and a modeling cohort. metabolites were detected and screened in the discovery cohort and then as the target metabolites for targeted detection in the modeling cohort. combined with preoperative imaging and pathological information, a prediction model of breast cancer sentinel lymph node metastasis based on serum metabolites would be established. subsequently, multi-center breast cancer patients will prospectively be included to verify the accuracy and stability of the model.


Eligibility criteria:
inclusion criteria: * pathological diagnosis of breast cancer * no preoperative therapy including chemotherapy or endocrine therapy * no distant metastasis * underwent mastectomy or breast-conserving surgery with sentinel lymph node biopsy * agreed to provide preoperative peripheral blood samples * had access to imaging, pathological and follow-up data for preoperative and postoperative evaluation of the disease exclusion criteria: * neoadjuvant therapy * presence of distant metastasis at time of diagnosis * primary malignancies other than breast cancer * bilateral breast cancer or previous contralateral breast cancer * undergo modified radical surgery for breast cancer without sentinel lymph node biopsy * incomplete pathological data and follow-up data * pregnancy and other conditions determined by the investigator to be ineligible for inclusion in the study

Keywords: breast cancer sentinel lymph node metastasis metabolic reprogramming artificial intelligence
a study to evaluate the impact of care4today® ibd, a smart system to facilitate the management of crohn's disease by patients and health care providers

Conditions: Crohn Disease

Summary: the purpose of this study is to describe the crohn's disease (cd)-related secondary healthcare resource utilisation of patients in the 6 months pre- and 12 months post-activation of care4today® inflammatory bowel disease (c4t ibd) alongside standard of care (soc) in the management of cd.


Eligibility criteria:
inclusion criteria: * participants with moderate to severe crohn's disease (cd), diagnosed at least 6 months prior to index date, as documented by the treating healthcare professional (hcp) * participants with at least 6 months of continuous care in the study centre prior to index date * participants who have agreed to install care4today® inflammatory bowel disease (c4t ibd) on their ios or android smartphone as part of their management of cd * participants providing informed written consent to participate in the study from the date of activation (including installation and linkage to hcp web interface) of the c4t ibd app on his/her smartphone exclusion criteria: * participants with presence of ileorectal or ileal pouch-anal anastomosis documented in their medical records * participants in remission for over 2 years as documented in their medical records * participants participating in an interventional clinical trial * participants participating in an observational study where the protocol interferes with the c4t study in the opinion of the principal investigator at each site * participants with insufficient command of english to interact effectively with c4t ibd and complete the study questionnaires in the opinion of the principal investigator at each site * participants unable or unwilling to provide their informed written consent to participate in the study
neoadjuvant folfirinox and preoperative chemoradiotherapy for locally advanced rectal cancer patients

Conditions: Rectum Cancer

Summary: a phase ii clinical trial compared standard tnt (mfolfox6 and crt) with preoperative chemoradiotherapy (crt) with neoadjuvant chemotherapy (ct) containing mfolfirinox in patients with locally advanced rectal cancer.

this open-label randomized, two-arm phase ii trial compared the standard total neoadjuvant approach (tnt) with neoadjuvant ct with mfolfirinox and preoperative crt in patients with locally advanced rectal cancer.

Eligibility criteria:
inclusion criteria: 1. histologically proven rectal adenocarcinoma. 2. stages ct3 with risk of local recurrence, ct4, or n positive, m0 and for which a multidisciplinary meeting recommend tnt. 3. resectable tumor, or considered as potentially resectable after crt. 4. no distant metastases. 5. patient eligible for surgery 6. world health organization (who)/eastern cooperative oncology group (ecog) performance status 0/1. 7. no heart failure or coronary heart disease symptoms (even controlled). 8. no peripheral neuropathy \> grade 1. 9. no prior radiotherapy of the pelvis for any reason and no previous ct 10. no major comorbidity that may preclude the delivery of treatment 11. adequate contraception in fertile patients. 12. adequate hematologic function. 13 adequate hepatic function. 14. signed written informed consent. exclusion criteria: 1. metastatic disease 2. unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles contraindication to 5-fu, or to oxaliplatin or to irinotecan, including gilbert disease or genotype ugt1a1 3. medical history of chronic diarrhea or inflammatory disease of the colon or rectum 4. medical history of angina pectoris or myocardial infarction 5. other concomitant cancer. 6. pregnant or breast-feeding woman. 7. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Keywords: neoadjuvant mfolfirinox tnt watch and wait approach complete clinical response sphincter sparing