Kornimate/medical-research-clean huggingface dataset:
slow and accelerated rehabilitation protocols

Conditions: Rotator Cuff Injuries; Rotator Cuff Tears; Pain, Shoulder

Summary: latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

a variety of surgical options are proposed in the treatment of massive cuff tears. the treatment options include acromioplasty and tuberoplasty, partial repair with or without soft tissue augmentation, latissimus dorsi transfer (ldt), superior capsular reconstruction (scr), and reverse total shoulder arthroplasty. among these options, ldt is a well-recognized technique that aims to rebalance the soft tissue tension around the shoulder joint in order to prevent superior escape of the humeral head and loss of function. from a biomechanical standpoint, the transferred tendon is theorized to function as a humeral head depressor by means of a tenodesis effect, as well as by increasing the active external rotation through the transfer vector. it is an established treatment option with favorable results, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Eligibility criteria:
inclusion criteria: * being in the age range of 18-65 years * being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests * symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months * having a good command of the turkish language * scoring above 24 in the mini mental state test * ≥80% compliance in completing the post-arcr phase 1 trainings * volunteering to participate in the study exclusion criteria: * diabetes mellitus * neurological problems * cervical disc herniation * visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.) * systemic inflammatory problems * hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization * former shoulder fractures on the affected side * advanced glenohumeral arthritis (hamada grade 3), * deltoid muscle dysfunction, * irreparable subscapularis tears, * active infection, * shoulder stiffness, * a history of previous shoulder surgery

Keywords: rotator cuff injuries tear pain shoulder
registry for hirschsprung disease of the belaps

Conditions: Hirschsprung Disease

Summary: registry for hirschsprung disease of the belaps (belgian association of pediatric surgery) protocol short title/acronym / sponsor name belaps principal investigator prof. dr. marc miserez medical condition or disease under investigation hirschsprung's disease purpose of clinical study to register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with hirschsprung's disease in belgium. primary objective the primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. secondary objective (s) evaluating the long-term results and evaluate risk factors for constipation / incontinence. study design prospective registry endpoints krickenbeck score, urinary, sexual and qol evaluation


Eligibility criteria:
inclusion criteria: hirschsprung disease, surgery exclusion criteria: -
prognostic prediction of npc based on mr diffusion-weighted imaging

Conditions: Patients With Nasopharyngeal Carcinoma

Summary: the purpose of this study is to explore whether the imaging model based on resolve-dwi sequence can exploiting the heterogeneity of nasopharyngeal carcinoma and indicate the prognosis, so as to provide intervention information for clinical decision-making. all patients were randomly divided into the training group and the validation group. radiomics features extracted from t2-weighted, dwi, apparent diffusion coefficient (adc), and contrast- enhanced t1-weighted were used to build a radiomics model. patients'clinical variables were also obtained to build a clinical model. model of training cohort was established using cross-validation for nasopharyngeal carcinoma prognosis by machine learning, including logistics regression, svm, knn, decision tree, random forest, xgboost, and then, the model will be verified in the validation cohort. area under the curve (auc) of the machine learning model was used as the main evaluation metric.


Eligibility criteria:
inclusion criteria: 1. patients with nasopharyngeal carcinoma diagnosed by pathology; 2. complete clinical data and mr imaging data; 3. without radiotherapy, chemotherapy or operation before mr examination. exclusion criteria: 1. incomplete follow-up data; 2. poor image quality and can not be used for analysis; 3. patients with other tumors in the past or at the same time.
clinical applications of a joystick in femoral shaft fractures

Conditions: Femur Shaft Fracture

Summary: this study will use a new "h" joystick for reduction on patients with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

this study will design a new "h" joystick for reduction (which has received the national utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Eligibility criteria:
inclusion criteria: * femur shaft fractures exclusion criteria: * not suitable to receive intramedullary nail treatment

Keywords: closed reduction locked intramedullary nailing
evaluating effects of curcumin in moderate to severe asthmatics

Conditions: Asthma

Summary: the purpose of this investigator-initiated study is to evaluate the effects of oral curcumin supplementation versus placebo in adult patients with moderate to severe asthma. curcumin, a derivative of turmeric, has been shown in animal models to inhibit the secretion of pro-inflammatory cytokines and decrease airway constriction and hyperreactivity with only a few observational studies available in humans with discordant results.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 and older 4. physician diagnosed moderate to severe asthma: (gina 2018) a. stable asthma that requires ics/laba and/or an additional controller agent (i.e. ltra, lama) 5. ability to take oral medication and be willing to adhere to the regimen 6. ability to speak and read english 7. if female and sexually active, should use effective forms of birth control exclusion criteria: 1. current use of turmeric (curcumin) or use within the last 7 days 2. current use of biologic therapy/ immunotherapy/ or bronchothermoplasty 3. pregnancy or lactation 4. known allergic reactions to components of turmeric (curcumin) 5. current use of anticoagulants, and history of coagulopathy or liver disease 6. inr greater than 2.0, ptt greater than 45.0 seconds

Keywords: asthma curcumin
parents as the agent of change for childhood obesity (paac)

Conditions: Obesity

Summary: the objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. this study provides state-of-the-art treatment for childhood obesity. parents and children will participate in treatment groups for 6 months. these treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. we are currently implementing this treatment in the healthy choices program which is part of the childhood obesity clinic at the university of minnesota. len epstein at the university of buffalo has been publishing on this treatment protocol for 30 years.

the objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. the central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. the specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity. the primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity. the secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment. this study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. the two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.

Eligibility criteria:
inclusion criteria: * an overweight child (\>95th%) in the family who is between the ages of 8-12. * a parent willing to participate and attend all treatment meetings. * family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment. * family willing to submit the $60 deposit. exclusion criteria: * child psychiatric disorder diagnoses (based on parent report). * child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed. * family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home. * child with physical difficulties that limit the ability to exercise. * child with an active eating disorder. all exclusionary and inclusionary criteria are similar to those in previous studies of epstein and colleagues and golan and colleagues.

Keywords: obesity childhood obesity exercise nutrition
an observational study in the united states to learn how venous thromboembolism, disseminated intravascular coagulation, and sepsis are related

Conditions: Sepsis; Venous Thromboembolism; Disseminated Intravascular Coagulation

Summary: this is an observational study in which data already collected from people with venous thromboembolism (vte) due to sepsis (blood poisoning) are studied. these people were hospitalized in an intensive care unit (icu) and may or may not have had disseminated intravascular coagulation (dic). in this observational study, only observations are made without participants receiving any advice or changes to their healthcare. vte is a condition that occurs when blood clots form in the veins, which can be dangerous. dic is a serious blood disorder that can cause clots throughout the body, blocking blood flow. people who have sepsis are at a higher risk of developing both vte and dic. researchers wanted to know if people who have sepsis developed dic before developing vte. to prevent vte in people with sepsis, it is important to know how severe the sepsis is, how it progresses, and whether dic is also present or not. in this study, researchers will assess patient data from a medical database in the united states (us). the main purpose of this study is to learn if there is a relationship between sepsis, dic, and vte. to do this, researchers will divide the participants with vte due to sepsis into three groups as follows: * participants who were diagnosed with dic based on the extent of blood clotting * participants who likely had dic but it was not diagnosed * participants who did not develop dic during the same hospital visit the researchers will collect the following information: * the number of participants who had vte due to sepsis also had dic * the change in participants' laboratory results and vital signs, such as heart rate and blood pressure, from the time their sepsis was diagnosed to the time their vte and dic were diagnosed the researchers will study the data collected between january 2007 and december 2021. the data will come from the participants' information stored in a database called the optum vte ehr which collects patient medical data from hospitals across the us. in this study, only available data from routine care are collected. no visits or tests are required as part of this study.


Eligibility criteria:
inclusion criteria: * admitted to an icu with the diagnosis of vte and sepsis during the same hospital icu admission exclusion criteria: * less than 18 yrs old * less than 365 days data available prior to index vte
allogeneic abcb5-positive dermal mesenchymal stromal cells for treatment of epidermolysis bullosa (phase iii, cross-over)

Conditions: Epidermolysis Bullosa

Summary: the aim of this clinical trial is to investigate the safety and efficacy of allo-apz2-ots administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (rdeb) compared to placebo. an additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-apz2-ots administered intravenously to subjects with jeb and to rdeb subjects \< 1 year.


Eligibility criteria:
inclusion criteria: 1. male or female subjects with a diagnosis of rdeb or jeb confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping (ifm); 2. subject is eligible to participate in this clinical trial based on general health condition; 3. subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and \< 9 months, no signs of acute infection; 4. patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure; 5. women of childbearing potential must have a negative urine pregnancy test at visit 1. women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial. exclusion criteria: 1. any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma; 2. any known allergies to components of the ip or premedication; 3. patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol; 4. pregnant or lactating women; 5. current or previous (within 30 days of screening) treatment with another ip, or participation and/or under follow-up in another interventional clinical trial; 6. previous participation in this clinical trial (except for screening failures); 7. clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; confidential 8. employees of the sponsor, or employees or relatives of the investigator.
chronic hypertension and pregnancy 2 (chap2) pilot project

Conditions: Hypertension in Pregnancy

Summary: the chap2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (htn) in pregnancy improves maternal and or neonatal outcomes. the primary objective of this pilot study is to determine if anti-htn treatment to bp\<130/80mmhg in pregnant patients with stage 1 htn is associated with a difference in birthweight percentile at delivery. patients with stage 1 hypertension in pregnancy will be randomized to bp goals of \<130/80mmhg or usual care to treatment only if bps ≥140/90mmhg. for this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to bp\<130/80mmhg and 37 to usual care.


Eligibility criteria:
inclusion criteria: * viable singleton gestation * no fetal anomalies * blood pressures 130-139/80-89mmhg on two occasions at least 4 hours apart prior to 20 weeks gestation * planning to deliver at uab hospital * no indication for pregnancy termination * receiving care at the uab prenatal clinics exclusion criteria: * declines randomization * known diagnosis of chronic hypertension ( bp ≥ 140/90mmhg) or current antihypertensive medication use * fetal demise diagnosed prior to enrollment * known major structural of chromosomal abnormalities prior to enrollment * contraindication to first line antihypertensive (nifedipine/ labetalol) * comorbidities requiring bp goals \< 130/80mmhg
intracardiac cd133+ cells in patients with no-option resistant angina

Conditions: Stable Angina

Summary: the purpose of the study is to evaluate the efficacy of therapy with autological cd133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. the main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.

patients with a stable angina pectoris (ccs ii-iv) can potentially benefit from treatment with autological cd133+ cell populations, which include cells with a higher expression of cardiac and endothelial differentiation markers. regent vsel trial will include patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. the main objective of the study is to assess the treatments influence on: * improvement of myocardial perfusion * global and segmental contractility (lvef) * occurrence of symptomatic angina * quality of life regent vsel is a prospective, randomized, double blind, placebo-controlled study with a planned number of 60 patients. randomization will be carried out according to a 1:1 mode. every patient will undergo a bone marrow aspiration. cd133+ cells will be isolated from bone marrow aspirates. patients randomized to experimental group will receive isolated cells (direct left ventricular muscle administration). patients enrolled to control group will get only a placebo solution injected into the muscle.

Eligibility criteria:
inclusion criteria: 1. stable angina ccs ii-iv despite maximum pharmacotherapy for at least 2 weeks since last medications change 2. presence of ≥ 1 myocardial segment with ischemia features in tc-99m spect 3. patients disqualified from revascularization procedures by heart team 4. patient age \> 18 and \< 75 year old 5. patient must provide written informed consent for participation in study exclusion criteria: 1. acute coronary syndrome in less than 6 months prior to enrollment 2. heart failure nyha iii-iv 3. lvef \<35% 4. presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm 5. previous cardioverter-defibrillator or cardiac stimulator implantation 6. allergy to contrast agents 7. history of malignancy 8. hiv, hbv, hcv infection 9. life expectancy less than 6 months 10. bleeding diathesis 11. renal insufficiency (gfr \< 30 ml/min/1.73m2) 12. pregnancy, lactation, or ineffective contraception in women of childbearing potential

Keywords: cd133+ stem cells coronary artery disease stable angina pectoris
vaginal stump infection after laparoscopic hysterectomy

Conditions: Laparoscopic Hysterectomy; Vaginal Infection

Summary: comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.

comparing two surgical techniques for vaginal stump infection after total laparoscopic or robot-assisted hysterectomy. analysis of patient-based and therapy-based risk factors with the aim of optimizing the surgical technique and objectifying the risk factors. control group: old colpotomy technique (3 z-sutures pds 0); intervention group: new colpotomy technique (3 z sutures with pds 0 and 1 continuous suture with v-loc 2-0)

Eligibility criteria:
inclusion criteria: 1. patient \> = 18 years old 2. indication for total laparoscopic or robot-assisted hysterectomy 3. benign uterine disease 4. signed informed consent for study participation exclusion criteria: 1. patient with malignant gynecological diseases 2. combination with other abdominal / vaginal interventions, except: * adhesiolysis * endometriosis removal (without rectovaginal endometriosis) * conization * hysteroscopy / curettage 3. immunosuppressive therapy with cytostatics, glucocorticoids, hiv 4. bleeding tendency / haemophilia 5. acute infection

Keywords: vaginal closure technique
miromatrix biological mesh for hiatal hernia repair

Conditions: Hiatal Hernia

Summary: miromatrix medical has developed miromesh® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. miromesh received fda 510(k) clearance with an indication for reinforcement of soft tissue on march 31, 2014 under k134033. this study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting miromesh for hiatal hernia repair.


Eligibility criteria:
inclusion criteria: * between 18 and 80 years old on the day of study enrollment * able and willing to sign the consent form and comply with all study visits and procedures * able to undergo elective laparoscopic hiatal hernia repair * free of cognitive or speech impairment * documented, symptomatic type ii or iii hernia ≥5cm in the axial/vertical dimension * commit to non-smoking for at least 4 weeks prior to procedure exclusion criteria: * previous operation of the esophagus or stomach * sensitivity to porcine material * pregnant or plan to be pregnant within next 2 years * immunocompromised or at risk of immunosuppression (i.e. be hiv positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the investigator * require emergent operation for acute gastric volvulus or strangulation * american society of anesthesiology (asa) class 4 or greater * bmi ≥40 * life expectancy of less than 2 years at the time of enrollment * associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. crohn's disease) * any condition in the opinion of the investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements