Kornimate/medical-research-clean huggingface dataset:
trial of impact of crime group intervention for jail inmates

Conditions: Crime; Substance Abuse; HIV Risk; Criminogenic Thinking; Shame

Summary: this pilot study is designed to evaluate the efficacy of the impact of crime (ioc) group intervention for jail inmates. the hypothesis is that participants in ioc will show decreases in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy, which in turn will be reflected in reduced recidivism (official records and self report), relative to those randomly assigned to a treatment as usual group.


Eligibility criteria:
inclusion criteria: * must be 18 years or older * must be male * must be currently incarcerated jail inmate * must be sentenced * must speak, read, and write in english with sufficient proficiency to use workbook and participate in group sessions * must be assigned to the jail's "general population" exclusion criteria: * actively psychotic * assigned "keep separate" from other group members

Keywords: crime substance abuse hiv risk criminogenic thinking shame guilt restorative justice victim impact group
difference between rehabilitation therapy and stem cells transplantation in patients with spinal cord injury in china

Conditions: Spinal Cord Injuries

Summary: the morbidity of spinal cord injury (sci) is increasing significantly in china. the methods to treat sci patients in sequela stage update are poor. though traditional rehabilitation therapy is the routine method to treat sci in sequela stage, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. rehabilitation therapy can prevent the process of muscle atrophy and joint stiffness. however, it can not repair the damaged nerve function. studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of sci in animals without any severe side effect. in this study, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 sci patients (20 cases in early stage and 20 cases in sequela stage). the investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients who accept neither stem cell therapy nor rehabilitation. on this basis, the investigators can compare the efficacy of these two treatments.

patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.

Eligibility criteria:
inclusion criteria: 1. patients or their curator must be able to give voluntary consent. 2. patients or their curator must be able to understand the information of study and in which group they are. 3. 20 years - 50 years of age can be enrolled. 4. both male and female can be enrolled. 5. patients have clear history of traumatic injury, and the spinal cord injury are confirmed by all of the examinations including mri, electromyogram and electrophysiology. exclusion criteria: 1. mental disorders 2. myelitis 3. women in pregnancy 4. cancer

Keywords: spinal cord injuries stem cell transplantation rehabilitation
efficacy of licorice on reducing salivary streptococcus mutans versus chlorohexidine in caries risk patients

Conditions: Caries, Dental

Summary: to compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.

a total number of fifty-two patients will be enrolled in the study. they will be divided into two groups: study group and control group. study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. salivary bacterial count will be evaluated for both groups.

Eligibility criteria:
inclusion criteria: * over 18 years old * co-operative patients * not allergic to licorice * not allergic to chlorohexidine exclusion criteria: * pregnancy * allergic patients to licorice * allergic patients to chlorohexidine * lack of compliance * evidence of parafunctional habits * patients with periodontal disease * xerostomia * participants that receive any microbial agent two weeks prior to the study

Keywords: streptococcus mutans licorice chlorohexidine caries index
aortic distensibility

Conditions: Abdominal Aortic Aneurysm

Summary: can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

hypothesis: ecg-gated multidetector ct and ecg-gated dual source ct can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Eligibility criteria:
inclusion criteria: * aaa must be at least 3 cm to a maximum 4.9cm cross-sectional diameter. * bmi 31 or less. * creatinine results \<2.0 and within six months prior to scan. * us patients must have only normal creatinine (0.9 to 1.4) for one year before study visit. * patients who are originally scheduled for us, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial cta. exclusion criteria: * creatinine \> 2.0. * creatinine \ 1.4 for those who are scheduled for us. * atrial fibrillation or other arrythmia. * known aaa greater than 5 cm in size. * allergy to contrast dye.

Keywords: abdominal aortic aneurysm
study of tislelizumab in combination with chemotherapy compared to chemotherapy alone for participants with urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.


Eligibility criteria:
key inclusion criteria: 1. male or female aged 18 to 75 years on the day of signing the informed consent form (icf) 2. histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (uc) 3. must be eligible to receive cisplatin or carboplatin in the investigator's judgment 4. have had no prior systemic chemotherapy for locally advanced or metastatic uc 5. must be able to provide fresh or archival tumor tissues with an associated pathological report. 6. must have evaluable disease (either measurable or non-measurable) as defined per recist v1.1. 7. eastern cooperative oncology group (ecog) performance status 0 or 1. 8. adequate organ function before randomization: key exclusion criteria: 1. received prior therapies targeting pd-1, pd-l1, pd-l2, ctla4, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways. 2. any approved anticancer therapy within 28 days before randomization. 3. active leptomeningeal disease or uncontrolled, untreated brain metastasis 4. participants with uncontrolled hypercalcemia 5. participants with active autoimmune diseases or history of autoimmune diseases that may relapse 6. history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases 7. a known history of hiv infection. 8. prior allogeneic stem cell transplantation or organ transplantation. 9. history of severe hypersensitivity reactions to other monoclonal antibodies. 10．history of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds. note: other protocol defined inclusion/exclusion criteria may apply.
singapore tympanostomy tube delivery system study

Conditions: Otitis Media

Summary: the objective of the study is to evaluate the safety and efficacy of the acclarent tympanostomy tube delivery system (ttds) in the placement of tympanostomy tubes (tts) in patients indicated for such treatment for chronic otitis media with effusion (ome) or recurrent acute otitis media (aom).


Eligibility criteria:
inclusion criteria: 1. \>= 1 year of age 2. diagnosed with either chronic otitis media with effusion or recurrent acute otitis media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion. 3. either male or female - exclusion criteria: 1. history of sensitivity or reaction to anaesthesia 2. markedly atrophic, retracted, atelectatic or perforated tympanic membrane. 3. otitis externa 4. active acute otitis media 5. thickened tympanic membrane 6. thick mucoid effusion (also known as "glue ear") 7. otitis media pathology requiring t-tubes -
effect of core stability versus conventional exercise for functional ambulation of calf muscle

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (koa) is a degenerative joint disease causing pain, stiffness, and reduced quality of life. while treatments often focus on drugs or surgery, noninvasive exercises like core stabilization and ankle/foot strengthening show potential but lack comparative studies. understanding anatomical factors like achilles tendon (at) thickness is crucial for targeted rehabilitation, though measurement reliability remains an issue. this study aims to compare the effects of these exercises on koa symptoms and evaluate the use of digital calipers for at thickness measurement, aiming to enhance clinical management of koa.

the objective of the study is: 1. to determine the interrater and intrarater reliability of digital calliper to measure the side to side achilles tendon thickness. 2. to determine the impact of 24 sessions of core stability translated in gait ambulation. 3. determines the relationships between achilles tendon thickness (att), knee symptoms/functions, and foot alignment in knee oa patients, considering their interconnected biomechanical nature. 4. compare the effects of core stability and ankle-foot strengthening exercises on clinical outcomes in koa patients

Eligibility criteria:
inclusion criteria: * 40 years old, had been diagnosed with koa based on acr, and * having grade ii or iii osteoarthritis by k/l criteria. exclusion criteria: * post-traumatic osteoarthritis * lower limb sensorimotor dysfunction, * any history of knee fracture/ tumor/ infection and hip/knee surgery. * total knee replacement patients. * neurological disease. * patient received physical therapy treatment from last 6 months. * inflammatory arthritis (rheumatoid arthritis) * use of any intra-articular injections (steroid/ hyaluronic acid/ prp.) from last 3-6 months.

Keywords: knee arthritis tendon
a prospective multicenter study to assess the clinical outcomes of current phacoemulsification approach to cataract extraction versus the micor system device

Conditions: Cataract Surgery

Summary: the purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the micor system device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.

this is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the micor system device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. only fda cleared phacoemulsification devices can be used per indications. both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. the 3 arms of the study groups are as follows: * group 1 phaco subject cohort. * group 2 micor system subject cohort, non-use of miloop. * group 3 micor system subject cohort, use of miloop optional.

Eligibility criteria:
inclusion criteria: 1. able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits. 2. willing and able to understand and complete the informed consent document. 3. subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery. 4. subjects ≥ 18 years of age. exclusion criteria: 1. subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction. 2. concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit. 3. subjects that are pregnant, lactating or planning to become pregnant during the course of the study.
gut microbiome in orthopaedics: revision total knee arthroplasty

Conditions: Revision Total Knee Arthroplasty; Osteoarthritis, Knee

Summary: many patients who receive knee replacement surgery must return for a revision (or repeat) surgery due to ongoing pain, stiffness, infection, or implant loosening. the role of the gut microbiome-the collection of bacteria and other microbes within the human gastrointestinal tract-is just beginning to be recognized in orthopaedics. the gut microbiome has been found to affect the immune response and bone regulation, potentially contributing to infection or loosening after total joint replacement. antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, yet they might also harm gut microbiota and reduce their potentially beneficial effects. as a result, understanding the relationship between gut microbiota and surgical outcomes has become increasingly important. therefore, this study aims to determine if there are differences in gut microbiota composition between patients with well-functioning knee replacements and those requiring revision knee replacements. additional study aims include assessing inflammation, implant loosening, metal ion levels, and circulating bacteria in blood or tissue between well-functioning or failed knee replacements.


Eligibility criteria:
inclusion criteria: * scheduled to undergo a revision tka * willing and able to comply with follow-up requirements * ability to provide informed consent * ability to read, write, and speak english exclusion criteria: * pregnancy * less than 3 months post-operation from primary surgery * diagnosis of periprosthetic fracture * scheduled for dair (debridement, antibiotics, and implant retention) revision surgery * scheduled for stage 2 pji revision

Keywords: revision tka gut microbiome implant loosening inflammation weight-bearing computed tomography pet/ct
endometriosis and brominated flame retardant (endotox study)

Conditions: Endometriosis

Summary: the investigators wish to highlight, in a case-control design, if there is an increased concentration of bfrs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . pairing will be operate on age (+/- 5 years compared to the case ) , bmi ( bmi 5 classes described by the has) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .


Eligibility criteria:
inclusion criterion for de cases : * age : 18-45 years old * deep endometriosis with or without endometriomas that need surgery (clinical examination, mri, surgery) * accessing to the omental and/or parietal adipose tissue * non opposition of the patients for the samples collection and consent for the present study. inclusion criterion for the controls : * patients without any history of endometriosis and without suggestive symptomatology. often patients operated for cesarean section. * possible access to the adipose tissue of the omentum or abdominal wall exclusion criterion for the cases : * pregnancy * death exclusion criterion for controls : * pregnancy * death

Keywords: endometriosis, chemical contaminants, bfrs
topical itraconazole in the treatment of basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: this research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.

basal cell carcinoma is the most common type of skin cancer in caucasians worldwide. although rarely metastatic, it can be locally destructive causing disfigurement and pain. current therapies include surgical removal, local destruction, radiotherapy and others. advances in understanding the molecular basis behind bccs indicate that mutations in the hedgehog signaling pathway can lead to the development of many sporadically occurring basal cell carcinomas (bccs). an oral drug that targets the hedgehog signaling pathway has been shown to be effective in treating patients with metastatic and inoperable bccs. there is evidence that itraconazole, a commonly prescribed antifungal medication may also affect this pathway. it is not known whether itraconazole ointment applied topically can affect the growth of bccs.

Eligibility criteria:
inclusion criteria: * participants must be over the age of 18 years * male * women who do not have child-bearing potential (history of hysterectomy, post-menopausal) * have a biopsy confirmed bcc that measures at least 6mm in size at the time of the initial evaluation (visit #1); * participant must be willing and comply with the requirements of the protocol; * participant must have the ability to understand and communicate with the investigator; * participant must provide informed consent. exclusion criteria: * subject with significant congestive heart failure (chf) or history of chf, chronic renal failure, hepatic failure, neuropathy * subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous t-cell lymphoma, erythroderma; * subjects on systemic medications known to affect the hedgehog pathway (see appendix i) * subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine * subjects with history of hypersensitivity to azoles * subjects with gorlin syndrome * subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than bcc/squamous cell skin cancers) * subjects who do not speak english or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator; * subjects with a history of keloids or excessive scarring; * subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum * women of child-bearing age/potential and/or able to conceive

Keywords: skin cancer basal cell carcinoma
a clinical study evaluating the safety, tolerability and initial efficacy of skg0106 intravitreal injection in diabetic macular edema (dme) patients

Conditions: Diabetic Macular Edema

Summary: this is a clinical study to evaluate the safety, tolerability and initial efficacy of skg0106 intravitreal injection in diabetic macular edema (dme) patients.

this is an open, dose-escalation clinical study to evaluate the safety, tolerability and initial efficacy of skg0106 intravitreal injection in diabetic macular edema (dme) patients in china.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained prior to all assessments. * age ≥18 years at screening. * type 1 or type 2 diabetes mellitus at screening. * study eye criteria: * decreased visual acuity attributable primarily to dme. * dme involves the macular center. exclusion criteria: * active proliferative diabetic retinopathy in the study eye. * any current or previous ocular disease in the study eye other than dme that could interfere with macular evaluation or affect central vision at screening or baseline. * any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline. * history of idiopathic or autoimmune uveitis in the study eye at screening or baseline. * prior gene therapy in either eye. * history of vitreoretinal surgery in the study eye. * uncontrolled blood pressure at screening or baseline defined as systolic blood pressure (sbp) ≥160 mmhg or diastolic blood pressure (dbp) ≥100 mmhg. * history of treated or untreated malignancy of any organ system within the past 5 years. * pregnant or lactating women. * women of reproductive age, defined as all women who are biologically capable of being pregnant, unless they use highly effective contraceptive methods between the time of study drug administration and 3 months after eos (end of study).

Keywords: dme
impact of evolocumab in cardiac transplant patients with cav

Conditions: Heart Transplant

Summary: coronary allograft vasculopathy (cav) is diffusely accelerated atherosclerosis of a transplanted heart. evolocumab (repatha) is an fda-approved drug for lowering low density lipoprotein (ldl) in patients who have not received a heart transplant. this drug works as a pcsk9-inhibitor. the primary objective of this study is to measure the impact of pcsk9-inhibitors on serum ldl in heart transplant patients with cav after 12 weeks compared to baseline.

heart transplant remains the treatment of choice for patients with advanced heart failure. coronary allograft vasculopathy (cav) is diffusely accelerated atherosclerosis of the donor heart, and limits long term survival after transplant. the pathophysiology of cav is complex and involves smooth muscle proliferation, inflammatory infiltrates, and lipid deposition. to date, only statin therapy has reduced cav-related mortality. pcsk9 inhibitors are a new lipid lowering therapy shown to reduce cardiovascular clinical events in patients with coronary artery disease. we hypothesize that pcsk9 inhibition via evolocumab will significantly lower low density lipoprotein (ldl) and be well-tolerated in transplant patients with cav. this phase ii, open label, single center trial with enroll up to 40 heart transplant patients with cav for treatment with evolocumab for one year. the primary outcome will be percent change in ldl at 12 weeks. secondary outcomes will include change in cav progression, impact of evolocumab on immunosuppression regimens and transplant rejection, and change in serum lipids after 52 weeks. results of this study are intended to provide safety data in heart transplant patients with cav and assess secondary outcomes including cav progression and impact on immunosuppression and transplant rejection.

Eligibility criteria:
inclusion criteria: * heart transplant patients 19-80 years of age * coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac catheterization * able to provide signed informed consent exclusion criteria: * cardiac allograft vasculopathy (cav) grade 3 * rejection requiring iv therapy in the prior 3 months * infection requiring iv therapy in the prior 3 months * active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3 times the upper limit of normal * current or recent use of a pcsk9 inhibitor within the past 12 weeks * organ transplant recipient other than heart * renal dysfunction defined as glomerular filtration rate (gfr) \< 20 ml/min * known allergy to evolocumab or its components

Keywords: coronary allograft vasculopathy lipid heart transplant low density lipoprotein proprotein convertase subtilisin/kexin type 9 pcsk9