Kornimate/medical-research-clean huggingface dataset:
belatacept evaluation of nephroprotection and efficacy as first-line immunosuppression (benefit)

Conditions: Kidney Transplantation; Chronic Kidney Failure

Summary: the purpose of this study is to learn if belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. effects on kidney function and patient survival as well as drug safety will also be studied.


Eligibility criteria:
inclusion criteria: * the subject is a recipient of a living donor or deceased donor kidney transplant. * male or female, 18 or older exclusion criteria: * first time recipient, pra \>- 50% or for retransplantation pra \>- 30%. * if retransplantation, previous graft loss cannot be due to acute rejection. * positive cross match. * subject receiving extended criteria donor (ecd) organ * for long-term extension study-subjects who have completed three years of study treatment (through week 156)
online or face-to-face treatment for insomnia?

Conditions: Insomnia

Summary: the object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. in this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. participants on the waiting-list receive online treatment after the first post-test. the investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.


Eligibility criteria:
inclusion criteria: * insomnia disorder according to dsm-5 * sleep onset latency/wake after sleep onset \> 30 minutes , three times or more a week * insomnia three months or longer * access to internet * possibility to travel to one of the treatment sites exclusion criteria: * earlier cognitive behavioral treatment for insomnia * start other psychological treatment in the last 6 months * doing shift work * major depression disorder * pregnancy or breast feeding * schizophrenia or psychosis * suicidal plans * sleep apnea * drugs or alcohol abuse
clinical trial of laparoscopic pelvic and para-aortic lymphadenectomy and uterine blood vessel blocking for precision diagnosis and treatment in advanced cervical cancer

Conditions: Cervical Cancer, Stage IIB; Cervical Cancer Stage IIIA; Cervical Cancer Stage IIIB; Cervical Cancer, Stage IVA

Summary: cervical cancer is the most common reproductive malignancy in developing country. due to local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (figo iib - iva) , so that radiation combined with chemoradiation (rctx) is a traditional treatment nowadays. lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the 5-year survival rate is less than 50%. therefore, it needs to explore a new strategy for improving the prognosis of advanced cervical cancer. the prognosis of cervical cancer is closely related to its stages ,while the current figo clinical stage is too subjective , for example different gynecologic oncologists may give different diagnosis to the same patient. mri, ct, pet/ct imaging examinations are commonly used as a referrence for clinical staging, but the sensitivity and specificity are not satisfied. in addition, lymph node metastasis significantly impacts the prognosis of cervical cancer . however, the lymph node invasion is not in current staging criteria. precision treatment after surgical staging is recommended by nccn recently .surgical staging in patients with advancedcervical cancer is safe and does not delay primary rctx in few randomized study.whether overall survival benefit the long-term clinical follow-up surgical staging is unknown.blocking bilateral uterine artery can effectively reduce the tumor size and increase the operability , which has been conformed in locally advanced cervical cancer. furthermore, ovarian dysfunction caused by rctx could be avoided by ovarian transposition via surgical staging . based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer , which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel blocking and ovarian transportation, in order to perform individualized postoperative rctx, reduce tumor load , preserve ovarian function and improve life quality.


Eligibility criteria:
inclusion criteria: * pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma * the pathological staging:iib,iiia,iiib,iva exclusion criteria: * underwent surgery or radiation and chemotherapy

Keywords: cervical cancer precision medicine individualized treatment surgical staging
conventional-therapy & fes-therapy in-veritas effects study

Conditions: C5 Palsy

Summary: this randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and fes-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent c5 palsy.

this randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and fes-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent c5 palsy. secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and fes-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional mri analysis.

Eligibility criteria:
inclusion criteria: * new unilateral or bilateral, persistent c5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy exclusion criteria: * contraindication for fes-t * contraindication for neurophysiological testing * contraindication for mri scanning * uncontrolled cardiovascular conditions * other medical conditions that can limit treatment protocols * other neurological diseases * significant persisting mental illness * diagnosed learning disabilities * substance abuse over 6 months prior to recruitment * hearing and visual deficits sufficient to affect test performance * reduced passive range of motion (rom) of the shoulder ("frozen shoulder") * inability to participate in and intensive outpatient rehabilitation program

Keywords: functional electrical stimulation therapy degenerative cervical myelopathy
lamictal as add-on treatment for bipolar i disorder in pediatric patients

Conditions: Bipolar Disorder

Summary: the study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with bipolar i disorder. the study consists of 4 phases: screen (approximately 2 weeks), open label phase (up to 18 weeks), randomized phase (up to 36 weeks) and taper and follow-up phase (up to 4 weeks).


Eligibility criteria:
inclusion criteria * subject is male or female between the ages of 10 and 17 years, inclusive. * subject has a diagnosis of bipolar i disorder and is currently experiencing a manic/hypomanic, depressed, or mixed mood episode * subject is currently receiving a stable treatment regimen. * subject is living with his/her custodial parent(s) or legal guardian(s) and has contact with them on a daily basis. exclusion criteria * subject has been diagnosed with a primary axis i disorder (with the exception of bipolar i disorder, adhd, anxiety disorders, oppositional defiant disorder, or conduct disorder) or any axis ii disorder. * subject currently has signs or symptoms of psychosis or a history of psychosis within the previous four weeks. * subject has been diagnosed with epilepsy, autism, asperger's syndrome, or tourette's syndrome. * subject has experienced a serious rash, such as stevens-johnson syndrome or toxic epidermal necrolysis, or a rash otherwise requiring hospitalization. * subject has experienced a rash related to prior lamictal use, or for whom lamictal treatment was discontinued for clinically significant safety reasons. * subject has received any antidepressant medication, or atomoxetine, during the four weeks prior to the screen visit. * subject has initiated psychotherapy within 2 months prior to the screen visit, or plans to initiate psychotherapy during the trial. * subject in the 10-12 year old age group has a body mass index (bmi) less than or equal 15 or greater than or equal to 30; a subject in the 13-17 year old age group has a bmi less than or equal to 17 or greater than or equal to 34. * subject tests positive for illicit drug use at the screen visit, has a history of alcohol or substance abuse or dependence (other than nicotine dependence) within the past three months, or has a positive blood alcohol level at the screen visit. * subject, in the investigator's judgment, poses a current homicidal or serious suicidal risk, has made a suicide attempt within the twelve months preceding the screen visit, has ever been homicidal.

Keywords: bipolar i pediatric lamictal adolescent
gastrointestinal and health-related quality of life outcomes in patients with simultaneous pancreas-kidney transplants

Conditions: Pancreas Transplantation; Kidney Transplantation

Summary: treatment with the immunosuppressive drug mycophenolate mofetil (mmf) may result in gastrointestinal (gi) complications in some patients. this study will assess if a switch from mmf to enteric-coated mycophenolate sodium (ec-mps) results in improved gi and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any gi complaints under mmf-based immunosuppressive treatment.


Eligibility criteria:
inclusion criteria: * received simultaneous pancreas-kidney (spk) transplant at least 3 months prior to study enrollment * receiving immunosuppressive regimen that includes mmf in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mtor inhibitor, steroids at least for three months at time of study enrollment) * receiving mmf for at least 1 month prior to enrollment; maximal mmf dose 2000 mg/d. exclusion criteria: * patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also scp of ec-mps) * if applicable, gi symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea) * acute rejection \< 1 month prior to study enrollment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: simultaneous pancreas-kidney transplantation mycophenolate gi problems
the effect of microneedle pretreatment on topical anesthesia

Conditions: Pain

Summary: this study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.

this study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. the study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. the study will be performed on the volar forearm. prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * allergy to lidocaine * smokers
pursed lip breathing in interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: this randomized, cross-over study aims at describing the effect of pursed lip breathing on exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.

the use of pursed lip breathing (plb) to improve exercise tolerance in copd patients has been widely documented. however, its efficacy in patients with interstitial lung disease (ild) has yet to be confirmed. this study aims to determine if plb improves perceived exertion and exercise capacity during a six-minute walk test (6mwt) in patients with ild. to achieve this, a prospective randomized crossover trial will be performed, in which patients with ild and restrictive ventilatory defect will be recruited via the ild clinic of hôpital notre-dame. the study will be performed in a single visit, on the day where patients attend a routine physician-prescribed follow-up 6mwt. patients will be asked to perform a total of two 6mwt. patients will be randomized to perform the first test with or without using plb, and the order will be reversed for the second test, with patients serving as their own control. during tests, ventilatory variables will be continuously measured using a portable metabolic cart. the observed parameters will be: perceived exertion using the modified-borg scale, respiratory rate, minute-ventilation, heart rate, peripheral oxygen saturation, and 6-minute walk distance (6mwd). it is expected that the use of plb will be associated with a decrease of at least one unit on the modified borg scale, which would be clinically significant. moreover, it is expected that the decrease in dyspnea with plb will be related to a decrease in respiratory rate minute ventilation during 6mwt. the clinical impact of this study could be significant as therapies allowing the improvement of dyspnea in patients with ild are scarce.

Eligibility criteria:
inclusion criteria: * diagnosis of interstitial lung disease, based on the results of a multidisciplinary diagnosis discussion. * restrictive ventilatory defect (i.e. total lung capacity (tlc) \< 80% of predicted value) on pulmonary function testing. exclusion criteria: * active cancer * history of severe heart disease * neurological or orthopaedic problem that could interfere with exercise performance * physiological mixed syndromes (i.e. concomitant restrictive and obstructive defects) * exacerbation of disease or hospitalisation in the last 4 weeks prior to enrollment * long-term oxygen therapy

Keywords: pursed lip breathing interstitial lund disease exercise physiology
comparision of the analgesic effects of intravenous ibuprofen and tenoxicam in acute migraine attack

Conditions: Migraine; Analgesic Affect; Emergency Medicine

Summary: the aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. the main questions it aims to answer are: 1. is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics? 2. is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack. treatments will; 1. be administered in 100 cc saline to ensure blinding in the group. 2. randomisation will be done by closed envelope method. 3. numerical pain scale (nrs) will be used to evaluate the analgesic efficacy of the drugs. nrs scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment. 4. any side effects due to medication will be recorded.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65. * having a known diagnosis of migraine. * exclusion of secondary causes to explain the headache in the emergency department. * having migraine during a migraine attack and not having received any medical treatment for migraine before the application. exclusion criteria: * being under 18 years of age. * being pregnant or breastfeeding. * being admitted to the emergency department with headache due to causes other than migraine (secondary). * being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission. * having a history of allergy to any of the drugs to be used in the study. * having a history of comorbidities for which the drugs to be used in the study are contraindicated.

Keywords: anti-inflammatory agents non-steroidal acute migrane attack
anatomical classifications of inferior mesenteric artery

Conditions: Colorectal Cancer

Summary: the vascular branches of inferior mesenteric artery (ima) involve superior rectal artery(sra),sigmoid artery(sa) and the left colic artery(lca). different levels of ligation of the (ima) are applied in rectal cancer surgery, including retain or not retain the left colic artery(lca). retained the lca would facilitate the vascularity. the variations of vessels are more frequent in the combinations of branches, while lca, sa and sra may vary from people to people. which contribute to the difficulty of surgery to retain the lca.. as a result, a better understanding of the anatomical branches classification of ima is a must during operation. however, existing studies of ima's branches combination are very rare and often single-centered with minimal samples. in order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of ima and the surgical outcome of each type


Eligibility criteria:
inclusion criteria: 1. patients who undergoing laparoscopic rectal cancer surgery. 2. pathology: adenocarcinoma or huge adenomas proven by colonoscopic biopsy. 3. localization: tumor located between distal sigmoid colon and anal canal. 4. patients have to be aware of the aim of the trial, and have signed the informed consent. exclusion criteria: 1. history of any gastrointestinal surgery. 2. patients with emergent surgery.
the objective of this study is to evaluate the efficacy and safety of botulax® in patients with essential blepharospasm.

Conditions: Essential Blepharospasm

Summary: the purpose of this study is evaluate the efficacy and safety of botulax® in the treatment of essential blepharospasm.

multi-center, single arm, open-label, phase iv clinical trial to evaluate the efficacy and safety of botulax® in subjects with essential blepharospasm

Eligibility criteria:
inclusion criteria: 1. men and women at the age of 18 or older 2. subjects diagnosed with essential blepharospasm with jankovic rating scale (jrs) frequency and severity sum score ≥2 at screening 3. individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form 4. subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study exclusion criteria: 1. subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication 2. subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.) 3. subjects with secondary blepharospasm 4. subjects with the hemifacial spasm 5. subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study 6. subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin hcl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics) 7. subjects who administered medications similar to the investigational product (botulinum toxin type a) within 12 weeks 8. subjects with systemic neuromuscular junction disorders: myasthenia gravis, lambert-eaton syndrome, or amyotrophic lateral sclerosis 9. pregnant and lactating women 10. women of childbearing potential who are planning to become pregnant within the next 3 months or are not using an appropriate method of contraception (contraceptive methods with an annual failure rate of less than 1% if used properly and continuously, including implant, injection, oral contraceptive, at least one barrier method such as intrauterine device \[iud\], hormone iud, abstinence, or vasectomized partner)

Keywords: essential blepharospasm
study to compare the efficacy and safety of passive immunization with tnm002 injection and human tetanus immunoglobulin as prophylaxis against tetanus

Conditions: Tetanus

Summary: tnm002 injection is a recombinant fully human native monoclonal antibody (mab) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.


Eligibility criteria:
inclusion criteria: 1. chinese male or female adults aged ≥ 18 years; 2. participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus; 3. participants who provide signed written informed consent form. exclusion criteria: 1. known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins; 2. suspect or diagnosed as tetanus; 3. previously diagnosed as immunoglobulin a (iga) deficiency with anti-iga antibodies 4. prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; 5. current alcohol abuse, drug abuse or drug addiction other protocol defined inclusion/exclusion criteria may apply

Keywords: tetanus prophylaxis
postoperative incidence of atrial fibrillation following cardiac surgery

Conditions: Atrial Fibrillation (AF); Hypomagnesemia; Cardiac Surgery

Summary: introduction: postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. in this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation. methods: an analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.


Eligibility criteria:
inclusion criteria: * adults in postoperative cardiac surgery exclusion criteria: * preoperative atrial fibrillation * without complete information regarding plasmatic magnesium postoperative measurements