Kornimate/medical-research-clean huggingface dataset:
care management for the effective use of opioids

Conditions: Low Back Pain; Pain

Summary: the care management for the effective use of opioids (cameo) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. the study aims are to compare the interventions' (pharm vs. beh) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.

the general purpose of the care management for the effective use of opioids (cameo) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in va primary care settings for chronic low back pain (clbp). the cameo trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for clbp. the investigators' study sample will target 272 veterans with moderate to severe clbp despite long-term opioid therapy. patients from five primary care clinics at the roudebush va medical center and two community based outpatient clinics will be recruited to participate in cameo and randomized to one of two treatment arms. the pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (med). patients in the behavioral arm (cbt) will receive pain self-management/coping skills training. the trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months. study aims: among veterans with chronic low back pain refractory to long-term opioid therapy 1. to compare the interventions' (med vs. cbt) effects on pain intensity and function over 12 months 2. to compare the interventions' effects (med vs. cbt) on other relevant outcomes * health-related quality of life * pain catastrophizing * depression * anxiety * disability * opioid misuse and opioid dose

Eligibility criteria:
inclusion criteria: veterans will be eligible if they have: * chronic lower back pain of at least moderate intensity * pain for 6 months * on chronic opioid therapy * and access to a working telephone exclusion criteria: exclusion criteria includes: * severe medical conditions * active psychosis * schizophrenia * active suicidal ideation * pending back surgery * moderately severe cognitive impairment * involvement in ongoing pain trials * and pregnant or trying to become pregnant the investigators will exclude veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability the investigators will not exclude those with a past history of substance abuse.

Keywords: back pain care management pain patient outcomes patient-center care primary care
autologous hbv-specific t cell receptor engineered t cells (tcr-t) in patients with hbv-related advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: adoptive cell therapy with tcr-t cells targeting hbv antigens represents an innovative opportunity for treatment of hbv-related hcc. scg101 is a genetically modified autologous tcr-t cell therapy with a natural high-avidity tcr directed towards the hla-a\*02-restricted hbsag peptide. this is a phase 1 clinical study of scg101 alone and with pd-1/pd-l1 checkpoint inhibitors in hbv-related hcc.

this is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of scg101, with and without pd-1/pd-l1 checkpoint inhibitors, in patients with hbv-related hcc. lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to scg101 infusion.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed, or imaging diagnosed hcc 2. hla-a \*02 genotyping 3. hbsag positive in serum or tumor tissue 4. have at least one measurable lesion at baseline as per mrecist and recist v1.1 criteria 5. child-pugh score ≤ 7 6. ecog performance status of 0 or 1 7. life expectancy of 3 months or greater 8. patient with adequate organ function exclusion criteria: 1. uncontrolled portal vein or inferior vena cava tumor thrombosis 2. untreated or active central nervous system (cns) metastasis or other clinically significant cns diseases 3. active or uncontrollable infections 4. history of organ transplantation 5. lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample 6. history of positive results for human immunodeficiency virus (hiv) 1 or 2 or known acquired immunodeficiency syndrome (aids) 7. prior exposure to any cell therapy 8. other severe medical conditions that may limit subject's participation in this trial

Keywords: hcc
a 6-month open-label extension study to the b2061014 study to evaluate the safety, tolerability and efficacy of dvs sr in the treatment of children and adolescents with mdd

Conditions: Major Depressive Disorder

Summary: this is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (dvs sr) in the treatment of child and adolescent outpatients with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * completed study b2061014 and who in the investigator's opinion would benefit from long term treatment with dvs sr * willingness and ability to comply with scheduled visits, treatment plan and procedures exclusion criteria: * subject requires precaution against suicide * subject not in a generally healthy condition

Keywords: major depressive disorder mdd depression
monitoring of implant diseases: diagnosis and monitoring with ammp-8 test technology

Conditions: Peri-Implant Health; Peri-Implantitis and Peri-implant Mucositis

Summary: 68 patients underwent the ammp-8 chair-side test as well as clinical traditional measurement methods. those who had one or more implants in their mouth were selected as patients. the condition of the attachment tissues of these implants is monitored at a control visit after five years.

patients who arrive for maintenance follow-up are included in the study. the trational measurement technique is used to follow the health of peri-implant tissues.

Eligibility criteria:
inclusion criteria: * the participation previously study implant patient exclusion criteria: * has not received antibiotic treatment within 6 months

Keywords: ammp-8 peri-implant diseases mucositis prevention maintenance
feasibility of respace™ hydrogel to establish a stable cervical-rectal space

Conditions: Uterine Cervical Neoplasms

Summary: in this study, 5 subjects will be enrolled and the cumulative d2cc dose for rectum during brachytherapy will be recorded as the primary outcome measures.

this is a phase i prospective study of 5 patients to determine if peg hydrogel (respace™) reduces the radiation dose delivered to the rectum during radiation therapy for cervical cancer by increasing the space between the cervix and the anterior rectal wall. in the other word, the purpose of this study is to assess whether the use of respace™ hydrogel results in a reduction of radiation exposure to the anterior rectum.

Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3d brachytherapy. * karnofsky score ≥ 70. * subjects aged ≥ 18 years and ≤ 75 years. * subjects must be able to cooperate in completing the entire study. * the subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate mri. * no contraindications to ct scanning. * subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form. exclusion criteria: * subjects who have received prior pelvic radiotherapy. * subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.) * subjects with other primary malignancies * subjects with contraindications to radiotherapy, as determined by the investigators * subjects with injection site infections. * subjects who are allergic to the ingredients of the device. * subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators * persons with severe mental illness, cognitive impairment and thinking disorders. * participants in other drug clinical trials or medical device clinical trials 1 month prior to screening * pregnant or lactating women or those who plan to get pregnant within the last six months * subjects who cannot be followed up as prescribed by the doctor * other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollment

Keywords: cervical cancer hydrogel spacer
minimal invasive deformity correction (mid-c) system for early onset scoliosis

Conditions: Scoliosis; Scoliosis Idiopathic; Scoliosis;Congenital

Summary: early onset scoliosis (eos) is defined as scoliosis with onset under the age of ten years, regardless of etiology. it is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. currently there are two basic treatment options available for eos: non-surgical and surgical. apifix ltd. has developed a novel growing rod system for surgical treatment of eos, the mid-c system. it is indicated for patients with a scoliosis of 35 to 75 degrees cobb angle


Eligibility criteria:
inclusion criteria: 1. patients with eos aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses. 2. standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees cobb angle 3. "normal" or hypokyphotic sagittal contour (t5-t12 ≤ 50⁰ degrees) 4. primary curve should be reduced to \< 35 degrees cobb angle on lateral bending/traction/stretch x-ray- the residual rigid segment must be ≤ 35 degrees 5. patients with ≤ 25 degrees trunk rotation based on scoliometer measurement 6. subject in good general health 7. subject and both subject's guardians/legal representatives are willing to sign a written informed consent form exclusion criteria: 1. eos with more than one structural curve or a single curve involving more than 8 segments 2. high tone neuromuscular diagnoses 3. primary curve cobb angle \> 75 degrees 4. kyphosis \> 50 degrees 5. previous scoliosis surgery 6. neural axis abnormality observed by an mri scan 7. known allergy to titanium 8. active systemic disease, such as aids, hiv, or active infection 9. systemic disease that would affect the subject's welfare or overall outcome of the study. 10. severely mentally compromised

Keywords: early onset scoliosis (eos)
the safety of totally laparoscopic versus laparoscopy-assisted total gastrectomy.

Conditions: Gastric Cancer

Summary: to compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years； 2. primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.； 3. clinical stage ct1n0m0, ct1n1m0, ct2n0m0； 4. the gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. it is expected that total gastrectomy with d1+/d2 lymph node dissection achieves r0 resection (multiple primary cancers are also applicable)； 5. bmi(body mass index)\<30 kg/m2； 6. no history of upper abdominal surgery (except for laparoscopic cholecystectomy)； 7. no prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.； 8. preoperative ecog (eastern cooperative oncology group) performance status score 0 or 1； 9. preoperative asa (american society of anesthesiologists) scoring i-iii； 10. sufficient vital organ functions； 11. signed informed consent. exclusion criteria: 1. preoperative examination indicates disease stage cstage ii or above； 2. women during pregnancy or lactation； 3. suffer from other malignant tumors within 5 years； 4. preoperative body temperature ≥ 38°c or complicated with infectious diseases requiring systemic treatment； 5. severe mental illness； 6. severe respiratory disease； 7. severe liver and kidney dysfunction； 8. history of unstable angina or myocardial infarction within 6 months； 9. history of cerebral infarction or cerebral hemorrhage within 6 months； 10. continuous application of glucocorticoid within 1 month (except for topical application)； 11. accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ； 12. the patient has participated in or is participating in other clinical studies (within 6 months).
study of ono-8539 in patients with overactive bladder

Conditions: Overactive Bladder

Summary: the objective of this study is to investigate efficacy, safety and tolerability of ono-8539 in patients with overactive bladder.


Eligibility criteria:
inclusion criteria: * patients with medical history of overactive bladder symptoms for \> 6 months exclusion criteria: * patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Keywords: ono-8539 overactive bladder oab
eccentric exercise and fatigue in multiple sclerosis

Conditions: Multiple Sclerosis; Fatigue

Summary: the goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (ms). the primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with ms?. participants will be asked to come for two sessions for two weeks. in the first week, subjects will undergo a bout of either traditional or eccentric resistance training. the next day they will return to assess their level of fatigue. the following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. the difference between the subjects level of fatigue for either condition will be compared.

persons with multiple sclerosis (ms) have mobility deficits. exercise is commonly used to treat these mobility deficits, but must be done so judiciously in order to limit the effects of fatigue, one of the most common disease findings. in persons with ms ,fatigue can limit the amount of exercise performed. eccentric training, where a muscle is lengthened under resistance has been shown to produce greater gains in strength with less energy expenditure when compared to traditional strength training where a muscle is both lengthened and shortened under resistance. however, eccentric strength training has been shown to result in delayed onset muscle soreness, which may also limit how much exercise a person with ms can perform. the purpose of the study is to compare the impact of eccentric versus traditional strength training programs on fatigue and persons with multiple sclerosis. the hypothesis is that there will be no difference in fatigue measurements between the two conditions. if the hypothesis is correct, it will suggest that eccentric training should be the subject of further study to assess it's feasibility and effectiveness, in treating mobility deficits in person with multiple sclerosis. a randomized crossover design will be used. ambulatory participants with a diagnosis of ms will be randomized into either a eccentric or traditional training condition. each training condition will consist of a single session of training. the following day, the patient will return and their levels of fatigue assessed. the next week, the subjects will return and crossover, undergoing whatever type of training they did not experience in the previous week, and the impact of the training will again be assessed.

Eligibility criteria:
inclusion criteria: * definitive diagnosis of multiple sclerosis. * ability to walk for 6 minutes continuously with or without assistive device * ability read, understand and sign and informed consent exclusion criteria: * evidence of recent exacerbation in the last 2 months prior to starting the study * orthopedic, cardiopulmonary, or non -ms neurologic condition that could interfere with carrying out the study protocol

Keywords: exercise resistance training
a study to evaluate mavacamten in adolescents with symptomatic obstructive hypertrophic cardiomyopathy

Conditions: Cardiomyopathy, Hypertrophic

Summary: the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (hcm).


Eligibility criteria:
inclusion criteria: * diagnosis of hcm * presence of lvot obstruction * presence of symptoms exclusion criteria: * phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction * evidence of lvef \<50% in prior 6 months * planned escalation in hcm therapy or upcoming intervention (eg, major cardiac surgery, hcm medication dose increase) other protocol-defined inclusion/exclusion criteria apply.

Keywords: hcm mavacamten obstructive hypertrophic cardiomyopathy scout scout-hcm pediatric hcm pediatric hypertrophic cardiomyopathy symptomatic hcm ohcm
intrafamilial transmission of hepatitis b virus: frequency, risk factors, and role of hepatitis b vaccination

Conditions: HBV Transmission

Summary: the primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of hbv; the second is trying to explore the potential risk factors of such a transmission .as a secondary aim, immunologic status of the household contacts vaccinated for hepatitis b will be evaluated to assess the efficacy of hepatitis b vaccination and its role in prevention of intra-familial transmission of hbv

hepatitis b virus (hbv) infection is a global health issue; it is estimated that 257 million persons have chronic hbv (asgeir et al., 2021). the major routes of hbv transmission include blood, sexual contact, vertical (from infected mothers to her children) and horizontal (between the spouses or children) transmission (şükran et al., (2018). the household transmission of hbv is also a major health issue; it represents a challenge to the health system. higher rates of hbv infection were reported among the household contacts of chronic hbv carriers; the prevalence of hbv infection among the family members of patients with chronic hbv can reach to 57%. factors affecting the risk of transmission include socio-demographic status, family role (infected mothers increase the risk of transmission) and viral markers of the index case (masomeh et al., 2016).the diagnosis of hbv infection is generally based on serological (hepatitis b surface antigen) and molecular assays (hepatitis b virus deoxyribonucleic acid) (chen et al., 2017).although the three-dose vaccination for hepatitis b provides more than 90% seroprotection rates (van den ende c, et al, 2017); approximately 10% of vaccinated persons may be at risk of getting infected. available data about the current status of intra-familial transmission of hbv among our community members are lacking; we need to determine the magnitude of such a major public health problem

Eligibility criteria:
inclusion criteria: * : the household contacts of patients with chronic hbv infection will be included in the study. exclusion criteria: * those with prior diagnosis of hbv infection following the date of the primary case infection.

Keywords: intrafamilial transmission of hbv.
pacap induced migraine attacks in patients with high and low genetic load

Conditions: Migraine Without Aura

Summary: the investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by pacap compared to patients with few genetic loci associated with migraine (low genetic load).

migraine is a very prevalent neurological disorder with a strong genetic factor. the common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. recently, 12 genetic loci have been identified to be associated with migraine with (ma) and without aura (ma) in four large genome-wide association studies (gwas). the functional consequences of this genetic variant in humans are yet unknown. pacap is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. pacap can induce migraine attacks in mo patients via an adenosine monophosphate (camp) dependent pathway. also, a recent study has showed that intracellular accumulation of camp is crucial for the induction of migraine attacks. the phenotype of the migraine inducing effects of pacap might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.

Eligibility criteria:
inclusion criteria: * migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine. exclusion criteria: * other primary headache * a history of cerebrovascular disease and other cns- disease * a history suggesting ischaemic heart disease * serious somatic and mental disease * hypo- or hypertension * abuse of alcohol or medicine (opioid analgesics). * pregnant or breastfeeding women.
comparative study of sham versus mild® procedure in patients diagnosed with symptomatic lumbar central canal stenosis

Conditions: Lumbar Spine Stenosis Central Canal

Summary: this is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.


Eligibility criteria:
inclusion criteria: * symptomatic and lumbar spine stenosis (lss) primarily caused by dorsal element hypertrophy. * prior failure of conservative therapy and oswestry disability index (odi) score of \>20%. * radiologic evidence of lss, ligamentum flavum hypertrophy (typically \> 2.5mm)confirmed by pre op mri and/or ct. * central canal cross sectional area clearly reduced per mri/ct report. * if present, anterior listhesis ≤ 5.0mm (preferred) and stable. * able to walk at least 10 feet unaided before being limited by pain. * available to complete 26 weeks of follow-up. * a signed informed consent form is obtained from the subject. * adults at least 18 years of age. exclusion criteria: * prior surgery at intended treatment level. * history of recent spinal fractures with concurrent pain symptoms as determined by the investigator. * disabling back or leg pain from causes other than lss (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). * disk protrusion or osteophyte formation severe enough to confound study outcome. * facet hypertrophy severe enough to confound study outcome. * bleeding disorders and/or current use of anti-coagulants. * use of acetylsalicylic acid (asa) and/or non-steroidal anti-inflammatory (nsaid) within five days of treatment. * epidural steroid administration within prior 3 weeks(of procedure or sham) * inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (copd), obesity, etc.). * metabolic wound healing pathologies deemed by investigator to compromise study outcome. * dementia and/or inability to give informed consent. * pregnancy and/or breastfeeding. * on workman's compensation or considering litigation associated with back pain.

Keywords: lumbar spine stenosis decompression