Kornimate/medical-research-clean huggingface dataset:
phase ii study of immunization with a hepatitis c virus (hcv) antigen peptide vaccine

Conditions: Chronic Hepatitis C

Summary: the objectives are 1. to determine the immunological profile (cd4+, cd8+ cells, dth) induced by immunization with hcv antigen peptide vaccine with polyarginine. 2. to document virological (hcv-rna) and biochemical (alt) responses following immunization with hcv antigen peptide vaccine with polyarginine. 3. to assess the safety of immunization with hcv antigen peptide vaccine with polyarginine.

this is a double blind, randomized, parallel group, controlled, multicenter phase ii study. 60 patients will be enrolled and assigned to one of the 5 dose or control groups. each study group will include 8 patients. each patient will receive a total of 6 injections according to the dose of the assigned study group. the injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141. the volume of each injection will be 0.5 ml in all groups.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic hepatitis c * non-response to or relapse from primary standard hcv therapy * hla a2 positive * hcv-rna positive * hcv antibodies positive * liver biopsy within 30 months prior to inclusion * hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal) * male and female * from 18 to 65 years * written informed consent obtained prior to study entry exclusion criteria: * any degree of liver cirrhosis or fibrosis of ishak score ≥ 4 (for grading table, see appendix 2: the ishak modified hepatic activity index (hai)) * any liver disease other than hepatitis c * history of autoimmune disease * immunodeficiency including post-organ-transplantation * hiv infection * immunosuppressive therapy * any acute infections within 4 weeks prior to inclusion * history of severe hypersensitivity reactions, anaphylaxis or atopy * diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years * active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period * pregnancy or lactation * unreliable contraception * alcohol consumption * drug abuse or addiction within 12 months prior to inclusion * participation in a methadone program * participation in another study within 1 month prior to enrolment
a study to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in us veterans with genotype 1 chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C; Cirrhosis; Hepatitis C Virus

Summary: the purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in us veterans with genotype 1 chronic hepatitis c virus infection.


Eligibility criteria:
inclusion criteria: * us military veteran currently receiving healthcare through the veterans health administration * screening laboratory result indicating hepatitis c virus (hcv), genotype 1-infection * positive for hepatitis c antibodies or hcv rna at least 6 months before screening, and hcv rna \> 1,000 iu/ml at the time of screening or hcv rna \> 1,000 iu/ml at the time of screening with a liver biopsy consistent with chronic hcv-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis c disease) exclusion criteria: * women who are pregnant or breastfeeding * positive test result for hepatitis b surface antigen (hbsag) or anti-hiv antibodies (hiv ab) * prior or current use of any investigational or commercially available anti-hcv agents other than ifn, pegifn, rbv or sofosbuvir * any current or past clinical evidence of child-pugh b or c classification * confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to screening or on an ultrasound performed at screening for participants with cirrhosis

Keywords: chronic hepatitis c interferon-free hepatitis c genotype 1 hepatitis c virus hepatitis c cirrhosis
surveillance in ulcerative colitis: narrow band image versus chromoendoscopy for high-risk groups

Conditions: Ulcerative Colitis; Dysplasia

Summary: the risk of colorectal cancer (crc) is increased in patients having ulcerative colitis (uc). patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of crc and require regular and short-interval surveillance colonoscopy. recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (ce) or narrow band image (nbi) technique in uc at risk for crc. however, the diagnostic yield of nbi-based surveillance and ce-based surveillance is not extensively investigated in the high-risk uc population. the investigators aimed to compare the dysplasia detection rate of nbi with that of ce in uc patients with a high risk of crc by performing a multicenter, randomized controlled trial.


Eligibility criteria:
inclusion criteria: * at least one of the followings should be satisfied; 1. a patient having extensive ulcerative colitis with 8-year or longer disease duration 2. a patient having both ulcerative colitis and primary sclerosing colitis 3. a patient having a previous history of dysplasia at the colitic segment within recent 5 years exclusion criteria: * all of the following conditions should be excluded for 1st surveillance colonoscopy study 1. a patient who underwent total or segment colectomy. 2. a patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk 3. a patient who has known thrombocytopenia (less than 80,000/µl in recent 6 months 4. a patient who has a coagulopathy 5. a patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dl within 6 months of study participation 6. a patient who has already undergone surveillance colonoscopy within 1 year * all of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study. 1. a patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial. 2. a patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk 3. a patient who has known thrombocytopenia (less than 80,000/µl in recent 6 months 4. a patient who has a coagulopathy 5. a patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dl within 6 months of study participation

Keywords: chromoendoscopy narrow band image surveillance
does physical therapy prevent total knee arthroplasty in patients with end stage osteoarthritis

Conditions: Knee Osteoarthritis

Summary: purpose: for the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty. participants:patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty. procedures: patients will be randomized to either receive physical therapy or no treatment. they will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.this will be determined by change in promis (patient reported outcome measurement information system) score and prevention of surgery.


Eligibility criteria:
inclusion criteria: * adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty. exclusion criteria: * age less than 18 y/o * any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc) * previous knee surgery * inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation * known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
study comparing circular stapler-assisted colostomy vs hand-stitching colostomy of colorectal cancer patients

Conditions: Colorectal Carcinoma

Summary: conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. there are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. the use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.but all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.the aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.

it has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.thus, various postoperative colostomy complications are inevitable after surgery. surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications. so we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.

Eligibility criteria:
inclusion criteria: * receiving permanent colostomy because of colorectal cancer * age of ≥18 and ≤80 exclusion criteria: * not willing or incapable to comply with all study visits and assessments * evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

Keywords: circular stapler-assisted colostomy
incubator weaning of moderately preterm infants

Conditions: Infant, Newborn; Infant, Moderate Preterm

Summary: the objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants. the hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.


Eligibility criteria:
inclusion criteria: * gestational age 29 0/7 to 33 6/7 weeks at birth * birth weight less than 1600 grams * greater than 48 hours of age * current weight less than 1540 grams * in an incubator exclusion criteria: * receiving phototherapy * receiving respiratory support (including cpap, ventilation, hfnc \> 2 lpm) * receiving blood pressure support * designated for transfer to referral hospital while in incubator * known major congenital or chromosomal anomaly

Keywords: incubator weaning moderately preterm infants growth velocity
buprenorphine maintenance for opioid addicts - 1

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.


Eligibility criteria:
please contact site for information.

Keywords: opioid-related disorders
patient specific intraoral inverted-l osteotomy modified with inferior alveolar nerve relocation in corrective mandibular surgery

Conditions: Class III Malocclusion

Summary: bilateral sagittal split osteotomy (bsso) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. the aim of this study is to introduce a novel modification of the intraoral inverted l ramus osteotomy (ilro) to overcome these limitations in mandibular setback surgery. preoperative cbct was requested for virtual planning and fabrication of cutting and drilling guides. cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (ian), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. the guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. inferior alveolar nerve function was regained perfectly one year post-operatively. this procedure introduces a robust alternative to the bsso osteotomy in some cases of mandibular setback surgery.


Eligibility criteria:
inclusion criteria: * adult patients. * patients with skeletal class iii malocclusion. * patients with thin mandibular rami with minimal medullary bone. * patients with inferior alveolar nerve proximity to the buccal cortex. * patients with lateral bending of the inferior mandibular border at molar angle region. * patients with high mandibular foramen. exclusion criteria: * patients with previous extensive jaw surgery. * mandibular pathological lesions. * patients with temporomandibular joint dysfunction.
efficacy of sirolimus-based, steroid avoidance immunosuppression african americans

Conditions: End Stage Renal Disease; Kidney Transplantation

Summary: african americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. this increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes. this study will evaluate: 1. whether a sirolimus based steroid avoidance regimen in african americans may decrease the risks of drug-related toxicities, 2. decreased rates of metabolic complications such as post-transplant diabetes, 3. the effect of sirolimus plus a reduced dose cyclosporine on renal allograft function.

this is an open labeled prospective trial with race matched historical controls. the treatment group (experimental arm) will be african american de novo solitary renal transplant recipients. the control arm will consist of race matched solitary renal transplant recipients who received a cyclosporine (csa) -based immunosuppressive regimen. the subjects will be matched for organ source (living donor vs. cadaveric). the experimental treatment arm will have an immunosuppression regimen consisting of sirolimus, reduced dose cyclosporine, thymoglobulin, and only 3 doses of steroids.

Eligibility criteria:
inclusion criteria: * african american recipient race * solitary cadaveric or living donor renal transplantation * age ≥18years at the time of transplantation * negative pregnancy serum test in females with childbearing potential exclusion criteria: * age \< 18 years at the time of transplantation * multi-organ transplant recipient * currently taking steroids * white blood cell count \< 3,000 * platelet count \< 100,000 * triglycerides \>400mg/dl * cholesterol \> 350 mg/dl * unwillingness to comply with study procedures * allergic reaction to sirolimus allergy to polyclonal antilymphocyte drugs (thymoglobulin)
healing track clinical trial

Conditions: Chronic Back Pain

Summary: this is a randomized clinical trial to evaluate a digital pain reprocessing therapy (prt) intervention for chronic back pain (cbp). the purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (cbp). some people with cbp experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for cbp. this study will assess changes in pain intensity from prt intervention compared to a standard of care (soc) control group in adults with cbp. soc is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual. the research team plans to enroll 180 participants who will be randomized into one of three groups.


Eligibility criteria:
inclusion criteria: * aged 21 to 70 * chronic back pain- cbp will be defined according to the criteria established by a recent nih task force * pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. that is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. * patients must rate pain intensity at 4/10 or greater on the brief pain inventory-short form (bpisf) (on the item measuring average pain over the last week). * participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner. * able to use a smartphone exclusion criteria: * back pain associated with compensation or litigation issues as determined by self-report within the past year * leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy * cauda equina syndrome, as screened for by self-reported inability to control bowel or bladder function * self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder * self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols
ssgj-705 monotherapy and combination therapy in advanced her2-expressing solid tumors

Conditions: Locally Advanced, Recurrent or Metastatic Malignancies

Summary: this study was an open-label phase ⅱ study to evaluate the safety and efficacy of ssgj-705 monotherapy and combination therapy in patients with advanced her2-expressing solid tumors.

this study includes 2 parts: part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).

Eligibility criteria:
inclusion criteria: * males and/or females over age 18. * histologically and/or cytologically documented local advanced or metastatic nsclc/bc/gc/gejc. * eastern cooperative oncology group (ecog) performance status of 0-1. * expected survival \>3 months. * signed informed consent form. exclusion criteria: * any remaining aes \> grade 1 from prior anti-tumor treatment as per ctcae v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. * pregnant or nursing women or women/men who are ready to give birth. * symptomatic central nervous system metastasis. * allergy to other antibody drugs or any excipients in the study drugs. * inadequate organ or bone marrow function.

Keywords: advanced malignancies
trial to determine the efficacy and safety of jcar017 in adult participants with aggressive b-cell non-hodgkin lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to evaluate the efficacy and safety of jcar017 in participants with aggressive b-cell non-hodgkin lymphoma (b-nhl)

this is a study to determine the efficacy and safety of jcar017 in adult participants with aggressive b-cell nhl. the study will enroll participants in europe and japan with diffuse large b-cell lymphoma (dlbcl) not otherwise specified (nos; de novo or transformed follicular lymphoma \[tfl\]), high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangements with dlbcl histology (hgbl), follicular lymphoma grade 3b (fl3b), and primary central nervous system lymphoma (pcnsl). participants with secondary central nervous system (cns) involvement are allowed. once enrolled, participants will undergo leukapheresis to enable jcar017 cell product generation. upon successful jcar017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of jcar017. jcar017 will be administered by intravenous infusion. participants will be followed for approximately 2 years after their jcar017 infusion for safety, disease status, survival and health-related quality of life. delayed adverse events following exposure to gene modified t cells will be assessed and long-term persistence of these modified t cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after jcar017 infusion as per competent authority guidelines.

Eligibility criteria:
inclusion criteria: * histological confirmation of diagnosis at last relapse * adequate organ function * adequate vascular access for leukapheresis procedure exclusion criteria: * prior history of malignancies, other than aggressive relapsed/refractory non-hodgkin lymphoma, unless the participant has been in remission for ≥ 2 years with the exception of non-invasive malignancies * received previous cd19-targeted therapy * progressive vascular tumor invasion, thrombosis, or embolism other protocol-defined inclusion/exclusion criteria apply

Keywords: non-hodgkin lymphoma aggressive b-cell non-hodgkin lymphoma diffuse large b-cell lymphoma relapse / refractory lymphoma transplant not eligible high-grade b-cell lymphoma primary central nervous system lymphoma transformed follicular lymphoma follicular lymphoma grade 3b jcar017 liso-cel
efficacy and safety study of npc-01 to treat dysmenorrhea

Conditions: Dysmenorrhea

Summary: the purpose of this study is to determine whether npc-01 is effective in the treatment of dysmenorrhea.

the main objective of this study is to confirm the effectiveness and safety profile of npc-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea). additionally we also investigate the differences of effectiveness of npc-01 in comparison with ikh-01 in the treatment of secondary dysmenorrhea as a reference, because ikh-01 is already marketed at them. to achieve these, closed testing procedure is used in this study. after confirming statistical differences between npc-01 and placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (npc-01, placebo), and secondary dysmenorrhea (npc-01, ikh-01 and placebo).

Eligibility criteria:
inclusion criteria: * dysmenorrhea exclusion criteria: * severe hepatopathy * pregnant woman