Kornimate/medical-research-clean huggingface dataset:
the efficacy of hlx208 (braf v600e inhibitor) with cetuximab for metastatic colorectal cancer (mcrc) with braf v600e mutation after first-line treatment

Conditions: CRC

Summary: an open, multicenter phase ii clinical study to evaluate safety and efficacy of hlx208 (braf v600e inhibitor) combined with cetuximab for metastatic colorectal cancer (mcrc) with braf v600e mutation after first-line treatment


Eligibility criteria:
inclusion criteria: * age\>=18y * good organ function * expected survival time ≥ 3 months * metastatic/recurrent advanced braf+ mcrc that have been diagnosed histologically and have failed first line treatment * ecog score 0-1; exclusion criteria: * arm 1 ： previous treatment with braf inhibitors or mek inhibitors * symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). * active clinical severe infection; * a history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
normal values for esophageal and pyloric impedance planimetry under general anesthesia (normaflip)

Conditions: Esophageal Dysfunction; Pylorus Dysfunction

Summary: impedance planimetry using endoscopic functional lumen imaging probe (endoflip) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. it allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. examination is useful performed under sedation. general anesthesia might affect distensibility values. the aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.


Eligibility criteria:
inclusion criteria: * subject older than 18 years and younger than 80 years * subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, helicobacter pylori screening, or submucosal dissection * subject with health insurance * written informed consent exclusion criteria: * patient younger than 18 years or older than 80 years * pregnancy or breast feeding * previous history of esophago-gastric surgery or vagotomy * previous history of parkinson disease or diabetes mellitus * contra-indication to upper gastro-intestinal endoscopy * esophageal varices * esophageal diameter smaller than 5 mm * contra-indication to general anesthesia * hiatal hernia greater than 3 cm on endoscopy * esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection * typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (gerd)-q score greater or equal to 8 * nausea, vomiting or epigastric pain * dysphagia with sydney score greater ou equal to 50 * incapability to give consent * no written informed consent * participation to another study at the same time

Keywords: distensibility impedance planimetry esophagus esophago-gastric junction pylorus
photodynamic therapy in treating patients with stage iii or stage iv melanoma

Conditions: Melanoma (Skin)

Summary: rationale: photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. photodynamic therapy may be effective in treating melanoma. purpose: phase i/ii trial to study the effectiveness of photodynamic therapy in treating patients who have stage iii or stage iv melanoma.

objectives: i. determine the safety of photodynamic therapy with verteporfin and detox-b adjuvant in patients with stage iii or iv melanoma. ii. determine the clinical response in patients treated with this regimen. iii. determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients. iv. determine the ablation of cutaneous tumors in patients treated with this regimen. outline: this is a multicenter study. patients undergo photodynamic therapy with verteporfin and detox-b adjuvant. treatment repeats every 2 weeks for a total of 3 courses, each to a different melanoma lesion. both non-treated and treated tumors are measured prior to study and at months 2, 4, and 6. immune profile is also assessed prior to study and at months 2, 4, and 6. projected accrual: a total of 30 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: diagnosis of stage iii or iv melanoma at least 3 cutaneous tumors for treatment (treatment tumors) and 1-7 additional cutaneous, visceral, or lymph node tumors for response assessment (marker tumors) treatment tumors must be on trunk, arms, or legs and be 1.0-3.6 cm in longest dimension measurable disease by calipers or ct scan no cns metastases by ct scan patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 2,500/mm3 neutrophil count at least 1,000/mm3 platelet count at least 50,000/mm3 hemoglobin at least 9 g/dl hematocrit at least 27% hepatic: bilirubin no greater than 2 times upper limit of normal (uln) ast/alt no greater than 2 times uln alkaline phosphatase no greater than 2.5 times uln renal: creatinine no greater than 2 times uln prior concurrent therapy: biologic therapy: at least 4 weeks since prior biologic therapy or immunotherapy no concurrent biologic therapy chemotherapy: at least 4 weeks since prior chemotherapy no concurrent chemotherapy endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy no concurrent radiotherapy surgery: no concurrent surgical removal of melanoma lesions designated for treatment or response assessment other: no other concurrent therapy for melanoma

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma
efficacy of desensitizers in reducing post-operative sensitivity following composite restorations

Conditions: Sensitivity

Summary: composite is one of the common aesthetic restorations used in the dentistry. with the advancements in the biomaterials the application of the composites has broadened. however due to various factors the composites are associated with dental sensitivity. hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class i composite restoration.

a double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class i cavity were randomly assigned to 4 groups of 20 patients each: group c (control group), group gl (gluma group), group sf (shield force plus group), and group tc (telio cs group). the class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. the postoperative pain/sensitivity level was recorded according to the visual analogue scale (vas) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.

Eligibility criteria:
inclusion criteria: the selection criteria: * age was 20-45 years. * vital teeth, (electric pulp test) * apical periodontal ligament space radiographically identified * the remaining dentin thickness at least 1mm. exclusion criteria: * restored, periodontally weak nonvital teeth are excluded.

Keywords: gluma sheildforce plus telio cs desensitisers
renal, endocrine, and bone changes in response to ftc/tdf in uninfected young men who have sex with men (ymsm).

Conditions: HIV Infection

Summary: this is a prospective observational cohort sub-study of subjects enrolled in the adolescent medicine trials network for hiv/aids interventions (atn) 110 (nct01772823) or atn 113 (nct01769456), which is a prospective interventional trial.

this is a prospective observational cohort sub-study of subjects enrolled in the atn 110 (nct01772823) or atn 113 (nct01769456) study. all subjects will be followed for at least 48 weeks. subjects who meet specific bone or renal criteria at week 48 of the atn 110 (nct01772823) or atn 113 (nct01769456) study will be followed for an additional 48 weeks in the extension phase of atn 110 (nct01772823) or atn 113 (nct01769456) and atn 117 (nct01769469). the maximum duration of participation will be 96 weeks. there is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (ftc)/tenofovir (tdf) (truvada®) toxicities will be obtained for this sub-study at visits that are required by the atn 110 (nct01772823) or atn 113 (nct01769456) study. measurement of bone mineral density (bmd) and bone mineral content (bmc) by dual-energy x-ray absorptiometry (dxa) scan are planned as a part of the atn 110 (nct01772823) and atn 113 (nct01769456) studies, and results will be utilized for the analysis in this study. this study does not require extra bmd or bmc measurements.

Eligibility criteria:
inclusion criteria: * has been enrolled in atn 110 (nct01772823) or atn 113 (nct01769456) , and * willing and able to provide written informed consent exclusion criteria: -subjects exempted from undergoing dxa scans in atn 110 (nct01772823) or atn 113 (nct01769456) are not eligible to enroll in atn 117 (nct01769469).

Keywords: tenofovir emtricitabine truvada renal, endocrine, bone changes hiv prevention prep
blossom smart expander technology in breast reconstruction in participants with breast cancer undergoing mastectomy

Conditions: Breast Carcinoma; Breast Disorder

Summary: this phase 1 trial studies how well blossom smart expander technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. blossom smart expander technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. it may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.

primary objectives: i. to assess the clinical effectiveness of the application of blossom smart expander technology in 2-staged tissue expander/implant-based breast reconstruction. secondary objectives: i. patient satisfaction. ii. patient self-reported pain. iii. incidence of complications. outline: after mastectomy, participants undergo 2-staged implant-based breast reconstruction (ibr) with the blossom smart expander technology comprising of the blossom syringe assist device connected to the mentor spectrum adjustable saline breast implant. after completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., brca mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy * no prior breast surgery (excluding biopsy and lumpectomy) or breast radiation * ability to understand and the willingness to sign a written informed consent document * no life expectancy restrictions * eastern cooperative oncology group (ecog) or karnofsky performance status will not be employed * no requirements for organ and marrow function exclusion criteria: * recent steroid use * no major medical comorbidities (defined as american society of anesthesiologists \[asa\] iii or greater) * no connective tissue disorder * prior breast surgery, excluding biopsy and lumpectomy * history of or plan for breast radiation * pregnancy and nursing patients will be excluded from the study * no restrictions regarding use of other investigational agents * no exclusion criteria related to history of allergic reactions * no exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent * no other agent-specific exclusion criteria * no exclusion of cancer survivors or those who are human immunodeficiency virus (hiv)-positive
screening platform for clinical trials in advanced colorectal cancer

Conditions: Colorectal Cancer; Advanced Colorectal Cancer

Summary: the eortc gastrointestinal tract cancer group and the eortc headquarters wish to set up a european screening platform for advanced colo-rectal cancer (crc) patients. the goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials. currently some of the most challenging clinical questions arise from the molecular sub-division of crc that would theoretically allow to inhibit the specific, altered pathways in the patients. a major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients. the eortc crc screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.


Eligibility criteria:
inclusion criteria: * colo-rectal cancer (advanced or metastatic) * before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations. exclusion criteria: * absence of patient's consent
gait initiation and transition from double to single support in patients with unilateral primary coxarthrosis

Conditions: Primary; Coxarthrosis

Summary: the study consists to evaluate the impact of prosthetic surgery (pth and rth) on kinematic and dynamic parameters (joint torques) of the lower limbs during gait initiation in patients with primary coxarthrosis. patients included in the study will undergo a three-dimensional gait analysis. dynamic gait analysis is multidimensional, measuring kinematic parameters (joint amplitudes: ankles, knees, hips, etc.) and dynamic parameters (assessment of joint torque from ankle, knee, hip to lower limb during gait initiation).


Eligibility criteria:
inclusion criteria: * men or women aged 18 and over * with primary coxarthrosis (any stage) * consulting in the orthopedic departments of participating centers in anticipation of hip surgery (pth/rth), or for advice only. * written consent signed by the patient * affiliation with a social security scheme exclusion criteria: * disabling orthopaedic conditions: symptomatic contralateral hip/knee disease symptomatic gonarthrosis or homolateral total knee prosthesis history of surgery on the affected hip history of fracture of the lower limb in the past year history of lower limb sprain in the last 3 months neurological or degenerative disease * pregnant or breast-feeding * adults under guardianship, curatorship or safeguard of justice * cognitive impairment making it impossible to understand the protocol * approach other than moore posterolateral (for pth and rth groups)

Keywords: coxarthrosis hip arthroplasty gait initiation
effect of dopamine on specific processing of shame and embarrassment in parkinson's disease

Conditions: Parkinson Disease

Summary: shame and embarrassment are two self-conscious emotions frequently experienced by parkinson's disease (pd) patients. shame and embarrassment scores strongly correlate with patient's quality of life, anxiety and depression ratings. however, the neurobiology of shame and embarrassment in pd and the influence of dopaminergic replacement therapy (drt) is poorly understood. the aim of this study is to characterize how brain structures and neuronal networks involved in parkinson's disease-related shame, non-parkinson's disease related shame and neutral control scenarios, are modulated by dopaminergic replacement therapy. for this purpose, functional mri and connectivity measures between the basal ganglia and shame-related network will be analyzed while pd patients will perform a shame-induction task during both on- (i.e. during the effect of drt) and off-drt (i.e. during the withdrawal of drt) conditions. correlation with clinical measures will be made.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease (pd) based on united kingdom parkinson's disease society brain bank criteria * patients in the pd phase called "motor and non-motor fluctuations stage". * presence of motor and non-motor fluctuations are based on: 1. for motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of the movement disorder society unified parkinson's disease rating scale iv 2. for non-motor fluctuations: a score of 2 on item iii of the behavioral assessment of parkinson's disease * to be on dopaminergic replacement therapy. healthy controls: subjects without any known central nervous system (cns) lesion or cns clinical signs on examination exclusion criteria: * age greater than 80 years * dementia or mild cognitive impairment based on a score \<26 on the moca * ongoing depression with suicidal ideation * any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory cerebrovascular disease or other serious progressive physical diseases * participating in a pharmacological study * any mri contraindications * intolerable "off" states when the effects of the pd medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning upon waking) * inability to provide informed consent (legal guardianship) * inability to speak or read french.
emotional prosody recognition and decision making inf fmri and vulnerability to suicide

Conditions: Suicide

Summary: suicide is known to be frequent in depression, and in most of the psychiatric diseases. but as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability. this trial will study two fmri paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls. the main goal will be to correlate fmri activation during the two paradigms in subjects vulnerable to suicide. the secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fmri activations.


Eligibility criteria:
inclusion criteria: * right-handed, * depressed suicide attempters for the first group, * depressed patients with past history of suicidal acts for the second group, * depressed patients with no history of suicidal acts for the third group, * healthy controls for the fourth group. exclusion criteria: * another psychiatric trouble than depression, * another psychotrope treatment than ssri/snri and/or benzodiazepine at inclusion and/or one month before, * for the first and secand groups : more than fous suicidals acts within the past 3 years, * deficits that do not allow test realisation (visual audition troubles, cognitif deficits, * prosopagnosia, * pregnancy, * severe central nervous system disease or somatic disease, * mri contra-indication, * major benefiting from a legal protective measure, * no coverage care.
perioperative management and outcomes of minimally invasive esophagectomy

Conditions: Esophageal Cancer

Summary: the investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed.


Eligibility criteria:
inclusion criteria: * patients received esophageal reconstruction in 2015. exclusion criteria: * age \<18 * not malignancy
evaluating anti-tobacco message effectiveness among lesbian, gay, bisexual, and transgender young adults

Conditions: Tobacco-Related Carcinoma

Summary: this trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and transgender (lgbt) young adults at risk for the use of more than one tobacco product (polytobacco use). polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among lgbt young adults. this trial seeks to determine effective communication of polytobacco use risk to at-risk lgbt young adults.

primary objectives: i. identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks to lesbian, gay, bisexual, transgender (lgbt) young adults. participants view anti-tobacco messages and rate them for perceived effectiveness and reactance.

Eligibility criteria:
inclusion criteria: * young adults (age 18-35 years) * live in the united states at least 50% of the sample also: * are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at least once)
a long-term, 3-year, follow-up study for patients completing the ks-gig-001-01 study

Conditions: Lumbosacral Radiculopathy

Summary: this is a long-term, 3-year, follow-up study for patients completing the ks-gig-001-01 study

this is a long-term, 3-year, follow-up study for patients completing the ks-gig-001-01 study (a phase 1/2a, first-in-human, double-blind, placebo-controlled study to evaluate the safety and therapeutic activity of single ascending doses of kls-2031 administered by transforaminal epidural injection in patients with neuropathic pain from lumbosacral radiculopathy). following the end of the open-label safety extension period of the ks-gig-001-01 study (visit 14), patients will enter the long-term follow-up period. these patients will continue to be monitored for aes (including aes of special interest) and serious aes (saes) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.

Eligibility criteria:
inclusion criteria : to be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below: 1. patients that have completed the ks-gig-001-01 study and were in the active treatment group 2. patients having signed the consent forms for both the ks-gig-001-01 study and this long term, 3-year follow-up study exclusion criteria : to be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below: 1. enrollment in another aav or other gene therapy trial

Keywords: lumbosacral radiculopathy lsr