Kornimate/medical-research-clean huggingface dataset:
evaluation of mm-151 + nal-iri + 5-fu + leucovorin in ras/raf wild-type metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: a phase 1b/2a study evaluating the combination of mm-151 + nal-iri + 5-fu + leucovorin in ras/raf wild-type metastatic colorectal cancer.

part 1: patients will be enrolled to determine the maximum tolerated dose, safety and tolerability of mm-151 + nal-iri + 5-fu + lv in patients with mcrc that are ras/raf wild-type. part 2: patients will be enrolled at the maximum tolerated dose of mm-151 in combination with nal-iri + 5-fu + lv to characterize initial efficacy in conjunction with levels of irinotecan and sn-38 measured in tissue.

Eligibility criteria:
inclusion criteria: * patients must be greater than 18 years of age * patients must be able to provide informed consent * patients must have kras/nras/braf wild-type colorectal cancer * willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 120 days following the last dose of any study therapy). this applies to women of childbearing potential as well as fertile men and their partners exclusion criteria: * patients who have had previous pelvic radiation treatment * patients who are pregnant or lactating * patients who have untreated (primary) or uncontrolled central nervous system (cns) (primary or metastatic) malignancies; patients with cns metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial. * history of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. * patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment

Keywords: phase i cancer egfr metastatic colorectal cancer oncology ras/raf wild-type nal-iri egfr inhibitor oligoclonal antibody nanoliposome nanoliposomal irinotecan
a study to test the impact of pf- 00299804 on how the body handles dextromethorphan in cancer patients

Conditions: Advanced Malignant Solid Tumors

Summary: research in test tubes suggests that may affect cytochrome p450 2d6 (cyp2d6), an important enzyme that is responsible for eliminating many drugs that cancer patients need to take, including dextromethorphan. the purpose of this study is to test the impact of pf-00299804 on the activity of cyp2d6, and how the human body handles dextromethorphan.

to assess the effect of repeated dosing with 45 mg qd pf-00299804 on the pharmacokinetics of dextromethorphan, a cyp2d6 probe, in cancer patients with advanced malignant solid tumors.

Eligibility criteria:
inclusion criteria: * patients with a histologically or cytologically confirmed advanced malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies; * eastern cooperative oncology group (ecog) performance status 0-1. patients with performance status 2 could be eligible upon agreement between sponsors and investigators; * adequate bone marrow, renal, liver and cardiac functions; exclusion criteria: * history of interstitial lung disease (ild). * drugs with known cyp2d6 inhibitory effects * drugs that are highly dependent on cyp2d6 for metabolism. * women who are pregnant or breastfeeding.

Keywords: phase 1 pf-00299804 dextromethorphan cyp2d6 inhibition cancer patients
absorbatack evaluation of postoperative pain following laparoscopic hernia repair

Conditions: Hernia, Inguinal; Hernia, Ventral

Summary: the objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. the study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.


Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent and comply with the schedule of protocol assessments * age \> 18 years * subjects undergoing laparoscopic hernia repair with parietex or parietex composite reinforcements depending on indication and fixation of reinforcements with helical tackers (protack, covidien) or absorbable tacks (absorbatack, covidien) in accordance with recommendations for use exclusion criteria: * pregnancy * patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair * known active infection or any major episode of infection requiring hospitalization or treatment with iv antibiotics or oral antibiotics within 30 days prior to screening * history of alcohol or drug abuse within 6 months prior to screening * history of chronic pain condition requiring more than 30 days of medical management * use of an additional nonresorbable means of fixation (inguinal) * patients considered not able to comply with the protocol and follow up schedule * asa grade of 4 or above

Keywords: hernia
digital colposcopy in finding cervical intraepithelial neoplasia

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. purpose: this clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.

objectives: * to identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic imaging. * to measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy. * to evaluate the effect of acetic acid on the image contrast obtained. * to compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (leep). outline: this is a multicenter study. participants undergo routine colposcopy as part of their regular colposcopic evaluation. the digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. participants also undergo loop electrosurgical excision procedure (leep). the digital colposcopic images are compared with tissue removed during leep. additional surrogate biomarkers under development are also measured using tissue samples removed during leep, such as quantitative histopathology measurements, dna tests for the copy number changes, and tests for the incorporation of viral hpv dna.

Eligibility criteria:
criteria: inclusion criteria: * included subjects will be ≥18 years old. * included subjects will not be pregnant. * included subjects will have a negative urine pregnancy test. * included subjects will be scheduled for colposcopy and/or leep treatment at the vgh women's clinic. * included subjects will indicate understanding of the study. * included subjects will provide informed consent to participate. exclusion criteria: * individuals \<18 years old will be excluded. * pregnant individuals will be excluded. * individuals that have had an operation to remove their cervix will be excluded. prior concurrent therapy: * see disease characteristics

Keywords: cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
efficacy and safety of ykp3089 in subjects with treatment resistant partial onset seizures

Conditions: Partial Epilepsy

Summary: this study is to evaluate the efficacy of ykp3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. also to evaluate the safety and tolerability of ykp3089.


Eligibility criteria:
inclusion criteria: * diagnosis of treatment resistant partial epilepsy; * history of epilepsy for at least 2 years; * have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period. * currently treated on a stable dose of : * 1 - 3 aed's for at least 12 weeks prior to randomization. * vns will not be counted as aed; however the parameters must remain stable for at least 4 weeks prior to baseline. * benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 aed. therefore only a maximum of two additional approved aeds will be allowed. exclusion criteria: 1. a history of alcoholism, drug abuse, or drug addiction within the past 2 years. 2. subject has had status epilepticus within past 1 year. 3. subject has had greater than 2 allergic reactions to an aed or one serious hypersensitivity reaction to an aed. 4. subjects taking felbamate with less than 18 months continuous exposure. 5. subjects receiving phenytoin, phenobarbitone or metabolites of these drugs. 6. no active suicidal plan/intent or active suicidal thoughts in the past 6 months. 7. history of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt. 8. subject meets criteria for current major depressive episode (within 6 months). 9. use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to visit 1.

Keywords: partial onset seizures treatment resistant partial epilepsy
dpbrn persistent pain and root canal therapy

Conditions: Root Canal Therapy; Persistent Tooth Pain

Summary: the purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the dpbrn "peri-operative tooth pain" study. this study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the dpbrn "peri-operative tooth pain" study.


Eligibility criteria:
inclusion criteria: * 19-70 years old * permanent adult tooth requiring its first non-surgical root canal therapy * patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure will be included to avoid problems of correlation within patients exclusion criteria: * evidence of prior root canal therapy, including iatrogenic, but not disease-induced pulp access of the tooth being considered * patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia,mental disability) * patients unable to return for 6 month follow-up

Keywords: post-operative pain root canal therapy feasibility post-surgical persistent pain
erector spinae plane block in minimal invasive cardiac surgery

Conditions: Pain, Postoperative

Summary: studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.


Eligibility criteria:
inclusion criteria: * elective valve replacement exclusion criteria: * chroic renal failure * chronic liver failure
robot-assisted laparoscopic myomectomy is an improvement over laparotomy in patients with a limited number of fibroids

Conditions: Fibroid Uterus

Summary: this is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. both groups had 3 or fewer fibroids confirmed by pre-operative mri or on final pathology report. charts were reviewed for surgical and post-operative variables


Eligibility criteria:
inclusion criteria: * uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative mri. exclusion criteria: * significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
a drug-drug interaction (ddi) study of morphothiadine mesilate/ritonavir in healthy subjects

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to evaluate the drug-drug-interaction (ddi), pharmacokinetics (pk) and tolerability of morphothiadine mesilate/ritonavir combined with entecavir or tenofovir disoproxil fumarate in healthy subjects

this is a 2-part study with each part is an open-label, crossover study in healthy adult subjects. total 56 subjects will be enrolled into the study and divided into 2 part (part a and part b), 28 subjects in each part. part a is to evaluate the drug-interaction between gls4/rtv and etv, part b is to evaluate the drug-interaction between gls4/rtv and tdf. with each part, the subject will be split into two groups and receive study drug per the defined treatment periods of day 1, day 11-20 and day 21.

Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions * be able to complete the study according to the trail protocol * subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures * male subjects and must be 18 to 45 years of age inclusive * body weight ≥ 50 kg and body mass index（bmi）between 18 and 28 kg / m2, inclusive * physical examination and vital signs without clinically significant abnormalities. exclusion criteria: * use of \>5 cigarettes per day during the past 3 months * known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies) * history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits or 100 ml of wine) * donation or loss of blood over 450 ml within 3 months prior to screening * 12-lead ecg with clinically significant * positive for viral hepatitis (including hepatitis b and c), hiv and syphilis * subjects deemed unsuitable by the investigator for any other reason.
effects of denosumab on bone microarchitecture after total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this study evaluates single dose of denosumab in decreasing systemic and periprosthetic bone resorption after total knee arthroplasty compared to placebo in 60 patients (30 placebo and 30 denosumab) within 2 months after surgery. this study also evaluates the anti-rankl effect of single dose of denosumab in serum, skeletal muscle, synovium, fat, and cartilage.


Eligibility criteria:
inclusion criteria: patients with bilateral knee osteoarthritis treated with staged bilateral total knee arthroplasty, with an interval of 8 weeks exclusion criteria: patients allergies to denosumab patients with previous osteoporosis treatment patients with renal failure patients with previous bisphosphonate treatment for more than 5 years patients failed to finish contralateral total knee arthroplasty at 8 weeks
treatment of rectovaginal crohn's fistula by combination of taam injection and biological plug placement

Conditions: Rectovaginal Fistula; Crohn Disease

Summary: interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

the goal of this clinical trial is to compare, the efficacy of * circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus * endoanal mucosal flap in terms of clinical and radiological healing (combined remission) in patients with crohn's rectovaginal fistulas refractory to standard treatment, secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.

Eligibility criteria:
inclusion criteria: * confirmed crohn's disease * presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months) * the patient has received, understood and signed the informed consent to actively participate in the study. * the patient is able to understand the conditions of the study and to participate for the whole duration. exclusion criteria: * presence of oostomy * patients with active hiv, hepatitis c (hcv), hepatitis b (hbv), tuberculosis or other uncontrolled septic conditions. * patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure. * patients with abdominal localization of crohn's disease who may require general surgery during the study. * patients with active oncological or lymphoproliferative diseases * pregnant or breastfeeding women

Keywords: microftactured adipose tissue biologic mesh endoanal flap liposuction
rtms for the treatment of affective symptoms in patients suffering from dementia

Conditions: Behavioral and Psychiatric Symptoms of Dementia

Summary: this is a monocentric prospective, randomized, double-blind placebo-controlled study. it is designed to evaluate the superiority of the rtms over sham treatment of depressive symptoms in the context of dementia. it is aimed at a population ≥ 65 years old, with affective bpsd. we wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. patients will be randomly assigned to the sham or rtms group. the sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. after inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks


Eligibility criteria:
inclusion criteria: * informed consent as documented by their and their proxy's signature (appendix informed consent form) * consent for mri * age ≥ 65 years * clinical dementia rating scale (cdr) ≥ 1 * npi-q σ (\*anxiety + \* apathy/indifference + \* dysphoria/depression) ≥ 3 * cornell scale for depression in dementia (csdd) ≥ 10 exclusion criteria: * history of schizophrenia, bipolar disorder, schizoaffective disorder * history of macroscopic stroke. * unstable somatic pathologies * insufficient collaboration for the rtms procedure * drug freeness or drug adjustment as clinically required is not an exclusion criterion. * the proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study. * any contraindications to performing an mri (cf crf) and rtms (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure
a research study to assess the mechanism by which glucovance, metformin, and glyburide work to control glucose levels in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this clinical research study is to support earlier observations that glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.


Eligibility criteria:
adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an hba1c greater than 6.7%

Keywords: type 2 diabetes mellitus
effect of sleep extension in prevention to sleep deprivation

Conditions: Healthy

Summary: the approach of a competition can be associated to a decrease in sleep duration and quality which can negatively impact athlete's performance and health (injury risk, fall, accident). ultra-endurance competitions even involve partial and/or total sleep deprivation over one or several nights. studied investigating this question suggest that endurance performance under sleep deprivation is altered, mainly because of an effect on the rate of perceived exertion (rpe), which regulates effort intensity. one of the methods used by athletes to limit the impact of sleep deprivation in competition is to implement sleep extension in the days prior to a competition. however, few studies have investigated the impact of sleep deprivation et its reproducibility on performance and fatigue during a prolonged running exercise, as well as the efficiency of prior sleep extension. the importance of such a preventive measure might also depend on individual resistance to sleep deprivation, which is variable between persons and could have genetic determinants. this aspect remains under-studied, particularly regarding the impact of sleep deprivation on physical performance. therefore, this study aims at investigating the effects of sleep deprivation and prior sleep extension on prolonged duration performance.


Eligibility criteria:
inclusion criteria: * volunteer who signed the written consent form. * man or woman. * aged 18-50. * physically active and running at least one session of more than one hour per week. * haven't participated in any competition in the month before the first visit. * not participating in any competition during the study. * usual sleep time between 6h-8h per night. exclusion criteria: * - any chronic pathology. * working night shift. * having sleep disorders: score \> 5 at pittsburg sleep quality index. * excessive sleepiness: score \>10 at epworth sleepiness scale.

Keywords: sleep deprivation sleep extension endurance running fatigue
plating clavicle fractures

Conditions: Clavicle Fracture, Non Union/Malunion

Summary: the anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. patients will be randomized to anterior-inferior or superior plating. validated shoulder scoring systems will be used to assess outcome. specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Eligibility criteria:
inclusion criteria: * active duty, reservists, national guard service members * completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments) * a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment) * chronic nonunion and malunion fractures * no medical contraindications to general anesthesia * provided informed consent. exclusion criteria: * an age of less than eighteen years or greater than sixty five years * a fracture in the proximal or distal third of the clavicle not amenable to plating * a pathological fracture * an associated head injury (a glasgow coma scale score of \<15 at 21 days after injury) * an inability to comply with followup * a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy) * a lack of consent.