Kornimate/medical-research-clean huggingface dataset:
a study of the pd-l1xcd27 bispecific antibody cdx-527 in patients with advanced malignancies

Conditions: Non-small Cell Lung Cancer; Breast Cancer; Gastric Cancer; Renal Cell Carcinoma; Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Cholangiocarcinoma; Bladder Urothelial Carcinoma; MSI-H Colorectal Cancer; Esophageal Cancer; Hepatic Cancer; Head and Neck Cancer; Other Solid Tumors

Summary: this is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

this study will determine the safety, tolerability and activity of cdx-527. eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of cdx-527. the dose-escalation part of the study will determine the safety profile of cdx-527 and determine which dose(s) of cdx-527 will be studied in the expansion part of the study. the expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation up to 40 patients will be enrolled. all patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Eligibility criteria:
key inclusion criteria: 1. recurrent, locally advanced or metastatic solid tumor cancer excluding the following: msi-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma. 2. receipt of all standard therapies for the tumor type 3. measurable (target) disease by irecist 4. if of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment 5. willingness to undergo a pre-treatment and on-treatment biopsy, if required key exclusion criteria: 1. history of severe hypersensitivity reactions to other monoclonal antibodies. 2. previous treatment with any anti-cd27 antibody. 3. inadequate washout period from prior therapy as defined in the protocol. 4. patients who have received more than 0 or 1 prior pd-1/pd-l1 inhibitor depending on their tumor type 5. major surgery within 4 weeks prior to study treatment. 6. use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment. 7. other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. for all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll. 8. thrombotic events within the last 6 months prior to study treatment 9. active, untreated central nervous system metastases. 10. active autoimmune disease or documented history of autoimmune disease. 11. history of (non-infectious) pneumonitis or has current pneumonitis. 12. active diverticulitis 13. known infection of hiv, hepatitis b, or hepatitis c. there are additional criteria your study doctor will review with you to confirm your eligibility for the study.
open-trial on the prevention of chronic migraines with the cefaly device

Conditions: Migraine

Summary: the main objective of this study was to assess the safety and efficacy of the cefaly® e-tns device as a prophylactic treatment of chronic migraine in adult patients.

the purpose of this pilot study was to assess the safety and efficacy of the cefaly® e-tns device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Eligibility criteria:
inclusion criteria: * patients with a history of chronic migraine meeting the diagnostic criteria listed in ichd-iii beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. they are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours. both patients with or without acute medication overuse (medication overuse headache - moh) will be recruited exclusion criteria: 1. women: pregnant, lactating or \<6 months post partum 2. for patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period. 3. for patients treated with botox, no injection within 4 months before start of baseline or during the study. 4. diagnosis of other primary or secondary headache disorders, except of medication overuse headache 5. a beck depression inventory score of \>24 at baseline 6. psychiatric disorders that could have interfered with study participation 7. intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific cefaly program)
stereotactic body radiation therapy (sbrt) for unresectable liver metastases

Conditions: Liver Metastases; Colorectal Cancer; Anal Canal Cancer; Gastrointestinal Neuroendocrine Tumors

Summary: this is a phase ii study to determine the efficacy of sbrt to treat liver metastases in patients with colorectal adenocarcinoma, carcinoma of the anal canal and gastrointestinal neuroendocrine tumors that are not amenable to surgery. patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent. therefore, sbrt is being considered as a potentially curative procedure.


Eligibility criteria:
inclusion criteria: * karnofsky performance scale (kps) equal or greater than 70 * 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm * lesions considered unresectable or patients considered unfit for surgery * histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors. * absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent. * minimum interval of 2 weeks between systemic chemotherapy and sbrt. * adequate bone marrow function defined as: * absolute neutrophils count \> 1,800 cells / mm 3 * platelets \> 100,000 cells / mm 3 * hemoglobin \> 8.0 g / dl ( transfusion or other intervention accepted) exclusion criteria: * concomitant chemotherapy * prior radiotherapy to the upper abdomen * pregnancy * underlying cirrhosis * active hepatitis or clinically significant liver failure * prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease * severe comorbidity * current anticoagulant treatment

Keywords: sbrt radiation neoplasm metastasis colorectal neoplasms anal canal neuroendocrine tumors
a bioequivalence study, comparing two formulations of ivermectin lotion, 0.5%

Conditions: Lice; Head Lice

Summary: a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing ivermectin lotion, 0.5%

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing ivermectin lotion, 0.5% to sklice (ivermectin) lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their ova

Eligibility criteria:
inclusion criteria: * subjects 18 years of age or older must have provided irb-approved written informed consent and sign a hipaa authorization. * subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. exclusion criteria: * subjects with a history of hypersensitivity or allergy to or any component of the study product. * subject with history of irritation or sensitivity to pediculicides or hair care products.
evaluation of vitoss with and without bma for benign cavitary lesions

Conditions: Bone Diseases

Summary: this is a retrospective, two-arm study reviewing the healing of cavitary defects in patients treated with vitoss alone versus those treated with vitoss with bone marrow aspirate (bma). there will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in patients identified during the retrospective portion of the study. it is thought that the inclusion of bma will facilitate the resorption of the graft material, leading to better long-term bone healing.


Eligibility criteria:
inclusion criteria: * males and females \>/= 18 years of age at the time of surgery * patients treated with vitoss alone or vitoss with added bma between 2004 and 2012 * willing and able to provide informed consent to participate in and follow study requirements (including a radiologic assessment) exclusion criteria: * patients with a known post-traumatic defect * active infection at the time of implantation * history of bone marrow disorders * contraindications to the use of supplemental bma
imaging of in vivo sigma-2 receptor expression with 18f-iso-1 positron emission tomography in metastatic breast cancer

Conditions: METASTATIC BREAST CANCER

Summary: pilot study using \[18f\]iso-1 pet/ct to image sigma-2 receptor binding in metastatic breast cancer. correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. the target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. ct, mri, bone scan, ultrasound, fdg pet/ct) * plan to start new systemic therapy for metastatic disease. * participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening. * inability to tolerate imaging procedure in the opinion of an investigator or treating physician. * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
evaluating the effects of a computerized training program coupled with cognitive behavioral therapy (cbt) for ocd.

Conditions: Obsessive-Compulsive Disorder

Summary: this study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (cbt) for ocd.

this study will evaluate the effectiveness of a computerized training program (called personalized computerized inhibitory training, or pcit) coupled with cognitive behavioral therapies (cbt) consisting of exposures and response prevention in treating obsessive compulsive disorder (ocd) in patients who previously underwent cbt, but still have residual symptoms.

Eligibility criteria:
inclusion criteria: * principal diagnosis of ocd (assessed by scid). * clinically significant ocd symptoms (y-bocs score of at least 14). * allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study. * have access to a computer or laptop. exclusion criteria: * individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by scid). * patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system. * patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry. * patients with a history of more than 8 hours of therapist-assisted erp for ocd in the past 6 months, * vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded). * active suicidality warranting immediate clinical care.
effects of aerobic exercise on occupational burnout

Conditions: Burnout Syndrome

Summary: the aim of the present study is to investigate the impact of regular aerobic exercise on psychopathology, cortisol secretion, bdnf, sleep, cognitive performance, and psychological functioning in people suffering from professional burnout. pre- and postassessments after 12 weeks of training will be performed.


Eligibility criteria:
inclusion criteria: * burnout * male participants * non-smokers exclusion criteria: * psychiatric disorders * smokers * physical diseases
discovering novel cancer treatment options using a comprehensive ngs-based liquid molecular testing panel in the community setting ("dinosaur ii")

Conditions: Stage III Solid Tumors; Stage IV Solid Tumors

Summary: to prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive l i q u i d molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.


Eligibility criteria:
inclusion criteria: * patients who have given informed consent in accordance with the methods and procedures of this study * diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care * patients who have not received treatment related to his/her cancer * patients who are willing to sign a release of medical records to the research team * male and female patients ≥18 years of age * patients under oncology care * sufficient clinical status for collection of blood sample within usual care exclusion criteria: * patients considered minors in the jurisdiction where the protocol is conducted * patients who are prisoners and pregnant women * patients who cannot provide consent and did not sign a power of attorney
clinical transformation of organoid model to predict the efficacy of gc in the treatment of intrahepatic cholangiocarcinoma

Conditions: Organoids; Intrahepatic Cholangiocarcinoma

Summary: the clinical incidence of intrahepatic cholangiocarcinoma (icc) is high and insidious, and the prognosis of advanced patients is poor. the clinical manifestations of traditional chemotherapy gc and emerging targeted therapy are different in most patients, and there is still no effective scheme to evaluate the differences in individual patient reactivity. patient-derived tumor organoids (pdo) are 3d-cultured tissues based on tumor cell dryness that reproduce a variety of biological characteristics of parental tumors in vitro and have similar drug responsiveness to tumors in vivo. this project plans to use clinical cases and optimized organoid culture system to first construct relevant organoids from unresectable icc patient puncture samples. secondly, based on the organoid model of intrahepatic cholangiocarcinoma, the clinical efficacy of gc regimen was predicted, and in vitro and in vivo drug screening was conducted to explore the guidance of patient-derived tumor organoids for clinical treatment. then, multi-omics data of organoids and in vitro and in vivo drug efficacy evaluation model were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: - histologically confirmed intrahepatic cholangiocarcinoma they are between 18 and 80 years old written informed and signed consent form biopsy sample of the intrahepatic bile duct exclusion criteria: - under 18, over 80 informed consent cannot be given biopsy samples were not available

Keywords: organoid
ovarian stimulation and intrauterine insemination in women with polycystic ovarian syndrome

Conditions: Infertility; Polycystic Ovarian Syndrome; Intrauterine Insemination

Summary: the study null hypothethesis is: intrauterine insemination (iui) does not improve pregnancy rates in women with polycystic ovary syndrome. infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either iui or timed intercourse (ti)


Eligibility criteria:
inclusion criteria: - women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of world health organization (who 2010) exclusion criteria: male factor infertility

Keywords: infertility pcos iui
asthma and indoor-air: reducing exposures

Conditions: Asthma

Summary: two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. one intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (hvac) system. the second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. each participant will receive true air filtration for a year and a placebo for a year. during the placebo period a sham filter will be used that removes very little of the particles. measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eno).


Eligibility criteria:
inclusion criteria: * 6-12 years of age * living in fresno, san bernardino or riverside counties. * physician diagnosed asthma, as stated by the participant's caregiver. * in the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row. exclusion criteria: * children living in homes where more than 2 cigarettes are smoked per week in the home. * children that spend 2 or more nights per week in another home. * children living in homes that are planning on moving in the next 2 years. * children living in homes that keep their windows open most of the time. * children living in homes that have existing high efficiency filtration.
brain changes in stimulant dependent subjects - 8

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to identify the neurophysiologic indicators of cocaine or methamphetamine use and withdrawal, to examine the relationship between subjects' reports of depression, craving, and stimulant use, and neurophysiologic measures, and to identify neurophysiologic measures which can be used to identify new treatments for stimulant dependence.

by incorporating qeeg into clinical trails, the plan is to develop physiologic markers of treatment efficacy, and to aid in the identification of effective treatments.

Eligibility criteria:
inclusion criteria: m/f ages 21-50. meet dsm-iv criteria for cocaine dependence. agree to conditions of the study and sign informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: stimulant dependence
evaluation of a model for the early diagnosis of colorectal cancer by the detection of 5-hydroxymethylcytosine (5-hmc) in plasma cell-free dna to the community colorectal cancer screening program

Conditions: Colorectal Cancer; Colorectal Neoplasms

Summary: the incidence rate and mortality of colorectal cancer are increasing year by year. most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. however, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in china. according to the data from shanghai xuhui district center for disease control and prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%. this project plans to use the latest colorectal cancer screening technology, namely, 5hmc detection in peripheral blood and dna methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in xuhui district, shanghai. it is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. at the same time, to explore the screening efficiency of the early diagnosis model of 5hmc cancer.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years old and\<75 years old; * the initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive)； ③ receive sample collection; ④ sign the informed consent form. exclusion criteria: ① history of colorectal cancer, colorectal adenoma, and treatment; * enteroscopy was performed after the initial screening was positive; ③ the subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.
effect of custom foot orthoses in patients with psoriatic arthritis

Conditions: Psoriatic Arthritis; Foot Arthritis

Summary: foot involvement is a major concern in psoriatic arthritis (psa). the patients could experience severe levels of foot pain and disability and reduced mobility and quality of life. previous studies showed that the use of custom foot orthoses (cfo) was effective to improve foot pain and perceived disability in patients with foot disease associated with rheumatoid arthritis. however, there are no records in the literature on the effectiveness of cfo in psa patients. therefore, our objective was o explore the effects of cfo on foot pain, foot function, gait spatiotemporal parameters (stp), and ambulatory physical activity (apa) in psa patients with foot involvement. in this pre-experimental exploratory study, 22 psa patients having stable medication in the last 3 months preceding the recruitment were recruited. all the patients wore functional cfo designed by an experimented podiatrist during a 7-week period. foot and lower limb pain and foot function were measured at baseline (t0) and after the 7-week period using the numerical rating scale (nrs) and the foot function index (ffi), respectively. gait function was assessed by recording spatiotemporal parameters (stps) during a 10-meter walk test using an instrumented gait analysis system (mobility lab) at t0 and t7. freeliving walking activities (step count, freeliving cadence, time spent in different ambulatory physical activity (apa) intensities) at t0 and t7 were recorded over 7 days using accelerometer data collected from an instrumented sock worn by the participants during waking hours.


Eligibility criteria:
inclusion criteria: * aged between 20 and 70 years * diagnosed with psoriatic arthritis by a rheumatologist * having moderate to severe foot pain scored at least 3 on the numeric rating scale * having stable medication for the three months preceding the study exclusion criteria: * having diabetes or neurological disease that may affect the feet * having recent traumatic foot injury * having received specific interventions for the feet (ex: foot orthoses, orthopedic shoes, intraarticular steroid injection) for the three months preceding the study. * having a recent history of foot surgery.