Kornimate/medical-research-clean huggingface dataset:
a first-in human (fih) trial to find out if regn10597 is safe and how well it works for adult participants with advanced solid organ malignancies

Conditions: Melanoma; Clear-Cell Renal-Cell Carcinoma (ccRCC); Advanced Solid Tumors

Summary: this study is researching an experimental drug called regn10597 (called "study drug"). the study is focused on patients with certain solid tumors that are in an advanced stage. the aim of the study is to see how safe, tolerable, and effective the study drug is. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

phase 1: conducted in the united states phase 2: conducted globally

Eligibility criteria:
key inclusion criteria: dose-escalation cohorts: 1. histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy 2. participants are required to submit archival tissue with optional fresh biopsy dose-expansion cohorts: 1. histologically of cytologically confirmed diagnosis of melanoma or ccrcc tumors with criteria, as defined in the protocol 2. participants are required to submit fresh pretreatment biopsy during screening key exclusion criteria: 1. prior treatment with interleukin 2 (il2)/il15/il7 2. prior treatment with anti pd-1/pd-l1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol 3. has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from aes 4. has had prior anti-cancer immunotherapy within 2 months prior to study therapy 5. has ongoing immune-related aes prior to initiation of study drug, as defined in the protocol 6. has known allergy or hypersensitivity to components of the study drug 7. has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study drug 8. has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments note: other protocol defined inclusion / exclusion criteria apply.

Keywords: advanced solid organ malignancies locally advanced metastatic non-uveal unresectable primary or secondary resistance to programmed cell death protein 1 (pd-1)/ programmed cell death ligand 1 (pd-l1)
phase i clinical trial of a candidate pcv13 in healthy people

Conditions: Pneumococcal Infections

Summary: streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. since the licensure of pcv7, pcv10, pcv13 and pcv15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. this is a single center, blinded, randomized, positive-controlled phase i clinical trial to evaluate the safety and explore the immunogenicity of a candidate pcv13 in healthy people aged 2 months (minimum 6 weeks) and above.


Eligibility criteria:
inclusion criteria: * satisfy the age requirements of the clinical trial; willing to provide proof of identity; * subjects or guardians must provide informed consent forms with personal signature and date; * male and female of childbearing age should agree to take effective contraception measures; * subjects or guardians can obey the requirements of the clinical study; * axillary temperature below 37.3 °c. exclusion criteria: * laboratory indicators (expect those have no clinical significance) out of normal ranges required; * received any pneumococcal vaccine; * allergic history to any drugs, vaccine or vaccine-related component; * infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition; * infants diagnosed with pathological jaundice that lasts for 2\~4 weeks and occurs repeatedly; * breast-feeding or pregnant women, or positive u-hcg; * high blood pressure uncontrolled by medication; * known or suspected immune deficiency or immune suppression; * serious congenital malformation, history of organ resection or serious chronic illness; * received blood products or intravenous immunoglobulin (except hepatitis b immunoglobulin); * history of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae; * history of convulsions, epilepsy or encephalopathy or a family history of mental illness; * a vaccination-related contraindications that other investigator believes; * plans to participate in or is participating in any other clinical study; * any other factors judged by investigator that may interfere subject's compliance with the protocol.

Keywords: pneumonia, pneumococcal
pre post evaluation of temperature, steps, and glucose with additional time spent outdoors in an urban and rural setting

Conditions: Temperature; Exercise; Diabetes Mellitus, Type 2

Summary: this research was designed with partners to determine differences in temperature exposures in urban and rural communities in alabama. the investigators hypothesized that significant differences in temperature exposure exist between urban and rural settings. time spent outdoors has been previously positively associated with greater physical activity. built environment components in urban versus rural environments and ambient temperatures experienced during the summer may pose barriers to time spent outdoors. persons with type ii diabetes mellitus may find it more difficult to overcome temperature barriers due to reduced thermoregulation capacity. this analysis will result in a more precise picture of temperature exposure as well as behavioral factors that may mediate exposure.

the investigators gathered individual-level temperature exposure data by asking 180 female participants to wear a small thermometer on their shoe for 7 days. ninety participants were recruited from birmingham al (urban) and 90 from rural west central alabama. the first two days participants were asked to go about their normal daily activities. during the next 5 days of participation, participants were asked to add an additional 30 minutes of time spent outdoors. as a secondary outcome, steps were measured via pedometers worn by participants. a subgroup of participants with self-reported doctor diagnosed type ii diabetes also recorded their fasting glucose each morning of participation.

Eligibility criteria:
inclusion criteria: * female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week. exclusion criteria: * medical condition that limits the amount of time able to be spent outdoors.

Keywords: rurality
posterior lateral fusion (plf) with dynesys

Conditions: Spondylolisthesis

Summary: the primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the dynesys spinal system. secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.

this study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.

Eligibility criteria:
inclusion criteria: * spondylolisthesis of less than grade ii at the index level (degenerative with intact pars) * will receive a decompression for lumbar stenosis * symptoms of leg and/or back pain * one pathological level * between the ages of 20 and 80 at the time of surgery * non-responsive to non-surgical treatment for at least six months exclusion criteria: * osteolytic spondylolisthesis * planned complete facetectomy * two or more pathological levels (and as enumerated int he dynesys spinal system instructions for use) * use in the cervical spine * active systemic or local infection * extreme obesity as defined by a body mass index (bmi)over 40. bmi calculated using appendix a, adapted from the national heart, lung, and blood institute, clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. * pregnancy * mental illness * severe osteoporosis or osteopenia. the world health organization defines osteoporosis as bmd\<-2.5t. professional discretion should be used and if bone quality is in question a dexa scan is recommended. * sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate * alcohol or drug abuse * patient unwilling or unable to follow postoperative instructions * soft tissue deficit not allowing sound closure * any medical or physical condition that would preclude the potential benefit of spinal surgery * inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices; * any medical or mental condition which would exclude the patient at high risk from surgery of the severity

Keywords: dynamic stabilization dynesys fusion success immobilization of spinal segments as an adjunct to fusion in the treatment of the following: acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine degenerative spondylolisthesis with objective evidence of neurologic impairment failed previous fusion (pseudarthrosis).
efficacy trial of healthy together ("juntos")

Conditions: Obesity; Activity, Motor; Diet, Healthy

Summary: the purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as healthy together ("juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among hispanic adolescents.


Eligibility criteria:
inclusion criteria: adolescent 1. lives with participating biological parent or legal guardian; 2. self-identifies as hispanic; 3. is between the ages of 12-15years old; 4. has access to a smartphone; 5. does not meet recommendations for physical activity as determined by a validated 2-item screener; 6. does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener; 7. exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener parent 1. is the biological parent or legal guardian of and lives with the adolescent; 2. self-identifies as hispanic; 3. has access to a smartphone; exclusion criteria: adolescent 1. has bmi \<5th (underweight) or ≥95th percentile (obesity); 2. has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention; 3. has parent-reported responses on a physical activity readiness questionnaire (par-q) that indicates a serious health issue, and a physician does not approve participation; 4. has a parent-reported cognitive or developmental delay (e.g., down syndrome) that may interfere with understanding program materials. parent 1. provides par-q responses that indicate a serious health issue and a physician does not approve participation; 2. reports family plans to move out of south florida during the study follow-up period

Keywords: hispanic, family, digital health, obesity prevention, physical activity, nutrition
optimization of an online stepwise therapeutic device based on a cognitive-behavioral approach for cancer patients with insomnia

Conditions: Cancer; Insomnia

Summary: determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)


Eligibility criteria:
inclusion criteria: * adults patients, * with a diagnosis of localized or metastatic cancer, * during or after their treatment, * in one of the following three cancer centres: gustave roussy (villejuif), montpellier cancer institute (montpellier), and léon bérard center (lyon) * with a significative score on the self-screening insomnia severity index score (isi ≥ 8) * able to readily read and understand french, * able to use informatic tools confidently and with internet access, * who have signed the online consent form, * affiliated to a social security system or beneficiary of the same. exclusion criteria: * patient with a visual, hearing or cognitive disability that is incompatible with the study, * simultaneous participation in another study evaluating a treatment of insomnia, * patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
hand grip strength in athletic and non-athletic girls at different phases of menstrual cycle

Conditions: Grip; Athlete; Non-athlete; Menstrual Cycle

Summary: the study was designed as an observational study

the study was designed as an observational case-control study

Eligibility criteria:
inclusion criteria: - 1. the participant had regular menstrual cycles, which were confirmed by using a calendar for three consecutive menstrual cycles, 2. the participant ages ranged from 16 to 22 years old, 3. the body mass index (bmi) ranged from 18.5 to 25 kg/m2. 4. for athletic group, they had participated in basketball and tennis teams for 3 to 4 years. 5. for non-athletic group, they had a sedentary life without any sport activities. exclusion criteria: * participants were excluded from the study if they had: 1. irregular menstrual cycle 2. pelvic inflammatory diseases, pelvic infection or gynecological diseases. 3. any musculoskeletal disorders of upper extremity or surgery, cardiovascular, pulmonary, neurological or systemic conditions. 4. receiving contraceptives or any hormonal therapy.

Keywords: menstrual cycle female sex hormones athletic female power
alcohol screening and pre-operative intervention research study

Conditions: Alcohol Drinking

Summary: this study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.

the study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. study subjects will be outpatients at a large health system in the midwestern united states and fulfill the study's inclusion criteria. subjects will be randomized to one of two intervention conditions: health coaching or brief advice.

Eligibility criteria:
inclusion criteria: * referred for elective or semi-elective surgery or pre-operative assessment in the next 120 days * meet criteria for "risky drinking" as defined by study staff exclusion criteria: * displays or shows evidence of psychotic symptoms * undergoing surgeries that commonly require local anesthesia only

Keywords: elective surgery
racial disparities in pneumococcal vaccination in managed care

Conditions: Pneumococcal Disease Prevention

Summary: the goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population.

patients randomized to the intervention arm received a telephone call from managed care nurses asking about their pneumococcal vaccination status and whether they would like to be vaccinated. we compared six month follow-up of pneumococcal vaccination in electronic medical records for the intervention versus control group. we tested the percent vaccinated in each randomization arm using chi-square tests for proportions.

Eligibility criteria:
inclusion criteria: - recommended for pneumococcal vaccination according to age or medical comorbidity exclusion criteria: - already known to have received pneumococcal vaccine

Keywords: pneumococcal vaccination coverage with no disease or efficacy outcomes recorded
aneurysm packing with the expandable trellix coil system - a prospective safety study

Conditions: Ruptured or Unruptured Cerebral Aneurysms

Summary: apex-fih is a first-in-human, open-label prospective multicenter study of the trellix embolic coil system for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms


Eligibility criteria:
inclusion criteria: * subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure * aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm * if ruptured aneurysm: either wfns grade 1 or 2, or hunt and hess 1 or 2 * if unruptured aneurysm: subject grade modified rankin scale mrs 0 - 2 * investigator plans to use ≥70% in volume trellix coils to fill target aneurysm exclusion criteria: * prior treatment (surgical or endovascular) of the target aneurysm * planned treatment of multiple aneurysms in index procedure * planned use of other modified coils (matrix, hydrocoil or fibered coils) * planned use of liquid embolic material * life expectancy less than 12 months * presence of arteriovenous malformation * fusiform, mycotic, traumatic, or tumoral aneurysms * intended or planned aneurysm treatment by parent vessel occlusion * clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure
the analgesic effect of nitroglycerin patch for postoperative pain after total knee replacement

Conditions: Total Knee Arthroplasty

Summary: patients who undergo general anestheesia for total knee arthroplasty pften have sever postoperative pain which hinders their rehabilitation. nitroglycerin patches have been found to cause alleviation of pain especially when used in conjuction with morphine. therefore we propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how it affects pain scores or causes less nedd for morphine after surgery.

patients undergoing total knee arthroplasty will be randomized into two groups: control and placebo. eache patient will undergo total knee arthroplasty under general anesthesia. both groups will get the same anesthetic protocal. at the end of surgery, before awakening patients will recieve either a nitroglycerin or placebo patch on their back. both the participant and the investigator will be blinded to the group assisignment. at the end of surgery both groups will recieve morphine for postoperative pain. in the recovery room they will be given patient controlled analgesia with morphine. an investigator blinded to study assisignment will record pain scores, sedation scores, nauseau and vomiting. patients will be given patient controlled analgesia for 24 hours and they will be followed for pain levels, morphine use, sedation and nauseau levels. the nitroderm or placebo patch will be removed after 24 hours.

Eligibility criteria:
inclusion criteria: * healthy patients undergoing total knee arthroplasty exclusion criteria: * pshychiatric disorder * allergy to nitroglycerin or morphine * chronic renal failure * migraine headaches * hypotension

Keywords: nitroglycerin morphine patient controlled analgesia total knee arthroplasty
can a specific omt protocol influence patient pain and associated analgesia use for primary headache disorders?

Conditions: Headache Disorders; Headache; Analgesia; Opioid Use; Osteopathy

Summary: the purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. osteopathic manipulative treatment (omt) has been shown to help headache symptoms. the investigators like to see if regular omt sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. in this randomized controlled trial, a set sequence of omt will be compared to light touch sham protocol. investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.

the purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (omt) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. previous research has suggested that omt may alleviate headache symptoms. this randomized controlled trial aims to determine whether regular omt sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. the study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. participants will be randomly assigned to either receive omt or a light touch protocol. investigators will compare questionnaires assessing quality of life and functionality scales. pain levels and medication use will be logged daily throughout the study.

Eligibility criteria:
inclusion criteria: * 18 to 75 years of age * takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches). * 3 months or greater history of headaches or migraines * patient able to tolerate omt based on osteopathic physician discretion and with consideration of absolute and relative contraindications to omt exclusion criteria: * current diagnosis of neoplasm * history of headache secondary to trauma or concussion * history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, brain arteriovenous malformation (avm), vertebral artery disease) * acute psychiatric diagnosis * pregnancy * history of substance use disorder

Keywords: osteopathic manipulative medicine osteopathic manipulative treatment headache