Kornimate/medical-research-clean huggingface dataset:
a study of participants with chronic kidney disease previously treated with react

Conditions: Diabetic Kidney Disease; CAKUT; Chronic Kidney Diseases

Summary: the purpose of this study is to evaluate the safety of supplemental react injections in participants with chronic kidney disease (ckd) who have previously received react treatment.

a phase 1, open-label trial where up to 10 participants will enroll in the trial after parent react protocol eos visit completion. participants may undergo a biopsy to manufacture react if additional biopsy tissue is required. participants will receive 2 react injections separated by 6 months. all participants will be followed for 12 months post last supplemental react injection.

Eligibility criteria:
inclusion criteria: 1. the participant has received react in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period. 2. the participant is male or female, 30 to 80 years of age on the date of informed consent. 3. the participant has a documented clinical diagnosis of an egfr greater than or equal to 14 and less than or equal to 50 ml/min/1.73m2, not requiring renal dialysis. 4. the participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary. exclusion criteria: 1. the participant has a history of renal transplantation. 2. the participant has received dialysis for more than 30 days. 3. the participant has received any other investigational products after completion of react injections within 3 months of screening. 4. the participant has a urinary albumin-to-creatinine ratio (uacr) of greater than 5,000 mg/g. 5. the participant has hemoglobin levels less than 10 g/dl and is not responsive to the standard medical intervention for ckd-related anemia prior to screening.

Keywords: react cakut dkd
clinical evaluation of the aptima® combo 2® assay using the panther™ system

Conditions: Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection

Summary: the objectives of this study are to establish the performance characteristics of the ac2 (aptima combo 2) assay on the panther system for the sample types cleared for use on the tigris and dts (direct tube sampling) systems and to demonstrate the repeatability and reproducibility of the ac2 assay on the panther system.

the results of this protocol ac2ps-us11-001 (nct01733069) are based on samples collected from protocol actps-us10-001(nct01358799). the registration for nct01358799 was withdrawn because the samples were not tested under protocol actps-us10-001, instead they were tested under the protocol registered here ac2ps-us11-001 (nct01733069).

Eligibility criteria:
inclusion criteria: •the subject is at least 14 years of age at the time of informed consent and is sexually active * the subject reports symptoms consistent with a suspected std (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort. * if the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected std(s), is undergoing screening evaluation for a possible std(s), and/or is scheduled for a routine exam that may include a pelvic exam * the subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an irb (institutional review board) approved waiver for parental consent for minors) exclusion criteria: •a potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following: * the subject took antibiotic medications within the last 21 days * the subject is underage (as defined by the irb (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an irbapproved waiver for parental consent for minors) * the subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
assessment of ovarian reserve in women with rheumatologic diseases

Conditions: Rheumatologic Diseases; Ovarian Reserve; Infertility

Summary: our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . in our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (amh).


Eligibility criteria:
inclusion criteria: * rheumatologic disease exclusion criteria: * none
neurocognitive enhancement in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. subjects in this study will be randomized to receive neurocognitive enhancement therapy (net) or to a wait list and then net . secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.


Eligibility criteria:
inclusion criteria: 1. male or female. 2. subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data. exclusion criteria: 1. presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury. 2. subjects with a reading level below grade 6, as assessed with the wide range achievement test - reading recognition subtest, will be excluded because of the likelihood of not understanding task instructions. 3. subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.
safety/efficacy study of oxycodone hcl/niacin to treat pain after bunionectomy

Conditions: Pain

Summary: the purpose of this study is to determine whether oxycodone hcl and niacin are effective in the treatment of pain following bunionectomy surgery.

this was a phase iii, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of acurox™ tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery. patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (iv) sedation. eligible patients who reported moderate or severe pain within 6 hours after surgery entered the treatment phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of acurox™ tablets (ocyxcodone hcl/niacin). the treatment phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). toradol (ketorolac tromethamine) was available as a rescue medication upon request.

Eligibility criteria:
inclusion criteria: * patient is male or female at least 18 years of age * for women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * patient is scheduled to have a bunionectomy * patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery exclusion criteria: * patient has a current disease or history of a disease that will impact the study or the patient's well-being * patient has used or intends to use any of the medications that are prohibited by the protocol * patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen * patient is hypersensitive to any of the medications to be used in the study * patient has taken another investigational drug within 30 days prior to screening

Keywords: pain
68ga-psma-11 patients with newly diagnosed and recurrent prostate cancer (firefly)

Conditions: Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant

Summary: this is a prospective, phase 2, single-center, open-label study of 68ga-psma-11 pet scans in patients with biochemically recurrent prostate cancer or those diagnosed and untreated with high risk or very high risk localized prostate cancer, or oligometastatic (defined as three or fewer metastatic lesions on conventional imaging) prostate cancer (using nccn classification for localized disease). approximately 300 patients are planned for enrollment in this study, divided into two cohorts. cohort a will be 225 patients in the recurrent setting. cohort b will be 75 patients in the up-front newly diagnosed setting. after a screening period (6-week window), eligible patients will undergo baseline assessments as per the schedule of study activities. patients will receive a single dose of 68ga-psma-11 and undergo a pet/ct or pet/mri imaging study.


Eligibility criteria:
inclusion criteria: * males greater than 18 years of age. * histologically proven adenocarcinoma of the prostate. diagnosis must be stated in a pathology report and confirmed by the investigator. * patients must meet the criteria of one of the following cohorts: cohort a: (n=225) biochemical recurrence; defined as any of the following: * psa ≥ 0.2 ng/ml and rising in at least two consecutive tests (at least one week apart) within 6 months of date of consent for patients treated with radical prostatectomy. * psa \>2.0 ng/ml above the nadir and rising post-radiation (external beam or brachytherapy) +/- hormones, in at least 2 consecutive tests (at least one week apart) within 6 months of consent * in patients with no prior definitive surgery or radiation, psa ≥ 2 ng/ml greater than the post therapy nadir after androgen deprivation therapy. note: patients whom have had more than one prior therapy, should be defined recurrent by their most recent therapy type. for patients who have had any adt, are mcrpc, shall fall into that category for allocation and eligibility. cohort b: (n=75) no prior treatment defined as one of the following: o patient has primary diagnosis of "high risk" or "very high risk" localized prostate cancer, or regional prostate cancer (txn1m0) or oligometastatic cancer (txnxm1) with less than three metastatic lesions by conventional imaging) and has not received prior treatment. note: high risk/very high risk is denoted by gleason 8-10, or psa \>20, or clinical stage t3a/t4 disease (see nccn guidelines v1.2020). patients in this cohort must be considered candidates for initial definitive therapy at the time of study enrollment. * life expectancy of \>6 months * patients should have a comprehensive metabolic panel, psa, and testosterone drawn within 4 weeks of imaging exclusion criteria: * claustrophobia or any other condition that would preclude pet/ct imaging. * patients with known metastatic prostate cancer, with 4 or more lesions on conventional imaging

Keywords: 68 ga-psma-11 prostate cancer metastatic prostate cancer
a study of pf-06263507 in patients with advanced solid tumors

Conditions: Neoplasms; Carcinoma, Non Small Cell Lung; Breast Neoplasms; Ovarian Neoplasms

Summary: to assess the safety and tolerability at increasing dose levels of pf-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended phase 2 dose.


Eligibility criteria:
inclusion criteria: * diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available. * performance status of 0 or 1. * adequate bone marrow, kidney, liver, and heart function. exclusion criteria: * brain metastases requiring steroids. * major surgery or anti-cancer therapy within 4 weeks of study treatment start. * active bacterial, fungal or viral infection.

Keywords: adc 5t4 pf-06263507 solid tumors lung cancer breast cancer ovarian cancer cancer tumors neoplasm metastasis
sdsu move/me muevo project

Conditions: Childhood Obesity

Summary: the purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention \& control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors.

the primary aim is to evaluate the effectiveness of a multi-level intervention to prevent the onset of overweight and obesity in 7-9 year old children. the recreation center site intervention emphasizes changes in quantity and quality of physical activity and nutrition-related offerings within the centers. the home site intervention targets the home environment and household rule setting delivered via family health coaches and tailored to the needs of the family. five hundred forty one (541) families were recruited to participate in this project. participants were selected in part based on residence in proximity to participating recreation centers. eighteen (18) families living up to 3 miles from each of the 30 recreation centers involved in the project were be recruited to participate. for each family, one child was recruited between the ages of 5 and 8 years old and this child's primary caregiver was enrolled in the study. the study's primary outcome is body mass index (kg/m2). comparisons: control vs. intervention

Eligibility criteria:
inclusion criteria: * primary residence within 3 miles of recreation center * children ages 5-8 at baseline * commit to participate in study for 3 1/2 years * participating parent must be a legal guardian of the child * parent and child must be able to speak and read english or spanish * willing to be randomly assigned to control or intervention exclusion criteria: * child has a medical/health/psychological condition or is taking a medication that may impact the child's physical activity, diet or weight to confound bmi * parent or child is unable to read and speak english or spanish * family plans to move during the next 3 1/2 years

Keywords: recreation centers families obesity prevention
evaluation of effectiveness and safety of hybrid coronary revascularization

Conditions: Percutaneous Coronary Revascularization; Coronary Stenosis; Coronary Artery Disease Progression; Coronary Artery Bypass Grafting

Summary: this study evaluated the effectiveness and safety of hybrid coronary revascularization in real-world practice.


Eligibility criteria:
inclusion criteria: * age 20 and more * hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery) * written consent exclusion criteria: * previous cabg(coronary artery bypass graft) * life expectancy ≤1 year

Keywords: hybrid coronary revascularization
dexamethasone for pain after shoulder surgery

Conditions: Shoulder Impingement Syndrome; Arthritis

Summary: the purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Eligibility criteria:
inclusion criteria: * arthroscopic subacromial decompression and/or acromioclavicular resection * general anaesthesia * daysurgery, horsens hospital exclusion criteria: * incompetent * pregnant * age under 18 or over 90 years * allergy toward dexamethasone * diabetes * active gastric ulcer * untreated hypertension * glaucoma * daily use of glucocorticoids or strong opioids * daily use of analgesics for unrelated illness * myasthenia gravis * mitochondrial disorders
ctdna after chemotherapy in elderly patients with acute leukemia

Conditions: Acute Leukemia

Summary: this study will monitor ctdna after chemotherapy in elderly patients with al

this study will use droplet digital pcr (ddpcr) method to quantify peripheral blood plasma mutant allele frequency (maf) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of ctdna .

Eligibility criteria:
inclusion criteria: * written informed consent * male * not pregnant female * patients \>=60 years old * diagnosis of acute leukemia exclusion criteria: * pregnancy * hiv positive * patients \>=100 years old
electronic consultation for ad/adrd residents experiencing infectious diseases

Conditions: Alzheimer's Dementia; Nursing Homes; Antibiotics; Dementia

Summary: pilot study to evaluate the feasibility of a pilot embedded pragmatic cluster randomized controlled trial to reduce the duration of antibiotic therapy and number of antibiotic prescriptions in nursing home residents with ad/adrd.

the overall objective of the proposed investigation is to assess the feasibility of a pilot embedded pragmatic cluster randomized controlled trial (epct) to reduce the duration of antibiotic therapy and number of antibiotic prescriptions among nursing home residents with ad/adrd. with the support of three independently owned and operated nursing homes that are unaffiliated with an academic medical center, we have developed the multicomponent intervention, ecare-id (electronic consultation for ad/adrd residents experiencing infectious diseases). ecare-id consists of three components: 1) tele-id video clinical consultation services for nursing home residents; 2) electronic consultation (e-consultation) services for healthcare personnel at participating nursing homes; and 3) tele-id video antibiotic stewardship services for healthcare personnel including pharmacists at participating nursing homes.

Eligibility criteria:
inclusion criteria - residence in a participating nursing home exclusion criteria: - not willing to consent to the study
investigation of cigarette cravings in smokers

Conditions: Cigarette Smoking; Addiction Nicotine; Tobacco Use

Summary: interventions to disrupt memory reconsolidation have held promise for the treatment of stress- and anxiety-related disorders. in the present study, the investigators will examine whether an intervention based on these principles, called memory updating, could be adapted for reward-seeking behaviors. to test this, non-treatment seeking tobacco smokers will be exposed to smoking cues and/or stress, two stimuli known to trigger smoking. it is predicted that exposure to a stress task will enhance the cues' motivational salience and yield greater susceptibility to the memory updating procedure. as an add-on, the investigators will examine covid-associated changes in substance use and whether participants in the memory updating groups might be more resilient to these effects. it is predicted that the changes in substance use will depend on whether the substances are used primarily in social settings.

non-treatment seeking cigarette dependent smokers will be randomized to one of four testing conditions: 1) a non-stressful task followed by neutral cues, 2) the non-stressful task followed by smoking cues, 3) a stressful task followed by neutral cues, or 4) the stressful task followed by smoking cues. ten minutes after the intervention, participants will undergo a 60-minute extinction procedure consisting of smoking-related videos, images and smoking paraphernalia. cue reactivity test sessions will take place 24 hours, 2 weeks and 6 weeks following the intervention. covid-associated changes in substance use will be quantified over three telephone interviews: one at the end of march / beginning of april 2020 (at the start of the pandemic), one at the end of april / beginning of may, and a final one which will be instituted if feasible once the infection rates and social distancing policies have decreased.

Eligibility criteria:
inclusion criteria: * scoring 5 or higher on the fagerström test for cigarette dependence * willingness to abstain from smoking for 4 hours prior to each laboratory visit exclusion criteria: * currently using cigarette cessation products * endocrinological problems * significant mental or physical health conditions * pregnancy

Keywords: memory updating reconsolidation
quitting schedule mobile smartphone application in helping participants to quit smoking

Conditions: Cigarette Smoker; Current Every Day Smoker; Current Smoker; Malignant Neoplasm

Summary: this trial studies how well a mobile smartphone application called quitting schedule works in helping participants to quit smoking. quitting schedule is based on webcassi, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to md anderson cancer center (mdacc) patients and served as a portal for non-patients to find information regarding smoking cessation advice and treatments. quitting schedule may help participants to quit smoking.

primary objectives: i. to adapt the internal algorithms of the scheduled reduced smoking approach in computer assisted stop smoking intervention for the world wide web (webcassi) into a smartphone application (app): quitting schedule. ii. once the smartphone app is developed, a pretesting phase with smoker seeking care at mdacc tobacco treatment program or another community service such as equality texas, lesbian, gay, bisexual, transgender, and queer (lgbtq) advisory board of the city of houston, montrose center, avenue 360 and lesbian health initiative will follow. iii. to culturally and linguistically adapt quitting schedule app into spanish language. iv. to implement a feasibility trial in idc (colombia), incan (mexico), and inen (peru). outline: aim i: participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while mdacc ehealth adapts webcassi into a smartphone app: quitting schedule. aim ii: participants pre-test the quitting schedule mobile smartphone app for 5 weeks.

Eligibility criteria:
inclusion criteria: * current smokers (those who smoke at least 5 cigarettes a day; confirmed with carbon monoxide (co) levels equal or above 7 parts per million ) newly enrolled in the tobacco treatment program at mdacc (aim 2 ) * male or female (aim 2) * adult cancer patients - 18 years or older (aim 2) * current smokers seeking care at the tobacco treatment program at md anderson and at houston area community services who have smoked at least 100 cigarettes in lifetime * willing to download and use the app quitting schedule (aim 2) * willing to set a quit smoking date within 5 weeks of the enrollment (aim 2) * ownership of an iphone or android smartphone (aim 2) exclusion criteria: * unwillingness to participate in the study (aim 2) * enrolled in another cessation program (aim 2) * current use of nrt or other smoking cessation medications,e.g. varenicline or bupropion outside of the md anderson institution (aim 2) * expired co levels below 7ppm (aim 2)