Kornimate/medical-research-clean huggingface dataset:
human amniotic epithelial cells treatment for ovarian insufficiency

Conditions: Premature Ovarian Failure

Summary: this project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.

premature ovarian insufficiency (poi) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. now, there is no exact and effective treatment to restore ovarian function. human amniotic epithelial cells (haecs) are derived from human amniotic epithelium. haecs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. in order to further study the role of haecs in poi treatment, this project will conduct minimally invasive implantation with haecs in 20 cases of poi patients, and evaluate the changes of ovarian function and the safety of haecs implantation. haecs is prepared by chongqing icell biotechnology co.,ltd., which is a subsidiary of shanghai icell biotechnology co.,ltd.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of poi, excluding genetic disease caused by patients; poi diagnostic criteria: patients that \ 25 iu/l. 2. have fertility requirements; 3. agree to sign the designed consent for the study. exclusion criteria: 1. breast cancer, ovarian cancer and other cancer/tumor; 2. contraindications for pregnancy; 3. coagulation disorder and other abnormal physical conditions.
the role of neuroactive steroids in stress, drug craving and drug use in cocaine use disorders

Conditions: Cocaine-Related Disorders

Summary: to use pregnenolone (preg; 300; 500mg) daily versus placebo (pla) as a probe to assess the role of neuroactive steroids in individuals with cocaine use disorder (cud).

this experimental study aims to examine the effects of preg on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with cud; and c) sex differences in all of these outcomes. the study's hypothesis is that preg vs pla will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (hpa) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with cud.

Eligibility criteria:
inclusion criteria: * male or female individuals, ages 18 to 60. * subjects must meet current dsm-v criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use. * subject has voluntarily given informed consent and signed the informed consent document. * able to read english and complete study evaluations. exclusion criteria: * women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control. * meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/pcp, excluding alcohol and nicotine. * any current use of opiates or past history of opiate use disorder. * current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse. * any psychotic disorder or current axis i psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders. * significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study. * abstinent from cocaine for more than two weeks prior to admission. * hypotensive individuals with sitting blood pressure below 90/50 mmhg.
influence of pharmacist and student pharmacists on medication adherence in community pharmacy setting in underserved population

Conditions: Diabetes; Medication Non Adherence; Blood Pressure; Pharmacist-Patient Relations

Summary: the overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.

diabetes affects approximately 30.3 million people in the u.s. and is the 7th leading cause of death (ada 2019). uncontrolled diabetes leads to various complications including cardiovascular disease, kidney disease, diabetic retinopathy, peripheral neuropathy, and lower extremity amputation. estimated healthcare expenditure for individuals with diabetes is approximately $327 billion per year (ada 2017). in san bernardino county, the prevalence of diabetes was higher (12.4%) than the national rate (9.4%). more specifically, the federally qualified health center in which the loma linda university (llu) community pharmacy serves has a diabetes prevalence rate of about 16% (hrsa 2017). to decrease risk of diabetes complications, hba1c is recommended to be \ 9% (ada 2019). given high prevalence rates of uncontrolled diabetes in this high-risk population, it is pivotal that individuals are provided with appropriate diabetes self-management strategies, regular monitoring, and preventative care by their primary care provider to adequately control the disease. numerous studies illustrate that clinical pharmacists improve health outcomes for chronic disease managements with medication therapy management (mtm) services in underserved patients. additionally, team-based or coordinated care with the community pharmacist and the patient's health care providers has also demonstrated to assist with improvements in clinic outcomes of chronic diseases. recently, combination of blister packaging and mtm services have been shown to improve medication adherence and clinical endpoints. given the high prevalence of diabetes in this community, there is a critical need to achieve improvement in clinical diabetes outcomes possibly via monthly blister packaging and mtm services including point-of-care testing (poct).

Eligibility criteria:
inclusion criteria: * ≥18 years of age, any gender * hemoglobin a1c \>8.5% * taking total of ≥5 medications and taking ≥2 anti-diabetes medications exclusion criteria: * unable to give informed consent * individuals included in inland empire health plan's complex care program
diabetic shoulder mobility

Conditions: Diabetes Mellitus

Summary: the primary goal of this project is to determine how advanced glycation end-product (ages) accumulation and shoulder movement (humeral thoracic range of motion and "activity count") interact to contribute to shoulder limited joint mobility (ljm), pain and disability, and if an intervention consisting of a tailored dose of stretching and active shoulder movement can reduce these problems in people with diabetes mellitus (dm). the investigators will focus on the following measures that span health domains; skin intrinsic fluorescence to measure ages; ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and "activity counts" to measure shoulder movements; and the disability of the arm, shoulder and hand (dash) questionnaire to measure patient reported pain and disability. the investigators will test the innovative hypothesis that metabolic and movement factors interact to cause severe shoulder problems in people with dm and that an optimized shoulder movement intervention can have an important impact on reducing the development of limited joint mobility, pain and disability in this population.


Eligibility criteria:
inclusion criteria: * individuals with type 2 dm and duration of diagnosed diabetes more than 10 years or type 2 dm and presence of a 'positive prayer sign' or shoulder flexion \< 150 degrees; disability of arm, shoulder and hand (dash) scores in the range of \<70%; between the age of 40-70 will be recruited. exclusion criteria: * currently diagnosed adhesive capsulitis * diagnosed rotator cuff tear * recent (6 months) upper extremity injury and/or fractures * surgery in the upper extremity or thorax * cervical radiculopathy * thoracic outlet syndrome * stroke with residual upper extremity involvement * severe skin allergies in area to be tested * rheumatic conditions * known connective tissue diseases * carpal tunnel syndrome * use of a cane * individuals who engage in heavy upper extremity/ overhead use (ie, painters, tennis players) because they likely have a different mechanism of injury than those with low shoulder activity.
endocardial pacing in on-table non-responders in cardiac resynchronization therapy

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether left ventricular endocardial pacing exhibits a greater acute hemodynamic response during biventricular pacing in patients who do not show this response to standard cardiac resynchronization therapy.

cardiac resynchronisation therapy (crt) with biventricular pacemakers and implantable cardiac defibrillators (icd) has proven to be a valuable therapy in selected patients with systolic heart failure, ameliorating both morbidity and mortality. however, with current selection criteria and implant technique, about 20 to 30 % of patients remain non-responders. non-responders might be due to failing selection criteria or methodology in casu echocardiography. however, an important number of non-responders may result of sub-optimal positioning of the left ventricular lead, remote from the site of delayed activation. endocardial left ventricular stimulation may ameliorate the shortcomings of epicardial stimulation. the advantage of an endocardial approach is the absence of phrenic nerve stimulation which regularly complicates epicardial pacing, a more predictable pacing threshold and much less restriction to position the lead in the area of interest. transseptal left ventricular endocardial pacing has already been used in patients in whom standard epicardial pacing was not applicable.

Eligibility criteria:
inclusion criteria: 1. age ≥18y 2. lvef ≤35% 3. qrs-duration ≥0.12 seconds 4. nyha functional class iii or iv despite optimal medical therapy defined as use of angiotensin-converting enzyme inhibitors or angiotensin-ii receptor blocker and beta-blockers unless they are not tolerated or contra-indicated 5. sinus rhythm or atrial fibrillation exclusion criteria: 1. episode of acute heart failure ≤3 months 2. change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-ii receptor blockers ≤3 months 3. unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months 4. chronic atrial arrhythmias other than atrial fibrillation 5. any mechanical or biological valve prosthesis 6. atrial septal defect 7. right-to-left shunt 8. severe pulmonary hypertension (systolic pulmonary artery pressure \>90 mmhg) 9. uncontrolled arterial hypertension 10. known allergy to sulphur hexafluoride 11. end-stage renal or hepatic disease 12. inability to provide written informed consent 13. pregnancy or childbearing potential without use of birth-control measurements 14. general contra-indications to magnetic resonance imaging

Keywords: electrophysiologic techniques, cardiac
safety of ascending doses of niclosamide (uni911 inhalation) in healthy volunteers

Conditions: Covid19

Summary: this is a phase 1 randomized, double-blind, parallel group, placebo-controlled study to assess the safety of ascending doses of uni911 inhalation in healthy volunteers in preparation for evaluation in adults with covid-19

this is a phase 1 randomized, double-blind, parallel group, placebo-controlled study to assess the safety of ascending doses of uni911 inhalation in healthy volunteers in preparation for evaluation in adults with covid-19 64 subjects will be sequentially enrolled to receive dosage of uni911 inhalation or placebo. 4 sentinel subjects (one per cohort 1, 2 ,3 and 4 ) will be treated in an open-label manner to confirm the safety of each dose sequentially. 40 subjects will be randomly assigned (3:1) to either active or placebo. for the last 2 cohorts, a total of 20 healthy volunteers will be enrolled to receive multiple doses of uni911 inhalation.

Eligibility criteria:
inclusion criteria (main ones): 1. signed informed consent form (icf) 2. male or non-pregnant and non-lactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. females must have a negative urine beta-human chorionic gonadotropin hormone (hcg) pregnancy test prior to dosing. (women who are postmenopausal or who had tubal ligation/hysterectomy do not need to have a pregnancy test done and do not need to agree to use contraception.) 3. ecg without clinically significant abnormalities (including qtcf \< 450 ms) 4. age ≥ 18 and \< 65 years at the time of signing icf 5. normally active and in good health by medical history and physical examination 6. minimum 80% of predicted lung function, including fev1 after beta2-agonist, tlc, dco, and cpet with pulse oximetry 7. chest x-ray without clinically significant abnormalities exclusion criteria (main ones): 1. enrollment in an uni911 study in the previous 6 months 2. clinically significant allergy (as judged by the investigator) or history of significant adverse reaction to niclosamide or related compounds, to any of the excipients used. 3. underlying condition that may interfere with inhalation of the ip 4. current acute or chronic condition (incl. copd, asthma, or other severe respiratory disease, cv disease, diabetes mellitus, obesity, malignant and autoimmune diseases) unless considered clinically irrelevant and stable by the investigator 5. renal impairment (egfr \< 60 ml/min/1.73m2) or hepatic impairment (as judged by the investigator)
osteoporotic vertebral compression fractures: can kyphoplasty improve lung function? a prospective evaluation

Conditions: Osteoporotic Vertebral Compression Fractures; Lung Function

Summary: patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. furthermore, it comes to the sintering of the vertebra and a so-called hunchback. this also contributes to the poorer expansion of the lung. pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume. kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture. in order to prove the thesis the results of lung function test (fev1, pef) are assessed.


Eligibility criteria:
inclusion criteria: * over 50 years * vas over 49, odi over 29 * radiographic evidence of a 1.1, 1.2, 1.3 fractures * patients mentally capable to sign informed consent exclusion criteria: * high-energy trauma * known tumor involvement * osteonecrotic fractures * burst fractures or pedicle fractures * previous surgical treatment for a vertebral body compression fracture * patient has paget's disease * bmi \> 35 * uncontrolled diabetes hbac1c \> 7% * severe cardiopulmonary disease * myelopathy * long-time steroid therapy

Keywords: improvement of lung function (fev1, pef) visual analog scale oswestry disability index radiographs pre and post op
open-label, dose-finding study to determine antibody response to g17dt treatment in patients with gastric cancer.

Conditions: Gastric Cancer

Summary: an open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with stage i-iii gastric cancer. the first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.


Eligibility criteria:
inclusion criteria: * histologically confirmed uicc stage i, ii or iii gastric adenocarcinoma. must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial * male or female and over 18 years of age * must have a life expectancy of at least three months * world health organization performance status of 0 to 1 * given written conformed consent exclusion criteria: * gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study * history of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix * previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies * concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids * females who pregnant, planning to become pregnant or lactating * taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study * previously received g17dt treatment * haemoglobin (hb) \< 10.0 g/dl white blood cell count (wbc) \< 4.0 x 10\^9/l platelets \< 100 x 10\^9/l

Keywords: gastric cancer, stomach neoplasms,
understanding public attitudes towards the covid-19 vaccination

Conditions: Covid19; Vaccination

Summary: the objective of this study is to better understand public attitudes towards coronavirus disease 2019 (covid-19) vaccination. this understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of covid-19 in under-served and vulnerable communities.

the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) has rapidly instigated a global pandemic. as of this writing, there are more than 33 million documented cases of infection in the united states (us). furthermore, in the us, covid-19 has disrupted the economy, overwhelmed the healthcare system, led to widespread school cancellations, and caused more than 595,000 deaths since march 2020. the availability of three highly effective vaccines against covid-19 within a year of the start of the pandemic is an extraordinary achievement and cause for great optimism. however, a significant proportion of adults in the u.s. have not accepted vaccination against covid-19. efforts are needed to identify effective messages and communication strategies to overcome covid-19 vaccine hesitancy. to address this need, the investigators plan to conduct two rapid surveys among massachusetts residents, to assess attitudes towards covid-19 vaccination.

Eligibility criteria:
inclusion criteria: * massachusetts resident * adult (age 18 and over) * english or spanish speaking exclusion criteria: • non-english or spanish speaking
dynamic congruence total knee replacement vs posterior-stabilized

Conditions: Osteo Arthritis Knee; Surgery; Joint Diseases

Summary: this study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either zimmer biomet nexgen with posterior stabilization and bioimplanti k-mod cruciate-retaining with dynamic congruence

the aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (ps) or dynamic congruence (dc) implants. materials and methods to this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \[1:1\]. all participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career. before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and vas (visual analogue scale). after the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of bts smart device. this device uses passive markers technology and registers the movement by six cameras. to perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the davis protocol. markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the v metatarsal bone). participants will walk barefoot for 10 meters quadruple times. following time-space and kinematic parameters will be assessed: time-space parameters single stance time (t1) \[%\] swing time (t2) \[%\] double-stance time (t3) \[%\] step length (sl) \[m\] mean gait velocity (vm) \[m/s\] cadence (c) \[number of steps/min\] kinematic parameters: operated knee range of flexion during swing phase \[°\]

Eligibility criteria:
inclusion criteria: * agreement to participate in the study * bmi (kg/m2) less than 40 * ability to walk for 10 meters * knee flexion more or equal of 90 degrees exclusion criteria: * unwillingness to participate in the study * osteoarthritis due to the rheumatological disease * disorders associated with nerve-muscle signal transmission * neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity

Keywords: osteoarthritis knee congruence posterior-stabilized cruciate-retaining
resistance exercise volume and hypertrophic response variability in elderly

Conditions: Aging; Muscle Hypertrophy

Summary: the study aimed to investigate the effects of resistance training volume manipulation on whole muscle hypertrophy among non-responders and responders to a low resistance training dose (single-set).

the magnitude of muscle hypertrophy in response to resistance training (rt) is highly variable between individuals (response heterogeneity). manipulations in rt variables may modulate rt-related response heterogeneity; yet, this remains to be determined.

Eligibility criteria:
inclusion criteria: * 60 years and older * not engaged in regular resistance and/or aerobic training for at least six months before the intervention exclusion criteria: * diagnosed type i diabetes mellitus * arrhythmia * noncontrolled hypertension * any major orthopedic musculoskeletal condition * use of any dietary supplement or drug with potential anabolic effects

Keywords: aging muscle mass muscle strength resistance exercise sets
hiv disclosure and medication adherence, a pilot study

Conditions: HIV Infection

Summary: the investigators believe that disclosure of hiv status could influence medication adherence. if disclosure leads to social support, adherence could be improved. this study purpose is to assess correlation between disclosure and medication adherence, and to describe people whose hiv status has been disclosed to.

pharmacists administer a questionnaire to each consecutive subject taking part in the adherence-enhancing program at the pharmacy of the department of ambulatory care and community medicine in lausanne. this questionnaire assesses disclosure, response to disclosure, and living situation. adherence is measured by electronic monitoring and pill count.

Eligibility criteria:
inclusion criteria: * hiv infection * enrolled in the adherence-enhancing program exclusion criteria: * inclusion visit * not french or english speaker

Keywords: medication adherence hiv infection disclosure