Kornimate/medical-research-clean huggingface dataset:
retinal nerve fiber layer thickness changes in parkinson disease: a meta-analysis

Conditions: Parkinson Disease

Summary: optical coherence tomography (oct) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (rnfl) and measure its thickness. a reduction of the rnfl thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, cadasil and alzheimer's disease. different studies have reported rnfl changes also in parkinson's disease (pd),a common neurodegenerative disease characterized by motor dysfunctions, originally described by james parkinson in 1817. pd is characterized by selective dopaminergic neuronal cells loss, which may correlate with rnfl thinning. previous studies on this subject, however, reported contradicting results. some investigations reported reductions of the rnfl thickness while others did not. in the present study, in order to determine whether rnfl thickness is reduced in pd patients, we performed a meta-analysis and systematically evaluated rnfl thickness measurements with oct in a series of pd patients and in the healthy control groups.


Eligibility criteria:
inclusion criteria: 1. case-control studies; 2. patients with pd were compared with healthy controls; 3. all subjects underwent rnfl thickness measurement by oct; 4. studies should provide the data of peripapillary rnfl thickness; 5. sample size ≥10 in each group. exclusion criteria: 1. authors did not make rnfl measurements; 2. study without healthy control group; 3. the outcome values can not be used for meta-analysis; 4. duplicated articles.

Keywords: retinal nerve fiber layer thickness optical coherence tomography parkinson disease
ventrointermediate nucleus (vim dbs) and working memory

Conditions: Essential Tremor

Summary: this is part of a larger study for which participants have already completed memory and thinking tests. in this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (et) patients. we are especially trying to figure out how stimulation on each side of the brain may affect working memory.


Eligibility criteria:
inclusion criteria: et patients: * clinical diagnosis of essential tremor affecting the upper extremities. * previous unilateral or bilateral dbs of the vim * ages 40 -70 * a useable pre-surgical mr scan controls: * spouse or acquaintance of enrolled patient participant * ages 40 - 70 exclusion criteria: et patients: * clinical evidence of other neurological conditions * significant psychiatric condition controls: * clinical evidence of other neurological conditions * significant psychiatric condition

Keywords: essential tremor
gestational diabetes mellitus and cardiovascular disease: the role of vascular dysfunction

Conditions: Gestational Diabetes Mellitus; Pregnancy

Summary: the purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.


Eligibility criteria:
inclusion criteria: * healthy women of self-identified african descent (black) and european (white) ancestry, * 18-40 years of age, * body mass index \< 35 kg/m2 * history of regular menstrual cycles, * are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age) * have no pregnancy-associated complications to-date * are in good health free of hypertension, as well as thyroid, cardiac, or renal disease. exclusion criteria: * history of smoking * are taking potentially vasoactive medications

Keywords: gestational diabetes mellitus pregnancy cardiovascular disease risk
extension study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine

Conditions: Episodic Migraine

Summary: the purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.


Eligibility criteria:
inclusion criteria: * written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. * participants must be using a medically acceptable and effective method of birth control during the course of the entire study. * eligible participants who completed the double-blind treatment period (visit 7) and the follow-up period (visit 8), if applicable, depending on the timing of study initiation, of study 3101-301-002 (nct03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures). exclusion criteria: * female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. women of childbearing potential must have a negative urine pregnancy test at visit 1. * hypertension as defined by sitting systolic bp \> 160 mm hg or sitting diastolic bp \> 100 mm hg at visit 1. * participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: migraine aura
rollover study of vx-770 in cystic fibrosis subjects

Conditions: Cystic Fibrosis

Summary: the primary objective of the study was to evaluate the safety of long-term vx-770 treatment in participants with cystic fibrosis (cf). the secondary objective of the study was to evaluate the efficacy of long-term vx-770 treatment in subjects with cf.

this open-label, rollover study of orally administered vx-770 was conducted in participants with cf to evaluate the safety and efficacy of long-term vx-770 treatment. participants who were previously enrolled in study 102 (vx08-770-102/nct00909532) and study 103 (vx08-770-103/nct00909727), and met certain criteria were eligible to enroll in this study (study 105/vx08-770-105/nct01117012).

Eligibility criteria:
inclusion criteria: 1. participants who have completed the assigned study treatment in study 102 or study 103 2. participants who are females of childbearing potential must have a negative urine pregnancy test on day 1 (first dose of vx-770) 3. participants who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator 4. participants of child bearing potential and who are sexually active must meet the contraception requirements 5. participants must sign the informed consent form (icf), and where appropriate, assent must be obtained exclusion criteria: 1. participants with a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject 2. participants with a history of study treatment intolerance as observed in their previous vx-770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject 3. participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements 4. participants taking any inhibitors or inducers of cytochrome p450 3a4 (cyp3a4), including certain herbal medications (for example, st. john's wort) and grapefruit/grapefruit juice
clinical study on the safety and effectiveness of vagus nerve stimulation in the treatment of refractory depression

Conditions: Refractory Depression

Summary: based on the mechanism hypothesis and clinical efficacy of vns in treating refractory depression, this study will evaluate the safety and efficacy of vns in treating refractory depression through a small sample of clinical trials

this clinical trial is a prospective, self - controlled clinical validation study. subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. after admission, subjects received vagus nerve stimulation and conventional treatment. enrolled 10 subjects. parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. patients with treatment-resistant depression (patients with hamilton depression scale (hamd) score reduction rate still less than 50% after adequate treatment with two or more antidepressants) 2. age 18-65; male or female 3. the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes 4. hamd-17 score\> 17 was at baseline exclusion criteria: 1. pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures 2. a patient who is or has been diagnosed with a mental disorder other than depression; depressive episode with psychotic symptoms 3. patients currently at serious risk of suicide 4. prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine 5. patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy) 6. accept other clinical trials 7. patients requiring systemic mri after implantation
controlled study of stage 3 osteonecrosis treatment by bone marrow

Conditions: Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Summary: in stage 3 osteonecrosis (on) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 on of the femoral head.


Eligibility criteria:
inclusion criteria: 1. patients who have a non traumatic on of the femoral head 2. stage 3 on (subchondral fracture). 3. age \> 18 years 4. be able and willing to participate in the study exclusion criteria: 1. evidence of malignant disorder in the past five years 2. patient unable to undergo a mri. 3. patient who is positive for an hiv, hepatitis b or c infection.

Keywords: osteonecrosis cell-based therapy bone marrow mesenchymal stem cell hip core decompression
glu-coach: a peer-mentoring intervention to reduce disparities in continuous glucose monitor (cgm) use

Conditions: Type 1 Diabetes

Summary: this is a study to develop and evaluate a peer mentoring intervention for black and latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (cgm) device. this device is a standard of care to improve diabetes management related to diet, exercise, and insulin. use of cgm has been shown to improve health outcomes, but is not used by adolescents of color. peer mentors may help improve usage.

in phase 1, investigators developed the intervention with a stakeholder advisory group. in phase 2, investigators will conduct a small clinical trial to evaluate the intervention. phase 1 is complete with the focus of this registration being phase 2, the clinical trial.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody * self-identification as black and/or latinx. * ability of participant to comprehend and communicate in written and spoken english, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have english fluency) * access to personal cellphone or tablet to participate in remote video sessions with the peer mentor * naïve to or not currently using cgm. "current" use is defined as any cgm used for clinical management of t1d for \> 1 week within the last three months. exclusion criteria: * participants with a prior severe skin reaction to cgm sensor or adhesive. * current use of cgm * current or planned pregnancy * inability to comprehend or communicate in spoken/written english * subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.

Keywords: continuous glucose monitor
effects of hypertonic saline solution (nacl 3%+nahco3) on nasal inflammation in children with ar. rinasol- pilot study

Conditions: Allergic Rhinitis

Summary: the main objective of rinasol project is to assess in patients with seasonal allergic rhinitis the effect of hypertonic saline solution nacl 3%+nahco3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology. the secondary objective is the symptom score assessment by t5ss questionnaire (total symptom score 5)


Eligibility criteria:
inclusion criteria: * clinical history of allergic rhinitis (for at least 1 year) * 6 years old ≤ children age ≤ 14 years old * total symptom score 5: \>5 in the last 4 days before screening. exclusion criteria * signs of acute infections of upper and lower respiratory tract. * metabolic, immunological, systemic diseases * respiratory tract deformity * systemic/topical therapies with antibiotics or corticosteroids in the previous 30 days. * active smoker.

Keywords: children
supernormal oxygen delivery for patients with severe burns

Conditions: Burn Surgery; Dobutamine

Summary: this is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.

this is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. the groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.

Eligibility criteria:
inclusion criteria: * severe burn patients exclusion criteria: * patients or families refuse to sign consent
phase i clinical study of av-1959r: abeta-targeting anti-alzheimer's vaccine

Conditions: Alzheimer Disease; Alzheimer Disease (AD); Alzheimers Disease Prevention

Summary: this phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted av-1959r vaccine in healthy adults aged 40-60. participants will receive three intramuscular injections of either adjuvanted av-1959r (100 µg or 300 µg) or adjuvanted placebo at weeks 0, 4, and 14, followed by an 8-week follow-up. researchers will monitor for side effects and measure anti-aβ antibody levels to assess immune response. this study will help determine if av-1959r is safe and effective in generating a targeted immune response.


Eligibility criteria:
inclusion criteria: * healthy male or female adults, 40-60 years old. * bmi 18.0-32.0 kg/m². * no significant medical conditions or abnormal mri, ecg, or lab tests. * signed informed consent and ability to follow study procedures. * females must be postmenopausal or surgically sterile. * males must use contraception or be vasectomized. exclusion criteria: * history of alzheimer's, stroke, or neurodegenerative disease. * mri abnormalities, such as infarcts or microbleeds. * serious illness, surgery, or hospitalization in the last 4 weeks. * significant heart, lung, liver, kidney, or immune disorders. * recent drug/alcohol abuse or severe allergies. * abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, hiv, hepatitis b/c positive). * use of investigational drugs or amyloid/tau therapies in the last year. * chronic use of immunosuppressants, anticoagulants, or blood products. * pregnant, breastfeeding, or women of childbearing potential. * recent blood donation (\>400 ml) in the last 30 days.

Keywords: vaccine ad prevention precinical ad asymptomatic ad alzheimer disease
exercise for breast cancer patients (excap)

Conditions: Fatigue

Summary: the purpose of this study is to examine if exercise helps improve cancer-related fatigue. hypothesis: a structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

fatigue is a frequently reported side effect of cancer treatment. fatigue related to cancer and its treatment is different from fatigue occurring in other situations and its specific causes have not been identified. exercise may or may not improve this type of fatigue. the purpose of this study is to examine how cancer treatments impact normal lifestyle physical activity patterns and participation in physical activity, as well as the ability of a walking and progressive resistance exercise program to reduce cancer-related fatigue in breast cancer patients. this study also examines if the walking and progressive resistance exercise program improves other factors such as quality of life, depression, anxiety, ability to sleep, self esteem, cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and immune function (as measured by inflammatory cytokines).

Eligibility criteria:
inclusion criteria: * have a primary diagnosis of breast cancer, * have a functional capacity rating of 60 or greater on the karnofsky performance scale, when assessed by the oncologist (or physician's designee) * be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). have a life expectancy of \>1 year as determined by the patient's oncologist. * have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program. * be able to read english. * be 21 years of age or older. * give informed consent. exclusion criteria: * have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis. * have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the par-q and radiation oncologist (or physician's designee) * be identified as in the active or maintenance stage of exercise behavior as assessed by the 1-item exercise stages of change short form.

Keywords: exercise breast cancer fatigue
3d-qfr in non-selected angiographic stenosis. a spanish multicentre study.

Conditions: Coronary Stenosis; Coronary Artery Disease

Summary: physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach. however, against the current recommendations, revascularisation in most of patients with chronic coronary syndromes still relies on coronary angiography alone. the increase in costs and in procedural complexity of wire-based physiology may explain the latter. therefore, a novel non-invasive functional quantitative flow ratio (qfr) index was created in order to solve it. a retrospective and multicentre study is performed to assess the 5-year prognosis of patients undergoing coronary angiography through a centralized qfr analysis. consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015 were included. aims of the study: * to evaluate the prognosis of stable coronary disease depending on the functional assessment of coronary artery disease. * to determine the % of percutaneous coronary interventions that could be avoided if this study had been carried out through functional assessment of coronary artery disease based on 3-dimensional vessel reconstruction.


Eligibility criteria:
inclusion criteria: * consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015. exclusion criteria: 1. previous coronary artery bypass grafting. 2. \ 90 years. 3. angiographic acquisitions that make it impracticable to perform qfr analysis (patients will be included for descriptive purposes). 4. if a patient has undergone several unscheduled coronary angiographies during the study period, the first will be included as the index case and the following as a follow-up event.

Keywords: quantitative flow ratio coronary physiology computational physiology
efficacy and safety of hepatitis b vaccine in chronic kidney disease patients

Conditions: Chronic Kidney Disease; Hepatitis B

Summary: this is an open label clinical study designed to evaluate the safety and immunogenicity of sci-b-vac hepatitis b vaccine compared to engerix-b hepatitis b vaccine in dialysis patients. the study hypothesis is that vaccination with sci b vac will achieve a higher seroprotection rate and a higher anti-hepatitis b surface antibody serum titer level than vaccination with engerix-b dialysis patients will be categorized as "naïve" or "previously vaccinated" and each group will be randomized to treatment. naïve patients randomized to sci-b-vac hepatitis b vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or engerix-b hepatitis b vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. previously vaccinated patients randomized to sci-b-vac hepatitis b vaccine will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or engerix-b hepatitis b vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. all vaccines will be administered via intra-muscular injection to the deltoid muscle. the study will consist of three periods: a screening period of up to four weeks, a 24-week open-label treatment period, and a 24-week safety follow-up period. the total expected duration of the study per subject is 52 weeks as follows: screening period: approximately 4 weeks; treatment period: 24 weeks; and follow up period: 24 weeks. the primary endpoint is the by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-hepatitis b surface antibody ≥ 10 iu/ml) 4 weeks after the last vaccination with either sci-b-vac or engerix-b. secondary endpoints include anti-hepatitis b surface antibody geometric mean concentrations calculated for all subjects upon last active dose; the proportion of subjects with anti-hepatitis b surface antibody concentrations equal to or above 10 iu/ml for all subjects at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer levels of anti-hepatitis b surface antibodies at 12, 24 and 52 weeks following the first vaccination. a by-vaccine comparison of adverse events will also be performed.


Eligibility criteria:
inclusion criteria: * three months dialysis treatment for chronic kidney disease; anti-hepatitis b surface antibody titer levels \< 10 iu/ml exclusion criteria: * anti-hepatitis b surface antibody titer levels \> 10 iu/ml * hepatitis b surface antigen positive

Keywords: dialysis hepatitis b