Kornimate/medical-research-clean huggingface dataset:
effect of an amino-acid-based blend on human growth hormone (hgh) and fibromyalgia (fm) symptoms

Conditions: Fibromyalgia

Summary: the purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by igf-1) and clinical symptoms in individuals with treatment-resistant fm and low-normal hgh.

low hgh levels have been observed in approximately 1/3 of individuals with fm. low hgh levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with fm and several studies have demonstrated symptom improvement in individuals with fm and low hgh who received rhgh therapy. the amino acid-based blend represents a novel mechanism for increasing endogenous hgh production. it has been shown to produce an increase in endogenous hgh levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hgh release. the amino acid-based blend may be a safe and effective treatment for fm in individuals with poorly controlled fm and low-normal hgh. this study will investigate the effect of taking the amino acid blend on igf-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant fm and low-normal hgh. after being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. standard care for fibromyalgia will continue.

Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of fm for at least 10 years, poorly controlled fm symptom, and receiving standard of care treatment at the private medical practice of susan pekarovics, md 2. have low to normal levels of hgh (screening igf-1 levels between the 15th and 50th percentile for age-appropriate levels) 3. female participants of childbearing potential will agree to avoid pregnancy during the study. 4. capable of giving signed informed consent exclusion criteria: 1. human growth hormone deficiency (ghd) 2. individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of \>0 on item 9 (suicidal ideation) on the patient health questionnaire-9 (phq-9) 3. pregnant women or women who wish to become pregnant 4. history of substance abuse 5. previous treatment with recombinant human growth hormone (rhgh) 6. individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-english speakers, economically disadvantaged individuals, employees of the study sponsor/site.
vasodilator free measure of fractional flow reserve

Conditions: Coronary Stenosis

Summary: narrowing of coronary arteries interferes with blood flow and can cause chest pain. cardiologists sometimes quantify the extent of the narrowing by measuring the fractional flow reserve (the ratio of the pressure in the aorta to the pressure downstream of the narrowing under conditions of maximal flow). we propose a new technique based on principles of wave intensity analysis (wia) to better assess coronary stenosis and the significance of the narrowing without the need for administration of vasodilator agents such as adenosine. this would simplify assessment and improve our ability to advise patients whether stent treatment will help their symptoms.


Eligibility criteria:
inclusion criteria: * patients with coronary stenosis exclusion criteria: * patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure * unable to consent * contraindications to adenosine * contraindications to cardiac mri

Keywords: coronary stenosis wave intensity analysis instantaneous flow reserve ifr fractional flow reserve
naion treatment with oral prednisolone and erythropoietin injection

Conditions: Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Summary: this randomized double-blind clinical trial is performed on all recent (within the last 5 days) naion patients referred to hospitals affiliated to the shahid beheshti university of medical sciences, iran. the patients will be equally and randomly assigned into two experimental groups and a control group. the first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. the second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. in addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. the third group will receive placebo. eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. sita standard visual field testing will be done using the visual field analyzer humphrey 750 field (carl zeiss, usa). the thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (cirrus zeiss cirrus hd-oct, carl zeiss, usa). the q-q plot and kolmogorov-smirnov tests will be performed to test normal distribution of data. descriptive statistics including frequency, percentages, standard deviation, median and range will be used. other statistical test including anova, kruskal-wallis, chi-square, and fischer's exact tests will be performed. all statistical analyses will be performed in spss (version 20) at significance level of 0.05.


Eligibility criteria:
inclusion criteria: - all naion patients (maximum time of disease occurrence: 5 days) referred to emergency department of labbafinejad, torfeh and imam hossein hospitals exclusion criteria: 1. glaucoma or any ocular, neurologic or systemic disease affecting the vision 2. abnormal laboratory test results such as esr and crp 3. history of ocular surgery 4. history of receiving medication for naion 5. uncontrolled systemic disease such as diabetes or hypertension 6. contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression 7. contraindications of erythropoietin administration, such as polycythemia 8. unwillingness to participate in the study
hcv test and treat utilizing simplified hcv patient education

Conditions: Hepatitis C

Summary: the study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis c virus (hcv) treatment initiation and treatment completion.

viral hepatitis c (hcv) represents a major public health concern and is associated with significant morbidity and mortality. hcv screening and treatment among people who use drugs is challenging due to barriers leading to loss within hcv care cascades at most centers providing addiction care. one critical element that would improve access to hcv therapy would be a test, educate and treat system, where people obtain drug on the same day as they are confirmed as hepatitis c viremic.

Eligibility criteria:
inclusion criteria: * men and women age greater or equal to18 at study entry or emancipated minors over greater or equal to 16 to less or equal 70 years at study entry * hcv antibody positive * hcv treatment naïve (no prior treatment with an approved or investigational anti hcv medication) exclusion criteria: * current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry * history of hepatocellular carcinoma (hcc) * any history of active hepatitis b or positive hbsag positive test * hcv rna undetectable

Keywords: hepatitis c virus
a safety and efficacy study of travoprost 0.004% compared to latanoprost 0.005% in patients with chronic angle-closure glaucoma

Conditions: Glaucoma, Angle-Closure; Ocular Hypertension

Summary: to demonstrate that the intraocular pressure(iop)-lowering efficacy of travoprost (0.004%) is equal or better than that of latanoprost 0.005% in patients with chronic angle-closure glaucoma.


Eligibility criteria:
adult patients of any race and either sex with chronic angle-closure glaucoma.

Keywords: glaucoma poag oag oht
recurrent laryngeal nerve's motor function: sometimes motor fibers may also be located in the posterior branch

Conditions: Recurrent Laryngeal Nerve Injuries

Summary: the investigators hypothesized that, sometimes the posterior branch of the recurrent laryngeal nerve may also have motor function. the investigators aimed to evaluate motor function of the branches in the branching recurrent laryngeal nerves in this study.

this study group consisted of consecutive patients, undergoing thyroid and parathyroid surgery with ionm. both anterior and posterior branches of the recurrent laryngeal nerves were assessed separately by both electromyography endotracheal tube for adduction and finger palpation for detection of laryngeal twitch due to posterior cricoarytenoid abduction. the recurrent laryngeal nerves having motor function only in the anterior branches were defined as group 1, whereas the nerves having motor function both in the anterior and posterior branches were as group 2.

Eligibility criteria:
inclusion criteria: 1. patients who underwent parathyroid/thyroid surgery with intraoperative neuromonitoring , 2. patients who had normal vocal cord functions preoperatively. - exclusion criteria: 1. preoperative recurrent laryngeal nerve palsy, 2. intentional nerve transection because of cancer invasion, 3. assessment failure of recurrent laryngeal nerve function due to the deficiency of the intraoperative neuromonitoring equipment,. 4. parathyroidectomy operations that recurrent laryngeal nerves were not fully dissected. -

Keywords: motor function of the extralaryngeal branches intraoperative neuromonitoring recurrent laryngeal nerve
comparison study of a new combination of 2 marketed medications (esomeprazole and naprosyn) versus naprosyn alone

Conditions: Healthy

Summary: the purpose of this study is to determine whether the absorption of naproxen from the pn 400 combination (naprosyn and esomeprazole) tablets is similar to that from the naproxen tablets (naprosyn®), which are currently sold in australia.


Eligibility criteria:
inclusion criteria: * subjects must have a body weight greater than 50 kg and bmi within the range 18-30(inclusive). * subjects must be in good health, as assessed during pre-study medical examination and by review of screening results * subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent exclusion criteria: * significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration. * ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first period 1 dose

Keywords: gi pain healthy participants safety bioavailability
release of nociceptin from granulocytes in sepsis

Conditions: Sepsis; Septic Shock; Sepsis Syndrome; Severe Sepsis

Summary: nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. there is evidence that it may have a role in controlling the immune response to infection, and may act as a link between the brain and immune system. in infection, or after surgery, there is an increase in nociceptin, and subjects greater elevations of nociceptin have a poorer outcome. there is evidence that cells of the immune system may produce nociceptin, although it is not yet known which cells are capable of producing it, and what "switches on" production. this study aims to determine 1. which cells of the immune system can produce nociceptin 2. if there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections


Eligibility criteria:
inclusion criteria: * for septic patients; 1. participant is willing and able to give informed consent for participation in the study, or if lacking capacity, a next of kin or advocate is willing and able to give assent for participation in the study. must be able to read and understand english. 2. male or female, aged 18 years or above. 3. diagnosed with sepsis and admitted to the intensive care unit. 4. able (in the investigators opinion) and willing to comply with all study requirements. 5. willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study. healthy volunteers; 1. participant is willing and able to give informed consent for participation in the study. must be able to read and understand english. 2. male or female, aged 18 years or above and be 3. in good health. 4. have had no course of medication, whether prescribed or over-the-counter, in the four weeks before first study dose and no individual doses in the final two weeks other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives 5. able (in the investigators opinion) and willing to comply with all study requirements. 6. willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study. exclusion criteria: * 1. conditions which may make phlebotomy hazardous to the participant (such as significant bleeding disorders or anaemia, or allergy), or to the investigator (blood viral infection). 2. any significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 3. participants who have participated in another research study involving an investigational product in the past 12 weeks.
experimental denture pastes

Conditions: Dental Plaque; Denture Stomatitis; Oral Candidiasis; Oral Hygiene

Summary: this trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) a proprietary denture-specific paste (active comparator); (2) 0.2% chloramine t; (3) 1.0% chloramine t; (4) 0.01% fluorosurfactant. each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.


Eligibility criteria:
inclusion criteria: * completely edentulous * good general health * patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures) * regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years * both denture bases and artificial teeth should be composed by acrylic resin exclusion criteria: * unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures) * absence of deposits of biofilm at baseline

Keywords: chloramine t complete denture dental plaque index dentifrice denture bases denture cleansers edentulous mouth fluorosurfactant oral health toothpaste
early neo2 registry of the acurate neo2 tavi prosthesis

Conditions: Aortic Valve Stenosis

Summary: the early neo2 registry will study up to 500 patients treated with the updated boston acurate neo2 tavi prosthesis at various european hospitals. the data is gathered from routine healthcare and there are no study-mandated additional procedures. the main endpoint is a combined efficiency and safety endpoint after 30 days. imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

background and rationale the boston scientific acurate neo2 tavi prosthesis was launched commercially in europe in september 2020 as a successor to the original acurate neo prosthesis. modifications include an added sealing skirt. the original acurate neo failed to reach non-inferiority to other tavi prostheses in two randomized trials. there is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the ce-mark study of the acurate neo2. project objectives to gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the acurate neo2 in various european sites. karolinska will be the coordinating center for data collection. methods data will be collected in an anonymous form and sent to karolinska for compilation and statistics. data collection will continue until 500 patients are reached (april, 2021). statistics standard descriptive statistics will be used for the main results. for the comparison to scope data (with the original acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry). core lab studies the core lab analyses will be performed at corrib in galway (prof. serruys et al).

Eligibility criteria:
inclusion criteria: * that a acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started). exclusion criteria: * none

Keywords: tavr
pre-operative radiograph of deep carious lesions as a predictive tool for pulpal exposure

Conditions: Deep Caries

Summary: preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. the preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. in clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. this lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. their interpretation is considered imprecise and is not used as a diagnostic element. the aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.


Eligibility criteria:
inclusion criteria: -pre-operative radiographs of deep carious lesions treated with decat protocole, unless they were out of the study. exclusion criteria: * impossibility to assess carious lesion on radiograph, and amalgam restorations that impairs correct examination of carious lesion * radiographs of poor quality and screen captures
the effect of teriparatide on bone union in unstable intertrochanteric fracture patients treated with pfna

Conditions: Unstable Intertrochanteric Fracture; Pertrochanteric Fracture of Femur, Closed

Summary: phase iii, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with proximal femoral nail antirotation (pfna) assessed by radiographic and clinical outcomes.

patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks. all patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 iu/week of vitamin d2. patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. each participant will be in the study for 6 months in total.

Eligibility criteria:
inclusion criteria: 1. male and female patient, age ≥ 50 years at the time of screening 2. unstable intertrochanteric fracture (ao/ota 31-a2 and 31-a3) 3. treated by proximal femoral nail antirotation (pfna) exclusion criteria: 1. known hypersentivity to teriparatide or any form of pth or analogue 2. metabolic bone disease other than primary osteoporosis (including hyper parathyroidism and paget's disease of bone) 3. increased baseline risk of osteosarcoma (paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation) 4. history of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study. 5. pre-existing of hypercalcemia (total serum calcium \>10.5 mg/dl or 2.6 mmol/l) 6. abnormally elevated serum intact parathyroid hormone at screening (serum pth \> 70 pg/ml) 7. severe vitamin d deficiency (25-hydroxyvitamin d \< 12 ng/ml) 8. unexplained elevations of alkaline phosphatase (alp \> 120 ul) 9. severe renal impairment (crcl \< 30 ml/min) 10. current treatment with digoxin and necessary to continue use during the study 11. concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (serms), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin d3 analogs. (previous treatment is allowed but must be discontinued at screening) 12. previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening. 13. previous treatment with teriparatide, pth or other pth analogs, or prior participation in any other clinical trial studying teriparatide, pth or other pth analogs

Keywords: terriparatide, bone fracture healing, pfna
efficacy and mechanisms of energy medicine to decrease chronic knee pain in outpatient settings

Conditions: Ostheoporosis of the Knee

Summary: this study will assess the efficacy and mechanisms behind energy medicine in reducing chronic knee pain within an outpatient setting. this study will investigate a form of energy medicine (em) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. the positive control group will receive acupuncture and the negative control group will receive a sham intervention.


Eligibility criteria:
inclusion criteria: * presence of knee pain lasting for at least six months * no radiation of knee pain * no acupuncture treatments in the previous six months * failure to respond completely to the medications given by their orthopedic or pain management specialist * knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (nrs) * complaints of morning stiffness lasting less than 30 minutes * not be in active physical therapy (pt) for the duration of the trial. * adult patients ≥18 years of age * english speaking exclusion criteria: * any concurrent diagnosis of systemic disease * other concurrent treatments such as massage, acupcunture, pt or any kind of energy medicine * bleeding disorder * trypanophobia (fear of needles or injections). * have medical condition that causes difficulty in saliva production/collection (i.e.: sjogren's syndrome)