Kornimate/medical-research-clean huggingface dataset:
phase 2 spectra study to evaluate the safety and efficacy of opl-0401 in patients with diabetic retinopathy

Conditions: Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy

Summary: opl-0401-201 is a multicenter study to investigate the safety and efficacy of opl-0401 in patients with diabetes mellitus (dm) with diabetic retinopathy.

opl-0401-201 is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of opl-0401 in patients with diabetes mellitus (dm) with npdr or mild pdr with or without diabetic macular edema (dme).

Eligibility criteria:
inclusion criteria * adults ≥ 18 years; * diabetes mellitus (type 1, type 2 or other forms); * females who are not a woman of childbearing potential (wocbp) or who agree to use contraception; * at least one eye with moderately severe to severe npdr (drss levels 47 or 53) or mild pdr (drss level 61); * patients with or without diabetic macular edema (dme) may be eligible if they meet protocol specified eligibility criteria; * best corrected visual acuity (bcva) early treatment of diabetes retinopathy study (etdrs) letter score in the study at screening ≥69 letters (approximate snellen equivalent of 20/40 or better) without ci-dme, or ≥75 letters when ci-dme is present (approximate snellen equivalent 20/32 or better); * anti-vascular endothelial growth factor (vegf) or any laser treatment is not required nor anticipated in the study eye for least 6 months. exclusion criteria: * body mass index ≥ 45 kg/m2 * uncontrolled diabetes mellitus such as hemoglobin a1c (hba1c) \> 11% or patients who are not currently treated for their diabetes; * uncontrolled hypertension defined as systolic \> 160mmhg or diastolic \> 100 mmhg (despite hypertensive medication); * proliferative diabetes retinopathy (pdr) with the exception of mild pdr (drss 61); * evidence of retinal neovascularization (with the exception of mild pdr); * any previous diabetic retinopathy treatment with focal or grid laser photocoagulation or pan-retinal photocoagulation (prp); * history of previously treated dme with fluocinolone acetonide implant (iluvien®) injection; * visual acuity loss due to an ocular condition that would not improve from treatment of dr or resolution of dme (i.e., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition); * history of vitreoretinal surgery; * intraocular surgery in the study eye within 3 months of randomization or anticipated over the course of the study; * uncontrolled glaucoma (e.g. visual field loss or defined as (iop) ≥ 25 mmhg despite treatment with anti-glaucoma medication); * evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye /any intraocular inflammation or infection in either eye within 3 months prior to randomization.

Keywords: diabetic retinopathy diabetic macular edema non-proliferative diabetic retinopathy proliferative diabetic retinopathy
improvement of fatigue symptoms in the iron deficiency anemia with iron succinylate therapy

Conditions: Anemia; Iron-deficiency; Iron Deficiency Anemia; Fatigue

Summary: the treatment of anemia depends on its cause. patients with underlying iron-deficient anemia should be treated or referred to a specialist (eg gynecologist, gastroenterologist) for treatment.deficiency anemia are global health problems and common medical conditions seen in everyday clinical practice. iron is vital for biological functions, such as breathing, energy production, dna synthesis, and cell proliferation. iron deficiency refers to the reduction of iron stores and precedes the occurrence of iron deficiency anemia. iron deficiency anemia is a more severe condition in which low levels of iron are associated with anemia and the presence of small cellular red blood cells.

the diagnosis of anemia is based on the patient's symptoms and blood tests. blood tests refer to hemoglobin, hematocrit, and the number of red blood cells (per cubic centimeter or millet of blood). also, the status of iron stores in the body can be measured by measuring ferritin. with these blood tests it can be determined per os treatment: the dosage of elemental iron required to treat anemia due to iron deficiency in adults is 120 mg per day for three months. an increase in hemoglobin by 1g / dl after one month of treatment shows an adequate response to treatment and confirms the diagnosis. in adults, treatment should be continued for three months after correction of anemia to allow replenishment of iron stores. patient noncompliance may be an obstacle to oral therapy due to the occurrence of gastrointestinal side effects such as epigastric discomfort, nausea, diarrhea and constipation. these effects can be reduced when iron is taken with meals but its absorption can be reduced by 40%. in addition, taking medications such as proton pump inhibitors and agents that reduce gastric acid hypersecretion (eg chronic atrophic gastritis, recent gastrectomy or abdominal incision) reduce iron absorption.

Eligibility criteria:
inclusion criteria: * 16-90 yers * iron deficiency anemia * treatment with iron succinylate * fatigue symptoms * informed consent * compliance with study procedures exclusion criteria: * anemia caused by other parameters (non-iron-deficiency)
biostimulation after tooth extraction

Conditions: Dental Caries in Children; Wound Heal

Summary: this study evaluated the effect of low-level laser therapy on postoperative pain and wound healing in children undergoing primary molar extractions 40children, 6-10 years of age, systemically healthy, and had atraumatic extraction indications of bilateral primary molar teeth were included in the study. a randomly selected tooth was extracted under local anesthesia in the first session. only the clot formation on the socket was observed and photographed in the control group. other group extractions were performed 2weeks later. the lllt group was treated with a 980 nm wavelength doctor smile wiser diode laser and photographed. non-epithelialized surface measurements were performed with the imagej program. pain assessment was performed with the wong-baker pain scale. statistical analyses were performed with spss software.


Eligibility criteria:
inclusion criteria: * indication for tooth extraction in bilateral primary molars * did not have any systemic disease * the use of antibiotics and painkillers was stopped at least 12 hours ago exclusion criteria: * require complicated tooth extractions * systemic disease * the use of antibiotics and painkillers in 12 hours
influence of adiposity on igf-1 and fitness response to exercise in cancer survivors

Conditions: Cancer; Overweight and Obesity

Summary: this is a pilot feasibility study of an investigation of the influence of excess adiposity on cardiorespiratory fitness (crf), insulin-like growth factor-1 (igf-1), and metabolic responses to a standardized aerobic exercise program in cancer survivors. this investigation attempts to isolate the influence of adiposity on these responses. we will enroll overweight, obese, and normal weight cancer survivors with a primary diagnosis of breast, prostate, or colorectal cancer who have completed all cancer-related treatment. participants will engage in a 15-week aerobic exercise intervention with pre- and post-intervention assessments.


Eligibility criteria:
inclusion criteria: * primary cancer diagnosis of breast, prostate, or colorectal cancer * completion of all cancer-related treatment \> than 6 months prior and \< 5 years prior to enrollment * ability and willingness to participate in a supervised exercise program * all participants will be required to obtain a signed physician clearance to participate in exercise form prior to enrollment exclusion criteria: * presence of a secondary active cancer diagnosis or metastatic disease * any current cancer treatment (including hormonal treatment) or planned cancer treatment in the next 5 months * greater than 100 min of self-reported regular exercise per week * bmi \< 18.5 (underweight) * any significant metabolic condition, such as diabetes. individuals with pre-diabetes or metabolic syndrome will not be excluded, but this information will be recorded. * any medical condition that would impact the safety of, or participation in, an exercise program or exercise testing, including: * orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries * advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia * pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease * known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months
the effects of training and relaxation on fibromyalgia.

Conditions: Fibromyalgia

Summary: effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.

a multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). a person-centred model of exercise was used. the intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists. secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. please see references of published articles for details.

Eligibility criteria:
inclusion criteria: acr 1990 criteria for fibromyalgia - exclusion criteria: other dominating pain condition, severe disease preventing from participating in physical exercise -

Keywords: strength exercise physical exercise physiotheraphy
total versus partial omentectomy in the treatment of gastric cancer

Conditions: Stomach Neoplasms; Interleukin; Stomach Cancer; Gastric Cancer; Digestive System Neoplasm

Summary: the main purpose of this study is to evaluate the role of the type of omentectomy (partial or total) in the treatment of tis - t3 gastric cancer without serosal infiltration. the second purpose is to monitoring the blood levels of immunological factors (interleukins, t cell subtypes, etc.) pre-and postoperatively, depending on the type of omentectomy.

gastric cancer is the second common tumor type. in 2020, the incidence of gastric cancer was over one million and caused about 770 000 tumor-associated deaths worldwide. although the improvement of the perioperative oncological therapy is unquestionable, the major point of the treatment is radical surgical intervention. laparoscopic technic is widespread in the treatment of gastric cancer, too. for the oncological radicality total or subtotal gastrectomy with d2 omentectomy is necessary, but the opinions are divided about the role of the omentectomy. total omentectomy in laparoscopic operations takes more time and increases the postoperative morbidity, blood loss, and opportunity of the anastomosis insufficiency, and the incidence of the omental metastases is just between 3,8 - 5%. based on this, many international guidelines allow partial omentectomy in early gastric cancer. at the same time, in advanced gastric neoplasm, the place of the partial omentectomy is still unclear. with this prospective, randomized, multicentric study we plan to compare the total and partial omentectomy in the surgery of tis - t3 gastric cancer with the analysis of the postoperative morbidity and mortality and long-term survival factors.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-iii., karnofsky performance score (kps) \>60, eastern cooperative oncology group (ecog) 0-1 * tis-t3 gastric cancer without serosal infiltration and treated with the radical operation (r0; d2 lymphadenectomy, lymph nodes \>16) * clinical stadium: tis-3; m0 * written informed consent provided * good patient compliance * no previous chemotherapy or irradiation exclusion criteria: * serosal infiltration and/or distant metastasis, omental infiltration, peritoneal carcinosis, positive abdominal cytological lavage * organ transplantation and/or immunological disease and/or immunomodulation therapy * another primary tumor * decompensated chronic disease (for example: liver cirrhosis with ascites, kidney failure treated with hemodialysis, new york heart association (nyha) iv. cardiac status, etc.) * unsuccessful follow-up

Keywords: gastric cancer total omentectomy partial omentectomy stomach cancer interleukin immunological answer
comparisons of blood pressure control ability between hpi, clearsight, and conventional nibp during neuraxial anesthesia in cesarean section

Conditions: Intraoperative Hypotension; Cesarean Section

Summary: the goal of this study is to compare the blood pressure control ability with hpi, clearsight, and conventional nibp during neuraxial anesthesia in cesarean section. the main question it aims to answer is: anesthesiologists can have a better control of blood pressure during cesarean section with hpi than with conventional nibp. during the surgery, the participants will be monitored with standard monitor and hpi with clearsight and will be randomly assigned to three groups, including hpi group, clearsight group, and nibp group. anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. investigators will compare the time-weighted average mean arterial pressure \< 65mmhg with in three groups. secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.


Eligibility criteria:
inclusion criteria: * 20 - 50 year-old parturients * scheduled cesarean delivery * neuraxial anesthesia exclusion criteria: * parturients with preeclampsia * parturients with cardiovascular disease above nyha functional class 2 * parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases. * severe perioperative arrhythmias with or without hemodynamic instability * failed neuraxial anesthesia or regional blockade level below t6
acute whey protein and casein supplementation: effect on protein metabolism after resistance exercise

Conditions: Sports Nutrition; Protein Supplementation

Summary: the proteins of human breast milk are the most important endocrine signaling system that promotes neonatal growth by increasing the release of insulin, insulin-like growth factor-1 (igf-1), and the leucine-mediated mammalian target of rapamycin complex 1- (mtorc1) signaling of pancreatic β-cells. remarkably, the branched-chain amino acids (bcaas) leucine, isoleucine, and valine are involved in the growth-promoting effects of milk, protein biosynthesis, and metabolism because they physiologically stimulate insulin secretion the present study sought to investigate the effects of the combination of whey protein and casein in the ratio of 80:20 ("whey protein: casein" or "casein: whey protein") as breast milk proportion on the peak and the period of the permanence of branched-chain amino acids in the blood circulation, final metabolites of protein metabolism and delayed onset muscle soreness (doms) after a single bout of fasting or a resistance exercise session.

the present study investigated the effects of the association of wp and casein in the ratio of 80:20, a similar ratio of human breast milk, on blood branched-chain amino acids (bcaas) profile by hplc technique, markers of protein metabolism (creatinine, urea, and urine nitrogen) and delayed onset muscle soreness (doms) after a single bout of resistance exercise. a double-blind, crossover and acute study was conducted with ten men (age 29 ± 8 y; bmi: 25.4 ± 2.9 kg/m2; 77 ± 12 kg; 1.74 ± 0.09 m) that were randomly assigned to five supplementation treatments: wp - whey protein; cas - casein; wp/cas - 80% wp/20% cas; cas/wp - 80% cas/ 20% wp; pla - placebo. participants were submitted to the following evaluations: performance sessions, blood collection for each session for the bcaas profile determination, two food records, 3-days assessment of doms (24h, 48h, 72h) after each treatment.

Eligibility criteria:
inclusion criteria: * healthy * practice resistance training at least 3x a week exclusion criteria: * smokers * muscle injures * cardiovascular diseases * diabetes mellitus * lactose intolerance
unraveling targets of therapy in bronchial thermoplasty in severe asthma (tasma) extension study

Conditions: Severe Asthma

Summary: this study evaluates the longterm clinical outcomes, including safety and efficacy parameters after bronchial thermoplasty (bt) treatment over a period of 5 years. all patients included in de tasma trial in the netherlands will be asked to participate in the tasma extension study.


Eligibility criteria:
inclusion criteria: * subject participation in the tasma study * ability and willingness to provide informed consent. * ability to comply with the study protocol exclusion criteria: * subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.

Keywords: bronchial thermoplasty long term interventional bronchoscopy
open-label extension of study r727-cl-1003 (nct01266876) to evaluate the long-term safety and efficacy of alirocumab (regn727) in participants with heterozygous familial hypercholesterolemia (hefh)

Conditions: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia

Summary: the primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with hefh who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme a (hmg-coa) reductase inhibitors (statins), with or without other lipid-modifying therapies (lmts).


Eligibility criteria:
key inclusion criteria: 1. prior participation in and the successful completion of the r727-cl-1003 study (nct01266876). 2. patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study 3. a negative urine pregnancy at the screening/baseline visit for women of childbearing potential key exclusion criteria: 1. reported a drug-related serious adverse event (sae) or drug-related clinical or laboratory adverse event (ae) in the r727-cl-1003 study that resulted in early termination or withdrawal 2. significant protocol deviation in r727-cl-1003, such as non-compliance by the investigator or patient 3. low-density lipoprotein (ldl) apheresis within 12 months before the screening/baseline visit note: other exclusion criteria applied
piezowave for treatment on lateral and medial elbow tendinopathies

Conditions: Elbow Tendinopathy; Golfer's Elbow; Medial Epicondylitis; Lateral Epicondylitis; Tennis Elbow

Summary: within the outpatient rehabilitation clinic, therapists provide therapeutic interventions to treat patients with various tendinopathies, including lateral and medial epicondylosis. current conservative treatment includes immobilization for forced rest of the inflamed tendons and muscles, as well as mobilizations to focus stimulation of synovial fluid, provide movement to nourish cartilage, promote periarticular extensibility, and provide sensory and proprioceptive input. musculoskeletal disorders can accompany both local and referred pain patterns that need to be assessed and treated. when an acute trauma or repetitive micro-trauma occurs, that may result in decreased range of motion and increased pain causing the onset of weakness and function of the affected extremity. an alternative approach is through the provision of piezowave myofascial acoustic compression therapy (myact), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. the focused sound waves produced by the piezowave myact device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. it is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain. there is currently limited research to support the benefit in regards to increased function and decreased pain when the piezowave myact is used for the treatment of lateral and medial epicondylosis. of the limited research available, treatment with non-invasive shock wave therapy, complications are low and effect is achieved in most cases within three to five sessions. if piezowave myofascial acoustic compression therapy (myact)) is applied as treatment for symptoms of lateral and medical elbow tendinopathies, then the patient will experience increased function demonstrated by quick dash (disability of the arm, shoulder and hand) score and decreased pain demonstrated by subjective reporting on the numeric pain rating scale.


Eligibility criteria:
inclusion criteria: * tendinopathy symptoms referred for occupational therapy by physician. * positive provocation tests exclusion criteria: * contraindications for shock wave * infections * tumor tissue * blood clotting disorder * blood thinning medication use * pregnancy * lung tissue in focal area * head * air-containing organs * elbow fracture * history of corticosteroid injections less than eight weeks/two months, prior to initiation of occupation therapy treatment for lateral or medial epicondylosis. the goal would be to have elimination of any residual benefit from the injection.
paroxetine versus placebo for vasomotor symptom management in surgical menopause

Conditions: Menopause Syndrome; Menopause Surgical; Hot Flashes

Summary: evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism

vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. these symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy. due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. for this reason, the use of non-hormonal therapy has been investigated. since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.

Eligibility criteria:
inclusion criteria: * patients with surgical menopause attending ihss outpatient clinic. * patients with surgical menopause with presence of hot flashes and night sweats. * surgical menopausal patients with episodes of anxiety and palpitations. * patients with surgical menopause who receive treatment for 6 months with paroxetine. * patients who after reading and explanation of the informed consent agree to participate voluntarily. exclusion criteria: * patients medicated with psychotropic drugs, including all sedatives and hypnotics. * patients under treatment with menopausal hormone therapy. * patients with impaired hepatic or renal function. * patients with unstable heart disease. * patients with a history of self-destructive behaviors. * patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.

Keywords: menopause syndrome menopause surgical hot flashes paroxetine