Kornimate/medical-research-clean huggingface dataset:
study of saf312 as an eye drop for treatment of eye pain following photorefractive keratectomy (prk) surgery

Conditions: Postoperative Ocular Pain After PRK Surgery

Summary: the purpose of this study is to determine if saf312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (prk) surgery


Eligibility criteria:
inclusion criteria: * normal eye exam except for refractive error at baseline. * myopia should not exceed -4.00 diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline. exclusion criteria: * monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (snellen) or 55 letters (edtrs), at baseline. * any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline. * previous refractive or corneal surgery (such as lasik, prk, radial keratotomy, pterygium removal, corneal transplantation). * chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing. other inclusion and exclusion criteria apply.

Keywords: ocular pain photorefractive keratectomy (prk) saf312 corneal epithelial defect
improving acl reconstruction outcomes: cbpt

Conditions: ACL Injury; ACL - Anterior Cruciate Ligament Rupture; ACL Sprain; ACL Tear

Summary: the overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (cbpt) for improving knee function, return to sport, and quality of life outcomes in patients following acl reconstruction (aclr). the study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for aclr (cbpt-aclr) and telephone-based education. the central hypothesis is that the cbpt-aclr participants relative to the education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.


Eligibility criteria:
inclusion criteria: 1. english speaking (due to feasibility of employing study personnel to deliver and assess the study intervention); 2. 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis); 3. no previous surgery to either knee; 4. time from injury to surgery 12 months or less; 5. active participation in a sport on a weekly basis prior to injury exclusion criteria: 1. bilateral simultaneous acl reconstructions; 2. revision aclr; 3. any concurrent ligament (mcl, lcl, or pcl) surgical procedures; 4. concurrent osteotomies or meniscus transplantations; 5. surgery secondary to trauma, tumor, or infection; 6. having workman's compensation insurance for surgery; 7. on active military duty; 8. medical history of schizophrenia or other psychotic disorder; and 9. unable to provide stable address and access to a telephone
multicenter laser va registry of percutaneous coronary interventions (lava)

Conditions: Arteriosclerosis; Coronary Artery Disease; Laser-assisted Percutaneous Coronary Interventions

Summary: this is a multi-center, investigator initiated study that will prospectively and retrospectively examine treatment strategies and outcomes of patients who underwent percutaneous coronary interventions (pci). the goal of this multi-center, investigator initiated, registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing laser-assisted pci among various participating centers. the study is a purely observational, chart review study and involves retrieval and compiling of data based on clinically indicated procedures and follow-up clinical and procedural outcomes. the information collected will be used to determine the frequency of laser-assisted pci performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and subsequent) outcomes.


Eligibility criteria:
inclusion criteria: * patients who have undergone/will be undergoing laser-assisted pci at each of the participating centers during the study period. * willing and able to provide informed consent. exclusion criteria: * not eligible candidate as per review by investigator.
effect of oral supplementation with probiotics

Conditions: Obesity

Summary: effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial.

the purpose of the study is to determine whether oral probiotic supplementation affects cardiometabolic risk, intestinal epithelial permeability, metabolic activity and intestinal flora composition, mineral content, and lifestyle in obese women with metabolic syndrome. probiotics are a group of non-pathogenic microbes that bring health benefits to the host. their use enables the variety and proper functioning of intestinal microflora. the use of probiotics increases the amount of bifidobacteria and lactobacilli, what directly affects the reduction of endotoxemia by sealing the intestinal wall, as well as the improvement of fat, carbohydrate and insulin metabolism. the project is due to evaluate the effect of supplementation with selected probiotics in patients with metabolic syndrome on: * lipid metabolism- total cholesterol, hdl and ldl cholesterol and triglycerides, * blood glucose concentration, * blood pressure values, * anthropometric parameters, * quality of life, * the contentl of minerals,

Eligibility criteria:
inclusion criteria: * body mass index (bmi) equal to or greater than 30 kg/m2 * age 45 to 70 years * stable body weight (\< 3 kg self-reported change during the previous three months) * written informed consent to participate in the study, * \> = 1 year after the last menstrual period; * abdominal obesity - waist circumference\> 80 cm; * body fat content measured by bio-impedance ≥ 33%; exclusion criteria: * secondary obesity or secondary hypertension * diabetes type i * gastrointestinal disease; * dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up; * a history of use of any dietary supplements within the one month prior to the study * taking antibiotics within 1 month before starting the study; * clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis; * simultaneous participation in a study that affects weight change or use of diet / medication / nutritional behaviors affecting body weight changes; * consumption of pre- and probiotic-enriched products (for at least 3 weeks prior to the first screening visit) and products with high fiber content or large amounts of fermented foods (\> 400g / day); * hormone replacement therapy; * a history of infection in the month prior to the study * nicotine, drug or alcohol abuse * vegetarian diet; * or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results

Keywords: probiotics metabolic syndrome obesity microbiome
effects of raloxifene on hormone levels

Conditions: Breast Cancer

Summary: blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian function. however, because these hormone levels vary from day to day, blood samples must be taken very often or elaborately timed to specific phases of the menstrual cycle. a method has now been developed for measuring estradiol and progesterone levels in saliva. this study will test the accuracy of this method and examine whether salivary levels of these hormones change after treatment with raloxifene. hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the clinical study, "a phase ii trial of two doses of raloxifene in women at risk of developing invasive breast cancer." participants will provide a saliva sample every morning for about a month during three collection periods-1 month before beginning raloxifene treatment, and 3 and 12 months after treatment starts. patients will be given kits for collecting the samples and mailing them to the laboratory at the end of each collection period.

deviations from normal levels of serum e(2) and p are of interest in evaluating ovarian function. however, the day-to-day variations in these levels necessitates serial blood sampling or elaborate efforts to time blood draws within specific phases of the menstrual cycle. a noninvasive method for assessment of the levels of sex steroids on a daily basis using saliva has been developed. this study will assess the levels of estradiol and progesterone during 3 menstrual cycles (pre-drug and after 3 and 12 months of raloxifene therapy) in pre-menopausal women participating in a pilot chemoprevention trial of raloxifene.

Eligibility criteria:
patients must be enrolled on protocol 98-c-0123 (mb #402) or this same protocol at the national naval medical center.

Keywords: breast hormones prevention saliva serum
influence of depressive mood on rehab outcome

Conditions: Depressive Mood

Summary: the purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.


Eligibility criteria:
inclusion criteria: * 2-week in-house-rehab at an acute geriatric unit * ability to take part in assessments * understanding german language * informed consent exclusion criteria: * anti-depressive medication shorter than 4 weeks before enrollment * in-house rehab \< 14 days * advanced stage of dementia

Keywords: rehabilitation exercise outcome measurement
the effects of moxibustion on ulcerative colitis

Conditions: Ulcerative Colitis

Summary: to investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

a total of 60 patients with uc were randomly divided into the following 2 groups: a) herb-partition moxibustion (treatment group) and b) sham herb-partition moxibustion (control group). all patients in the trial will be treated with moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. mri will be used to observe the changes on brain structure and function in patients with uc, and further research on the characteristics of the brain nerve response of these patients with herb-partition moxibustion. in addition, tissue morphology and molecular biology tests will be conducted to observe the regulation and expression of vdr and antimicrobial peptides in the intestinal mucosa of uc patients. all these steps will be done in order to provide experimental basis for the mechanism of the effects of herb-partition moxibustion in the treatment of uc.

Eligibility criteria:
inclusion criteria: * meet the diagnosis of uc * mayo ≤10 * patients do not receive any medicine, or if they are receiving medicine, it should be aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month), and must kept the same dose as before throughout the trial; * patients should have not received antibiotic, biologicals within 3 months prior to entering the study; * signing a written informed consent. exclusion criteria: * patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases; * pregnancy or lactation; * the psychiatric patients; * current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness; * learning disability; * claustrophobia; * presence of metallic implants in the body;
the effect of insoluble yeast beta-glucan intake on pre-diabetic patients

Conditions: Pre-diabetic

Summary: there is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.however,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. this is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.


Eligibility criteria:
inclusion criteria: * aged between 18-65 years * meet the pre-diabetes diagnostic criteria recommended by world health organization (who) in 1999 exclusion criteria: * allergic to test substances * known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases * known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently * usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks * unable to cooperate with researchers or maintain ordinary dietary habit

Keywords: yeast beta-glucan immune function prediabetes gut microbiota
a study to evaluate the safety and tolerability of azd7442 in chinese adults

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: to evaluate the safety and tolerability of a single dose of 600 mg azd7442 administered iv (intravenous) to chinese adults (including those with stable medical conditions).

a phase ii, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of azd7442 for administration to prevent and treat coronavirus disease 2019 (covid-19) in chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years 2. negative results of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) quantitative reverse transcriptase polymerase chain reaction (qrt-pcr) 3. healthy or medically stable participants 4. contraceptive within 365 days post dosing exclusion criteria: 1. medical condition: * known hypersensitivity to monoclonal antibody (mab) or investigational product (ip) component. * acute illness including fever on the day prior to or day of dosing. * any other significant disease increase the risk to participant study. 2. laboratory related: * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.0 × upper limit of normal (uln), alkaline phosphatase (alp) \> 1.5 × uln, or tbl (total bilirubin) \> 1.5 × uln (unless due to gilbert's syndrome). * serum creatinine \> 176 μmol/l. * haemoglobin \< 10g/dl. * platelet count \< 100 × 10\^3/μl. * white blood cell count \< 3.5 × 10\^3/μl or neutrophil count \< 1.5 × 10\^3/μl. * other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results. 3. covid-19 infection history/any receipt of mab indicated for covid-19. 4. prior/concomitant treatment: receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to day 1

Keywords: coronavirus covid-19 azd7442
a study in healthy participants to evaluate the effect of jnj-54175446 on amyloid biomarkers and cytokine profiles in cerebrospinal fluid and plasma

Conditions: Healthy

Summary: the primary purpose of this study is to investigate the effects of jnj-54175446 (dose response) on levels of aβ fragments (aβ1-42, aβ1-40, aβ1-38, aβ1-37) in plasma and cerebrospinal fluid (csf), the effects of jnj-54175446 on markers of (neuro) inflammation/protection in blood and csf and the pharmacokinetics of jnj-54175446 followed by single and multiple dose administration.


Eligibility criteria:
inclusion criteria: * participants must have a body mass index (bmi) between 18 and 32 kilogram (kg)/ meter (m)\^2, inclusive (bmi = weight/height\^2) * participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) part 1 and 2 (elderly participants): * healthy male or female participants between 55 and 75 years of age, inclusive * participant must be healthy on the basis of both physical and neurological examination performed at screening and at admission to the clinical unit part 1 (young participants): - healthy male participants between 18 and 45 years of age, inclusive exclusion criteria: * participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the investigator considers should exclude the participant * participant has a history of hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) positive, or other clinically active liver disease, or tests positive for hbsag or anti-hcv at screening (per screening evaluations) * participant has a history of human immunodeficiency virus (hiv) antibody positive, or tests positive for hiv at screening (per screening evaluations) * participant has a history of malignancy within 5 years before screening * participant has signs of increased intracranial pressure based on fundoscopy at screening
study of paliperidone er in adolescents and young adults with autism

Conditions: Autism

Summary: this 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone er in adolescents and young adults with autism. hypothesis:paliperidone er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.


Eligibility criteria:
inclusion criteria: * males and females between ages of 12 and 21 years * tanner sage iii or iv (post-pubertal) * diagnostic and statistical manual fourth edition text-revised (dsm-iv-tr) diagnosis of autism * outpatient * ability to swallow pills * antipsychotic medication-free for at least 2 weeks * score of 4 or more on the clinical global impressions severity scale * score of 18 or higher on the aberrant behavior checklist irritability scale * mental age of 18 months or greater based on testing * subjects must be in good physical health exclusion criteria: * asperger's disorder, pervasive developmental disorder not otherwise specified (pdd nos), rett's disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, fragile x syndrome, tuberous sclerosis * a significant medical condition * an active seizure disorder * females who are pregnant * evidence of a prior adequate trial of paliperidone er * history of neuroleptic malignant syndrome * hypersensitivity to paliperidone er

Keywords: autistic disorder
prospective random comparing study on eus-guided pseudocyst drainage by naso-pancreatic tube and stents

Conditions: Pancreatic Pseudocyst

Summary: eus-guided pseudocyst drainage has been used world widely. now, most endoscopists tend to place several stents to drain the content of cyst into gi tract. in the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. so, the investigators designed this prospective random comparing study to confirm the result.


Eligibility criteria:
inclusion criteria: 1. adults with ages from 18-80 years old. 2. the pseudocysts were formed more than 3 months. 3. the size of pseudocyst is more than 5 cm. 4. the patient has the symptoms related with the pseudocyst. 5. the distance between gastric and the wall of the pseudocyst is less than 1 cm from ct image. 6. the consent form has been signed. exclusion criteria: 1. the patient can't accept the endoscopic procedure. 2. the patient has blood coagulation dysfunction. 3. the patient has mental disorders. 4. the patient has mild or severe cardiorespiratory insufficiency. 5. the patient has hypertension and can't be controlled to safe level. 6. diabetics whose blood sugar level can't be controlled to safe level. 7. patients with alcohol dependence 8. pregnant and lactating women. 9. the patients the investigator don't think suitable for this study.

Keywords: eus pancreatic pseudocyst drainage
pain relief and functional outcome after partial denervation of the wrist

Conditions: Wrist Arthritis

Summary: prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. the impact of psychological factors on postoperative outcome will be studied.


Eligibility criteria:
inclusion criteria 1. chronic wrist pain (≥6 months) due to posttraumatic arthritis after distal radius fracture or slac/snac arthritis or arthritis due to mb preiser/mb kienböck where surgical unloading of the bone isn't possible. 2. pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, nsaids, physiotherapy. exclusion criteria 1. rheumatoid or other inflammatory arthritis. 2. previous wrist surgery with simultaneous pin/ain neurectomy. 3. simultaneous arthritis or symptomatic instability of the distal radio ulnar (dru) joint on the ipsilateral side. 4. inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). 5. patient's wish for a definite procedure.