Kornimate/medical-research-clean huggingface dataset:
clinical study to compare visual performance of two trifocal iols

Conditions: Cataract; Lens Opacities; Presbyopia

Summary: prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal iols with different material

this is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. the patients will either be implanted with the hydrophobic iol finevision pod f gf or the hydrophilic iol finevision pod f. the primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected. subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. subjects would have the option for unscheduled visits if required medically. primary endpoint data will be collected at the 3 months follow up visit. data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * irregular astigmatism * age of patient \< 50 years * regular corneal astigmatism \>1.00 dioptres by an automatic keratometer or biometer or \>1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * amd suspicious eyes (determined by oct) * complicated surgery

Keywords: intraocular lens trifocal hydrophobic hydrophilic
ohrqol evaluation after functional therapy in jia patients

Conditions: Juvenile Idiopathic Arthritis

Summary: the aim of the study was to determine the changes in oral health-related quality of life (ohrqol) in patients with juvenile idiopathic arthritis (jia) and temporomandibular joint (tmj) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.

this prospective interventional study included 93 patients with jia and tmj disorders at the start of functional orthodontic therapy. children were prospectively followed in the 24 months of treatment and completed the oral health impact profile (ohip-14) before treatment (t0), and at 6 months (t1), 12 months (t2), and 24 months (t3) after the start of therapy.

Eligibility criteria:
inclusion criteria: the inclusion criteria were: * jia with unilateral or bilateral tmj arthritis treated with a functional appliance; * clear signs or symptoms of tmj arthritis based on clinical and radiological examination. * no administration of intra-articular tmj steroid injections throughout the course of the orthopaedic functional treatment. exclusion criteria: * previous orthodontic treatment; * history of maxillofacial surgery; * genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.
preliminary analysis of the soberlink alcohol breath analyzer system's (saba) clinical utility during aftercare

Conditions: Alcohol Use Disorder

Summary: this is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. the study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.


Eligibility criteria:
inclusion criteria: * adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment exclusion criteria: -
use of fish skin extracellular matrix (ecm) to facilitate chronic wound healing

Conditions: Pressure Ulcers; Venous Ulcers; Diabetic Ulcers; Chronic Ulcer of Foot; Trauma-related Wound

Summary: the clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ecm) in treating chronic wounds. the wound dressing is indicated for the management of difficult to heal and chronic wounds. the matrix is cut to fit the wound and is applied to the wound bed. an absorptive secondary dressing is put on top. further dressing of the wound depends on the etiology. the indications for use are: * partial and full-thickness wounds * pressure ulcers * venous ulcers * diabetic ulcers * chronic vascular ulcers * tunneled/undermined wounds * trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)


Eligibility criteria:
inclusion criteria: * venous leg ulcer * arterial leg ulcer * rheumatic leg ulcer * hydrostatic leg ulcer * ulcer where healing is delayed because of drug therapy * non-healing ulcer due to known or unknown causes exclusion criteria: * active infection

Keywords: adult aged aged, 80 and over bandages biological dressings chronic disease collagen epithelium extracellular matrix fibroblasts granulation tissue humans leg ulcer middle aged prospective studies soft tissue injuries treatment outcome varicose ulcer wound healing wounds and injuries
effect of lidocaine and ozone in injection for myofascial pain

Conditions: Myofascial Pain Syndromes

Summary: myofascial pain syndrome (mps) is a chronic soft tissue rheumatism characterized by tense, painful muscle bands, known as trigger points, located within the muscle or fascia. these trigger points typically lead to pain during movement, limiting muscle extension and reducing mobility. while various treatments exist for mps, the most common approach is injecting local anesthetic agents directly into the trigger points to relieve pain. recently, systemic and local ozone therapy has also gained popularity as an alternative treatment for mps. ozone can be injected directly into muscles in areas such as the back and waist to target pain and inflammation. the aim of this study is to investigate the clinical effectiveness of ozone therapy with lidocaine injection in patients diagnosed with mps.the aim of this study was to compare 2% non-vasoconstrictor lidocaine and ozone injections in the treatment of patients presenting to the clinic with myofascial pain syndrome and to determine the more therapeutic method.

60 patients between the ages of 18-65 diagnosed with mps were included in the study. the patients were randomly divided into four groups. as the control group, the first group was injected with isotonic saline, the second group was injected with 2% lidocaine without vasoconstrictor, the third group was injected with ozone gas and the fourth group was injected with ozonated isotonic saline. patients were evaluated with vas score before treatment, at 1, 2, 4 weeks and 3 months after treatment. in addition, quality of life was evaluated with hit-6 and pittsburgh sleep quality index (psqi) scales before treatment and at the 1st and 3rd months after treatment.

Eligibility criteria:
inclusion criteria: * no temporomandibular joint treatment within the last year. * presence of palpable trigger points in the unilateral/bilateral masseter muscle. * classified as asa 1 or asa 2. * chronic pain in the masseter muscle for at least the past three months. * presence of at least two palpable trigger points in the unilateral or bilateral masseter muscle, with a pain score of ≥ 3 on the visual analog scale (vas) upon palpation exclusion criteria: * history of allergy to any anesthetic agent. * use of anticoagulant medications. * use of analgesics, muscle relaxants, or antidepressants within the last month. * diagnosed with specific conditions such as migraine, neuromuscular junction disorders, fibromyalgia, depression, or schizophrenia. * history of trauma, tumor, or surgery in the head-neck region. * presence of skin infection in the relevant area.

Keywords: ozone lidocaine myofascial pain syndrome
the safety and effectiveness of protein supplements on cancer patients with nutritional risk and malnutrition

Conditions: Cancer; Malnutrition

Summary: nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. the current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.

an anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. intention-to-treat analysis (itt) and per-protocol analysis (pp) will be used in statistical analysis.

Eligibility criteria:
inclusion criteria: * • age\>=18years old; * initial treatment patients with lung/gastrointestinal/esophageal cancer * patients with nutritional risk (nrs-2002≥3) ; * patients are able to provide written informed consent. exclusion criteria: * • people who are allergic to whey protein. * participants received any drugs or supplements known to influence the outcomes, such as protein powder, anabolic steroids, or glucocorticoids before the 3 months preceding the study. * participants with gastrointestinal bleeding or intestinal obstruction, or any contraindication for oral intake * concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance. * participants with electronic or mental device. * women in pregnancy or lactation period

Keywords: protein malnutrition nutritional risk cancer
amplatzer piccolo occluder japan post-marketing database surveillance

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.

the surveillance will be conducted per the standards required by the ministry of health, labour and welfare (mhlw) and in the standards for post-marketing surveillances and studies \[except for those defined in the ministerial ordinance on good clinical practice for medical devices (mhlw ordinance no. 36, 2005)\] based on paragraph 4, article 23-2-9 (including application mutatis mutandis per article 23-2-19 of revised pal) of the law on securing quality, efficacy and safety of pharmaceuticals and medical devices, etc. (law no. 145, 1960, hereinafter referred to as "revised pal") by the marketing authorization holder or accredited foreign manufacturer of a medical device defined in paragraph 1, article 23-2-5 of revised pal.

Eligibility criteria:
inclusion criteria: the device is used to percutaneously close the pda of a patient who meets all of the following: * pda ≤4 mm in diameter * pda ≥3 mm in length * weight ≥700 g exclusion criteria: * age \<3 days * coarctation of the aorta * left pulmonary artery stenosis * cardiac output that is dependent on right to left shunt through the pda due to pulmonary hypertension * thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered * endocarditis, or infection that can cause bacteremia * allergic or potentially allergic to nickel
hn-bio: a study of head and neck mri and tumor microenvironment biomarkers

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the purpose of this study is to explore biomarker development in patients with newly diagnosed head and neck squamous cell carcinoma (hnscc) receiving curative therapy.

after being informed about the study and potential risks, all patients giving written informed consent will be assigned to cohort a or cohort b. cohort a will recruit up to 40 patients planned to receive curative radiotherapy for hnscc. patients will undergo a baseline fmri (functional magnetic resonance imaging) scan and within 72 hours a biopsy of the primary tumor will be performed in out-patient clinic. in week 2 of radiotherapy a further biopsy of the primary site will be performed with a paired fmri performed within 72 hours prior to biopsy assess evolving changes in imaging and tumor microenvironment biomarkers during radiotherapy. a further optional biopsy and paired mri scan in week 4 will be considered for patients who are tolerating therapy without toxicities. 16-24 hours prior to each biopsy the volunteer will take oral pimonidazole. cohort b will recruit up to 20 patients planned to receive curative surgery for hnscc. each patient will undergo a baseline fmri scan performed within one week prior to surgery. at time of initial consent they will receive a prescription for oral pimonidazole hydrochloride which they will be asked to take the 16-24 hours before planned surgery. following surgery whole tumor samples will be processed to permit spatial reconstruction of pimonidazole staining hypoxia to correlate with fmri imaging.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * histologically proven head and neck squamous cell carcinoma * primary or nodal disease \> 3cm for biomarker imaging * eastern cooperative oncology group (ecog) performance status 0-2 * planned for curative surgery or (chemo)radiotherapy * willingness to undergo repeat mri imaging * able to receive and understand verbal and written information regarding study and able to give written informed consent * adequate renal function: calculated creatinine clearance \>/= 30ml/min * be able to lie comfortably on back for 1 hour exclusion criteria: * as judged by investigator evidence of systemic disease that makes unsuitable for study * contra-indication for serial mri scans * previous solid tumor treated within last 5 years * pregnancy * history of gadolinium contrast allergy * non-reversible clotting abnormality
yiqi huoxue huatan granule for reducing mortality in copd with chronic respiratory failure

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Respiratory Failure

Summary: this study aims to establish the treatment scheme of yiqi huoxue huatan granule for chronic obstructive pulmonary disease (copd) with chronic respiratory failure (crf), reducing mortality, improving quality of life and forming high quality evidence.

copd is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in china. copd has become the third leading cause of death worldwide. copd complicated by crf is serious and has a high mortality rate. at present, ideal and effective treatment is inadequate. traditional chinese medicine (tcm) has some potential in improving outcomes in copd with crf. this is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of yiqi huoxue huatan granule on reducing mortality and improving quality of life in copd with crf. after a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. the primary outcomes are all-cause mortality and frequency of acute exacerbation of copd. the secondary outcomes include clinical symptoms, copd assessment test (cat), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. safety will also be assessed.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of stable copd; * arterial blood gas analysis meets criteria of pao2 \ 50mmhg during quiet breathing at sea level; * syndrome differentiation meets criteria of qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome； * age ranges from 40 years to 80 years; * with informed consent signed. exclusion criteria: * • crf resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.; * acute exacerbation of crf； * patients with severe cardiovascular and cerebrovascular diseases; * pregnant and lactating women; * patients with psychiatric disorders； * patients with diabetes; * patients who have participated in other clinical studies in the past 4 weeks; * patients who have experienced one or more acute exacerbation of copd in the past 4 weeks.

Keywords: chronic obstructive pulmonary disease chronic respiratory failure yiqi huoxue huatan granule
a research study to evaluate safety and efficacy of dur-928 in subjects with primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis

Summary: this is a research trial testing dur-928 (an experimental medication). the purpose of the trial is to assess whether treatment with dur-928 has any effect on the treatment of primary sclerosing cholangitis (psc). this trial will also assess safety (side effects).


Eligibility criteria:
inclusion criteria: * verified diagnosis of primary sclerosing cholangitis (psc) for at least 12 months, with or without inflammatory bowel disease (ibd). * serum alkaline phosphatase (alp) ≥ 1.5 times uln and with no \>15% fluctuation in the past 3 months. * in subjects receiving treatment with ursodeoxycholic acid (udca), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day. * subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing. exclusion criteria: * presence of documented secondary sclerosing cholangitis or small duct psc * bacterial cholangitis within 30 days prior to screening * presence of percutaneous drain or endoscopic bile duct stent * history of, or suspicion of cholangiocarcinoma. * prior liver transplantation, or currently listed for liver transplantation * presence of other concomitant liver diseases * moderate to severe active ibd or flare in colitis activity within the last 3 months * any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder * any active malignant disease (within 3 years), other than non-melanomatous skin cancer * human immunodeficiency virus (hiv) infection * existing or intended pregnancy, or breast feeding * has received medication from another clinical trial within the past 30 days
dexmedetomidine on microcirculation in septic shock

Conditions: Septic Shock

Summary: dexmedetomidine was found might be beneficial to sepsis. dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. however, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

septic shock is characterized by significant decline in vascular response and relative hypovolemia. fluids and exogenous catecholamines are mainstay. however, even after initial resuscitation, microcirculatory dysfunctions still exist, and represent a direct physiologic link to organ failure and death. therefore, therapeutic strategies aiming at improving microcirculation are performed. dexmedetomidine was found might be beneficial to sepsis. dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. however, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown. based on the hypothesis that dexmedetomidine might improve microcirculation in initial resuscitated septic shock patients, the study was to investigate the effects of dexmedetomidine on microcirculation in early septic shock patients despite initial resuscitation. meanwhile, to observe the possible mechanism of the effect, the correlation between dexmedetomidine dose and microcirculatory parameters as well as catecholamine level were performed.

Eligibility criteria:
adult patients who met the following inclusion criteria were enrolled in the study: 1) with septic shock defined by the 2001 sccm/esicm/accp/ats/sis international sepsis definitions conference for less than 24 hours. 2) after initial fluid resuscitation but still requiring norepinephrine to maintain arterial pressure or hyperlactacidemia. 3) need ongoing analgesia and sedation. 4) using advanced invasive hemodynamic monitoring techniques. exclusion criteria were as follows: 1. age less than 18 years. 2. pregnancy. 3. heart rate less than 55 beats per minute. 4. acute hepatic failure 5. brain injury.

Keywords: sepsis sedation microcirculation dexmedetomidine
microeconomic intervention to reduce hiv transmission in economically disadvantaged transgender women

Conditions: Hiv; Transgenderism

Summary: the purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. the ultimate purpose of the study is to test an intervention to improve financial conditions and reduce hiv risk behaviors in transgender women.

the study includes a microeconomic intervention which will provide education on a variety of economic and behavioral topics. participants will complete questionnaires on multiple occasions during the study.

Eligibility criteria:
inclusion criteria: * transgender woman * 18-45 years of age at least one of the following economic vulnerability factors: unemployment or underemployment \[less than 20 hours/week\], low income \[less than the medicaid poverty threshold\], housing insecurity in the past year or food insecurity in the past year • behavioral vulnerability to hiv transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral hiv transmission risk factor in the past 6 months: \[transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown hiv status). exclusion criteria: * obvious signs of intoxication or cognitive impairment * cannot speak english.