Kornimate/medical-research-clean huggingface dataset:
effect of xalacom® (latanoprost/timolol) and combigan® (brimonidine/timolol) fixed combination on intraocular pressure and ocular blood flow in patients with primary open angle glaucoma or ocular hypertension

Conditions: Retina; Ocular Physiology

Summary: glaucoma is one of the most common causes of blindness in the industrialized nations. for a long time glaucoma has been defined as a disease in which high intraocular pressure (iop) leads to irreversible optic disc damage and subsequent visual field loss. however, recent investigations show that iop is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. the role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. the main focus of glaucoma is still directed towards a decrease in iop. there is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. in the present study xalacom® (latanoprost/timolol) and the fixed combination of combigan® (brimonidine/timolol) will be compared with respect to their iop lowering efficacy as well as their ocular hemodynamic effects.


Eligibility criteria:
inclusion criteria: * men and women over 18 years * unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with iop between 22 -35mmhg * at least 3 reliable visual field testings * 4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors exclusion criteria: * history of acute angle closure * closed or barely open anterior chamber angle * mean deviation of visual field testing \> 10 * intraocular surgery or argon laser trabeculoplasty within the last six months * ocular inflammation or infection within the last three months * contact lenses * patients with bradycardia (heart rate \< 50 beats/min) * second and third degree heart block * asthma * copd * congestive heart failure * severe renal impairment (creatinine clearance \< 1.8 l/h) * history of hypersensitivity to one of the study drugs or drugs with similar chemical structure * topical or systematically/oral therapy with steroids * history of non-iop responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues * pregnancy

Keywords: xalacom combigan ocular blood flow
standard operating procedures for anti-hpv (human papillomavirus) antibody detection in first-void urine

Conditions: Human Papilloma Virus Infection

Summary: the aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against hpv (human papillomavirus).

participants of the hpv v503-004 study (phase iii clinical trial vaccinating (young) adult women in antwerp, eudract number: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. at 3.5 years, they will also be asked to fill in a brief questionnaire. the collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.

Eligibility criteria:
inclusion criteria: * participant of the hpv v503-004 study at ua/uza * willing to give informed consent (icf) to the cev research team

Keywords: antibodies vaccination self-sampling first-void urine hpv
vitamin d supplementation for the prevention of gdm

Conditions: Vitamin D; Gestational Diabetes

Summary: this study was a double-blind multicenter randomized controlled study.

this study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of gdm into intervention group (vitd3:1600 iu/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. the risk of gdm in pregnant women of the two groups was compared, the preventive effect of high-dose vitd supplementation during pregnancy on different subtypes of gdm was determined, and the effects of vitd supplementation on vitd nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational vitd supplementation during pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ pregnant women at high risk of gdm (meeting any of the following conditions) : a) bmi ≥24 kg/m2 before or during pregnancy; b) family history of diabetes or gdm; c) previous pregnancy diagnosed as gdm; d) with a history of macrosomia (≥4000 g); e) a history of abnormal glucose tolerance: 5.7-6.4% hba1c or 6.1-7.0 mmol/l fasting blood glucose. * sign informed consent. - exclusion criteria: * patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes); * hba1c ≥6.5% or fasting blood glucose \& gt;7.0 mmol/l with obvious symptoms of diabetes; * patients with current or past abnormalities in calcium metabolism (hypoparathyroidism/hyperthyroidism, kidney stones), high urinary calcium or hypercalcemia; * daily vitd intake \& gt;800 iu. ⑤ suffering from serious chronic diseases (heart, lung, liver, kidney and other dysfunction) or mental illness; * they cannot walk 100 meters safely; 7. multiple pregnancies or assisted reproduction; ⑧ need complex diet; * cannot speak mandarin fluently; ⑩ those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.
spinal anesthesia for cesarean delivery: bupivacaine with or without fentanyl

Conditions: Pain

Summary: the safest form of anesthesia for cesarean section is a spinal anesthetic. all spinal anesthetics contain a local anesthetic and/or a narcotic. a drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for cesarean deliveries in north america. another drug named fentanyl is the most commonly used narcotic. this study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.

there have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs. the main problem with bupivacaine is that it causes hypotension (low blood pressure). when fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. the main problem with fentanyl is itchiness and sleepiness. in the case of an emergency cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby. our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.

Eligibility criteria:
inclusion criteria: * healthy patients (asa 1 or 2) * bmi \< 40 * height between 5 \& 6 feet exclusion criteria: * parturients with pregnancy induced hypertension or preeclampsia * parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia * emergency delivery * triplet or greater multiple gestation

Keywords: cesarean section spinal
to evaluate the feasibility, safety, and efficacy of tet for fmt via colonic approach

Conditions: Inflammatory Bowel Diseases

Summary: no technique by placing a tube through anus into cecum for whole colon administration. this study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (tet) in fecal microbiota transplantation (fmt) through whole colon.

the previous reported fecal microbiota transplantation (fmt)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. fmt via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and fmt by colonoscopy was recommended for repeat fmt treatment in short period. traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.no technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat fmts.to solve these problems, investigators designed a new technique called transendoscopic enteral tubing (tet).the tet tube was fixed at cecum by clips under endoscopy. this study aimed to evaluate the feasibility, safety, and efficacy of tet for fmt via colonic approach.

Eligibility criteria:
inclusion criteria: * mild to moderate ulcerative colitis (montreal classification) exclusion criteria: * diagnosed as ulcerative colitis first time. * no history of using biologic, immunomodulatory therapy or corticosteroid therapy. * with contraindication of endoscopy.

Keywords: inflammatory bowel diseases fecal microbiota transplantation transendoscopic enteral tubing
impact of a lifestyle program on quality of life in pemphigus patients

Conditions: Pemphigus Disease

Summary: the aim of this study is to evaluate the impact of lifestyle modifications, including dietary changes and regular exercise, on skin-related quality of life in patients with pemphigus by assessing changes in skindex-16 scores over a three-month period.

the skin, the body's largest organ, serves as a critical protective barrier against environmental hazards and plays a pivotal role in immune defence. autoimmune diseases arise when the immune system erroneously targets the body's own tissues, leading to chronic inflammation and tissue damage. globally, the prevalence of these disorders is on the rise, significantly impacting patient morbidity and healthcare systems. pemphigus is a rare autoimmune blistering disorder characterized by the production of autoantibodies against desmogleins-proteins essential for cell-to-cell adhesion within the epidermis. epidemiologically, pemphigus vulgaris (pv) is the most common subtype, with incidence rates varying geographically. higher incidences are observed in regions such as the middle east, with iran reporting up to 5 cases per 100,000 people annually. in the arab world, pv predominates in countries like egypt, sudan, and morocco. complications of pemphigus are multifaceted. patients are susceptible to secondary bacterial, viral, and fungal infections due to compromised skin integrity, which can escalate to sepsis. oral mucosal involvement often leads to painful erosions, causing difficulties in alimentation and subsequent nutritional deficiencies. the psychological burden of pemphigus is considerable. chronic pain, visible lesions, and social stigma contribute to elevated rates of anxiety and depression among patients. studies indicate that approximately 30.7% of individuals with pemphigus experience anxiety or depressive disorders, underscoring the need for comprehensive psychosocial support in this population. therapeutically, systemic corticosteroids remain the cornerstone of pemphigus management, often supplemented with immunosuppressants and biologic agents like rituximab. while effective, these treatments carry risks; long-term corticosteroid use is associated with adverse effects such as osteoporosis, increased infection risk, and metabolic disturbances. despite advancements in therapeutic strategies, there remains a paucity of research focusing on lifestyle modifications as adjunctive measures in managing pemphigus. this study aims to explore the potential benefits of integrating lifestyle interventions to enhance patient outcomes, reduce treatment-related complications, and improve overall quality of life.

Eligibility criteria:
inclusion criteria: * 1. adults aged 18-65 years diagnosed with pemphigus. 2. willingness and ability to adhere to prescribed lifestyle modifications. exclusion criteria: * 1. presence of severe comorbidities that could impede adherence to dietary interventions and regular exercise 2. pregnancy or lactation

Keywords: lifestyle, quality of life, pemphigus
analysis of natural killer cell activity (nka) in whole blood in high risk subjects undergoing colonoscopy

Conditions: Immunity, Innate; Colorectal Cancer

Summary: this study will measure the activity of natural killer (nk) cells using the in vitro diagnostic device nk vue in high risk subjects (quebec risk categories p2, p3 and p4) scheduled for colonoscopy.

in quebec, subjects in risk category p2 are scheduled for colonoscopy due to high suspicion of cancer based on imaging, sigmoidoscopy or clinical exam. subjects in categories p3 and p4 are scheduled for colonoscopy for one of the following reasons: suspicion of having an inflammatory bowel condition, rectal bleeding, presence of occult blood in stool, unexplained iron deficiency anemia, recent change in bowel habits, family history of crc or adenomatous polyps or other hereditary colorectal diseases. often, colonoscopy is not performed within the government-prescribed recommended delays, leading to waiting lists for the procedure. analysis of nk cell activity may help identify those at risk for the presence of crc and therefore help prioritize subjects on these waiting lists, help manage resources and help convince subjects to have a colonoscopy. furthermore, all subjects will undergo a fit, allowing a determination of the ability of each test alone, as well as a combination of nk vue and fit, to predict outcome on colonoscopy.

Eligibility criteria:
inclusion criteria: 1. subjects aged 40 and over who are scheduled to undergo colonoscopy at the research site and who are classified in category p2, p3 or p4. 2. subjects who provide informed consent to participate in the trial exclusion criteria: 1. lack of understanding and/or participation due to illiteracy or inability to comprehend english or french 2. subjects in category p3 who are there due to knowledge or suspicion of an inflammatory bowel disease 3. previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment) 4. currently participating (or participated within the previous 120 days) in an investigational therapeutic study (in case of interference of the drug with the immune system) 5. subjects who underwent their colonoscopy and 1. the colonoscopy preparation was judged insufficient 2. the colonoscopy itself was judged insufficient or incomplete by the doctor 3. the biopsy sample was lost and cancer could not be pathologically confirmed 4. the colonoscopy detected an inflammatory bowel disease 6. female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.

Keywords: natural killer cells natural killer cell activity
a multicenter, randomized, double-blind, double-dummy trial of azithromycin sr compared with clarithromycin extended release for the treatment of pneumonia in adult patients

Conditions: Pneumonia

Summary: the study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (sr) at least as effective as 7 days of clarithromycin extended release (er), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (cap), and that both treatments were safe.


Eligibility criteria:
inclusion criteria: outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (wbc \>10,000/mm3) or greater than 15% immature neutrophils were included. patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a modified fine risk score of ≤ 70 (fine class i and ii). exclusion criteria: patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
intracoronary stem cell therapy in patients with acute myocardial infarction (scami)

Conditions: Acute Myocardial Infarction; Coronary Artery Disease

Summary: autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. the primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. the study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. based on the data of this analysis the final sample size will be calculated. the primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

there is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction with time to revascularization \>6 hours from symptom start * clear target vessel * large myocardial infarction defined as: proximal vessel occlusion, ck \> 1000 u/l, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass * potential prior thrombolysis * written informed consent exclusion criteria: * acute myocardial infarction with revascularization within 6 hours after symptom start * prior myocardial infarction * no clear target vessel * contraindication for magnetic resonance imaging (e.g. pacemaker, icd) * severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging) * prior hematologic disease * prior chemo therapy * prior stem cell transplantation * prior treatment with g-csf * known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis * local infection of puncture sites
choroidal thickness in optic neuropathy

Conditions: Optic Nerve Disorders

Summary: this study plans to learn more about the thickness of the choroid in patients with optic neuropathy. the choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the university of colorado hospital.


Eligibility criteria:
inclusion criteria: * age greater than 18 years, * diagnosis of optic neuropathy, * willing and able to sign an informed consent. exclusion criteria: * steroid use within the past 4 weeks, * inability to cooperate with optical coherence tomography (oct) testing, * relevant ocular comorbidities in the affected or unaffected eye, such as * glaucoma, * uveitis, * optic nerve hypoplasia, * age related macular degeneration, * refractive error greater than 5 spherical diopters.
using ambu aura-i laryngeal mask airway in cranial surgery

Conditions: Hypertension, Malignant; Airway Management

Summary: the investigators hypothesize that ambu aura-i lma can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.

in this study the investigators want to assess the safety of using sga devices in cranial surgery and comparing the effect of these devices with ett regarding hemodynamics stability throughout the procedure and intracranial tension.

Eligibility criteria:
inclusion criteria: 1. study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position. 2. aged 18 to 60 years. 3. asa 1 or 2. 4. gcs ≥ 13. exclusion criteria: 1. patients who are known hypertensive, history of cardiac diseases or chest diseases 2. patients with risk of aspiration (obesity with bmi ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery). 3. risk of difficult intubation 4. extensive intracranial tumours that may affect recovery of patients.

Keywords: hypertension airway laryngeal mask airway
a screening study to collect samples for taa, hla & hla loss of heterozygosity in patients with metastatic solid tumors

Conditions: Head and Neck Cancer; Cervical Cancer; Non Small Cell Lung Cancer; Melanoma; Ovarian Cancer; HPV16 Related Cancers

Summary: tscan therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived t cells are engineered to express a t cell receptor that recognizes cancer-associated antigens presented on specific human leukocyte antigen (hla) molecules. the purpose of this screening study is to collect samples to conduct hla genotyping, hla loss of heterozygosity (loh) and expression of tumor-associated antigens (taa) testing. these results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a tscan clinical treatment study.

this multicenter screening study will be conducted to determine a participant's tumor antigen expression profile, hla genotype and loss of hla for tscan sponsored clinical treatment study(s). no treatment intervention will occur as part of this screening study. participants will be required to provide a buccal swab to assess their hla status. if they are positive for certain types of hla, participants will provide saliva sample to assess hla loss of heterozygosity. in parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. if archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the subsequent visit. if eligible, participants will be referred to appropriate available interventional trial(s) at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent. * male or female aged ≥18 years at the time of signing the informed consent. * have one of the following histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor: * head and neck cancer * cervical cancer * non-small cell lung cancer * melanoma * ovarian cancer * hpv positive anogenital cancers * other cancers with a reasonable likelihood of expressing 1 or more antigens included in a tscan clinical trial, following approval by the tscan medical monitor or their delegate. * willing to provide a buccal swab for hla testing * willing to provide a saliva sample to use as a normal control for the loh assay * have access to an ffpe tumor block that is \<8 months old or is willing to provide a fresh core-needle biopsy. exclusion criteria: • participants undergoing anticancer therapy with curative intent such as tumor surgical resection with or without neoadjuvant/adjuvant therapy, or definitive chemoradiation, unless they have locoregionally advanced disease and are expected to have a high risk of relapse after their curative intent therapy as determined by the treating investigator.

Keywords: loss of heterozygosity hla taa mage-a1 adenocarcinoma squamous cell carcinoma epithelial carcinoma hpv positive cancers tscan therapeutics tscan-002 tscan-003 prame mage-c2 mage-a4