Kornimate/medical-research-clean huggingface dataset:
clinical comparison of two daily disposable toric soft contact lenses

Conditions: Astigmatism; Ametropia; Myopia

Summary: the primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing precision1™ for astigmatism (p1fa) soft contact lenses compared to another commercially available, soft toric contact lens, myday® toric (mdt).

study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. the total duration of an individual's participation in the study will be up to 28 days.

Eligibility criteria:
key inclusion criteria: * successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * able to wear contact lenses within a range of sphere \& cylinder power and axes. * willing to not use rewetting/lubricating drops at any time during the study. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * current or previous p1fa and mdt habitual lens wearers. * monovision and multifocal lens wearers. * participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses vision eye sight
vitamin d levels and postoperative pain in laparoscopic cholecystectomy

Conditions: Vitamin D Deficiency; Postoperative Pain

Summary: the deficiency of vitamin d is common in patients with gastrointestinal system disorders. vitamin d has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects. this prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in asa (american society of anesthesiologists) 1-3, 90 volunteer patients. in preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin d will be kept. postoperative will be applied to patient controlled analgesia to all patients for 24 hours. to determine the level of postoperative pain, the visual analog scale (vas) will be used in the clock unit and at the service 6, 12 and 24 hours. in this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin d.


Eligibility criteria:
inclusion criteria: * volunteer, * between the ages of 18-65, * least primary school graduate, * not using drugs that may affect cognitive functions, * non-alcohol substance use, * patients without psychiatric and neurological disease. exclusion criteria: * those with known psychiatric disease and drugs, * those with an important cardiovascular or central nervous system disease, * patients with pain syndromes or routinely using opioid. very urgent patients

Keywords: laparoscopic cholecystectomy vitamin d deficiency postoperative pain
tc-325 (hemospray™) vs. current standard of care in managing malignant gastrointestinal bleeding: a pilot study to inform a randomized controlled trial.

Conditions: MALIGNANT GASTROINTESTINAL BLEEDING

Summary: introduction: gastrointestinal (gi) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). although conventional endoscopic hemostasis methods improve outcomes in ugib due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower gi tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. all exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). the recent advent of tc-325 (hemospraytm) to canada, europe and asia - referred henceforth as tc-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). more robust controlled evaluative data are now needed. we propose to study the use of tc-325 in upper and lower malignant gi bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (rct).


Eligibility criteria:
inclusion criteria: * 18 years or older * able to comprehend the trial and provide written informed consent in french or english, or a close relative with power of attorney * patients who present with an upper or lower gi bleeding with a known luminal gi malignancy diagnosed within the past two years will be considered for enrolment. endoscopic confirmation of an active gi bleed arising from a malignant tumor will be required for final inclusion * rebleeding in patients who presented with acute gib with initial endoscopy suggesting a malignant source based on endoscopic appearance who have not been treated previously with tc-325 will also be included exclusion criteria: * refused by patient * pregnancy * bleeding from non-malignant gi sources such as gastritis/duodenitis, mallory weiss syndrome, peptic ulcer disease, varices, vascular malformations, radiation proctitis, polyps, hemorrhoids, and diverticulosis
postoperative pain after implementation of standardized pain therapy management in orthopaedic patients

Conditions: Postoperative Pain, Acute

Summary: the aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery.

a multimodal standardized pain management was implemented at the schulthess clinic in 2002, followed by the gradual introduction of a standardized ultrasound-guided perioperative regional anaesthesia program. along with these measures, an improved preoperative screening process for patients at risk of increased post-operative pain has been installed and an improved individual pain assessment in the perioperative period has been introduced. this allowed for the creation of pain trajectories, which the pain team started to use to identify gaps in the management of different patient groups. an example of a trajectory group is shown in figure 1. these pain trajectories have not yet been evaluated for the overall implementation cycle of the multimodal standardized pain management in order to further improve postoperative care especially for patients with a history of chronic pain and those prone to opioid overconsumption.we hypothesise that pain trajectories have changed significantly over the study period as standardised pain management has been implemented. we also hypothesise that patients with chronic pain and increased opioid consumption will have different pain trajectories compared to all other patients. however, we believe that the pain trajectories for different orthopaedic surgeries do not show much variation.

Eligibility criteria:
inclusion criteria: * patients undergoing primary hip and knee arthroplasties or revision surgery:chop code: 81.51, 81.52, 81.52, 81.54 * patients undergoing primary shoulder or revision surgery: chop codes: 81.80.11, 81.80.12, 83.64.11, 81.82.35, 81.82.45, 81.82.46, 81.82.47 * patients undergoing major spine surgery: chop code: 7a.6, 7a.7 exclusion criteria: - patients who did not sign general informed consent (for the schulthess clinic).

Keywords: multimodal pain protocol orthopedic surgery opioids
effect of different sars-cov-2 vaccine schedules and vaccination intervals on reactogenicity and humoral immunogenicity

Conditions: SARS-CoV2 Infection; Immunisation Reaction; Antibody Hypersensitivity; Tolerance

Summary: investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of sars-cov-2 antispike antibodies in health care workers after basic immunization and boost vaccination

the basic immunizations (first and second vaccination) were performed from january to june 2021 using the m-rna vaccine bnt162b2 (biontech/pfizer, b)9 and the vector-based vaccine chadox1-s (astrazeneca, a). bnt162b2 was used to boost vaccine all study population. the time interval between the basic immunisation and the boost vaccination varied. four vaccine-groups could be distinguished: group 1 received bnt162b2 with the second vaccination 3 weeks after the first vaccination. vaccinees of groups 2 and 3 received azd1222/chadox1-s as first vaccination and could choose after 12 weeks whether second vaccination with bnt162b2 or azd1222/chadox1-s should be carried out. this results in homologous (first: azd1222/chadox1-s, second: azd1222/chadox1-s) and heterologous (first: azd1222/chadox1-s, second: bnt162b2) vaccine combinations. group 4 received bnt162b2 with the second vaccination 6 weeks after first vaccination. blood samples were collected at six time points: four weeks, three and six months after completion of the basic immunization, immediately before boost vaccination, four weeks and three months after boost vaccination. reactogenicity after first, second, and boost vaccination was assessed using questionnaires to determine vaccine-induced adverse drug reactions (adr) within seven days after the respective vaccinations. in addition, demographic data (age, gender, occupational group, allergies) were collected, local and systemic vaccination reactions are differentiated and the need for medication and inability to work as a result of vaccination reactions are prospectively recorded.

Eligibility criteria:
inclusion criteria: * hospital staff who received covid-19 vaccination exclusion criteria: * lack of a written informed consent

Keywords: sars-cov2 covid-19 mrna vaccination vector based vaccination heterlogues vaccination homologues vaccination helcovac helios hildesheim covid-19 vaccination study
prevalence of nasal hyperreactivity in chronic upper airway inflammation

Conditions: Hyperactivity; Chronic Rhinosinusitis (Diagnosis); Chronic Rhinitis; Upper Respiratory Disease

Summary: rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. if the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. several causes are known, such as an underlying allergy ("allergic rhinitis", ar). if at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (crs). up to 2/3 of the ar and crs patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances... a phenomenon called "nasal hyperreactivity" (nhr). it is currently not clear why some patients suffer nhr while others do not. in this study, the investigators want to determine the prevalence and severity of nasal hyperreactivity in patients with chronic upper airway inflammation. to this end, patients and healthy controls will be asked to fill out a questionnaire inquiring presence and severity of nasal symptoms upon exposure to particular environmental triggers.


Eligibility criteria:
patients inclusion criteria: * age 18-65 y * nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain) * signed informed consent exclusion criteria: - current or medical history of malignancy in the last ten years controls inclusion criteria: * age 18-65 y * no nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain) * signed informed consent exclusion criteria: - current or medical history of malignancy in the last ten years
a single-cell approach to identify biomarkers of pulmonary toxicity for immune checkpoint blockade

Conditions: Pneumonitis, Interstitial; Immunotherapy; Immune-related Adverse Events

Summary: the main goal of this prospective non-interventional exploratory monocentric study is to characterize the immune cell composition of bronchoalveolar lavage (bal) fluid from cancer patients experiencing cancer therapy-induced pneumonitis on a single-cell scale. these mechanistic insights can directly lead to putative diagnostic biomarkers and therapeutic targets. a second highly clinically relevant hypothesis is that single-cell profiling of blood samples will reveal circulating biomarkers of icb toxicity, making non-invasive diagnosis feasible.

the investigators will apply single cell rna- and tcr-sequencing on up to 5,000 single cells per sample. additionally, cell surface protein expression can be integrated with the transcriptional information. various bioinformatics pipelines, including seurat, will be used to identify different cell clusters, which through marker gene expression will be assigned to known cell types, cellular subtypes or phenotypes. for instance, this will make it possible to monitor the abundance of pd-1/pd-l1 expressing t-cells, cytotoxic t-cells, immune-suppressive myeloid cells etc. the following parameters at single-cell level will be relevant, amongst others: * the composition and relative abundancies of established immune cell types (e.g. t cells (cd4+, cd8+ and regulatory subsets), nk cells, b cells, mdscs, macrophages, neutrophils, dendritic cells). transcriptomic data for each of these immune cell subtypes will be analyzed, allowing characterization of specific gene expression programs that define specific phenotypic states. * composition of all stromal cellular subtypes identified by single-cell transcriptomics. * a gene regulatory network for each cell type and cellular subtype (or cell state) will be established and master transcriptional regulators will be identified. individual t-cells and t-cell subclusters will be classified based on interferon activation, high rates of proliferation and transcription and increased granzyme expression, which are all indicative of t-cell activation. blood samples will be subjected to similar single-cell experimental procedures. first, peripheral blood mononuclear cells (pbmc) are isolated using ficoll density gradient centrifugation. single-cell transcriptome analysis in combination with cite-seq will be performed on 5000 pbmc. cellular composition will be determined using the same bioinformatic pipelines as used for processing the bal fluid cells.

Eligibility criteria:
inclusion criteria: * adult m/f/x (\>= 18 years) * patients receiving or having received treatment per guidelines * patients undergoing bronchoscopy with bal, for possible cancer treatment-induced pneumonitis * not included in other clinical trials * signed informed consent form exclusion criteria: • collected material not suitable for further processing in this study (e.g. bad quality). this decision will be made in consultation with a lab technician and/or bio-informatician, specialized in single-cell analysis.
metastatic spinal bone marrow response to radiation therapy using t1 weighted dynamic contrast-enhanced perfusion

Conditions: Solid Cancer; Metastatic Spinal Lesions

Summary: the purpose of this study is to assess imaging methods including dynamic contrast enhanced magnetic resonance imaging (dce-mri) and perfusion for the cancer that has spread to the spine. the study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.


Eligibility criteria:
inclusion criteria: * adult patients 18 years of age or older * known pathological diagnosis of any solid cancer. * metastatic spinal lesions 1 cm or greater in diameter. * patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions. note: the patients must have their treatments at mskcc. exclusion criteria: * patients with renal failure or history of allergic reaction to gadavist will be excluded. * patients who would be normally excluded from undergoing an mri examination as per memorial hospital for cancer and allied disease screening questionnaire for mri. * patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. * patients with inability to cooperate for an mri exam due to claustrophobia or high levels of anxiety. * female patients who are pregnant or nursing. * patients with egfr \< 30 are not eligible to higher risk of nsf.

Keywords: dynamic contrast-enhanced perfusion 14-203
mindfulness-based cognitive behavior therapy for bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (mbct) for improvement of symptoms associated with bipolar disorder, by comparing mbct to supportive psychotherapy. patients who participate in this study will be randomly assigned to receive either 1. state of the art group mbct, or 2. supportive group psychotherapy (which is considered part of the standard care available to patients at mgh).

we will conduct a randomized controlled trial of group mbct (n=30) vs. sp (n=30) and compare the benefits and durability of mbct vs. sp for decreasing symptoms in dsm-iv bipolar individuals over a 12-week period adjunctive to mood stabilizing medications coupled with individual-therapy sessions. we will also conduct follow-up assessments at 3, 6, 9, and 12 months after the active phase of the study. subjects in the mbct group will receive group therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation and relapse prevention for bipolar disorder. subjects in the sp group will receive support for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar disorder. the focus of sp is on reflecting and expressing feelings about current life issues. patients are supported and comforted when coping with difficult situations, depression, mood swings, or anger. we will assess mood, cognitive and psychosocial functioning before and after treatment for participants in both groups. finally, we will investigate the functional neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects with bipolar disorder as a predictor of treatment response using functional magnetic resonance imaging (fmri).

Eligibility criteria:
inclusion criteria: * mini diagnostic criteria for any bipolar disorder (type i, type ii, and nos) * written informed consent * men or women aged 18-65 * no episodes of mania in the previous 4 weeks. * able to read and understand english. exclusion criteria: * subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. these patients will be immediately referred to appropriate clinical treatment. * history of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as als, parkinson disease and any movement disorders, etc). * history or current diagnosis of the following dsm-iv psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months. * patients who have untreated hypothyroidism. * patients who have had electroconvulsive therapy (ect) within the 6 months preceding enrollment.

Keywords: bipolar disorder mood disorders residual symptoms depression mania hypomania bipolar bipolar i bipolar ii
multimodal postoperative analgesia following osa surgery

Conditions: Obstructive Sleep Apnea

Summary: assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using iv continuous infusion silicon device (accufuser) for postoperative analgesia following multilevel osa surgeries


Eligibility criteria:
inclusion criteria: * physical status of american society of anesthesiologists (asa) ii * age between 30 - 50 years * osa patients diagnosed by polysomnography and stop-bang questionnaire * enrolled for multilevel osa surgery exclusion criteria: * history of allergy to the study drugs * history of hepatic, cardiopulmonary or renal disease * history of any chronic pain on medication * history of substance abuse * psychiatric disorder * lack of patient cooperation.
triclosan-antibacterial sutures impact on the incidence of surgical site infection in laparoscopic surgeries.

Conditions: Laparoscopic Surgery; Surgical Wound; Surgical Site Infection

Summary: comparing the incidence of psi in cases using coated polyglactin 910 suture with triclosan and cases using polyglactin 910 suture without triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

in this prospective study, we will determine the incidence of psi in egypt as well as the impact of using coated polyglactin 910 sutures with triclosan in lowering the incidence of psi in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * age 18-75 * candidate for laparoscopic surgical intervention during the period of the study were included. exclusion criteria: * patient has immunodeficiency disorder. * patient receiving anti-cancer / immunosuppressive therapy. * patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
treatment of egyptian hepatitis c genotype 4 infected children and adolescents with combined ledipasvir/sofosbuvir

Conditions: Hepatitis C Genotype 4

Summary: this is an open, uncontrolled study of twenty-five chronic hcv infected patients carried out at yassin abdel ghaffar charity center for liver disease and research. the aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (ldv) and sofosbuvir (sof) for treating hcv genotype 4 in children aged 8 to 18. due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. safety will be measured by checking for adverse effects, while efficacy will be measured by real-time quantitative polymerase chain reaction (qpcr) detecting viral nucleic acids in blood samples.


Eligibility criteria:
inclusion criteria: * hcv chronic infection * treatment naive and treatment experienced (previous interferon treatment) * no cirrhosis or compensated cirrhosis exclusion criteria: * co-infection with hepatitis b (hbv) * other associated chronic liver illness * patients with history of hematemesis (non-cirrhotic portal hypertension) * patients with decompensated cirrhosis (as indicated by biopsy, fibroscan) * patients on drugs known to interact unfavorably (amioidarone, ..)